GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES

K061853 · Grace Medical, Inc. · ETB · Aug 18, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K061853
• Device Name: GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
• Applicant: Grace Medical, Inc.
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: Aug 18, 2006
• 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.

Device Story

Prostheses (ALTO, ALPO, FLTO, FLPO, Silverstein ALTO, Frisbee Myringopexy) facilitate sound conduction from tympanic membrane to inner ear by reconstructing ossicular chain segments. Used by otolaryngologists in surgical settings. Adjustable models feature medical-grade silicone sleeves on titanium shafts for intraoperative length customization; fixed-length models available in various sizes. Devices are implanted to restore hearing in patients with conductive loss. Design variations accommodate physician preference. Substantial equivalence established via comparison to existing PORP/TORP devices.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Materials include titanium/titanium alloy, hydroxylapatite, stainless steel, silicone, PTFE, and polyethylene. Features include circular, semi-circular, oval, oblong, or notched head shapes. Adjustable models utilize a silicone sleeve on a titanium shaft for length adjustment. Fixed lengths range from 0.5mm to 9.0mm. Supplied sterile.

Indications for Use

Indicated for functional restoration of the ossicular chain in patients with conductive hearing loss due to chronic middle ear disease, otosclerosis, congenital stapes fixation, secondary surgical intervention for persistent conductive hearing loss from prior otologic surgery, or surgically correctible 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

• BELL Prostheses (K972492)
• AERIAL Prostheses (K972585)
• Length-Adjustable Partial (BELL Vario) and Total (AERIAL Vario) Ossicular Prostheses (K990923)
• Smith & Nephew PORP & TORP (K002737)
• Smith & Nephew Off-Centered PORP (K002464)
• Gyrus ENT Brackman Modified TORP

Submission Summary (Full Text)

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KO61853

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Grace Medical Adjustable Length and Fixed Length Partial and Total Ossicular Replacement Prostheses

| Trade Name: | The family of Grace Medical Adjustable and Fixed Length Partial<br>& Total Ossicular Replacement Prostheses consists of:<br>Grace Medical ALTO (Adjustable Length Total Ossicular) Prostheses Grace Medical ALPO (Adjustable Length Partial Ossicular) Prostheses Grace Medical FLTO (Fixed Length Total Ossicular) Prostheses Grace Medical FLPO (Fixed Length Partial Ossicular) Prostheses Silverstein ALTO (Adjustable Length Partial Ossicular) Prostheses with Footplate Tack Grace Medical Frisbee Myringopexy (Fixed Length Partial Ossicular) Prostheses |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Partial Ossicular Replacement Prostheses<br>Total Ossicular Replacement Prostheses |
| Classification Name: | Partial Ossicular Replacement Prostheses (CFR 21 § 874.3450)<br>Total Ossicular Replacement Prostheses (CFR 21 § 874.3495) |
| 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: | June 30, 2006 |

Predicate Devices - The Grace Medical Adjustable Length Partial and Total Ossicular Prostheses are substantially equivalent to the predicate devices listed below.

| Predicate Device | Manufacturer | 510(k) Number<br>(if known) |
|-----------------------------------------------------------------------------------------|-----------------|-----------------------------|
| BELL Prostheses (Various Models) | Heinz Kurz GmbH | K972492 |
| AERIAL Prostheses (Various Models) | Heinz Kurz GmbH | K972585 |
| Length-Adjustable Partial (BELL Vario) and Total<br>(AERIAL Vario) Ossicular Prostheses | Heinz Kurz GmbH | K990923 |
| Smith & Nephew PORP & TORP | Gyrus ENT | K002737 |
| Smith & Nephew Off-Centered PORP | Gyrus ENT | K002464 |
| Gyrus ENT Brackman Modified TORP | Gyrus ENT | ? |

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

An ossicular replacement prosthesis is a device intended to the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.

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Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications for use include: Chronic middle ear disease, Otosclerosis, Congenital fixation of the stapes, Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and surgically correctible injury to the middle ear from trauma.

Materials – The Grace Medical Adjustable Length and Fixed Length Partial & Total Ossicular Replacement Prostheses are manufactured from the same or similar materials as the predicate devices. The Grace Medical Adjustable-Length PORP's and TORP's contain a medical grade silicone sleeve fixed to the titanium shaft which allows for adjustment to length by the user.

Design Features – Various designs of Grace Medical Adjustable Length Partial & Total Ossicular Replacement Prostheses are available to meet physician preference. The design features of the Grace Medical Adjustable Length and Fixed Length Partial & Total Ossicular Replacement raise no new safety or effectiveness issues.

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## Comparison Charts

| | GRACE<br>MEDICAL<br>ADJUSTABLE<br>LENGTH AND<br>FIXED LENGTH<br>PORPS & TORPS | GRACE<br>MEDICAL<br>PARTIAL &<br>TOTAL<br>PROSTHESES<br>(K972815) | BELL<br>PROSTHESES<br>KURZ<br>(K972492) | AERIAL<br>PROSTHESES<br>KURZ<br>(K972585) | VARIO<br>LENGTH-<br>ADJUSTABLE<br>PROSTHESES<br>KURZ<br>(K990923) | SMITH &<br>NEPHEW<br>PORP &<br>TORP<br>GYRUS ENT<br>(K002737) | SMITH &<br>NEPHEW OFF-<br>CENTERED<br>PORP<br>GYRUS ENT<br>(K002464) | GYRUS ENT<br>BRACKMAN<br>MODIFIED<br>TORP<br>GYRUS ENT<br>(KXXXXXX) |
|------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|
| Intended<br>Use | Total and Partial<br>Reconstruction<br>of the Ossicular<br>Chain | Total Partial<br>Reconstruction<br>of the Ossicular<br>Chain | Partial<br>Reconstruction<br>of the<br>Ossicular<br>Chain | Total<br>Reconstruction<br>of the<br>Ossicular<br>Chain | Total and<br>Partial<br>Reconstruction<br>of the Ossicular<br>Chain | Total and<br>Partial<br>Reconstruction<br>of the Ossicular<br>Chain | Partial<br>Reconstruction<br>of the Ossicular<br>Chain | Total<br>Reconstruction<br>of the<br>Ossicular<br>Chain |
| Head<br>Material(s) | Titanium<br>(Titanium Alloy) | Titanium<br>(Titanium<br>Alloy) | Titanium | Titanium | Titanium | Titanium<br>(Titanium<br>Alloy) | Hydroxylapatite | Plasti-pore |
| | Hydroxylapatite<br>(HA) | Hydroxylapatite | | | | | | |
| | HA-Coated Ti | Otosil (Silicone<br>w/ BaSO4) | | | | | | |
| | Stainless Steel | Polyethylene | | | | | | |
| | Silicone | PTFE | | | | | | |
| | | Stainless Steel | | | | | | |
| | | Silicone | | | | | | |
| Shaft<br>Material(s) | Titanium<br>(Titanium Alloy) | Titanium<br>(Titanium<br>Alloy) | Titanium | Titanium | Titanium | Titanium<br>(Titanium<br>Alloy) | Titanium<br>(Titanium<br>Alloy) | Plastipore w/<br>wire |
| | Ti w/Silicone<br>Sleeve | Polyethylene | | | | | | |
| | PTFE | PTFE | | | | | | |
| | Stainless Steel | Silicone | | | | | | |
| | Polyethylene | | | | | | | |
| | Silicone | | | | | | | |
| Head Shape | Circular | Circular | Circular | Circular | Circular | Circular | Oval | Round |
| | Semi-circular | Trapezoidal | | | | | | |
| | Oval | Oval | | | | | | |
| | Oblong | Notched | | | | | | |
| | Notched | | | | | | | |
| Functional<br>Length<br>(mm) | Fixed Sizes from<br>0.5 to 9.0 | 4.0 to 8.0 | 1.75 to 4.50 | 3.0 to 7.0 | Adjustable<br>model -<br>Trimmed to<br>length<br>Intraoperatively | 2.0 to 9.0 | Unknown | 8mm<br>Trimmable |
| | Adjustable<br>model -<br>Trimmed to<br>length<br>Intraoperatively | | | | | TORPs are<br>Trimmed to<br>length -<br>Intraoperatively | | |
| How<br>Supplied | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile |

Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not raise new issues regarding safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 8 2006

Grace Medical, Inc. c/o Mr. Jeff Cobb 8500 Wolf Lake Dr., Suite 110 Memphis, TN 38133

Re: K061853

Trade/Device Name: Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses

Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prostheses; Total Ossicular Replacement Prostheses Regulatory Class: II Product Code: ETB; ETA Dated: June 30, 2006 Received: July 18, 2006

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 (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 - Mr. Jeff Cobb

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/cdrl/industry/support/index.html.

Sincerely yours,

M.B. EgdelmisiMD

Malvina B. Eydelman, M.D. 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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Device Name:

510(k) Number: K061853

The family of Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses consists of:

- Grace Medical ALTO (Adjustable Length Total Ossicular) Prostheses .
- Grace Medical ALPO (Adjustable Length Partial Ossicular) Prostheses .
- Grace Medical FLTO (Fixed Length Total Ossicular) Prostheses .
- Grace Medical FLPO (Fixed Length Partial Ossicular) Prostheses .
- Silverstein ALTO (Adjustable Length Partial Ossicular) Prostheses with . Footplate Tack
- Grace Medical Frisbee Myringopexy (Fixed Length Partial Ossicular) . Prostheses
- a) 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<br>(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use<br>(Optional Format 1-2/96) |
|------------------------------------------|----------------------------------------------------|----|--------------------------------------------------|
| | (Division Sign-Off)<br>Division of Ophthalmic Ear, | | |
| | Nose and Throat Devices | | |