EXPRESS AND OASIS CHEST DRAIN

K043140 · Atrium Medical Corp. · CAC · Dec 8, 2004 · Anesthesiology

Device Facts

• Record ID: K043140
• Device Name: EXPRESS AND OASIS CHEST DRAIN
• Applicant: Atrium Medical Corp.
• Product Code: CAC · Anesthesiology
• Decision Date: Dec 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Express™ and Oasis™ Chest Drains are autotransfusion apparatuses used to evacuate air and fluid from the pleural or mediastinal cavity. Devices facilitate re-establishment of lung expansion and breathing dynamics; they also collect autologous blood from the patient for potential reinfusion in post-operative or trauma blood loss management. Used in clinical settings by healthcare professionals. Operation involves connection to the patient's chest cavity to drain fluids/air via vacuum or gravity; collected blood is stored for reinfusion. Output is the physical collection of drained fluids and blood, aiding clinical management of thoracic drainage and blood conservation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Autotransfusion apparatus (21 CFR 870.5830, Class II, Product Code CAC). Mechanical drainage system for pleural/mediastinal fluid and air evacuation. Includes collection chamber for autologous blood. No software or electronic components described.

Indications for Use

Indicated for patients requiring evacuation of air/fluid from the chest cavity or mediastinum, re-establishment of lung expansion, and collection of autologous blood for reinfusion in post-operative or trauma settings.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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