(121 days)
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.
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.
The Grace Medical Stapes Prostheses are manufactured from the same or similar materials as the predicate devices. Various designs of Stapes Prostheses are available to meet physician preference. Materials include Titanium, Fluoroplastic, Stainless Steel, Platinum, Tantalum, Silicone, and Nitinol. Shaft diameters range from 0.3 to 0.8 mm and functional lengths range from 3.0 to 6.5 mm. The devices are supplied sterile.
The provided documents do not contain information about specific acceptance criteria or a study designed to prove that the Grace Medical Partial Ossicular Replacement Prostheses meet such criteria.
The documents are a 510(k) summary for a medical device (Partial Ossicular Replacement Prostheses). In a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a dedicated study with defined acceptance criteria and statistical analysis.
Instead, the submission provides:
- Comparison Charts (Tables in sections {1} and {2}): These tables compare the Grace Medical device with several predicate devices based on attributes like:
- Intended Use
- Material(s)
- Shaft Diameter (mm)
- Functional Length (mm)
- Loop Dia (mm)
- How Supplied (Sterile)
The stated rationale for substantial equivalence is that "Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment as it is not present in the provided text.
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060518
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS JUN 2 8 2006 Grace Medical Partial Ossicular Replacement Prostheses
| Trade Name: | Partial Ossicular Replacement Prostheses |
|---|---|
| Common Name: | Partial Ossicular Replacement Prostheses |
| Classification Name: | Partial Ossicular Replacement Prostheses (CFR 21 § 874.3450) |
| Official Contact: | Jeff Cobb |
| Vice President of Regulatory Affairs & Quality | |
| Grace Medical, Inc. | |
| 8500 Wolf Lake Drive, Suite 110 | |
| Memphis, TN 38133 | |
| Telephone: | (901) 380-7000 |
| Telefax: | (901) 380-7001 |
| Date Prepared: | February 16, 2006 |
Predicate Devices - The Grace Medical Stapes Prostheses are substantially equivalent to the current Partial Ossicular Replacement Prostheses marketed by Grace Medical, Inc. (K991934) and Partial Ossicular Replacement Prostheses marketed by Gyrus ENT LLC.
Intended Use - The Grace Medical Stapes Prostheses have the same primary intended use as the predicate devices, which are intended to be implanted for the functional reconstruction of segments of the ossicular chain and to facilitate the conduction of sound wave from the tympanic membrane to the inner ear.
Ossicular replacement prostheses are indicated for the function 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 of Tubes - The Grace Medical Stapes Prostheses are manufactured from the same or similar materials as the predicate devices.
Design Features - Various designs of Stapes Prostheses are available to meet physician preference.
{1}------------------------------------------------
Comparison Charts
Grace Medical Cup Pistons vs. Grace Medical Cup Pistons (K991394) vs. Gyrus ENT "Richards" Bucket HANDLE PROSTHESIS VS. GYRUS ENT SMART PISTON VS. GYRUS ENT HOUSE-TYPE WIRE LOOPS VS. GYRUS ENT SHEA CUP AND SHEA PLATINUM/FLUOROPLASTIC PISTONS
| GRACEMEDICALCUPPISTONS | GRACEMEDICALCUP PISTON(K991394) | GYRUS ENT"RICHARDS"BUCKETHANDLE | GYRUS ENTSMarTPISTON(K003214) | GYRUS ENTHOUSE-TYPE WIRELOOPS | GYRUS ENTSHEA CUP ANDSHEA PLATINUM/FLUOROPLASTICPISTONS | GYRUS ENTCAWTHORNEPISTONS | |
|---|---|---|---|---|---|---|---|
| IntendedUse | PartialReconstructionof theOssicularChain | PartialReconstructionof theOssicularChain | PartialReconstructionof the OssicularChain | PartialReconstructionof theOssicularChain | PartialReconstructionof theOssicularChain | PartialReconstruction of theOssicular Chain | PartialReconstructionof the OssicularChain |
| Material(s) | TitaniumFluoroplasticStainless SteelPlatinumTantalumSiliconeNitinol | TitaniumFluoroplasticStainless SteelPlatinumTantalum | Stainless SteelFluoroplastic | FluoroplasticNitinol | Stainless Steel | FluoroplasticPlatinum | Stainless SteelFluoroplastic |
| ShaftDiameter(mm) | 0.3 to 0.8 | 0.4 to 0.8 | 0.4 to 0.6 | 0.4 to 0.8 | 0.8 | 0.3 | |
| FunctionalLength (mm) | 3.0 to 6.5 | 4.5 to 6.0 | 3.50 to 4.25 | 3.75 to 5.25 | 3.0 to 6.5 | 3.5 to 6 | 3.5 to 6.0 |
| HowSupplied | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile |
GRACE MEDICAL STAPES PROSTHESES VS. GRACE MEDICAL STAPES PROSTHESES (K991394), GRACE MEDICAL WIRE LOOP PISTONS (K991394), GYRUS ENT SCHUKNECHT PISTONS, GYRUS ENT HOUSE-TYPE WIRE LOOPS AND GYRUS ENT "RICHARDS" PLATINUM FLUOROPLASTIC PISTONS
| GRACEMEDICALSTAPESPISTONS | GRACEMEDICALSTAPESPISTONS(K991394) | GRACEMEDICALWIRE LOOPPISTONS(K991394) | GYRUS ENTSCHUKNECHTPISTONS | GYRUS ENTHOUSE-TYPE WIRELOOPS | GYRUS ENT"RICHARDS"PLATINUMFLUOROPLASTICPISTONS | GYRUS ENTCAWTHORNEPISTONS | |
|---|---|---|---|---|---|---|---|
| IntendedUse | PartialReconstructionof theOssicularChain | PartialReconstructionof theOssicularChain | PartialReconstructionof theOssicularChain | PartialReconstruction ofthe OssicularChain | PartialReconstructionof theOssicularChain | PartialReconstruction of theOssicular Chain | PartialReconstructionof the OssicularChain |
| Material(s) | TitaniumFluoroplasticStainless SteelPlatinumTantalum | TitaniumFluoroplasticStainless SteelPlatinumTantalum | TitaniumFluoroplasticStainless SteelPlatinumTantalum | Stainless SteelFluoroplastic | Stainless Steel | PlatinumFluoroplastic | Stainless SteelFluoroplastic |
| ShaftDiameter(mm) | 0.3 to 0.8 | 0.4 to 0.8 | 0.6 to 0.8 | 0.4 to 0.8 | 0.3 | ||
| FunctionalLength(mm) | 3.0 to 6.5 | 4.5 to 6.0 | 3.00 to 6.00 | 3.00 to 5.75 | 3.0 to 6.5 | 3.50 to 5.00 | 3.5 to 6.0 |
| HowSupplied | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile |
GRACE MEDICAL FLUOROPLASTIC PISTONS VS. GRACE MEDICAL FLUOROPLASTIC PISTONS (K991394), GYRUS ENT CAWTHORNE PISTONS, GYRUS ENT HOUSE-TYPE WIRE LOOPS AND GYRUS ENT CAUSSE PISTONS
{2}------------------------------------------------
Food and Drug Administration 510(k) Notification - Partial Ossicular Replacement Prostheses February 28, 2006
| GRACE MEDICALFLUOROPLASTICPISTONS | GRACE MEDICALFLUOROPLASTICPISTONS (K991394) | GYRUS ENTCAWTHORNEPISTONS | GYRUS ENTCAUSSEPISTONS | GYRUS ENTHOUSE-TYPEWIRE LOOPS | |
|---|---|---|---|---|---|
| Intended Use | Partial Reconstruction ofthe Ossicular Chain | Partial Reconstruction of theOssicular Chain | PartialReconstruction of theOssicular Chain | PartialReconstruction ofthe Ossicular Chain | PartialReconstruction ofthe Ossicular Chain |
| Material(s) | Fluoroplastic | Fluoroplastic | Stainless SteelFluoroplastic | PlatinumFluoroplastic | Stainless Steel |
| ShaftDiameter(mm) | 0.3 to 0.8 | 0.4 to 0.8 | 0.3 | 0.4 | |
| FunctionalLength (mm) | 3.0 to 6.5 | 4.5 to 6.0 | 3.5 to 6.0 | 6.0 | 3.0 to 6.5 |
| Loop Dia(mm) | 0.4 to 0.8 | 0.6 | 0.8 | 0.6 | |
| HowSupplied | Sterile | 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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2006
Grace Medical, Inc. c/o Mr. Jeff Cobb 8500 Wolf Lake Dr., Suite 110 Memphis, TN 38133
Re: K060518
Trade/Device Name: Partial Ossicular Replacement Prostheses Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prostheses Regulation Class: II Product Code: ETB Dated: February 24, 2006 Received: June 1, 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 (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.
{4}------------------------------------------------
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eychlenis, M.D.
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
{5}------------------------------------------------
K060$\overline{5}$18
510(k) Number: Device Name:
Partial Ossicular Replacement Prostheses
-
- Indications for Use
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.
- Indications for Use
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)
Thialolut
(Division Sign-Off) Division of Ophthalmic E Nose and Throat Dev 510(k) Number
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
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.(b)
Classification. Class II.