(30 days)
Not Found
Not Found
No
The summary describes a mechanical fixation device and lacks any mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is used for fixation of prosthetic material, performing a mechanical and structural function rather than a therapeutic one (e.g., healing, treating disease, or restoring function).
No
The device is indicated for fixation of prosthetic material to soft tissue, which is a therapeutic rather than diagnostic function.
No
The device description and intended use clearly describe a physical device (AbsorbaTack™ and Applicator) used for surgical fixation, not a software-only product.
Based on the provided information, the AbsorbaTack™ and Applicator are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fixation of prosthetic material to soft tissue during surgical procedures. This is a direct surgical intervention on the patient's body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a patient's health status, disease, or condition.
- Using reagents or calibrators.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The AbsorbaTack™ and Applicator are a surgical tool used for mechanical fixation within the body.
N/A
Intended Use / 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.
Product codes
GDW
Device Description
AbsorbaTack™ and Applicator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
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.
1
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