(130 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of the absorbable staples, with no mention of AI or ML.
No
The device is described as absorbable staples for temporary tissue approximation, which is a supportive rather than therapeutic function.
No
The device, INSORB™ absorbable staples, is used for subcuticular closure of skin to approximate tissue. Its intended use is therapeutic (tissue approximation), not diagnostic.
No
The device description clearly states it is a physical staple made from an absorbable copolymer, used in conjunction with a manual surgical stapler. There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the INSORB™ staples are used for the "subcuticular closure of skin" in various surgical procedures. This is a device that is implanted or used on the body during surgery, not for testing specimens taken from the body.
The information provided describes a surgical implant/fastener, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
INSORBTM Absorbable Staples are 5.1mm in length, 0.79mm thick, 3.48mm wide overall, and have barb tips that are 0.66mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).
INSORB™ staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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)
Prior to commercialization INSORB™ Absorbable Staples underwent testing to verify appropriate functional characteristics. This testing included an animal study, mechanical performance testing, and package testing. This testing demonstrates that the INSORBTM Absorbable Staples meet all required specifications.
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.
K915489, K915693, K022269, K974299, K962480
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
KO24117
page 1/2
APR 2 2 2003
A. 510(k) Summary
| SUBMITTER: | Incisive Surgical Inc.
1409 Fairfield Road
Minnetonka, MN 55305
Phone: 952-591-2543
Fax: 952-591-5989 |
| ------------ | ------------------------------------------------------------------------------------------------------------------- |
|---|
- CONTACT PERSON: Jim Peterson Vice President, Regulatory and Quality Affairs
December 12, 2002 DATE PREPARED:
TRADE NAME: INSORB™ Absorbable Staple
- Implantable Staple COMMON NAME:
CLASSIFICATION: 21 CFR 878.4750, Staple, Implantable Class II
PRODUCT CODE: GDW
PREDICATE DEVICE(S): The INSORB™ Absorbable Staple is substantially equivalent to the Autosuture Absorbable Subcuticular Closure Staple manufactured by United States Surgical (K915489), the Proximate Absorbable Staple manufactured by Ethicon Inc. (K915693), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon Inc. (Multiple 510(k)'s e.g K022269, K974299, K962480).
- DEVICE DESCRIPTION: INSORBTM Absorbable Staples are 5.1mm in length, 0.79mm thick, 3.48mm wide overall, and have barb tips that are 0.66mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).
INSORB™ staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
1
K024117
page 2/2
INTENDED USE: Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation. FUNCTIONAL & SAFETY TESTING: Prior to commercialization INSORB™ Absorbable Staples underwent testing to verify appropriate functional characteristics. This testing included an animal study, mechanical performance testing, and package testing. This testing demonstrates that the INSORBTM Absorbable Staples meet all required specifications. CONCLUSION: The INSORB™ Absorbable Staples from Incisive are substantially equivalent to the Autosuture Absorbable Subcuticular Closure Staple manufactured by United States Surgical (K915489), the Proximate Absorbable Staple manufactured by Ethicon Inc. (K915693), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon Inc. (Multiple 510(k)'s e.g K022269, K974299, K962480).
2
Image /page/2/Picture/2 description: The image shows a logo for the Department of Health. The logo consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. To the left of the profiles, the text "DEPARTMENT OF HEALTH" is arranged vertically, curving along the left side of the logo.
APR 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jim Peterson Vice President, Regulatory and Quality Affairs Incisive Surgical, Inc. 1409 Fairfield Road Minnetonka, Minnesota 55305
Re: K024117
Trade/Device Name: INSORB™ Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 2, 2003 Received: April 8, 2003
Dear Mr. Peterson :
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.
3
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam 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
4
Indications For Use Page
Device Name: INSORB™ Absorbable Staple
Indications For Use:
Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K624117
1