AUTO SUTURE BONE WAX by UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

This 510(k) submission for "Auto Suture* Bone Wax**" (K971680) falls under the category of a traditional 510(k) where substantial equivalence is primarily established through comparison to predicate devices, rather than through extensive clinical trials or performance studies with specific acceptance criteria that would typically be described for a new diagnostic or prognostic algorithm.

Therefore, the provided text does not contain the detailed information requested regarding acceptance criteria and a study proving a device meets them in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). This type of submission relies on the established safety and efficacy of previously marketed, substantially equivalent devices.

Specifically, the document states:

"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the FDA's clearance is based on the device being similar enough to predicate devices (Ethicon™ Bone Wax and Lukens™ Bone Wax) whose safety and effectiveness are already understood.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone performance is not present in this document.

However, I can extract the relevant information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria for device performance or provide a table of reported performance metrics in the way one would for a diagnostic device. The "performance" described focuses on the device's mechanism of action and material biocompatibility.

Acceptance Criterion (Implied)	Reported Device Performance
Material Biocompatibility	"All material components of Auto Suture* Bone Wax** have been evaluated for biocompatibility in accordance with ISO Standard #10993-1. The materials have been found to be safe for their intended use."
Intended Use	"Auto Suture* Bone Wax** is designed to control bleeding from bone surfaces by the creation of a mechanical barrier." (Similar to predicate devices)

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission does not describe a "test set" in the context of evaluating a diagnostic algorithm's performance. The substantial equivalence is based on device characteristics and intended use in comparison to predicate devices.
The material biocompatibility evaluation would have involved in vitro or in vivo tests, but specific sample sizes or data provenance for those tests are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No test set for ground truth establishment is described or implied in this 510(k) summary.

4. Adjudication method for the test set:

Not Applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is not an AI/software device, and no MRMC comparative effectiveness study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used:

Not Applicable for algorithm performance. The "ground truth" for this device's acceptance is its similarity to predicate devices in terms of materials, mechanism of action, and intended use, along with demonstrated biocompatibility of its components.

8. The sample size for the training set:

Not Applicable. This is not a machine learning device and therefore does not have a "training set."

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set, there is no ground truth for it.

Summary

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IX.	510(k) Summary of Safety and Effectiveness	OCT 24 1997
• SUBMITTER:	United States Surgical Corporation150 Glover AvenueNorwalk, CT 06856
• CONTACT PERSON:	Melissa Mazzoni
• DATE PREPARED:	May 5, 1997
• CLASSIFICATION NAME:	Unclassified
• COMMON NAME:	Bone Wax
• PROPRIETARY NAME:	Trademark name not yet determined
• PREDICATE DEVICES:	Ethicon™ Bone Wax (preamendment)Lukens™ Bone Wax (K791495)
• DEVICE DESCRIPTION:	Auto Suture* Bone Wax** is designed to controlbleeding from bone surfaces by the creation of amechanical barrier.
• INTENDED USE:	Auto Suture* Bone Wax** is indicated for usein control of bleeding from bone surfaces.
• MATERIALS:	All material components of Auto Suture* BoneWax** have been evaluated for biocompatibility inaccordance with ISO Standard #10993-1. Thematerials have been found to be safe for theirintended use.

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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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 2 4 1997

Ms. Melissa Mazzoni Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

Re: K971680 Trade Name: Auto Suture* Bone Wax ** Regulatory Class: Unclassified Product Code: MTJ Dated: August 22, 1997 Received: August 26, 1997

Dear Ms. Mazzoni:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Melissa Mazzoni

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

to coellato

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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IV. Indications For Use:

510(k) Number (if known): K97 1680

Auto Suture* Bone Wax** Device Name:

Indications For Use:

Auto Suture* Bone Wax** is indicated for use in the control of bleeding from bone surfaces.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X OR Over-The-Counter Use:_**_
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 1971680

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Regulation Number and Section

N/A