(85 days)
Not Found
Not Found
No
The summary describes a physical surgical device (anchor and applicator) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is used for fixation of prosthetic material to soft tissue during surgery. It is a surgical tool, not a device that provides therapy or treatment to a patient's condition.
No
Explanation: The device is indicated for fixation of prosthetic material to soft tissue, primarily in surgical procedures like hernia repair. This describes a therapeutic or surgical tool, not a device used to diagnose a medical condition.
No
The device description explicitly mentions "Absorbable Anchor™ and Applicator," which are physical components, not software. The intended use also describes fixation of prosthetic material, indicating a physical intervention.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair." This describes a surgical device used in vivo (within the body) during a procedure.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
The description of the Absorbable Anchor™ and Applicator clearly indicates a surgical implant and delivery system, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Absorbable Anchor™ 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
Absorbable Anchor™ and Applicator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle with three parallel lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
JUL 2 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
John 1. Shipp, Ph.D., CTO JMS. Inc. 1221 1st Street, South, 7a Jacksonville Beach, Florida 32250
Re: K041159
Trade/Device Name: Absorbable Anchor™ and Applicator Regulation Number: 21 CFR 878.4650 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: June 17, 2004 Received: June 17, 2004
Dear Dr. Shipp:
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 docs 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 - John I. Shipp, Ph.D., CTO
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) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(K) Number (if known):
Not known
Device Name:
Absorbable Anchor™ and Applicator
Indication for Use:
The Absorbable Anchor™ 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-the Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of |
510(k) Number $\frac{K04}{25} 1159$