GRACE DYNAMIC TORP

K091187 · Grace Medical, Inc. · ETA · Sep 14, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K091187
• Device Name: GRACE DYNAMIC TORP
• Applicant: Grace Medical, Inc.
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Sep 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• 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

Implantable prosthesis for functional reconstruction of ossicular chain; facilitates sound conduction from tympanic membrane to inner ear. Bridges gap between footplate and tympanic membrane or stapes and tympanic membrane. Used by surgeons in clinical settings for patients with conductive hearing loss. Device restores mechanical sound transmission path; improves patient hearing. No electronic components or software.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Materials: Unalloyed titanium (ASTM F67), titanium alloy (ASTM F136), medical-grade silicone, and hydroxylapatite (ASTM F1185). Mechanical implant; no energy source, connectivity, or software.

Indications for Use

Indicated for patients with conductive hearing loss requiring functional reconstruction of the ossicular chain due to chronic middle ear disease, otosclerosis, congenital stapes fixation, prior otologic surgery failure, or middle ear trauma.

Regulatory Classification

Identification

A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

Predicate Devices

• Kurz Aerial TORP (K972585)
• Grace Medical K-Helix Piston and Porp Partial Ossicular Replacement Prostheses (K080070)
• Grace Medical Adjustable Length TORP (K061853)

Submission Summary (Full Text)

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Food and Drug Administration
510(k) Notification – *Grace Dynamic Ossicular Replacement Prostheses*
Page 14 of 15
April 20, 2009

K091187

### 510(K) SUMMARY GRACE DYNAMIC OSSICULAR REPLACEMENT PROSTHESES

Trade Name:

Grace Dynamic Ossicular Replacement Prostheses

Common Name: Classification Name: Ossicular Replacement Prostheses Ossicular Replacement Prostheses

510(k) No .: Official Contact:

K091187 Jeff Cobb Consultant Grace Medical, Inc. 8500 Wolf Lake Drive, Suite 110 Memphis. TN 38133 [phone] [phone] April 20, 2009

Telephone: Telefax: Date Prepared:

#### Predicate Devices

- 1. Kurz Aerial TORP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K972585.
- 2. Grace Medical's K-Helix Piston and Porp Partial Ossicular Replacement Prostheses, cleared via 510(k) No. K080070.
- 3. Grace Medical's Adjustable Length TORP cleared via 510(k) No. K061853.

Intended Use - The Grace Dynamic 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.

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

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- Unalloyed titanium (ASTM F67) (i)
- (ii) Titanium alloy (ASTM F136)
- Medical Grade Silicone (iii)
- ASTM F1185 Hydroxylapatite (iv)

#### Comparisons

- 1. The Grace Dynamic Ossicular Replacement Prostheses are similar / dissimilar to the Kurz Aerial TORP in the following ways:
- Intended use The Grace Dynamic ORP bridges the gap between footplate . and TM or the stapes and TM: whereas, the Kurz TORP bridges the gap between footplate and TM.
- Materials of construction both devices contain titanium or titanium alloy; . whereas, the Grace Dynamic Ossicular Replacement Prostheses also contains medical grade silicone and hydroxylapatite.
- 2. The Grace Dynamic Ossicular Replacement Prostheses are similar to the Grace Medical K-Helix Piston in the following ways:
- Intended use The Grace Dynamic ORP bridges the gap between footplate . and TM or the stapes and TM; whereas, the K-Helix Piston bridges the gap between the footplate and the remnant of the incus.
- Materials of construction both devices contain titanium or titanium alloy; . whereas, the Grace Dynamic ORP also contains medical grade silicone and hydroxylapatite.
- 3. The Grace Dynamic Ossicular Replacement Prostheses are similar / dissimilar to the Grace Medical Fixed Length TORP's in the following ways:
- . Intended use - The Grace Dynamic ORP bridges the gap between footplate and TM or the stapes and TM; whereas, the Grace Medical Fixed Length TORP bridges the gap between footplate and TM.
- Materials of construction both devices contain titanium or titanium alloy, a . medical-grade silicone sleeve, and hydroxylapatite.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

SEP 1 4 2009

Food and Drug Administration 10903 New Hampsbire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Grace Medical, Inc. c/o Mr. Jeff Cobb Consultant Regulatory Affairs & Ouality 8500 Wolf Lake Drive, Suite 110 Memphis, TN 38133

Re: K091187

Trade/Device Name: Grace Dynamic Ossicular Replacement Prosthesis Regulation Number: 21 CFR 874.3495 Regulation Name: Total ossicular replacement prosthesis Regulatory Class: II Product Code: ETA Dated: August 4, 2009 Received: August 5, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Melvin R. Eydelman, M.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, 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: Grace Dynamic Ossicular Replacement Prostheses

### 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 X (Per 21 CFR 801.109)

OR

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

Daniel C. Clapp
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, a Nose and Throat Devices

510(k) Number K091187