MAMMARY SIZER, MAMMARY PROTHESIS SIZER

K984106 · Specialty Surgical Products, Inc. · MRD · Feb 12, 1999 · SU

Device Facts

• Record ID: K984106
• Device Name: MAMMARY SIZER, MAMMARY PROTHESIS SIZER
• Applicant: Specialty Surgical Products, Inc.
• Product Code: MRD · SU
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Indications for Use

The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created mammary pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

Device Story

Mammary Sizer is a single-use, temporary device for intraoperative placement within a surgically created mammary pocket. Used by surgeons during breast augmentation or reconstruction procedures to assess the appropriate volume for a permanent mammary prosthesis prior to final implantation. Device provides a physical template to assist the surgeon in clinical decision-making regarding implant size selection, potentially improving aesthetic outcomes and patient satisfaction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, temporary intraoperative sizer. Materials and specific technical dimensions not detailed in the provided documentation.

Indications for Use

Indicated for intraoperative use in patients undergoing mammary prosthesis implantation to evaluate appropriate prosthesis volume.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Mr. T. Jan Varner President Specialty Surgical Products, Inc. 302 North First Street P.O. Box 218 Hamilton, Montana 59840

Re: K984106 Trade Name: Mammary Sizer Regulatory Class: Unclassified Product Code: MRD Dated: November 16, 1998 Received: November 17, 1998

Dear Mr. Varner:

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 requirement, 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.

{1}------------------------------------------------

Page 2 - Mr. T. Jan Varner

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,

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

{2}------------------------------------------------

## K484

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Mammary Sizer ________________________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The mammary sizer is designed for single use, temporary intraoperative placement in a surgically The manmary pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

## (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 General Restorative Devices | |
| 510(k) Number | K984101 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)