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 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
Vacuum tubing set:
Two pedal Footswitch for actuation of the handpiece and vacuum system;
External Battery Charger.

AI/ML Overview

The provided 510(k) summary for the BD K-4000™ Microkeratome System does not contain detailed acceptance criteria or a specific study proving the device meets those criteria in the way a clinical trial or performance study for a diagnostic AI device would. Instead, this document is a summary for a medical device, specifically a surgical instrument, seeking substantial equivalence to predicate devices already on the market.

Therefore, the information requested, such as specific performance metrics (like sensitivity, specificity, F1 score), sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable in the context of this 510(k) submission for the BD K-4000™ Microkeratome System.

The document states:

"Performance studies were done to assess 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."

This indicates that the "study" was focused on demonstrating substantial equivalence to existing, legally marketed devices (BD K-3000™ Microkeratome, K984537 and K022637), rather than meeting specific quantifiable performance metrics against a defined ground truth for a diagnostic task. The criteria for acceptance were likely related to functional performance (e.g., cutting precision, safety features), material compatibility, and intended use, all benchmarked against the predicate devices.

Here's how to address the questions given the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Functional equivalence to predicate microkeratomes (BD K-3000™).	"All results from the studies show equivalence between the principal devices and the predicate devices."
Safety features comparable to predicate devices.	Implied by substantial equivalence and Class I classification.
Performance of corneal resection for refractive laser applications comparable to predicate devices.	Implied by substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. (The studies were likely bench testing, engineering verification, and perhaps limited in-vivo or ex-vivo testing comparing the device's functional outputs to predicate devices, rather than a clinical trial with a "test set" in the diagnostic sense.)
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable for this type of device and submission. Ground truth in this context would likely be engineering specifications, material standards, and functional output measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, not applicable. This is a surgical instrument, not a diagnostic AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This device is a battery-operated, fully automated microkeratome; its "performance" is inherently standalone in its function as a cutting device, but it doesn't involve "algorithms" in the AI sense or human-in-the-loop diagnostic interpretation. The user operates the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not explicitly stated but would likely be based on engineering specifications, physical measurements (e.g., blade precision, suction force), material properties, and comparison of outcomes (e.g., flap thickness, consistency) with the predicate devices through laboratory or ex-vivo testing.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied.

Summary

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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 Systems411 Waverley Oaks RdBuilding 2, Suite 229Waltham, MA 02452-8405
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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 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
BectonDickinson	BD K-3000™ Microkeratome	K984537	Sept. May 14, 1999
	BD K-3000™ Microkeratome(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 (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/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

・・

510(k) Number(if known)	K023092
Device Name	BD K-4000™ Microkeratome System
Indications forUse	The BD K-4000™ Microkeratome System is a batterypowered device intended to produce a corneal resectionfor refractive laser applications and procedures inOphthalmic surgery, such as Laser In-situ Keratomileuses(LASIK) surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature
(Division Sign-Off)

Division of Ophthalmic Ear,

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: 100 million in the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st

Nose and Throat Devises

.10(k) Number K023092

Presenption Use V (per 21 CFR 801.109) OR

Over-The Counter Use

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.