Who is the manufacturer of PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

Grace Medical, Inc. filed the 510(k) submission for PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K060518).

What is the FDA product code for PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

ETB. It is classified under 21 CFR 874.3450 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

Grace Medical Partial Ossicular Replacement Prostheses (K991934); Gyrus ENT Partial Ossicular Replacement Prostheses; Gyrus ENT SMarT Piston (K003214).

Who can help prepare an FDA 510(k) submission like PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K060518 · Grace Medical, Inc. · ETB · Jun 28, 2006 · Ear, Nose, Throat

Device Facts

Record ID	K060518
Device Name	PARTIAL OSSICULAR REPLACEMENT PROSTHESES
Applicant	Grace Medical, Inc.
Product Code	ETB · Ear, Nose, Throat
Decision Date	Jun 28, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3450
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Implantable prosthesis for middle ear; reconstructs ossicular chain to restore sound conduction from tympanic membrane to inner ear. Used by otolaryngologists in surgical settings. Device bridges gaps in ossicular chain; facilitates mechanical sound transmission. Benefits patient by correcting conductive hearing loss. Various designs available to accommodate physician preference and anatomical requirements.

Clinical Evidence

No clinical data provided; bench testing only. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Titanium, Fluoroplastic, Stainless Steel, Platinum, Tantalum, Silicone, Nitinol. Form factor: Piston/prosthesis designs with shaft diameters 0.3-0.8mm and functional lengths 3.0-6.5mm. Sterile, single-use implant. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients with conductive hearing loss requiring functional reconstruction of the ossicular chain due to chronic middle ear disease, otosclerosis, congenital stapes fixation, prior otologic surgery failure, or middle ear trauma.

Regulatory Classification

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.

Predicate Devices

Grace Medical Partial Ossicular Replacement Prostheses (K991934)
Gyrus ENT Partial Ossicular Replacement Prostheses
Gyrus ENT SMarT Piston (K003214)

Reference Devices

Gyrus ENT Richards Bucket Handle Prosthesis
Gyrus ENT House-Type Wire Loops
Gyrus ENT Shea Cup and Shea Platinum/Fluoroplastic Pistons
Gyrus ENT Cawthorne Pistons
Gyrus ENT Schuknecht Pistons
Gyrus ENT Causse Pistons

Related Devices

K091187 — GRACE DYNAMIC TORP · Grace Medical, Inc. · Sep 14, 2009
K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM · Invotec International, Inc. · Mar 3, 2003
K993234 — MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS · Micromedics, Inc. · Nov 10, 1999
K972815 — PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT · Grace Medical, Inc. · Oct 8, 1997
K991394 — STAPES PROSTHESES · Grace Medical, Inc. · May 18, 1999

Submission Summary (Full Text)

{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 - 1) 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. # (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