(30 days)
The AbsorbaTack™ and Applicator are indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
Not Found
This is an FDA Premarket Notification (510(k)) letter for a medical device. This type of document primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria, expert reviews, or specific sample sizes as would be found in a clinical study report.
Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth establishment is not available within the provided text.
The document states that the FDA has determined the device "AbsorbaTack™ and Applicator" is "substantially equivalent" to legally marketed predicate devices, which is the primary "acceptance criteria" for a 510(k) submission. This determination is based on the information provided in the premarket notification, but the specifics of that submission (e.g., bench testing, animal studies, or limited human data comparing to a predicate) are not detailed here.
In summary, none of the specific requested information regarding performance studies is present in this 510(k) letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 16 2007
Sorbx, LLC % Ms. Mary Lee Willetts P.O. Box 3614 Ponte Vedra Beach, Florida 32004
Re: K071061
Trade/Device Name: AbsorbaTack™ and Applicator Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 1, 2007 Received: May 2, 2007
Dear Ms. Willetts:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Mary Lee Willetts
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 (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use
K071061 510(k) Number (if known):
Not known
Device Name:
AbsorbaTack™ and Applicator
Indications for Use:
The AbsorbaTack™ and Applicator are indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
Prescription Use > Yes
AND/OR
Over-the-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Offise of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number /L071061
Indications for Use rev 1
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.