(24 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
The provided text is a U.S. FDA 510(k) clearance letter for the "Ocean Chest Drain" device. This document confirms the device's substantial equivalence to a predicate device and its approval for marketing.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or similar details that would typically be found in a study report or clinical trial summary.
The letter is a regulatory approval and does not describe the specific tests or data that led to that approval. It only states that the FDA "reviewed your Section 510(k) premarket notification" and found the device "substantially equivalent."
Therefore, I cannot provide the requested information based on the given input text.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the three branches of government.
JAN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph P. De Paolo Vice President Regulatory and Clinical Affairs Atrium Medical Corporation 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K043582
Trade/Device Name: Ocean Chest Drain Regulation Number: 880.6740 Regulation Name: Vacuum-Powered body Fluid Suction Apparatus Regulatory Class: II Product Code: KDQ Dated: December 23, 2004 Received: January 4, 2005
Dear Mr. Paolo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becases of 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 Interstate comments, or to that have been reclassified in accordance with the provisions of Amendinents, or to de research Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Commens , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the sixtration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
ff your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (boo as a controls. Existing major regulations affecting (I MA), it may of subject to back ade of Federal Regulations, Title 21, Parts 800 to 898. In your device ean be found in ther announcements concerning your device in the Ecderal Register.
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Page 2 - Mr. Paolo
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualles or that your device complies with other requirements mean that FDA nas made a decommanen and regulations administered by other Federal agencies. of the Act of ally rederal statues and regarents, including, but not limited to: registration You must compry with an alle Here Sing (21 CFR Part 801); good manufacturing practice and listing (21 CFR I art 607), laboling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set fortif in the quality bystems (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) This letter will anow you to ocgin mainting of substantial equivalence of your device to a premiarket notification: - The PDF initiation for your device and thus, permits your device to proceed to the market.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at no compliance at (240) 276-0115. 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 from the may obtain other generational and Consumer Assistance at its toll-free Driston (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K04358a
1 of 1
Indications For Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Ocean Chest Drain Device Name:__________________________________________________________________________________________________________________________________________________________________
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)
int 20m
(Division Sign-Off) (Division Sign-Om)
Division of Anesthesiology, General Hospital, Division of Anestical, Division of Anestheontal Devices
Page 1 of 1 __
510(k) Number: _
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.