K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K080070 · Grace Medical, Inc. · ETB · Apr 17, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K080070
• Device Name: K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
• Applicant: Grace Medical, Inc.
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: Apr 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: (a) Chronic middle ear disease, (b) Otosclerosis. (c) Congenital fixation of the stapes, (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and (e) Surgically correctible injury to the middle ear from trauma.

Device Story

K-Helix Piston and PORP are implantable prostheses for ossicular chain reconstruction; facilitate sound conduction from tympanic membrane to inner ear. Used by otolaryngologists in surgical settings to restore hearing in patients with conductive loss. Devices are manufactured from Nitinol and/or titanium; available in lengths 3.0mm to 18.0mm. Attachment via manual or heat crimp-assist. Prostheses replace damaged or fixed ossicles, restoring mechanical sound transmission to the inner ear, potentially improving patient hearing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Nitinol (ASTM F2063-05), unalloyed titanium (ASTM F67), titanium alloy (ASTM F136). Form factor: Ossicular prostheses, 3.0mm to 18.0mm lengths. Attachment: Manual or heat crimp-assist. Sterile supply.

Indications for Use

Indicated for patients with conductive hearing loss due to chronic middle ear disease, otosclerosis, congenital stapes fixation, prior otologic surgery failure, or middle ear trauma.

Regulatory Classification

Identification

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

Predicate Devices

• SMart ISJ Prosthesis (K033554)
• SMart Piston (K003214)
• Angular Prosthesis (Plester) (K972492)
• CliP Piston MVP (K042503)

Submission Summary (Full Text)

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K080070

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS APR 1 7 2008 K-Helix Partial Ossicular Replacement Prostheses

The family of K-Helix Partial Ossicular Replacement Prostheses Trade Name: consists of:

- · K-Helix Piston
- K-Helix PORP

| Common Name: | Partial Ossicular Replacement Prostheses |
|----------------------|--------------------------------------------------------------|
| Classification Name: | Partial Ossicular Replacement Prostheses (CFR 21 § 874.3450) |

| Official Contact: | Jeff Cobb<br>Vice President of Regulatory Affairs & Quality<br>Grace Medical, Inc.<br>8500 Wolf Lake Drive, Suite 110<br>Memphis, TN 38133 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Telefax: | [phone] |
| Date Prepared: | January 8, 2008 |

## Predicate Devices

- 1) SMart ISJ Prosthesis manufactured by Gyrus ENT LLC and cleared via 510(k) No. K033554.
- 2) SMart Piston manufactured by Gyrus ENT LLC and cleared via 510(k) No. K003214.
- 3) Angular Prosthesis (Plester) manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K972492.
- 4) CliP Piston MVP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K042503.

Intended Use - The Grace Medical Partial Ossicular Replacement Prostheses have the same primary intended use as the predicate devices.

An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:

- (a) Chronic middle ear disease,
- (b) Otosclerosis.
- (c) Congenital fixation of the stapes,
- (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
- (e) Surgically correctible injury to the middle ear from trauma.

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Material(s) - The Grace Medical Partial Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:

- (i) Nitinol (ASTM F2063-05)
- (ii) Unalloyed titanium (ASTM F67)
- (iii) Titanium alloy (ASTM F136)

Comparison Charts .

### K-HELIX PORP

| | K-Helix PORP<br>(Grace Medical, Inc.) | SMart ISJ<br>(Gyrus) | SMart Piston<br>(Gyrus) | Angular<br>Prosthesis<br>(Kurz) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------|---------------------------------|
| Intended Use | An ossicular replacement prosthesis is a device intended to be<br>implanted for the functional reconstruction of segments of the ossicular<br>chain and facilitates the conduction of sound wave from the tympanic<br>membrane to the inner ear. | Same | Same | Same |
| Material(s) | Nitinol and/or Titanium | Nitinol | Nitinol<br>Fluoroplastic | Titanium |
| Method of<br>Attachment | Manual or Heat Crimp-Assist | Manual or Heat<br>Crimp-Assist | Manual or<br>Heat Crimp-<br>Assist | Manual |
| Lengths | 3.0mm to 18.0mm | n/a | 3.0mm to<br>6.0mm | 4.25mm to<br>4.75mm |
| How<br>Supplied | Sterile | Sterile | Sterile | Sterile |

#### K-HELIX PISTON

| | K-Helix PISTON<br>(Grace Medical, Inc.) | SMart<br>ISJ<br>(Gyrus) | SMart Piston<br>(Gyrus) | Angular<br>Piston<br>(Kurz) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------|-----------------------------|
| Intended<br>Use | An ossicular replacement prosthesis is a device intended to be implanted for the<br>functional reconstruction of segments of the ossicular chain and facilitates the<br>conduction of sound wave from the tympanic membrane to the inner ear. | Same | Same | Same |
| Material(s) | Nitinol and/or<br>Titanium | Nitinol | Nitinol<br>Fluoroplastic | Titanium |
| Lengths | 3.0mm to 18.0mm | n/a | 3.0mm to<br>6.0mm | 4.25mm to<br>4.75mm |
| How<br>Supplied | Sterile | Sterile | Sterile | Sterile |

Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 7 2008

Grace Medical c/o Jeff Cobb VP Regulatory Affairs and Quality Assurance 8500 Wolf Lake Drive Suite 110 Memphis, TN 38133

Re: K080070

Trade/Device Name: K-Helix Piston and PORP Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: March 19, 2008 Received: March 21, 2008

Dear Mr. Cobb:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (OS) 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Marling B. Eggleton, M.D.

Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number:

Device Name: K-Helix Partial Ossicular Replacement Prostheses

The family of K-Helix Partial Ossicular Replacement Prostheses consists of:

- K-Helix Piston t
- K-Helix PORP

## Indications for Use:

An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:

- (a) Chronic middle ear disease,
- (b) Otosclerosis,
- (c) Congenital fixation of the stapes,
- (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
- (e) Surgically correctible injury to the middle ear from trauma.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2/96)

Karent Sohler

lon of Oohthalmic Ear,

K0 80070
510(k) Number