LogoFDA 510(k) Search
K Number
K063374
Device Name
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
Manufacturer
Grace Medical, Inc.
Date Cleared
2006-12-06

(28 days)

Product Code
ETB
Regulation Number
874.3450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. 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.
Device Description
The family of Grace Medical Nitinol Partial Ossicular Replacement Prostheses consists of: Nitinol Locking Incudo-Stapedial Joint Nitinol Locking Angular Piston Nitinol Locking Piston Nitinol Locking Malleus Piston Nitinol Locking PORP Footplate Shoe. The prostheses are manufactured from Nitinol (ASTM F2063-05), Unalloyed titanium (ASTM F67), Titanium alloy (ASTM F136), Hydroxylapatite (ASTM F1185), Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754), and Medical grade silicone.
More Information

K033554, K003214, K972492, K042503, K021479, K061853, K972815

Not Found

No
The summary describes a physical implantable device made of standard medical materials for ossicular chain reconstruction. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.

Yes
The device is intended for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound waves, which directly addresses a medical condition (conductive hearing loss) for therapeutic purposes.

No

Explanation: The device is an ossicular replacement prosthesis, which is designed for the functional reconstruction of the ossicular chain to restore hearing, not to diagnose a condition.

No

The device description explicitly states the prostheses are manufactured from various physical materials (Nitinol, Titanium, Hydroxylapatite, Fluoroplastic, Silicone), indicating it is a physical implantable device, not software.

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, tissue) to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
  • Device Description: The provided description clearly states that this device is an "ossicular replacement prosthesis" intended to be implanted in the middle ear. It is a physical device used for functional reconstruction within the body.
  • Intended Use: The intended use is 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." This is a surgical intervention, not a diagnostic test performed on a specimen.

The device is a medical device, specifically an implantable prosthesis, but it does not fit the definition of an In Vitro Diagnostic device.

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 Grace Medical Nitinol Partial Ossicular Replacement Prostheses consists of: Nitinol Locking Incudo-Stapedial Joint, Nitinol Locking Angular Piston, Nitinol Locking Piston, Nitinol Locking Malleus Piston, Nitinol Locking PORP Footplate Shoe.
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), (iv) Hydroxylapatite (ASTM F1185), (v) Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754), (vi) Medical grade silicone.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

inner ear, tympanic membrane, middle 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K033554, K003214, K972492, K042503, K021479, K061853, K972815

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 Grace Medical Partial Ossicular Replacement Prostheses

GEC - 6 2006

| Trade Name: | The family of Grace Medical Nitinol Partial Ossicular Replacement
Prostheses consists of:
Nitinol Locking Incudo-Stapedial Joint Nitinol Locking Angular Piston Nitinol Locking Piston Nitinol Locking Malleus Piston Nitinol Locking PORP Footplate Shoe |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | November 8, 2006 |

Predicate Devices

    1. SMart ISJ Prosthesis manufactured by Gyrus ENT LLC and cleared via 510(k) No. K033554.
    1. SMart Piston manufactured by Gyrus ENT LLC and cleared via 510(k) No. K003214.
    1. Angular Prosthesis (Plester) manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K972492.
    1. CliP Piston MVP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K042503.
    1. CliP Piston aWengen manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K021479.
    1. Adjustable and Fixed-Length PORPs manufactured by Grace Medical, Inc. and cleared via 510(k) No. K061853.
    1. Partial Ossicular Replacement Prosthesis manufactured by Grace Medical, Inc. and cleared via 510(k) K972815.

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 car. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:

1

  • (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(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)
  • (iv) Hydroxylapatite (ASTM F1185)
  • (v) Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754)
  • (vi) Medical grade silicone

Comparison Charts

.

NITINOL LOCKING INCUDO-STAPEDIAL JOINT

| | Nitinol Locking Incudo-Stapedial Joint | SMart
ISJ
(Gyrus) | SMart
Piston
(Gyrus) | Angular
Prosthesis
(Kurz) | Similarities or Differences |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------|---------------------------------|------------------------------------------------------------------------------------------------|
| 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 | Same |
| Material(s) | Nitinol | Nitinol | Nitinol
Fluoroplastic | Titanium | Substantially Equivalent |
| Method of
Attachment | Manual or Heat Crimp-Assist | Same | Same | Manual | Same as SMart ISJ and
SMart Piston. Different
than but SE to Kurz
Angular Prosthesis. |
| How
Supplied | Sterile | Sterile | Sterile | Sterile | Same |

NITINOL LOCKING ANGULAR PISTON

| | Nitinol Locking Angular Piston | SMart
ISJ
(Gyrus) | SMart Piston
(Gyrus) | Angular
Piston
(Kurz) | Similarities or
Differences |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------|-----------------------------|--------------------------------|
| 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 car. | Same | Same | Same | Same |
| Material(s) | Nitinol
Titanium | Nitinol | Nitinol
Fluoroplastic | Titanium | Substantially
Equivalent |
| Lengths | 3.0mm to 9.0mm | n/a | 3.0mm to
6.0mm | 4.25mm to
4.75mm | Substantially
Equivalent |
| How
Supplied | Sterile | Sterile | Sterile | Sterile | Same |

2

NITINOL LOCKING PISTON

| | Nitinol Locking Piston | SMart
ISJ
(Gyrus) | SMart Piston
(Gyrus) | Angular
Piston
(Kurz) | Similarities or
Differences |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------|-----------------------------|--------------------------------|
| 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 | Same |
| Material(s) | Nitinol
Titanium
Fluoroplastic | Nitinol | Nitinol
Fluoroplastic | Titanium | Substantially
Equivalent |
| Lengths | 3.0mm to 9.0mm | n/a | 3.0mm to 6.0mm | 4.25mm to
4.75mm | Substantially
Equivalent |
| How
Supplied | Sterile | Sterile | Sterile | Sterile | Same |

NITINOI. LOCKING MALLEUS PISTON

| | Nitinol Locking Malleus Piston | CliP Piston
MVP
(Kurz) | CliP Piston
aWengen
(Kurz) | Similarities or
Differences |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------|--------------------------------|
| 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
Titanium
Fluoroplastic | Titanium | Titanium | Substantially
Equivalent |
| Lengths | 3.0mm - 9.0mm | 5.00mm -
6.25mm | 4.0mm -
5.5mm | Substantially
Equivalent |
| How
Supplied | Sterile | Sterile | Sterile | Same |

Nitinol Locking PORP

| | Nitinol Locking PORP | SMart
ISJ
(Gyrus) | SMart Piston
(Gyrus) | Grace Adjustable and
Fixed-length PORPs | Similarities or
Differences |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------|-----------------------------------------------------------------------------------------|--------------------------------|
| 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 | Same |
| Shaft
Material(s) | Nitinol
Titanium
Silicone (sleeve on adjustable models) | Nitinol | Nitinol
Fluoroplastic | Titanium
Silicone (sleeve on adjustable
models) | Substantially
Equivalent |
| Head
Material(s) | Titanium
Hydroxylapatite | No
head | No head | Titanium
Hydroxylapatite | Same |
| Lengths | Fixed Sizes: 0.5mm to 9.0mm
Adjustable model - Trimmed
intraoperatively to length | n/a | 3.0mm to 6.0mm | Fixed Sizes: 0.5mm to 9.0mm
Adjustable model - Trimmed
intraoperatively to length | Substantially
Equivalent |
| How
Supplied | Sterile | Sterile | Sterile | Sterile | Same |

3

FOOTPLATE SHOE

| | Footplate Shoe | Grace HA Footplate Shoe
K972815 | Similarities or
Differences |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------|
| 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 |
| Material(s) | Nitinol
Titanium
Hydroxylapatite | Hydroxylpaptite | Substantially
Equivalent |
| Accommodates
Shafts with
Diameters: | 0.3mm to 1.07mm | 1.07mm | Substantially
Equivalent |
| How Supplied | Sterile | Sterile | Same |

Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness.

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Grace Medical, Inc. c/o Jeff Cobb Regulatory Affairs & Quality 8300 Wolf Lake Drive Suite 110 Memphis, TN

DEC = 6 2006

Re: K063374

Trade/Device Name: Partial Ossicular Replacement Prostheses, Nitinol Incudo-Stapedial Joint, Nitinol Angular Piston, Nitinol Piston, Nitinol Malleus Piston, Nitinol PORP and Footplate Shoc Regulation Number: 21 CFR 874.3450 Regulation Name: Partial ossicular replacement prosthesis Regulatory Class: Class II Product Code: ETB Dated: November 8, 2006 Received: November 8, 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.

5

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 premated nevice 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. Eychler S.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

6

510(k) Number: ¥063374

Device Name: Partial Ossicular Replacement Prostheses including: Nitinol Incudo-Stapedial Joint, Nitinol Angular Piston, Nitinol Piston, Nitinol Malleus Piston, Nitinol PORP, and Footplate Shoe

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)

Karus boha

X

e and Throat Devis

510(k) Number K063374