(98 days)
Not Found
No
The summary describes a physical implantable device made of standard medical-grade materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound waves to the inner ear, which aligns with the definition of a therapeutic device designed to restore or improve a bodily function.
No.
The device is an ossicular replacement prosthesis, which is a surgically implanted device used to reconstruct the ossicular chain for functional restoration of hearing, not to diagnose a condition.
No
The device description explicitly states the device is a family of ossicular replacement prostheses manufactured from materials like Nitinol and Titanium, which are physical components intended for implantation. This indicates a hardware device, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a device that is implanted into the middle ear to physically replace or reconstruct parts of the ossicular chain. Its function is to mechanically transmit sound waves, not to analyze biological samples.
The device is a surgical implant used for functional restoration within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
ETB
Device Description
The family of K-Helix Partial Ossicular Replacement Prostheses consists of:
- K-Helix Piston
- K-Helix PORP
The Grace Medical Partial Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:
- (i) Nitinol (ASTM F2063-05)
- (ii) Unalloyed titanium (ASTM F67)
- (iii) Titanium alloy (ASTM F136)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ossicular chain, middle ear, inner ear
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K033554, K003214, K972492, K042503
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS APR 1 7 2008 K-Helix Partial Ossicular Replacement Prostheses
The family of K-Helix Partial Ossicular Replacement Prostheses Trade Name: consists of:
- · K-Helix Piston
- K-Helix PORP
| 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: | January 8, 2008 |
Predicate Devices
-
- SMart ISJ Prosthesis manufactured by Gyrus ENT LLC and cleared via 510(k) No. K033554.
-
- SMart Piston manufactured by Gyrus ENT LLC and cleared via 510(k) No. K003214.
-
- Angular Prosthesis (Plester) manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K972492.
-
- CliP Piston MVP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K042503.
Intended Use - The Grace Medical Partial Ossicular Replacement Prostheses have the same primary intended use as the predicate devices.
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.
1
KoYoO7D
Material(s) - The Grace Medical Partial Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:
- (i) Nitinol (ASTM F2063-05)
- (ii) Unalloyed titanium (ASTM F67)
- (iii) Titanium alloy (ASTM F136)
Comparison Charts .
K-HELIX PORP
| | K-Helix PORP
(Grace Medical, Inc.) | SMart ISJ
(Gyrus) | SMart Piston
(Gyrus) | Angular
Prosthesis
(Kurz) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------|---------------------------------|
| 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. | Same | Same | Same |
| Material(s) | Nitinol and/or Titanium | Nitinol | Nitinol
Fluoroplastic | Titanium |
| Method of
Attachment | Manual or Heat Crimp-Assist | Manual or Heat
Crimp-Assist | Manual or
Heat Crimp-
Assist | Manual |
| Lengths | 3.0mm to 18.0mm | n/a | 3.0mm to
6.0mm | 4.25mm to
4.75mm |
| How
Supplied | Sterile | Sterile | Sterile | Sterile |
K-HELIX PISTON
| | K-Helix PISTON
(Grace Medical, Inc.) | SMart
ISJ
(Gyrus) | SMart Piston
(Gyrus) | Angular
Piston
(Kurz) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------|-----------------------------|
| 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. | Same | Same | Same |
| Material(s) | Nitinol and/or
Titanium | Nitinol | Nitinol
Fluoroplastic | Titanium |
| Lengths | 3.0mm to 18.0mm | n/a | 3.0mm to
6.0mm | 4.25mm to
4.75mm |
| How
Supplied | 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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2008
Grace Medical c/o Jeff Cobb VP Regulatory Affairs and Quality Assurance 8500 Wolf Lake Drive Suite 110 Memphis, TN 38133
Re: K080070
Trade/Device Name: K-Helix Piston and PORP Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: March 19, 2008 Received: March 21, 2008
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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Marling B. Eggleton, M.D.
Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number:
Device Name: K-Helix Partial Ossicular Replacement Prostheses
The family of K-Helix Partial Ossicular Replacement Prostheses consists of:
- K-Helix Piston t
- K-Helix PORP
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)
OR
Over-The-Counter Use (Optional Format 1-2/96)
Karent Sohler
lon of Oohthalmic Ear,
K0 80070
510(k) Number