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 Description

The BD 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.

AI/ML Overview

The information provided is about the Becton Dickinson K-3000™ Microkeratome System, a device for producing corneal resections in ophthalmic surgery. The document is a 510(k) PreMarket Notification from 2002.

Acceptance Criteria and Device Performance Study

The document indicates that the device's performance was evaluated through in-vitro studies using porcine eyes. The criteria tested were related to the quality and consistency of the corneal resection.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Flap thickness consistency, accuracy, and variability	Demonstrated
Safety of corneal resection	Demonstrated
Good quality of corneal resection	Demonstrated (Qualitatively evaluated by experienced surgeons)
Predetermined diameter	The device is intended to produce a corneal resection of a predetermined diameter. The study implies this was achieved.
Predetermined thickness	The device is intended to produce a corneal resection of a predetermined thickness. The study explicitly states "Flap thickness consistency, accuracy and variability" were demonstrated, implying the predetermined thickness was met.
Uniform surface quality	The device is intended to produce a corneal resection of uniform surface quality. The study reports "Good quality of corneal resection" and mentions qualitative evaluation of "corneal resection quality", implying this criterion was met.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated regarding the number of porcine eyes used. The text only mentions "in-vitro studies on porcine eyes."
Data Provenance: In-vitro studies on porcine eyes. This means the data is from animal tissue, not human patients. It is prospective testing in an ex-vivo setting. The country of origin of the data is not specified.

3. Number of Experts and Qualifications for Ground Truth of the Test Set:

Number of Experts: Four (4)
Qualifications of Experts: Described as "experienced surgeons." No further details on their specific specialties (e.g., ophthalmologists) or years of experience are provided.

4. Adjudication Method for the Test Set:

The document states that the four 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." This indicates a qualitative assessment by multiple experts, but no specific adjudication method (like 2+1 or 3+1 consensus) is detailed. It appears to be an independent qualitative evaluation by each surgeon.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The study focuses solely on the performance characteristics of the device itself and compares it to a predicate device for substantial equivalence, not on the improvement of human readers with AI assistance.

6. Standalone Performance (Algorithm Only):

This device is a physical surgical instrument, not an AI algorithm. Therefore, a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable and was not performed. The performance evaluated is of the device as a total system in operation.

7. Type of Ground Truth Used:

The ground truth for the performance evaluation was based on a qualitative assessment by "experienced surgeons" of the "quality of the stromal bed" and "corneal resection quality" on porcine eyes. This can be categorized as expert qualitative assessment / expert consensus on animal tissue.

8. Sample Size for the Training Set:

This device is a mechanical surgical instrument, not a learning algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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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

" "

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:●	411 Waverly Oaks RoadBLG 2, Suite 229Waltham, MA 02452-8405
Registration Number:●	1226073
Contact Person:	Eileen T. SchweighardtRegulatory Affairs ManagerTel No. 201-847-4570Fax No. 201-847-4881
Date of Summary:	August 5, 2002
Device
Trade Name:●	BD K-3000™ Microkeratome System
Classification Name:	Keratome and Accessories
Classification:●	Class I (reserved)
Performance Standards:	None Established under 514 of theFood, 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 TechnologiesInc. Technology rightsacquired by BDOphthalmic Systems	BD K-3000™MicrokeratomeSystem (formerlyITI KeratomeModel K-3000)	K 984537	May 14,1999
Microspecialties Inc.	MicrokeratomeBlade with HolderFor ITI KeratomeSystem	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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

(Division Sign-Off)	Deryl Kaup
Division of Ophthalmic Ear,Nose and Throat Devises
	K022637

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Or	Over-the-Counter Use

(Per 21 CFR § 801.109)
(Optional format 1-2-96)
000021

Regulation Number and Section

§ 886.4370 Keratome.

(a)
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.(b)
Classification. Class I.