(39 days)
Not Found
No
The summary describes a physical, absorbable staple and a manual stapler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a synthetic absorbable staple used for the temporary approximation of skin, which is a surgical tool rather than a device for treating or curing a medical condition.
No
Explanation: The device is described as absorbable staples intended for "subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a physical staple and is used in conjunction with a manual surgical stapler, indicating it is a hardware device.
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 "subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation." This describes a surgical device used directly on the patient's body for tissue closure.
- Device Description: The description details a physical staple used in conjunction with a surgical stapler.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. This device is used in vivo (in the body) for surgical closure.
N/A
Intended Use / Indications for Use
Synthetic absorbable INSORB staples are intended 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 0.8 mm apart. They are used in conjunction with a manual surgical stapler from Incisive Surgical Inc. (Note: manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the primary 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 F: 510(k) K120373 Summary
MAR 1 6 2012
| Submitter: | Incisive Surgical
14405 21st Avenue North, Suite 130,
Plymouth, MN 55447-2000 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David B. Herridge, Vice President, Ph: (952) 591-2543 ext. 19 |
| Date Prepared: | February 3, 2012 |
| 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 K090159 |
| 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 0.8 mm apart. They are used in
conjunction with a manual surgical stapler from Incisive Surgical Inc. (Note:
manual surgical stapler is a Class I exempt device pursuant to 21 CFR
878.4800 and is not the primary subject of this submission). |
| Intended Use: | Synthetic absorbable INSORB staples are intended 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. This Special
510(k) seeks only to more clearly communicate the device's intended use
for the subcuticular closure of skin. |
| Conclusion: | The modified INSORB Absorbable Staple described in this submission is
substantially equivalent to the predicate device. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2012
Incisive Surgical % Mr. David B. Herridge Vice President 14405 21st Avenue North, Suite 130 Plymouth, Minnesota 55447-2000
Re: K120373
Trade/Device Name: INSORB® Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: March 01, 2012 Received: March 05, 2012
Dear Mr. Herridge:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
2
Page 2 - Mr. David B. Herridge
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Exhibit D: Indications for Use
| 510(k) Number (if known): | K120373 |
|---|---|
| Device Name | INSORB® Staple |
| Indications for Use | Synthetic absorbable INSORB staples are intended |
| for the subcuticular closure of skin where an | |
| absorbable tissue fastener is desired for temporary | |
| tissue approximation. |
Prescription Use_ (Per 21 CFR 801. 109)
OR
Over-The-Counter Use_
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120373
Incisive Surgical, Inc.