BD K-4000 MICROKERATOME SYSTEM

K023092 · Becton, Dickinson & CO · HMY · Oct 18, 2002 · Ophthalmic

Device Facts

• Record ID: K023092
• Device Name: BD K-4000 MICROKERATOME SYSTEM
• Applicant: Becton, Dickinson & CO
• Product Code: HMY · Ophthalmic
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The BD K-4000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery. such as Laser In-situ Keratomileuses (LASIK) surgery.

Device Story

Battery-operated, fully automated microkeratome system; used in ophthalmic surgery for corneal resection. System components: console (motor drive, control circuitry, vacuum system, battery), surgical handpiece, vacuum tubing, two-pedal footswitch, external battery charger. Operated by ophthalmic surgeons in clinical settings. Device creates precise corneal cuts to facilitate refractive procedures like LASIK. Surgeon controls actuation via footswitch; vacuum system secures handpiece to eye. Provides mechanical precision for corneal tissue removal; improves surgical efficiency and accuracy.

Clinical Evidence

No clinical data. Performance studies were conducted to demonstrate equivalence to predicate devices; results confirmed equivalence.

Technological Characteristics

Battery-powered, fully automated microkeratome. Components include console with motor drive, vacuum system, and control circuitry; surgical handpiece; vacuum tubing; two-pedal footswitch; external battery charger. Class I device.

Indications for Use

Indicated for patients undergoing refractive laser surgery, including LASIK, requiring corneal resection.

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

• BD K-3000™ Microkeratome (K984537)
• BD K-3000™ Microkeratome (expanded claims for LASIK) (K022637)

Submission Summary (Full Text)

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023092

## 510(k) Summary of Safety and Effectiveness BD K-4000™ Microkeratome System

OCT 1 8 2002

### I. General Information

This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92

#### Establishment:

| Address: | BD Ophthalmic Systems<br>411 Waverley Oaks Rd<br>Building 2, Suite 229<br>Waltham, MA 02452-8405 |
|----------|--------------------------------------------------------------------------------------------------|
|----------|--------------------------------------------------------------------------------------------------|

- Registration Number: 1211998 . Eileen T. Schweighardt Contact Person: .
Requlatory Affairs Manager Telephone no.: 201-847-4570 Fax No. 201-847-4881

- . Date of Summary:
Device

.

September 17, 2002 BD K-4000™ Microkeratome

- Trade Name: ● Classification Name:
Performance Standards:

- . . Classification:
Keratome Class I reserved None Established under 514 of the Food, Drug and Cosmetic Act

- I . Safety and Effectiveness Information Supporting Substantial Equivalence
· Device Description

The BD K-4000™ Microkeratome System is a battery operated, fully automated Keratome. The Microkeratome is a precise cutting device uniquely designed for added comfort, speed and accuracy. The Microkeratome's unique shape is designed to offer more comfort and efficiency while delivering precision and accuracy.

The BD K-4000™ Microkeratome major components are:

- Console containing the motor drive and control circuitry, Vacuum system and battery ■ power source
- Front Panel controls for operating the system; ■
- Surgical Handpiece connected to the console by multi-conductor cable 체
- Vacuum tubing set: 지
- Two pedal Footswitch for actuation of the handpiece and vacuum system; I
- e External Battery Charger.

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023092

· Intended Use

The BD K-4000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery. such as Laser In-situ Keratomileuses (LASIK) surgery.

- · Synopsis of Performance Study Results
Performance studies were done the performance and equivalence of the principal devices to the predicate devices currently marketed in the United States.

All results from the studies show equivalence between the principal devices and the predicate devices. Therefore, the K-4000 is substantially equivalent to the predicate devices.

III. Predicate Device Summary Table

- · Substantial Equivalence
Based on comparison of the device features, materials, intended use and performance, the BD K-4000™ Microkeratome is shown to be substantially equivalent to the commercially available predicate devices in the table below. The predicate devices, K number, and clearance date are also identified in the table below.

| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---------------------|---------------------------------------------------------|----------|--------------------|
| Becton<br>Dickinson | BD K-3000™ Microkeratome | K984537 | Sept. May 14, 1999 |
| | BD K-3000™ Microkeratome<br>(expanded claims for LASIK) | K022637 | Pending |

Eileen J. Schweighardt

Eileen T. Schweighardt Regulatory Affairs Manager B D Ophthalmic Systems Becton Dickinson and Company

10/17/02.

Date

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a stylized human form or a bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Becton, Dickinson and Company c/o Eileen T. Schweighardt Regulatory Affairs Manager 1 Becton Drive Franklin Lakes, NJ 07417

Re: K023092

Trade/Device Name: BD K-4000™ Microkeratome System Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HMY Dated: September 17, 2002 Received: September 18, 2002

Dear Ms. Schweighardt:

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 - Eileen T. Schweighardt

This letter will allow you to begin marketing your device as described in your Section 510/ks 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 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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# Indications for Use Statement

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1. 1. 1. 1. 1.

Indications for Use Statement

| 510(k) Number<br>(if known) | K023092 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | BD K-4000™ Microkeratome System |
| Indications for<br>Use | The BD K-4000™ Microkeratome System is a battery<br>powered device intended to produce a corneal resection<br>for refractive laser applications and procedures in<br>Ophthalmic surgery, such as Laser In-situ Keratomileuses<br>(LASIK) surgery. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic Ear,

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Nose and Throat Devises

.10(k) Number K023092

Presenption Use V (per 21 CFR 801.109) OR

Over-The Counter Use