KERATOME SYSTEM

K974243 · Insight Technologies Instruments, LLC · HMY · Jan 20, 1998 · Ophthalmic

Device Facts

• Record ID: K974243
• Device Name: KERATOME SYSTEM
• Applicant: Insight Technologies Instruments, LLC
• Product Code: HMY · Ophthalmic
• Decision Date: Jan 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.

Device Story

The Model K-1000 Keratome System is a surgical instrument used to create a corneal flap. It consists of a console, a nitrogen-driven motor, and a keratome head. The system uses nitrogen gas to power a high-speed, low-torque motor that drives a reciprocating surgical blade. The keratome head is preset to produce a corneal resection approximately 160 microns in depth with a flap diameter of approximately 10.0mm. The device is operated by a physician in a clinical or surgical setting. The console provides footswitch controls for the motor and suction, with analog gauges to monitor nitrogen pressure and suction levels. The device is battery-operated or can be powered via a charger. Components contacting tissue are made of surgical stainless steel and are steam-sterilizable. By automating the corneal resection process, the device assists the surgeon in preparing the eye for subsequent procedures.

Clinical Evidence

Bench testing only. The device was designed and tested according to ANSI/AAMI ES1-1993 and IEC 601-1 standards for electrical safety. No clinical data was provided.

Technological Characteristics

Materials: Surgical stainless steel. Power: Nitrogen gas (turbine), 12V DC battery or AC charger. Dimensions: 28 x 23 x 20cm. Connectivity: None. Sterilization: Steam (gravity displacement at 250°F for 30 minutes). Standards: ANSI/AAMI ES1-1993, IEC 601-1. Mechanism: High-speed, low-torque nitrogen-driven motor with reciprocating blade.

Indications for Use

Indicated for the creation of a corneal flap in patients undergoing ophthalmic surgery.

Regulatory Classification

Identification

A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

Predicate Devices

• Lamellar Keratoplastv System Model L.K.S. (K970377)
• TurboKeratome System by SCMD Model MLK (K935342)

Submission Summary (Full Text)

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KCI14243

## 510K Summary Insight Technologies Instruments, LLC. Model K-1000 Keratome System

JAN 2 0 1998

Insight Technologies Instruments, LLC. 16 Higgins Drive Milford, CT 06460 Tel: [phone] Fax: [phone]

Submitters Name:

Charles Vassallo

Charles Vassallo

22 Dec 97

Date

Ref: 510K Premarket Notification

To: Document Control Clerk:

This summary of 510K safety and effectiveness information is being submitted for the Insight This banninaly of of of of the more, which an equivalence determination could be based.

| Trade/Proprietary Name: | Model K-1000 Keratome System |
|------------------------------------|------------------------------|
| Common/Usual Name: | Keratome |
| Classification Name: | Keratome |
| Establishment Registration Number: | In process at FDA |

#### Performance Standard:

Designed and tested following the suggested guidelines ANSI/AAMI ES1-1993. The low frequency leakage currents are well within the safe current limits for electromedical apparatus.

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The Insight Technologies Instruments, LLC, Model K-1000 Keratome is simular in design construction, and function to the devices as marketed by:

- Plancon Instruments, . ANTONY FRANCE 92160 Lamellar Keratoplastv System Model L.K.S. Reference 510k: K970377
- S.C.M.D. Keratomes of Arizona. FTN. HILLS. AZ 85268 TurboKeratome System by SCMD Model MLK Reference 510k: K935342

#### Descriptive Comparison:

Refer to "Attachment 1" for similarities and differences between the Insight Technologies Instruments LLC, Model K-1000 and the above predicated instruments.

#### Characteristics:

The model K-1000 keratome features a high speed, low torque nitrogen driven motor, which drives a reciprocating surgical blade will be a single-use, disposable device that will be filed under a separate 510k. The keratome head is preset to produce a corneal resection approximately 160 microns in depth with the corresponding blade insertion and flap diameter of approximately 10.0mm.

The model K-1000 keratome system is battery operated and may also operate from its charger. The power unit provides on/off footswitch controls for the keratome head and drive assembly, and suction to the suction ring. Analog gauges located on the front panel of the unit indicate nitrogen pressure and suction level supplying the appropriate connectors.

## Certification of Standards:

Insight Technologies Instruments certifies that the model K-1000 keratome will be manufactured according to ANSI/AAMIES 1-1993 "American National Standard for Electrical Safety" standard. It will also follow guidelines set by IEC 601-1, "Medical Electrical Equipment"

## Certification of Safety and Effectiveness:

When used according to the manufacturers' instructions, there are no adverse safety indications for the model K-1000 keratome.

Components that come in direct contact with tissue are made of surgical stainless steels commonly found in other surgical devices. These components can be steam sterilized using gravity displacement at 250 degrees for 30 minutes

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## Directions for Use:

Insight Technologies Instruments will enclose an operator's manual with every system. The power unit stenciling is located on the front and rear panels identify the system indicators, controls, fuse, and connectors. Affixed to the rear panel will be a self-stick label identifying the input power requirements, model number, part number, and serial number.

## Labeling:

The head and drive assembly labeling will consist of the company logo. The individual footswitches will be identified with a self-stick label.

#### Sterilization Methodology:

The user can sterilize the keratome head, turbine, stop ring, and suction ring using steam.

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# "Attachment 1"

## Comparison Chart Insight Technologies Instruments, LLC. Model K-1000 Keratome System

| Characteristic | ITI Model K-1000 | Plancon | S.C.M.D. |
|-------------------------|---------------------------------------|-----------------------------------------------|----------------------------------------|
| Turbine: | Nitrogen Gas | Nitrogen Gas | Nitrogen Gas |
| Oscillatory Speed: | 14,000 rpm | 14,000 rpm | 14,000-20,000 rpm |
| Blade Direction: | Oscillatory Sideways | Oscillatory Sideways | Oscillator Sideways |
| Blade Angle | 25° | 25° | 25° |
| Suction Ring: | Single, 10.0mm | 3.5 to 10.5mm | 3.5 to 10.5mm |
| Console Dimensions: | 11 x 9 x 8 inches<br>(28 x 23 x 20cm) | 11.8 x 9.3 x 6.3 inches<br>(30 x 23.5 x 16cm) | 15 x 18 x 9 inches<br>(38 x 46 x 23cm) |
| Console Weight: | 20lbs (9kg) | 18lbs(8kg) | 19lbs (kg) |
| Mains Power Protection: | 3.15 amp, slo-blo fuse | none | none |
| Input Voltage: | 12 volts DC | 12 volts DC | 12 volts DC |
| Charger: | 110 volts AC @ 60 Hz | 110 volts AC @ 60 Hz<br>100 volts AC @ 60 Hz | 110 volts AC 60Hz |

. •

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The overall design is simple and conveys a sense of official authority.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1998

Mr. Charles Vassallo Insight Technologies Instruments 16 Higgins Drive Milford, CT 06460

Re: K974243 Trade Name: Model K-1000 Keratome System Regulatory Class: I Product Code: 86 HMY Dated: November 10, 1997 Received: November 12, 1997

Dear Mr. Vassallo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR-Part 820) and that; through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Charles Vassallo

This letter will allow you to begin marketing your device as described in your 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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

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

Enclosure

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## Indications for Use Insight Technologies Instruments, LLC. Model K-1000 Keratome System

510(k) Number (if known):

Device Name: Model K-1000 Keratome System

The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denis L. M Carthy
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. **__**

Prescription Use ✓***_*** OR Over The Counter Use **_**
(Per 21 CFR 801.109) (Optional Format 1-2-96)