(30 days)
Not Found
No
The summary 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™ staples, is intended for temporary tissue approximation and subcuticular closure of skin. While it assists in surgical procedures for healing, it does not actively treat or cure a disease or condition, which is characteristic of a therapeutic device. It is a surgical fastener.
No
This device is a surgical staple intended for "subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation." Its function is mechanical in surgery, not diagnostic.
No
The device description explicitly states it is a physical staple and is used in conjunction with a manual surgical stapler, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "subcuticular closure of skin" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a surgical staple used for tissue approximation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body during surgery.
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 cleat 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
Exhibit I
JUL 26 2006
510(k) Summary
| Submitter: | Incisive Surgical
14405 21st Avenue North, Suite 130, Plymouth, MN 55447-2000 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Peterson, Vice President, Ph: (952) 591-2543 ext 14 |
| Date Prepared: | June 22, 2006 |
| Trade Name: | INSORB™ Absorbable Staple |
| Classification | Class II, 21 CFR 8787.4750, Staple, Implantable |
| Product Code: | GDW |
| Predicate Device
and 510(k) No. | INSORB™ Absorbable Staple
K033602 |
| Device
Description: | INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have cleat 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. |
| Statement of
Technological
Comparison | The subject device and the predicate device are identical except for:
- Sterilization Validation changed from VDmax to Method 1 to allow implementation of a 10-6 SAL validated gamma dose at less than 25kGy.
- Packaging includes a desiccant.
- Strength specifications for the staple following exposure to 37°C buffered saline for 7 days and 21 days have been increased 50% to accommodate the STRONGER staple fabricated by the refinements in the micromolding process, the lower gamma dose possible under a Method 1 validation, and the storage benefits of including a desiccant within the packaging.
- Shelf Life extended to 2 years. |
| Conclusion: | The modified INSORB Absorbable Staple described in this submission is substantially equivalent to the predicate device. |
Incisive Surgical, Inc.
.
Special 510(k)
June 22, 2006
CONFIDENTIAL
Page Joof 308
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
Incisive Surgical, Inc. % Mr. James Peterson Vice President 14405 21st Avenue North, Suite 130 Plymouth, Minnesota 55447-2000
Re: K061784
Trade/Device Name: INSORB™ Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 22, 2006 Received: June 29, 2006
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.
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 (240) 276-0115. Also, please contacthe 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,
hulul Lunes us
/ Mark N. Melkerson 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):
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ _______________________________________________________________________________________________________________________________________________________ (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)
Huler Lemen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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