MAMMARY SIZER

K961356 · General Surgical Innovations · MRD · Sep 23, 1996 · SU

Device Facts

• Record ID: K961356
• Device Name: MAMMARY SIZER
• Applicant: General Surgical Innovations
• Product Code: MRD · SU
• Decision Date: Sep 23, 1996
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U

Indications for Use

The GSI, Inc. Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

Device Story

Device: Mammary Sizer; used during plastic/reconstructive surgery. Input: saline/fluid via filler tube. Operation: balloon inflated to evaluate mammary prosthesis volume/symmetry in sub-glandular or sub-muscular tissue planes. Output: physical volume expansion for visual/tactile assessment by surgeon. Benefit: assists in selecting appropriate implant size/symmetry prior to permanent implantation.

Clinical Evidence

Bench testing only; includes biocompatibility, material strength, and volume rating testing.

Technological Characteristics

Material: smooth semi-elastomeric polyurethane. Components: balloon, balloon tubing, fluid leakage prevention attachment, female luer lock. Form factor: inflatable balloon sizer.

Indications for Use

Indicated for patients undergoing plastic and reconstructive surgery requiring determination of mammary implant volume and symmetry prior to permanent implantation.

Predicate Devices

• Mentor's Volume Sizer for Mammary Implants

Submission Summary (Full Text)

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SEP 23 1996
K961356

General Surgical Innovations, Inc.
3172A Porter Dr.
Palo Alto, CA. 94304

SMDA Summary
Attachment B

510(K) SUMMARY

Document Mail Center (HFZ-401)
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Rockville, Maryland 20850 USA

Summary of Safety and Effectiveness

**Contact Person**

Theresa M. Nazaroff
General Surgical Innovations, Inc.
3172A Porter Dr.
Palo Alto, CA
94304

**Device Name**

Mammary Sizer

**Substantial Equivalence and Conclusions**

The Mammary Sizer which is proposed for use in the sub-glandular of sub-muscular tissue plane is substantially equivalent to Mentor's Volume Sizer for Mammary Implants that are marketed for use in the area of plastic and reconstructive surgery.

**Intended Use**

The GSI, Inc. Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

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## Device Description

The GSI Mammary Sizer is designed to be used during plastic and reconstructive surgery when it is desirable to determine the correct volume and/or symmetry of mammary implants prior to implantation. The device is constructed of smooth semi-elastomeric polyurethane. The device consists of a balloon and balloon tubing used for filling the sizer. There is an attachment to prevent fluid leakage and a female luer lock at the proximal end of the filler tube.

## Testing Results and Conclusions

Testing performed to support the appropriateness of the Mammary Sizer for its intended use include biocompatibility, material strength, and volume rating.

Theresa M. Nazaroff
General Surgical Innovations, Inc.

March 30, 1996