ASMOTOM AUTOMATED TREPHINE SYSTEM

K013151 · Bkg Opthalmics USA, Inc. · HRG · Dec 14, 2001 · Ophthalmic

Device Facts

• Record ID: K013151
• Device Name: ASMOTOM AUTOMATED TREPHINE SYSTEM
• Applicant: Bkg Opthalmics USA, Inc.
• Product Code: HRG · Ophthalmic
• Decision Date: Dec 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4070
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The Primary and only purpose of this device is to produce cuts necessary for the corneal transplantation.

Device Story

ASMOTOM Automated Trephine System is an AC-powered surgical instrument used by ophthalmologists to perform penetrating corneal cuts for transplantation. The device utilizes a 12V motor to drive a blade at 16,500 RPM to achieve automated, preset-depth corneal incisions. It incorporates suction rings to stabilize the eye during the procedure and is operated via hand and foot switches. The system provides adjustable blade oscillation to facilitate precise tissue cutting. By automating the trephination process, the device assists surgeons in preparing the donor or recipient cornea, potentially improving the consistency and safety of corneal transplant procedures compared to manual techniques.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered trephine system. Materials: stainless steel and brass. Motor: 12V, 16,500 RPM. Vacuum: 0-800 mbar. Features: suction rings, adjustable blade oscillation, hand/foot switch control. Power: 90-240V, 50-60Hz. Form factor: handheld surgical instrument, 200g.

Indications for Use

Indicated for patients requiring corneal transplantation (keratoplasty).

Regulatory Classification

Identification

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

Predicate Devices

• Summit Technology K-B Microkeratome (K980675)

Submission Summary (Full Text)

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## DEC 1 4 2001

# K013151 510(K) SUMMARY
(as required by 807.92(c))

| Submitter of 510(k): | BKG Opthalmics USA, Inc.<br>7334 Hollister Ave., Suite I<br>Goleta, CA 93117 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | 805-685-9991<br>805-685-1292 |
| Contact Person: | Les Vorosmarthy |
| Date of Summary: | October 29, 2001 |
| Trade Name: | ASMOTOM Automated Trephine System |
| Classification Name: | Trephine, AC-Powered |
| Product Code: | HRG |
| Regulation Number: | 886.4070 |
| Predicate Device: | Summit Technology K-B Microkeratome K980675 |
| Intended Use: | The ASMOTOM Automated Trephine System is intended<br>to perform penetrating cuts of the central portion of the<br>cornea. The Primary and only purpose of this device is to<br>produce cuts necessary for the corneal transplantation. |

:

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## Device Comparison Chart

| Feature | BKG Ophthalmic<br>ASMOTOM | Summit K-B<br>Microkeratome |
|--------------------------------|-----------------------------------------|-----------------------------------------------------------|
| Indications for<br>Use | Keratoplasty | Same |
| Method of cut | Automatic - to preset<br>depth | Automatic - Step<br>motor controlled 0.1<br>to 3.0mm/sec. |
| Materials<br>(Patient Contact) | Stainless Steel and Brass | Stainless Steel,<br>Plastic, Glass,<br>Natural Diamond |
| Blade Oscillation | Adjustable, Patient<br>preset available | Adjustable, with<br>preset default |
| Manufacturer | Deutschmann -<br>Medizintechnik | Gebauer GMBH |
| Motor | 12 V | 12 V |
| Speed | 16,500 RPM | 5,000 - 20,000 RPM |
| Weight | 200 g | N/A |
| Power Supply | 90 V - 240 V | 100 V - 240 V |
| Frequency | 50 - 60 Hz | Same |
| Vacuum | 0 - 800 mbar | 0 - 1.0 bar |
| Suction Rings | Yes | Yes |
| Blades | 6.0 mm - 8.2 mm | Various |
| Off-Set Rings | 0.2 mm - 1.2 mm | Programmable |
| Hand Switch | Yes | Yes |
| Foot Switch | Yes | Yes |

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Image /page/2/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 lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2001

BKG Opthalmics USA, Inc. c/o Mr. Arthur Ward, Consultant 962 Allegro Lane Apollo Beach, FL 33572

Re: K013151

Trade/Device Name: ASMOTOM Automated Trephine System Regulation Number: 21 CFR 886.4070 Regulation Name: Trephine, AC-Powered Regulatory Class: I Product Code: HRG Dated: November 9, 2001 Received: November 13, 2001

Dear Mr. Ward:

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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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 prematicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph Rosenthal

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

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510(k) Number (if known): _

ASMOTOM Automated Trephine System Device Name:

#### Indications For Use:

The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the The ASMOTON of the cornea. The purpose of this device is to produce cuts necessary for the corneal transplantation.

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

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Dinas L. "C. Carter

(Division Sign-Off) Division of Ophthalmic Devices 101315 510(k) Number.