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An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":11,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":24,"medical_specialty_description":10,"summary_malfunction_reporting":25},{"fei_number":18,"registration_number":22},[19,20,21],"3004450998","1721676","3003790304",[19,20,21],"Y","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:48.758894+00:00",0,null,33,[],[33,42,50,59,66,74,83,91,98,106],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":39,"vector_similarity":40,"score":41},2440,"空気・酸素マスク","Ⅱ","35171000",0.147059,0.131783,0.690865,0.0292869,{"medical_device_id":43,"generic_name":44,"class_classification":36,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},2305,"気道粘液除去装置","43947000",0.130435,0.215217,0.685529,0.0280681,{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},780,"呼気肺人工蘇生器","Ⅲ","17141000",0.0740741,0.213636,0.704304,0.0163934,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":38,"vector_similarity":65,"score":58},1101,"ウマ心のう膜弁","Ⅳ","35591404",0.189189,0.555457,{"medical_device_id":67,"generic_name":68,"class_classification":62,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},197,"ブタ心臓弁","35591200",0.184211,0.139108,0.531167,0.016129,{"medical_device_id":75,"generic_name":76,"class_classification":77,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},3667,"シャントバルブ用アジャストメントツール","Ⅰ","70305000",0.162791,0.193853,0.55483,0.015873,{"medical_device_id":84,"generic_name":85,"class_classification":62,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},196,"ウシ心のう膜弁","35591100",0.170732,0.138107,0.498025,0.015625,{"medical_device_id":92,"generic_name":93,"class_classification":36,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":90},2414,"エアロゾル非再呼吸式マスク","35172000",0.0196078,0.193764,0.684,{"medical_device_id":99,"generic_name":100,"class_classification":36,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},1980,"換気用気管支閉塞カテーテル","70258000",0.0327869,0.137203,0.682507,0.0153846,{"medical_device_id":107,"generic_name":108,"class_classification":77,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":105},3868,"電動式ピンチバルブ","70467000",0.166667,0.160714,0.559704,[],{"510k":115,"classification":116,"enforcement":117,"event":118,"pma":119,"warning_letter":120},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":122,"definition_ja":123,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":29,"reviewed_at":29,"created_at":127,"updated_at":127},"一方向性気漏制御用気管支バルブ","肺の対象区域への気流を制限すること。肺葉切除術、区域切除術、または肺容量減少手術（LVRS）後に生じる遷延性気漏、または遷延性気漏に移行する可能性の高い有意な気漏を制御すること。術後7日目に存在する気漏は、強制呼気時または咳嗽時にのみ認められる場合を除き、遷延性気漏とみなされる。5日目に存在する気漏は、以下のいずれかに該当する場合には治療の対象として検討すべきである。すなわち、1）持続性である、2）正常な吸気相において認められる、または3）正常な呼気時に認められ、皮下気腫または呼吸機能の低下を伴う場合である。","本品は米国において、通常のクラスI／II／IIIという区分や510(k)・PMAといった標準的な審査経路ではなく、人道的機器適用免除（HDE：Humanitarian Device Exemption）という特別な制度のもとで規制されています。HDEは、対象となる疾患や病態の患者数が極めて少ない場合に適用される制度であり、有効性について通常のPMAで求められるような統計的証明を必要としない代わりに、安全性が確保されており、かつ人道上の観点から使用が正当化されることを示すことで、人道機器申請（HDE申請）を通じて市販が認められる仕組みです。","claude-sonnet-5","800e132551b03a6a080c51b4fb7f3b62eb83f920bd89dd1b9f78ae91e4b468ea","2026-08-24T02:20:14.132666+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":147,"model_name":125,"created_at":148,"updated_at":148},"本製品コードについては、510(k)およびPMAの実績は確認されていません。不具合報告(MDR)は累計で約30件あり、内訳は死亡が10件、傷害が13件、不具合(Malfunction)が8件と、死亡・傷害の比率が高くなっています。主な問題としては、適応外使用(Off-Label Use)、位置ずれ(Migration)、排出不良(Failure to Eject)が挙げられています。回収(リコール)の報告は確認されていません。",{"pma":131,"k510":132,"as_of":133,"events":134,"recalls":141,"top_problems":143},{"latest":29,"originals":28,"supplements":28},{"total":28,"last5y":28,"latest":29,"applicants":28},"2026-08",{"death":135,"other":136,"total":30,"injury":137,"last5y":138,"malfunction":139,"latest_month":140},10,2,13,14,8,"2023-07",{"total":28,"last5y":28,"latest":29,"class_i":28,"class_ii":28,"class_iii":28,"top_root_causes":142},[],[144,145,146],"Off-Label Use","Migration","Failure to Eject","0d962fabf4f39fb66a6f009c3bfe1080a9646dd09e90c16602845a5aeb0ebeb4","2026-08-24T05:01:48.414996+00:00",{"items":150,"total":28},[],{"items":152,"total":28},[],{"items":154,"total":28},[]]