SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS

K033554 · Gyrus Ent LLC · ETB · Nov 24, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K033554
• Device Name: SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
• Applicant: Gyrus Ent LLC
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: Nov 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SMart Offset Stapes Piston has the same intended use as the Angular Piston: bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery when this anatomical condition is present. The SMart ISJ Prosthesis has the same intended use as the Angular Prosthesis: bridging defects at the long incudal process with otherwise intact mobile chain.

Device Story

The SMart Offset Stapes Piston and SMart ISJ Prosthesis are middle ear implants used by surgeons to restore ossicular chain continuity. The Offset Stapes Piston bridges the stapes in otosclerosis cases, while the ISJ Prosthesis bridges defects at the long incudal process. Both devices feature nitinol wire loops that utilize shape-memory properties, allowing the surgeon to secure the loop around the incus via manual crimping or heat application. The Offset Stapes Piston includes a fluoroplastic shaft, while the ISJ Prosthesis uses a titanium bell. These implants are provided sterile for surgical implantation. By restoring the mechanical connection in the middle ear, the devices aim to improve sound conduction and hearing for the patient.

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

Implants consist of nitinol wire loops, fluoroplastic shafts (Offset Piston), and titanium bells (ISJ). Nitinol chosen for shape-memory properties to facilitate loop closure. Supplied sterile. Dimensions: Offset Piston (3.0-6.0mm length, 0.4-0.8mm diameter); ISJ Prosthesis (2.25mm, 3.25mm offset lengths).

Indications for Use

Indicated for patients with otosclerosis requiring stapes bridging, specifically surgical revision or primary surgery with a shortened incudal process (SMart Offset Stapes Piston); or patients with defects at the long incudal process with an otherwise intact mobile chain (SMart ISJ Prosthesis).

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

• Angular Piston (Heinz Kurz GmbH Medizintechnik)
• Angular Prosthesis (Plester) (Heinz Kurz GmbH Medizintechnik)

Reference Devices

• Gyrus ENT SMart Piston (K003214)

Submission Summary (Full Text)

{0}------------------------------------------------

### NOV 2 4 2003

Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits. The digits are '16033554'. The numbers are written in black ink on a white background. The numbers appear to be written in a casual, slightly slanted style.

Food and Drug Administration 510(k) Notification - SMart Partial Ossicular Replacement Prosthesis November 10, 2003

### 510(k) Summary of Safety and Effectiveness

| Trade Name: | SMart Offset Stapes Piston prosthesis |
|----------------------|---------------------------------------------|
| Common Name: | Middle Ear Piston |
| Classification Name: | Partial Ossicular Replacement Prosthesis (9 |
| | 874.3450) |
| Official Contact: | Gregory Sredin |
| | Manager of Regulatory Affairs |
| | Gyrus ENT |
| | 2925 Appling Road |
| | Bartlett, TN 38133 |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Date Prepared: | October 31, 2003 |

The SMart Offset Stapes Piston is substantially equivalent to the Angular Piston sold by Heinz Kurz GmbH Medizintechnik

#### Intended Use

The SMart Offset Stapes Piston has the same intended use as the Angular Piston: bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery when this anatomical condition is present.

### Material

The SMart Offset Stapes Piston differs from the predicate device in the material used. The predicate device used titanium whereas the SMart Offset Stapes Piston utilizes nitinol wire embedded in a fluoroplastic shaft. This is the same combination of materials that is utilized in the Gyrus ENT SMart Piston that was cleared by the FDA in K003214. (See Exhibit 6)

{1}------------------------------------------------

### 510(k) Summary of Safety and Effectiveness

| Trade Name:<br>Common Name:<br>Classification Name: | SMart ISJ prosthesis<br>Partial Ossicular Replacement Prosthesis<br>Partial Ossicular Replacement Prosthesis (S 874.3450) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Gregory Sredin<br>Manager of Regulatory Affairs<br>Gyrus ENT<br>2925 Appling Road<br>Bartlett, TN 38133 |
| Telephone:<br>Telefax: | [phone]<br>[phone] |
| Date Prepared: | October 31, 2003 |

The SMart ISJ Prosthesis is substantially equivalent to the Angular Prosthesis (Plester) sold by Heinz Kurz GmbH Medizintechnik

### Intended Use

The SMart ISJ Prosthesis has the same intended use as the Angular Prosthesis: bridging defects at the long incudal process with otherwise intact mobile chain.

### Material

The SMart ISJ Prosthesis differs from the predicate device in the material used. The predicate device uses gold and titanium whereas the SMart Offset Piston utilizes nitinol shaft and loops welded to a titanium bell.

{2}------------------------------------------------

# Table of Similarities and Differences

# SMart Offset Stapes Piston vs. Angular Piston

| | SMArt Offset Stapes Piston<br>(Gyrus ENT) | Angular Piston<br>(Heinz Kurz GmbH Medizintechnik) | Similarities or Differences |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bridging the stapes in cases of otosclerosis:<br>specifically for surgical revision in patients<br>with a shortened incudal process, and also in<br>primary surgery when this anatomical<br>condition is present | Bridging the stapes in cases of otosclerosis:<br>specifically for surgical revision in patients with<br>a shortened incudal process, and also in<br>primary surgery when this anatomical condition<br>is present | Same. No new indications for use. |
| Loop material | Nitinol | Titanium | Different. Nitinol is also biocompatible<br>and was chosen for its shape-memory<br>characteristics that allow the surgeon<br>to close the open loops around the<br>incus using a heat source in addition to<br>manual crimping. |
| Shaft material | Fluoroplastic | Titanium | Different. Fluoroplastic has a long<br>history as an implant material and was<br>chosen for its ability to be molded<br>around the shaft of the loops |
| Lengths | 3.0 mm through 6.0 mm (functional length) | 6.0 mm (overall length) | Comparable. The SMart is offered in<br>lengths of 3 - 6 mm, in 1-mm<br>increments to assist the surgeon in<br>selecting the optimal length for his<br>patient |
| Shaft Diameter | .4, .6, .8 mm | .4, .6 mm | Comparable. In addition to the .4 and<br>.6 mm shaft the SMart is also offered<br>in a .8 mm diameter for the surgeon<br>seeking more stability. Similar shaft<br>diameters are found in the Gyrus ENT<br>SMart Piston (K003214) |
| Offset | 1mm to 2mm | 2 mm | Comparable. The SMart piston will be<br>offered in offset lengths between 1 and<br>2 mm to allow the surgeon greater<br>flexibility in selecting the appropriate<br>size for his patient. |
| | Sterile | Sterile | Same |

{3}------------------------------------------------

## SMart ISJ prosthesis vs. Angular Prosthesis

| | SMart ISJ Prosthesis<br>(Gyrus ENT) | Angular Prosthesis<br>(Heinz Kurz GmbH Medizintechnik) | Similarities or Differences |
|-------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bridging defects at the long incudal<br>process with otherwise intact mobile chain. | Bridging defects at the long incudal process<br>with otherwise intact mobile chain. | Same. No new indications for use. |
| Loop material | Nitinol | Titanium | Different. Nitinol is also<br>biocompatible and was chosen for its<br>shape-memory characteristics that<br>allow the surgeon to close the open<br>loops around the incus using a heat<br>source in addition to manual<br>crimping. |
| Bell material | Titanium | Titanium/Gold | Same |
| Lengths of offset | 2.25 mm, 3.25 mm | 2.25 mm, 3.25 mm | Same |
| How supplied | Sterile | Sterile | Same |

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

NOV 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gyrus, ENT L.L.C. c/o Gregory Sredin Manager of Regulatory Affairs 2925 Appling Road Bartlett, TN 38133

Re: K033554

Trade/Device Name: SMart™ Offset Stapes Piston Prosthesis SMart™ ISJ Prosthesis

Regulation Number: 21 CFR 874.3450 Regulation Name: Partial ossicular replacement prosthesis Regulatory Class: Class II Product Code: ETB Dated: November 10, 2003 Received: November 12, 2003

Dear Mr. Sredin:

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.

{5}------------------------------------------------

Page 2 - Gregory Sredin

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Paizi Kiremthed

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Food and Drug Administration 510(k) Notification – SMart Partial Ossicular Replacement Prosthesis November 10, 2003

510(k) Number: Device Name:

SMart Offset Stapes Piston Prosthesis

#### Indications for Use:

- . Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition.
### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓
Counter
(Per 21 CFR 801.109)

Keren Golan

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

510(k) Number K033554

OR

Over-the-

(Optional Format 1-2-96)

{7}------------------------------------------------

Food and Drug Administration 510(k) Notification - SMart Partial Ossicular Replacement Prosthesis November 10, 2003

510(k) Number: Device Name:

SMart ISJ Prosthesis

Indications for Use:

- Bridging defects at the long incudal process with otherwise intact mobile chain. ●
### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| Counter | |
| (Per 21 CFR 801.109) | |

OR

Over-the-

(Optional Format 1-2-96)

Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K033554