AUTO SUTURE BONE WAX

K971680 · United States Surgical, A Division of Tyco Healthc · MTJ · Oct 24, 1997 · SU

Device Facts

• Record ID: K971680
• Device Name: AUTO SUTURE BONE WAX
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: MTJ · SU
• Decision Date: Oct 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Device Story

Auto Suture Bone Wax is a sterile, non-absorbable material used to control bleeding from bone surfaces. It functions as a mechanical barrier, physically plugging bleeding sites on bone. It is intended for use by surgeons in an operating room setting. The device provides immediate hemostasis by creating a physical seal, which aids in surgical site management and patient recovery.

Clinical Evidence

Bench testing only. Biocompatibility evaluated in accordance with ISO Standard #10993-1.

Technological Characteristics

Mechanical barrier material. Biocompatibility evaluated per ISO 10993-1. Non-absorbable.

Indications for Use

Indicated for control of bleeding from bone surfaces in patients requiring surgical intervention.

Predicate Devices

• Ethicon™ Bone Wax (preamendment)
• Lukens™ Bone Wax (K791495)

Submission Summary (Full Text)

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| IX. | 510(k) Summary of Safety and Effectiveness | OCT 24 1997 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| • SUBMITTER: | United States Surgical Corporation<br>150 Glover Avenue<br>Norwalk, 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)<br>Lukens™ Bone Wax (K791495) | |
| • DEVICE DESCRIPTION: | Auto Suture* Bone Wax** is designed to control<br>bleeding from bone surfaces by the creation of a<br>mechanical barrier. | |
| • INTENDED USE: | Auto Suture* Bone Wax** is indicated for use<br>in control of bleeding from bone surfaces. | |
| • MATERIALS: | All material components of Auto Suture* Bone<br>Wax** have been evaluated for biocompatibility in<br>accordance with ISO Standard #10993-1. The<br>materials have been found to be safe for their<br>intended use. | |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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