(49 days)
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.
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.
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. 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. Various designs of Grace Medical Adjustable Length Partial & Total Ossicular Replacement Prostheses are available to meet physician preference.
This is a 510(k) premarket notification for a medical device (Grace Medical Adjustable Length and Fixed Length Partial & Total Ossicular Replacement Prostheses), not a study evaluating software performance or an AI/ML device. Therefore, much of the requested information (acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and effect sizes) is not applicable or cannot be extracted from this document.
The document focuses on establishing substantial equivalence to predicate devices based on intended use, materials, and design features, rather than presenting a performance study against specific acceptance criteria for a new, unique device function.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative "acceptance criteria" for performance that would typically be found in a study for a new device's efficacy (e.g., a certain percentage improvement in hearing). Instead, the "acceptance" for this 510(k) is regulatory approval based on demonstrating substantial equivalence to legally marketed predicate devices.
The "reported device performance" is essentially that it has the "same primary intended use" and that "Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not raise new issues regarding safety or effectiveness." This statement serves as the qualitative assessment of its performance relative to existing devices.
The core "acceptance criteria" for a 510(k) submission are met if the device:
- Has the same intended use as a predicate device.
- Has the same technological characteristics as the predicate device; OR
- Has different technological characteristics from a predicate device AND the information submitted to FDA does not raise new questions of safety and effectiveness AND the device is as safe and effective as the predicate device.
The document implicitly "reports" that these criteria have been met through the comparative tables and the FDA's final letter of substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission based on substantial equivalence to existing devices, not a clinical performance study using a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth for a test set was established as part of this submission for direct device performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an implantable prosthesis, not an AI-assisted diagnostic tool or an imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and intended use.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm.
{0}------------------------------------------------
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& 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 |
|---|---|
| Common Name: | Partial Ossicular Replacement ProsthesesTotal Ossicular Replacement Prostheses |
| Classification Name: | Partial Ossicular Replacement Prostheses (CFR 21 § 874.3450)Total Ossicular Replacement Prostheses (CFR 21 § 874.3495) |
| Official Contact: | Jeff CobbVice President of Regulatory Affairs & QualityGrace Medical, Inc.8500 Wolf Lake Drive, Suite 110Memphis, TN 38133 |
| Telephone: | (901) 380-7000 |
| Telefax: | (901) 380-7001 |
| 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(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(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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
Comparison Charts
| GRACEMEDICALADJUSTABLELENGTH ANDFIXED LENGTHPORPS & TORPS | GRACEMEDICALPARTIAL &TOTALPROSTHESES(K972815) | BELLPROSTHESESKURZ(K972492) | AERIALPROSTHESESKURZ(K972585) | VARIOLENGTH-ADJUSTABLEPROSTHESESKURZ(K990923) | SMITH &NEPHEWPORP &TORPGYRUS ENT(K002737) | SMITH &NEPHEW OFF-CENTEREDPORPGYRUS ENT(K002464) | GYRUS ENTBRACKMANMODIFIEDTORPGYRUS ENT(KXXXXXX) | |
|---|---|---|---|---|---|---|---|---|
| IntendedUse | Total and PartialReconstructionof the OssicularChain | Total PartialReconstructionof the OssicularChain | PartialReconstructionof theOssicularChain | TotalReconstructionof theOssicularChain | Total andPartialReconstructionof the OssicularChain | Total andPartialReconstructionof the OssicularChain | PartialReconstructionof the OssicularChain | TotalReconstructionof theOssicularChain |
| HeadMaterial(s) | Titanium(Titanium Alloy) | Titanium(TitaniumAlloy) | Titanium | Titanium | Titanium | Titanium(TitaniumAlloy) | Hydroxylapatite | Plasti-pore |
| Hydroxylapatite(HA) | Hydroxylapatite | |||||||
| HA-Coated Ti | Otosil (Siliconew/ BaSO4) | |||||||
| Stainless Steel | Polyethylene | |||||||
| Silicone | PTFE | |||||||
| Stainless Steel | ||||||||
| Silicone | ||||||||
| ShaftMaterial(s) | Titanium(Titanium Alloy) | Titanium(TitaniumAlloy) | Titanium | Titanium | Titanium | Titanium(TitaniumAlloy) | Titanium(TitaniumAlloy) | Plastipore w/wire |
| Ti w/SiliconeSleeve | 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 | ||||||||
| FunctionalLength(mm) | Fixed Sizes from0.5 to 9.0 | 4.0 to 8.0 | 1.75 to 4.50 | 3.0 to 7.0 | Adjustablemodel -Trimmed tolengthIntraoperatively | 2.0 to 9.0 | Unknown | 8mmTrimmable |
| Adjustablemodel -Trimmed tolengthIntraoperatively | TORPs areTrimmed tolength -Intraoperatively | |||||||
| HowSupplied | 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.
{3}------------------------------------------------
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.
{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/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
{5}------------------------------------------------
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(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use(Optional Format 1-2/96) |
|---|---|---|---|
| (Division Sign-Off)Division of Ophthalmic Ear, | |||
| Nose and Throat Devices |
§ 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.