(49 days)
Not Found
No
The 510(k) summary describes a mechanical ossicular replacement prosthesis and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound waves, addressing conductive hearing loss caused by various conditions. This direct intervention to restore function and alleviate a medical condition classifies it as therapeutic.
No
The device is an ossicular replacement prosthesis, designed for reconstruction of the ossicular chain to facilitate sound conduction, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a family of ossicular replacement prostheses, which are physical implants made from materials like titanium and silicone. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The described device is an ossicular replacement prosthesis. Its function is to physically reconstruct segments of the ossicular chain in the middle ear to facilitate sound conduction. It is a surgically implanted device.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens from the patient. Its purpose is mechanical replacement and sound transmission.
Therefore, this device falls under the category of a medical device (specifically, a surgically implanted prosthesis) but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ETB; ETA
Device Description
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. The design features of the Grace Medical Adjustable Length and Fixed Length Partial & Total Ossicular Replacement raise no new safety or effectiveness issues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ossicular chain, middle ear, tympanic membrane, inner ear, stapes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K972492, K972585, K990923, K002737, K002464
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Prostheses
Total Ossicular Replacement Prostheses |
| Classification Name: | Partial Ossicular Replacement Prostheses (CFR 21 § 874.3450)
Total Ossicular Replacement Prostheses (CFR 21 § 874.3495) |
| 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: | 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
| | GRACE
MEDICAL
ADJUSTABLE
LENGTH AND
FIXED LENGTH
PORPS & TORPS | GRACE
MEDICAL
PARTIAL &
TOTAL
PROSTHESES
(K972815) | BELL
PROSTHESES
KURZ
(K972492) | AERIAL
PROSTHESES
KURZ
(K972585) | VARIO
LENGTH-
ADJUSTABLE
PROSTHESES
KURZ
(K990923) | SMITH &
NEPHEW
PORP &
TORP
GYRUS ENT
(K002737) | SMITH &
NEPHEW OFF-
CENTERED
PORP
GYRUS ENT
(K002464) | GYRUS ENT
BRACKMAN
MODIFIED
TORP
GYRUS ENT
(KXXXXXX) |
|------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|
| Intended
Use | Total and Partial
Reconstruction
of the Ossicular
Chain | Total Partial
Reconstruction
of the Ossicular
Chain | Partial
Reconstruction
of the
Ossicular
Chain | Total
Reconstruction
of the
Ossicular
Chain | Total and
Partial
Reconstruction
of the Ossicular
Chain | Total and
Partial
Reconstruction
of the Ossicular
Chain | Partial
Reconstruction
of the Ossicular
Chain | Total
Reconstruction
of the
Ossicular
Chain |
| Head
Material(s) | Titanium
(Titanium Alloy) | Titanium
(Titanium
Alloy) | Titanium | Titanium | Titanium | Titanium
(Titanium
Alloy) | Hydroxylapatite | Plasti-pore |
| | Hydroxylapatite
(HA) | Hydroxylapatite | | | | | | |
| | HA-Coated Ti | Otosil (Silicone
w/ BaSO4) | | | | | | |
| | Stainless Steel | Polyethylene | | | | | | |
| | Silicone | PTFE | | | | | | |
| | | Stainless Steel | | | | | | |
| | | Silicone | | | | | | |
| Shaft
Material(s) | Titanium
(Titanium Alloy) | Titanium
(Titanium
Alloy) | Titanium | Titanium | Titanium | Titanium
(Titanium
Alloy) | Titanium
(Titanium
Alloy) | Plastipore w/
wire |
| | Ti w/Silicone
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
Length
(mm) | Fixed Sizes from
0.5 to 9.0 | 4.0 to 8.0 | 1.75 to 4.50 | 3.0 to 7.0 | Adjustable
model -
Trimmed to
length
Intraoperatively | 2.0 to 9.0 | Unknown | 8mm
Trimmable |
| | Adjustable
model -
Trimmed to
length
Intraoperatively | | | | | TORPs are
Trimmed to
length -
Intraoperatively | | |
| How
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.
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 | | |