SILICONE CARVING BLOCK

K973728 · Hanson Medical, Inc. · MIB · Nov 13, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973728
• Device Name: SILICONE CARVING BLOCK
• Applicant: Hanson Medical, Inc.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Hanson Carving block is for carving a finished device by the surgeon for his own custom use. The square or rectangular blocks are designed for carving flatter devices for or recearing broom arrection of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carving curved devices such as malar and chin implants. This product will be delivered non sterile.

Device Story

Silicone carving blocks; raw material consists of polysiloxanes catalyzed by two-part system (Applied Silicone LSR series, Nusil MED 4211). Surgeon carves blocks into custom implants/onlays for skeletal defect correction (trauma/cancer) or facial augmentation (malar/chin). Delivered non-sterile; requires surgeon-performed sterilization. Device provides physical medium for custom surgical implant fabrication.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Silicone carving blocks; materials: polysiloxanes (Applied Silicone LSR series, Nusil MED 4211); additives: Iron Oxide and Titanium Oxide for opacity/radiopacity. Hardness: Shore A 5-60. Tensile strength: >600 PSI. Elongation: >400%. Non-sterile delivery.

Indications for Use

Indicated for use by surgeons to carve custom implants or bone onlays for surgical applications, including the correction of skeletal surface defects resulting from trauma or cancer resection, and the creation of malar or chin implants.

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 redrear Carving Block
• Allied Biomedical Contour Arred Block

Submission Summary (Full Text)

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长973728

Hanson Medical Inc. 19325 58th PL NE Seattle WA 98155 [phone]

NOV 1 3 1997

TAB G

#### 510 (k) Summary

### Substantial Equivalence

The Hanson Medical Carving block is Substantially Equivalent to the The Hanson redrear Carving Block and the Allied Biomedical Contour Arred Block. The Hanson Blocks is made from the same Silicone carving broom materials and manufacturing processes as the predicate device.

#### Intended Use

The intended use of the Hanson Carving block is for carving a finished device by the surgeon for his own custom use. The square or rectangular blocks are designed for carving flatter devices for or recearing broom arrection of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carving curved devices such as malar and chin implants. This product will be delivered non sterile.

#### Labeling

The labeling for this device will comprise a label for the inner package and a label for the outer box. Catalog numbers and sizes will be depicted on the labels. The package insert will contain instructions for use and sterilization. Product promotional literature will merely depict the sizes shapes and material hardness with minimal claims.

#### Physical and Chemical Properties

The physical properties of these devices are the same as the predicate device in that the same materials will be used. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is described as clear to slightly opaque. Pigments will be added such as Iron Oxide and Titanium Oxide to create opacity to light and Radiographic exam. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer. The Chemical components of this device are polysiloxanes catalyzed by a two part system. Refer to master files MAF 562 of Applied and MAF 612 of Nusil for complete material characterizations.

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510(k) Summary Carving Blocks Continued.

#### Package Description

The blocks will be packaged in a tyvec pouch and labeled with the fic brocks wirr be pashaged in a limensions. This inner package will be placed into a white thin paper box. This package will contain an praced theo a will be properly cushion with bubble wrap and shipped in a corrugated box. Package inserts will be placed into the inner box and a packing slip will be placed in the shipping box.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1997

Ms. Kathy Richardson Regulatory Affairs Hanson Medical Inc. 19325 58th Place NE Seattle, Washington 98155

Re: K973728 Trade Name: Silicone Carving Block Regulatory Class: Unclassified Product Code: MIB Dated: September 18, 1997 Received: September 30, 1997

Dear Ms. Richardson:

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 requirements , 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.

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## Page 2 - Ms. Kathy Richardson

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.

picseep

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

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# 510(k) Number(if known)_K973728

Device Name: Silicone Carving Block

Indications For Use:

Silicone Carving Blocks are to be used for carving implants or bone
s and and survives are to be the surgeon. The contour Silicone Carving Blocks are Lo be used for earmy an. The contour
onlays for various surgical uses by the surgen. The contour onlays for various surgical uses by che bargest.
carving blocks with curved surfaces lend themselves to carving chin
carving blocks with alrets carving brook malar implants.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) Division of General Restorative Devices |
|---------------|---------------------------------------------------------------|
| 510(k) Number | K973728 |

| Presecription Use | X |
|-------------------|---|
|-------------------|---|

OR

| | Over The Counter Use |
|--|----------------------|
|--|----------------------|