(32 days)
Not Found
No
The document describes a physical surgical staple and a manual stapler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device, INSORB™ Absorbable Staples, is intended for temporary tissue approximation (subcuticular closure of skin) in various surgical procedures, which is a structural rather than a therapeutic function.
No
The device, INSORB™ Absorbable Staples, is described as being used for "subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation." This is a therapeutic or surgical function, not a diagnostic one.
No
The device described is a physical medical device (absorbable staples) used in conjunction with a manual surgical stapler. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation" in various surgical procedures. This describes a device used on the body for a physical purpose (tissue approximation), not a device used in vitro (outside the body) to examine specimens for diagnostic information.
- Device Description: The description details the physical characteristics of the staples and their use with a surgical stapler. This aligns with a surgical implant/fastener, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other activity typically associated with IVDs.
Therefore, the INSORB™ Absorbable Staples are a surgical device, not an In Vitro Diagnostic.
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
GDW
Device Description
INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have barb tips that are 0.7 mm 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).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 6 2003
page 1 of 1
Exhibit E
510(k) Summary
| Submitter: | Incisive Surgical
14405 21st Avenue North, Suite 130
Plymouth, MN 55447-2000 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jim Peterson
Vice President
Ph: (952) 591- 2543 ext 14 |
| Date Prepared: | November 13, 2003 |
| Trade Name: | INSORB™ Absorbable Staple |
| Classification Name
and Number: | Class II, 21 CFR 8787.4750, Staple, Implantable |
| Product Code: | GDW |
| Predicate Device
Name and 510(k)
Number | INSORB™ Absorbable Staple
K024117 |
| Device Description: | INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm
thick, 3.5 mm wide overall, and have barb tips that are 0.7 mm
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). |
| 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. INSORB™ Absorbable Staples are 5 mm in
length, 0.8 mm thick, 3.5 mm wide overall, and have barb tips
that are 0.7 mm 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). |
| Statement of
Technological
Comparison | The subject device and the predicate device are identical except
for the method of sterilization. The subject device is sterilized
by Gamma Radiation. |
| Conclusion: | The modified INSORB Absorbable Staple described in this
submission is substantially equivalent to the predicate device. |
1
Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.
Public Health Service
DEC 1 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Peterson Vice President Incisive Surgical, Inc. 14405 21st Avenue North Plymouth, Minnesota 55447
Re: K033602
Trade/Device Name: INSORBTM Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: November 13, 2003 Received: November 18, 2003
Dear Mr. Peterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass mated in the enactment date of 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, de necs that have been rouire 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 11 70dr abless to such additional controls. Existing major regulations affecting your device can he 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.
2
Page 2 - Mr. James Peterson
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 enuitled, "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 yours,
Miriam C. Provost
for 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
3
Indications for Use
510(k) Number (if known): K033602
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 skip where an absorbable tissue fastener is desired for temporary tissue approximation.
Yes Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
No 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)
Miriam C. Provost
(Division Sign-Division of Genc Restorative and Neurological L . . . ces
Page 1 of
- Number K633602