MAMMARY SIZER

K982258 · Specialty Surgical Products, Inc. · MRD · Sep 8, 1998 · SU

Device Facts

• Record ID: K982258
• Device Name: MAMMARY SIZER
• Applicant: Specialty Surgical Products, Inc.
• Product Code: MRD · SU
• Decision Date: Sep 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Indications for Use

The Specialty Surgical Products Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

Device Story

Mammary Sizer is a manual surgical instrument used by surgeons during breast augmentation or reconstruction procedures. Device serves as a temporary placeholder to assist in evaluating appropriate mammary prosthesis volume prior to permanent implantation. Used in clinical/surgical settings; operated by physicians. Provides physical volume reference to aid clinical decision-making regarding implant size selection; benefits patient by facilitating selection of optimal prosthesis volume.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument; form factor designed for mammary volume assessment. Materials and sterilization methods not specified in provided text.

Indications for Use

Indicated for patients undergoing mammary prosthesis implantation to assist in determining appropriate implant volume.

Submission Summary (Full Text)

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

Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing right, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

SEP 8 1398 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. T. Jan Varner President and CEO Specialty Surgical Products, Inc. 302 North First Street Hamilton, Montana 59840

Re: K982258 Trade Name: Mammary Sizer Regulatory Class: II Product Code: MRD Dated: June 12, 1998 Received: June 26, 1998

Dear Mr. T. Jan 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 (OS) 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.

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}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Mammary Sizer

Indications For Use:

The Specialty Surgical Products Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

(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 | K982258 |

| Prescription Use | <div style="text-align:center;">X</div> | OR | Over-The-Counter Use |
|----------------------|-----------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)

: