BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME

K022637 · Becton, Dickinson & CO · HMY · Oct 16, 2002 · Ophthalmic

Device Facts

• Record ID: K022637
• Device Name: BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
• Applicant: Becton, Dickinson & CO
• Product Code: HMY · Ophthalmic
• Decision Date: Oct 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The BD K-3000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as in Laser In-situ Keratomileuses (LASIK) surgery. The corneal resection is consistently of a predetermined diameter, thickness and uniform surface quality for precise lamellar cuts and consistent flap generation.

Device Story

Battery-operated, automated microkeratome for corneal resection in LASIK surgery. Device features titanium handpiece with dual motors: one for blade oscillation, one for head translation across eye. Employs double dovetail suction ring for blade alignment and depth consistency. Operated by surgeons in clinical settings. Produces uniform corneal flaps of predetermined diameter and thickness. Benefits include increased surgical speed, accuracy, and flap consistency compared to manual methods. Handpiece automatically returns to home position post-resection.

Clinical Evidence

Bench testing only. In-vitro performance evaluation on porcine eyes assessed flap thickness consistency, accuracy, variability, and safety of corneal resection. Four experienced surgeons qualitatively evaluated stromal bed quality and blade sharpness, confirming performance consistency.

Technological Characteristics

Battery-powered, automated microkeratome. Materials: Titanium handpiece. Mechanism: Dual-motor system for blade oscillation and head translation; double dovetail suction ring for blade alignment. Form factor: One-piece fully assembled handpiece. Operation: Mechanical cutting.

Indications for Use

Indicated for patients undergoing refractive laser applications and procedures in ophthalmic surgery, specifically LASIK surgery, requiring corneal resection for lamellar cuts and flap generation.

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 System (formerly ITI Keratome Model K-3000) (K984537)
• Microkeratome Blade with Holder For ITI Keratome System (K980510)

Submission Summary (Full Text)

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<022637>

Becton Dickinson Ophthalmic Systems Franklin Lakes, New Jersey 07417 08/05/2002 2:24 PM

BD K-3000™Microkeratomc PreMarket Notification

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# IV. SMDA INFORMATION

# A. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

# 510(k) Summary Of Safety and Effectiveness

# 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: | BD Ophthalmic Systems | |
|---------------------------|------------------------------------------------------------------------------------------------------|--|
| Address:<br>● | 411 Waverly Oaks Road<br>BLG 2, Suite 229<br>Waltham, MA 02452-8405 | |
| Registration Number:<br>● | 1226073 | |
| Contact Person: | Eileen T. Schweighardt<br>Regulatory Affairs Manager<br>Tel No. 201-847-4570<br>Fax No. 201-847-4881 | |
| Date of Summary: | August 5, 2002 | |
| Device | | |
| Trade Name:<br>● | BD K-3000™ Microkeratome System | |
| Classification Name: | Keratome and Accessories | |
| Classification:<br>● | Class I (reserved) | |
| Performance Standards: | None Established under 514 of the<br>Food, Drug and Cosmetic Act | |

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2002

# Safety and Effectiveness Information Supporting Substantial Equivalence

# stantial Equivalence Declaration:

term "Substantial Equivalence" as used in this 510(k) Premarket Notification is to the definition of Substantial Equivalence found in the Federal . smetic Act, as amended and as applied under 21 CFR § 807, Subpart E, under a device can be marketed without pre-market upproval or reclassification. nination of substantial equivalency under this notification is not intended to have earing whatsoever on the resolution of patent infringement suits or any other t matters. No statements related to, or in support of, substantial equivalence shall be construed as an admission against interest under the US Patent Laws or application by the courts. I would

### ice Description

K-3000™ Microkeratome System is a battery operated, fully automated Keratome device to produce a corneal resection prior to laser ablation l laser applications and procedures such as, in Laser In-situ Keratomileusus K) surgery. The Microkeratome is a precise cutting device uniquely designed for comfort, speed and accuracy. The BD K-3000™ Microkeratome System enables
ons to cut precision flaps quickly and easily. The Microkeratome's unique shape is ned to offer more comfort and efficiency while delivering precision and accuracy. e Microkeratome system features:

- One-piece fully assembled handpiece allows complete assembly prior to positioning on the eve
- he handpiece is ergonomically designed and of titanium construction to increase rgeon comfort
- components are fully interchangeable for flexibility
- keratome system consistently produces a corneal resection of a predetermined er, thickness and uniform surface quality.
- ratome head assures depth consistency. The head houses a precision blade elivers constant drive alignment through a double dovetail suction ri
- keratome handpiece contains dual motors. One controls oscillation of the e and a second translates the head across the eve.

- teratome handpiece automatically returns to home position without oscillating.
# ntended Use

D K-3000™ Microkeratome System is a battery powered device intended to a corneal resection for refractive laser annlications and procedures in Ophthalmic such as in Laser In-situ Keratomileuses (LAS) K) surgery. The corneal resection is tently of a predetermined diameter, thickness and uniform surface quality for cise lamellar cuts and consistent flap generation 1700017

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022637 ) K-3000™Microkeratome PreMarket Notification

#### Becton Dickinson Ophthalmic Systems Franklin Lakes, New Jersey 07417 08/05/2002 2:24 PM Summary of Performance Study Results

Keratomes have been used for lamellar (partial thickness) resections for more thap 30 years. More recently, June 21, 2001 the FDA, ODE, Diagnostics and Surgical' Devices Branch, Division of Ophthalmic and Eat, Nose and Throat Devices has recognized keratomes can be labeled with LASIK indications in refractive surgery.

Performance evaluation utilizing in-vitro studies on porcine eyes demonstrated:

- Flap thickness consistency, accuracy and variability 내
- 이 Safety of corneal resection
- Good quality of corneal resection ■

Four (4) experienced surgeons rated the quality of the stromal bed after corneal resection of porcine eyes and qualitatively evaluated the Microkeratome blade sharpness and corneal resection quality.

The performance of the principle device in operation as a total system is substantially equivalent to the predicate device offering no new questions of safety or effectiveness.

#### Predicate Device Summary Table III.

### · Substantial Equivalence

Based upon the comparison of the intended use, technology and principles of operation, design and materials, the BD K-3000™ Microkeratome system can be shown to be substantially equivalent to the commercially available predicate devices indicated in the table below.

| Manufacturer | Predicate Device | K-Number | Clearance Date |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------|----------------|
| Insight Technologies<br>Inc. Technology rights<br>acquired by BD<br>Ophthalmic Systems | BD K-3000™<br>Microkeratome<br>System (formerly<br>ITI Keratome<br>Model K-3000) | K 984537 | May 14,1999 |
| Microspecialties Inc. | Microkeratome<br>Blade with Holder<br>For ITI Keratome<br>System | K-980510 | May 1, 1998 |
| | Thand t | | 8-5-02 |
| Eileen T. Schweighardt | Date | | |

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

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 6 2002

Becton Dickinson & CO. c/o Ms. Eileen Schweighardt Manager of Regulatory Affairs 1 Becton Drive Franklin Lakes, NJ 07417

Re: K022637

Trade Name: BD K-3000™ Microkeratome System Classification Regulation Number: 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HMY Dated: August 7, 2002 Received: August 8, 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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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 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/cdrlv/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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Becton Dickinson Ophthalmic Systems Franklin Lakes, New Jersey 07417 08/05/2002 2:24 PM

BD K-3000™Microkeratome PreMarket Notification

# B. STATEMENT OF INTENDED USE

510(k) Number (if known): __ K O 22-63 7

Device Name: BD K-3000™ Microkeratome System

Indications for Use:

The BD K-3000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as in Laser In-situ Keratomileuses (LASIK) surgery. The corneal resection is consistently of a predetermined diameter, thickness and uniform surface quality for precise lamellar cuts and consistent flap generation.

(Please do not Write below this line-continue on another page if needed)

| (Division Sign-Off) | <i>Deryl Kaup</i> |
|----------------------------------------------------|-------------------|
| Division of Ophthalmic Ear,Nose and Throat Devises | |
| | K022637 |

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <svg class="bi bi-check" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M13.854 3.646a.5.5 0 0 1 0 .708l-7 7a.5.5 0 0 1-.708 0l-3.5-3.5a.5.5 0 1 1 .708-.708L6.5 10.293l6.646-6.647a.5.5 0 0 1 .708 0z" fill-rule="evenodd"></path> </svg> </div> |
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| Or | Over-the-Counter Use |

(Per 21 CFR § 801.109)
(Optional format 1-2-96)
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