(23 days)
- To evacuate air and/or fluid from the chest cavity or mediastinum. .
- To help re-establish lung expansion and restore breathing dynamics. .
- To facilitate collection of autologous blood from the patient's pleural cavity or . mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.
Not Found
This document is a 510(k) clearance letter from the FDA for medical devices, specifically chest drains. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The letter acknowledges the company's "premarket notification of intent to market" and states that the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory clearance based on substantial equivalence, not a clinical study proving pre-defined performance metrics.
Therefore, I cannot provide the requested information from the provided text as it does not contain the details of a study with acceptance criteria and device performance.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2004
Atrium Medical Corporation c/o Mr. Joseph P. De Paolo VP Regulatory and Clinical Affairs 5 Wentworth Drive Hudson, NH 03051
K043140 Re:
Express™ Chest Drain and Oasis™ Chest Drain Regulation Number: 21 CFR 870.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: November 12, 2004 Received: November 15, 2004
Dear Mr. Paolo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sunce in the entrebate) 75 the enactment date of the Medical Device Amendments, or to conniner of the 1125 20, 1977) in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act (Act ) that do not require approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merchere, manel of the Act include requirements for annual registration, listing of general controlly provisions of vactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (too as controls. Existing major regulations affecting your device can may or subject to Saccil Regulations, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Joseph P. De Paolo
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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K043140 510(k) Number (if known):
Device Name: Atrium Medical Corporation Express™ Chest Drain and Oasis™ Chest Drain Indications For Use:
- To evacuate air and/or fluid from the chest cavity or mediastinum. .
- To help re-establish lung expansion and restore breathing dynamics. .
- To facilitate collection of autologous blood from the patient's pleural cavity or . mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Durner R. Volunel
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number 4043140
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).