(41 days)
Evacuate air and/or fluid from the chest cavity or mediastinum
Help re-establish lung expansion and restore breathing dynamics
Facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
Not Found
The provided text is an FDA 510(k) clearance letter for the "Atrium eDrain Chest Drainage System." It does not contain information about acceptance criteria, device performance, study details, ground truth, or sample sizes for an AI/ML powered device. The letter is a regulatory document confirming clearance for a traditional medical device (a powered suction pump) and references general manufacturing and labeling requirements.
Therefore, I cannot extract the requested information from this document.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: February 28, 2013
Atrium Medical Corporation % Ms. Christina Calderwood Senior Regulatory Affairs Associate 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K130131
Trade/Device Name: Atrium eDrain Chest Drainage System Regulation Number: 21 CFR 878,4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA. KDO Dated: January 11, 2013 Received: January 18, 2012
Dear Ms. Calderwood:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Christina Calderwood
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0
510k Submission eDra in Chest Drainage System
| 510(k) Number (if known): | K130131 |
|---|---|
| Device Name: | Atrium eDrain Chest Drainage System |
| Indications for Use: | Evacuate air and/or fluid from the chest cavity or mediastinumHelp re-establish lung expansion and restore breathing dynamicsFacilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area. |
| Prescription Use | X |
| Over-The-Counter Use | |
| AND/OR |
INDICATIONS FOR USE STATEMENT
(Part 2J CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Long H. Chen-A
IDN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Long H. Chen -
Long H. Chen
-A
0.9.2342.19200300.100.1.1=1300369056
Date: 2013.02.27 14:32:02 -05'00
(Division Sign-Off)
Division of Surgical Devices
510(k) Number K130131__
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.