HANSON MEDICAL GLUTEAL IMPLANT

K030809 · Hanson Medical, Inc. · MIB · Apr 21, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K030809
• Device Name: HANSON MEDICAL GLUTEAL IMPLANT
• Applicant: Hanson Medical, Inc.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Apr 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hanson Medical Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Gluteal Implant will be carvable, allowing the physician to customize the device shape for muscular defects.

Device Story

Hanson Medical Gluteal Implant is a solid, carvable silicone block; used by surgeons to customize implant shape for gluteal augmentation or reconstruction of muscular defects. Device is supplied non-sterile; requires autoclave sterilization by the user prior to implantation. Physician manually carves the silicone material to match individual patient anatomy. Benefits include improved aesthetic contouring and correction of soft tissue deficits.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material composition and manufacturing process comparisons.

Technological Characteristics

Material: Heat-cured, medical-grade, two-part liquid silicone system (LSR). Form factor: Solid carving block. Sterilization: Autoclavable (non-sterile supply).

Indications for Use

Indicated for patients requiring gluteal augmentation or reconstructive surgery to address muscular defects.

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Predicate Devices

• Hanson Medical Silicone Carving Block (K030809)
• AART, Inc. Gluteal Implants
• Silimed LLC Gluteal Implants

Submission Summary (Full Text)

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## APR 2 1 2003

K030809

## ATTACHMENT 7

## 510k SUMMARY STATEMENT

March 5, 2003

| Applicant: | Hanson Medical, Inc.<br>PO Box 1160, Kingston, Washington, 98346<br>Tel: [phone]) Fax: [phone] |
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| Contact<br>Representative: | John Harrison<br>Medical Devices Associates, International<br>Tel/Fax: [phone]) Email: [e-mail] |
| Proprietary Name: | Hanson Medical Gluteal Implant |
| Common Name: | Silicone Carving Block |
| Classification Name: | Elastomer, Silicone Block |

Hanson Medical Gluteal Implants are intended for augmentation, or as reconstruction to minimize muscular defects. The Hanson Gluteal Implant is carvable, allowing the physician to adapt the device shape to individual patient contours. They are manufactured using heat cured, medical grade, two part, liquid silicone system (LSR), silicones that meet FDA requirements for replacement of Dow's discontinued medical grade silicone analogues.

Hanson Gluteal Implants are substantially equivalent to itself (Hanson Medical Silicone Carving Block), and to the Gluteal Implants made by AART, Inc and Silimed LLC. Hanson Gluteal Implants employ the same materials, methods of manufacture, and are identical in dimension and very similar in others, to these predicate devices.

Hanson Gluteal Implants will be offered non-sterile. The implants will be packaged in autoclavable peel pouches labeled with a detachable traceability tab for patient record files. Autoclave sterilization details are provided in the package insert. The implants are finally boxed with package insert materials and labeled for shelving and shipping traceability.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2003

Hanson Medical, Inc. c/o John Harrison, Ph.D. Medical Devices Associates, International 5662 Calle Real, #331 Goleta, California 93117

Re: K030809 Trade Name: Hanson Medical Gluteal Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: II Product Code: MIB Dated: March 5, 2003 Received: March 13, 2003

Dear Dr. Harrison:

We have reviewed your Section 510(k) premarket 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) 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 - John Harrison, Ph.D.

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]: 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 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,

Miriam C. Provost

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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Page 1 of 1

510k NUMBER: K030809

DEVICE NAME: Hanson Medical Gluteal Implant

- INDICATIONS FOR USE:

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The Hanson Medical Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Gluteal Implant will be carvable, allowing the physician to customize the device shape for muscular defects.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:middle;">✓</div> |
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| Over-The-Counter-Use<br>(Optional Format) | |
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Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030809