SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2

K083780 · Audio Technologies S.R.L. · ETA · Mar 23, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K083780
• Device Name: SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
• Applicant: Audio Technologies S.R.L.
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear. Audio prostheses are successfully employed in case of otosclerosis, stapedo-vestibular ankylosis, outxome of otitis media, trauma, middle ear congenital malformations. Possible complication due to the use of prostheses in the middle ear include: fixation, displacement, extrusion of the prosthesis, incus necrosis, tympanic membrane perforation, perilymph fistula, labyrinthitis, otitis media, occlusion of oval and round window. Some of the prostheses are manufactured in different lengths, some others shall be trimmed during the surgical operation. Nevertheless the length of all the prostheses should be carefully assessed by means of a microsurgical gauge (code 02.14) The implant must be carried out by a qualified surgeon.

Device Story

Permanent middle ear implants for ossicular chain reconstruction; replaces damaged or missing ossicles. Manufactured from titanium, polyethylene, stainless steel, hydroxylapatite, platinum, PTFE, gold, silicone, or Nitinol. Available in various designs and lengths; some models trimmed intraoperatively by surgeon. Length assessment performed using microsurgical gauge. Implanted by qualified surgeons during otosurgery. Benefits include restoration of ossicular chain function lost due to disease, trauma, or congenital defects.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: titanium, polyethylene, stainless steel, hydroxylapatite, platinum, PTFE, gold, silicone, Nitinol. Form factor: various ossicular replacement designs (partial/total). Mechanical device; no energy source or software.

Indications for Use

Indicated for patients with middle ear pathologies including otosclerosis, stapedo-vestibular ankylosis, sequelae of otitis media, trauma, and congenital malformations requiring ossicular chain reconstruction.

Regulatory Classification

Identification

A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

Predicate Devices

• Richards (Smith & Nephew)
• Xomed (Xomed)
• Exmoor (Exmoor Plastics)
• Audio Technologies prosthesis

Submission Summary (Full Text)

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K083780

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Trade name: Common name: Classification name:

submitter:

Audio Prosthesis- Audio Technologies Prothesis for otosurgery Partial Ossicular Replacement Prosthesis Total Ossicular Replacement Prosthesis

MAR 2 3 2009

ప్రా

AUDIO TECHNOLOGIES S.r.I. Via Vallera 42 1-29100 - PIACENZA - Italy

Official contact:

dr. Franco Beoni (General Director) telephone: [phone]

fax number: +39.0523.770019

e-mail: [e-mail]

Date prepared:

November 25th, 2008

#### predicate devices:

The Audio Prosthesis - Audio Technologies, are substantially equivalent to Richards - marketed by Smith & Nephew, and/or Xomed - marketed by Xomed, and/or Exmoor - marketed by Exmoor Plastics and also Audio Technologies prosthesis.

### Description:

Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear.

Otosurgical prosthesis of the middle hear, are manufactured from a wide variety of materials: titanium, poliethylene (PE), stainless steel, hydroxylapatite (HA). platinum (Pt). politetrafluoroethylene (PTFE), gold, polimetilxilossano (silicon) and Nitinol, or combination of these materials.

Numerous designs are available for replacement of any or all of the bones of the ossicular chain.

#### Intended use:

For replacement for any or all of the bones of the ossicular chain in the middle ear

#### Indications for use

Audio prostheses are successfully employed in case of otosclerosis, stapedo-vestibular ankylosis, outxome of otitis media, trauma, middle ear congenital malformations. Possible complication due to the use of prostheses in the middle ear include: fixation, displacement, extrusion of the prosthesis, incus necrosis, tympanic membrane perforation, perilymph fistula, labyrinthitis, otitis media, occlusion of oval and round window.

Some of the prostheses are manufactured in different lengths, some others shall be trimmed during the surgical operation. Nevertheless the length of all the prostheses should be carefully assessed by means of a microsurgical gauge (code 02.14)

#### Comparison to predicate devices:

These devices have the same indications for use (Partial / Total Ossicular Replacement Prosthesis, for reconstruction of the ossicular chain that has lost its function, due to disease, trauma, or congenital defect), the same technological characteristics, i.e. materials (all widely accepted for middle ear reconstruction), and the same general design.

Slight design differences between Audio Technologies Prosthesis and the predicate devices should not affect the safety and effectiveness

Audio Technologies Srl

Sede legale: via Vallera, 42 - 29100 Piacenza (Italy) - tel. [phone], fax [phone] Produzione: via dell'Artigianato, 8 - 29020 Gossolengo, Piacenza (Italy) Cod. Fisc./Part. IVA 01086720339 - Reg. Imprese 01086720339 - R.E.A. 126383 - Cap. Soc. i.v. € 24000,00 [e-mail] - www.audiotechnologies.it

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Audio Technologies S.R.L. c/o Franco Beoni Via Vallera, 42 Piacenza, Italy 1-29100

# MAR 2 3 2009

K083780 Re:

> Trade/Device Name: Total/Partial Ossicular Replacement Prosthesis Regulation Number: 21 CFR 874.3495 Regulation Name: Total Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETA, ETB Dated: March 3, 2009 Received: March 11, 2009

Dear Dr. Beoni :

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.

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Page 2 - Dr. Franco Beoni

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Everlons, mD

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

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Audio Technologies Srl - 510(K) Notification

## Section 4. Indications for use statement

## Indication for Use

510(k) Number (if known): K083780 Device Name: Prosthesis for otosurgey Indication For Use:

Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear.

Audio prostheses are successfully employed in case of otosclerosis, stapedo-vestibular ankylosis, outxome of otitis media, trauma, middle ear congenital malformations. Possible complication due to the use of prostheses in the middle ear include. fixation, displacement, extrusion of the prosthesis, incus necrosis, tympanic membrane perforation, perilymph fistula, labyrinthitis, otitis media, occlusion of oval and round window.

Some of the prostheses are manufactured in different lengths, some others shall be trimmed during the surgical operation. Nevertheless the length of all the prostheses should be carefully assessed by means of a microsurgical qauge (code 02.14) The implant must be carried out by a qualified surgeon.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use NO (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Karen Barker

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

**510(k) Number** K083780

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