CP MEDICAL BONE WAX

K024372 · Cp Medical · MTJ · Jun 19, 2003 · SU

Device Facts

• Record ID: K024372
• Device Name: CP MEDICAL BONE WAX
• Applicant: Cp Medical
• Product Code: MTJ · SU
• Decision Date: Jun 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The CP Medical Bone Wax is intended to be used in the control of bleeding from bone surfaces.

Device Story

CP Medical Bone Wax is a sterile, single-use implantable mechanical aid composed of a beeswax and paraffin formulation. It is used to control bleeding from bone surfaces during surgical procedures. The device acts as a physical barrier to stop hemorrhage from bone. It is intended for use by surgeons in clinical settings. The device is supplied sterile for immediate use or nonsterile for OEM applications.

Clinical Evidence

No clinical data provided. Device is described as an implantable mechanical aid proven safe through non-clinical assessment and substantial equivalence to predicate devices.

Technological Characteristics

Composition: beeswax and paraffin formulation. Form factor: wax material for mechanical hemostasis. Manufacturing: compliant with cGMP and ISO quality standards. Sterilization: provided sterile (or nonsterile for OEM).

Indications for Use

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

Predicate Devices

• Ethicon Bone Wax (Preamendment)
• Lukens Bone Wax (K791495)
• Auto Suture Bone Wax (K971680)

Submission Summary (Full Text)

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K024372

## SAFETY AND EFFECTIVENESS SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with Volume 21 of the Code of Federal Regulations, this is to serve as a Summary of Safety and Effectiveness for the proposed CP Medical Bone Wax.

| Manufacturer: | CP Medical, Inc.<br>836 NE 24th Avenue<br>Portland, OR 97232<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sue Ridge, Technical Writer - RA/QA |
| Device Name: | Trade or Proprietary Name: CP Medical Bone Wax<br>Common Name: Bone Wax<br>Classification: Unclassified |
| Date Prepared: | April 15, 2003 |
| Device Description: | The proposed device is composed of a beeswax and paraffin formulation.<br>The proposed device is manufactured in compliance with cGMP and ISO quality standards. |
| Predicate Devices: | The proposed device is substantially equivalent to other legally marketed bone waxes, including Ethicon Bone Wax (Preamendment, Ethicon, Inc.), Lukens Bone Wax (K791495, Lukens Medical Corporation), and Auto Suture® Bone Wax (K971680, United States Surgical). |
| Indications: | The CP Medical Bone Wax is indicated for use in the control of bleeding from bone surfaces. The device is supplied sterile and is SINGLE USE ONLY. The device may be supplied nonsterile on OEM basis only. |
| Intended Use: | The CP Medical Bone Wax is intended to be used in the control of bleeding from bone surfaces. |
| Summary of Clinical and Non-Clinical Studies: | This device is proven to be reasonably safe for use as an implantable mechanical aid. |
| Comparison of Technological Characteristics: | The proposed device, Bone Wax, is similar, if not identical, to the predicate device in composition. Manufacture of this device, including QC testing, is in substantial compliance with current QSR and ISO quality standards. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, with three horizontal lines above them. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

Ms. Sue Ridge Regulatory Affairs Associate CP Medical, Inc. 836 NE 24th Avenue Portland, Oregon 97232

Re: K024372 Trade/Device Name: CP Medical Bone Wax Regulatory Class: Unclassified Product Code: MTJ Dated: April 15, 2003 Received: April 17, 2003

Dear Ms. Ridge:

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.

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Page 2 - Ms. Sue Ridge

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 [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

to 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

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## INDICATIONS FOR USE

| 510(k) (if known): | K024372 |
|--------------------|----------|
| DEVICE Name: | Bone Wax |

Indications for Use:

The CP Medical 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 _____________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Muriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K024372