(121 days)
No
The summary describes a physical implantable device for hearing restoration and makes no mention of AI or ML technology.
Yes
The device is intended for the functional restoration of the ossicular chain to correct conductive hearing loss, which is a therapeutic purpose.
No
The device is a partial ossicular replacement prosthesis, used for the functional reconstruction of the ossicular chain to restore sound conduction, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is a physical prosthesis manufactured from various materials like Titanium, Fluoroplastic, and Stainless Steel, intended for surgical implantation. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a partial ossicular replacement prosthesis. Its function is to be implanted into the middle ear to physically reconstruct the ossicular chain and facilitate sound conduction. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for the "functional reconstruction of segments of the ossicular chain" and "functional restoration of the ossicular chain." This is a surgical intervention, not a diagnostic test performed on a sample.
The device is an implantable medical device used for surgical treatment of hearing loss.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
ETB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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.
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
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
| | GRACE
MEDICAL
CUP
PISTONS | GRACE
MEDICAL
CUP PISTON
(K991394) | GYRUS ENT
"RICHARDS"
BUCKET
HANDLE | GYRUS ENT
SMarT
PISTON
(K003214) | GYRUS ENT
HOUSE-
TYPE WIRE
LOOPS | GYRUS ENT
SHEA CUP AND
SHEA PLATINUM
/
FLUOROPLASTIC
PISTONS | GYRUS ENT
CAWTHORNE
PISTONS |
|---------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------|
| Intended
Use | Partial
Reconstruction
of the
Ossicular
Chain | Partial
Reconstruction
of the
Ossicular
Chain | Partial
Reconstruction
of the Ossicular
Chain | Partial
Reconstruction
of the
Ossicular
Chain | Partial
Reconstruction
of the
Ossicular
Chain | Partial
Reconstruction of the
Ossicular Chain | Partial
Reconstruction
of the Ossicular
Chain |
| Material(s) | Titanium
Fluoroplastic
Stainless Steel
Platinum
Tantalum
Silicone
Nitinol | Titanium
Fluoroplastic
Stainless Steel
Platinum
Tantalum | Stainless Steel
Fluoroplastic | Fluoroplastic
Nitinol | Stainless Steel | Fluoroplastic
Platinum | Stainless Steel
Fluoroplastic |
| Shaft
Diameter
(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 |
| Functional
Length (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 |
| How
Supplied | 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
| | GRACE
MEDICAL
STAPES
PISTONS | GRACE
MEDICAL
STAPES
PISTONS
(K991394) | GRACE
MEDICAL
WIRE LOOP
PISTONS
(K991394) | GYRUS ENT
SCHUKNECHT
PISTONS | GYRUS ENT
HOUSE-
TYPE WIRE
LOOPS | GYRUS ENT
"RICHARDS"
PLATINUM
FLUOROPLASTIC
PISTONS | GYRUS ENT
CAWTHORNE
PISTONS |
|------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------|
| Intended
Use | Partial
Reconstruction
of the
Ossicular
Chain | Partial
Reconstruction
of the
Ossicular
Chain | Partial
Reconstruction
of the
Ossicular
Chain | Partial
Reconstruction of
the Ossicular
Chain | Partial
Reconstruction
of the
Ossicular
Chain | Partial
Reconstruction of the
Ossicular Chain | Partial
Reconstruction
of the Ossicular
Chain |
| Material(s) | Titanium
Fluoroplastic
Stainless Steel
Platinum
Tantalum | Titanium
Fluoroplastic
Stainless Steel
Platinum
Tantalum | Titanium
Fluoroplastic
Stainless Steel
Platinum
Tantalum | Stainless Steel
Fluoroplastic | Stainless Steel | Platinum
Fluoroplastic | Stainless Steel
Fluoroplastic |
| Shaft
Diameter
(mm) | 0.3 to 0.8 | 0.4 to 0.8 | | 0.6 to 0.8 | | 0.4 to 0.8 | 0.3 |
| Functional
Length
(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 |
| How
Supplied | 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 MEDICAL
FLUOROPLASTIC
PISTONS | GRACE MEDICAL
FLUOROPLASTIC
PISTONS (K991394) | GYRUS ENT
CAWTHORNE
PISTONS | GYRUS ENT
CAUSSE
PISTONS | GYRUS ENT
HOUSE-TYPE
WIRE LOOPS |
|---------------------------|--------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Intended Use | Partial Reconstruction of
the Ossicular Chain | Partial Reconstruction of the
Ossicular Chain | Partial
Reconstruction of the
Ossicular Chain | Partial
Reconstruction of
the Ossicular Chain | Partial
Reconstruction of
the Ossicular Chain |
| Material(s) | Fluoroplastic | Fluoroplastic | Stainless Steel
Fluoroplastic | Platinum
Fluoroplastic | Stainless Steel |
| Shaft
Diameter
(mm) | 0.3 to 0.8 | 0.4 to 0.8 | 0.3 | 0.4 | |
| Functional
Length (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 | |
| How
Supplied | 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