The Summit Krumeich-Barraquer Microkeratome is an automated version of the Eyetech-Barraquer-Krumeich Swinger Refractive Set found substantially equivalent under K954058. Other than the automated cutting action option of the electronic model, both microkeratomes share the following basic description. The Microkeratome is a medical "instrument" exclusively designed for use in ophthalmic surgery. This instrument should only be installed, used and serviced by suitably qualified personnel. The speed of forward movement during cutting and the frequency of oscillation of the blade can be individually set and controlled by the operator. The instrument will remain programmed until the data is overwritten by new data. For safety reasons the instrument is equipped with an electrical energy and vacuum reserve which is maintenance free. There is enough reserve energy and vacuum stored that in the event of an electrical failure or loss of main voltage at an inconvenient point in the procedure, the procedure can still be completed. The primary function of this instrument is to make a thin anterior corneal lamellar section leaving the cornea attached nasally by means of a hinge or to remove or harvest the cornea completely. The suction ring is responsible for positioning the microkeratome over the eye. The microkeratome has an oscillating blade, which, with a defined advancing speed (0.1 to 3.0mm/sec.) is guided over the cornea of the patient. The frequency of oscillation and the advancing speed of the blade greatly influence the quality of the cut surface.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the Summit Krumeich-Barraquer Microkeratome, dated December 15, 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define specific acceptance criteria in terms of quantitative performance metrics (e.g., cut depth accuracy, flap diameter consistency, complication rates) that the new device must meet. Instead, the "acceptance" in this context is the FDA's determination of substantial equivalence (SE) to a legally marketed predicate device.

The document provides a Feature Comparison Table which implicitly suggests the "performance indicators" considered for SE:

Feature	Summit K-B Microkeratome Performance	Predicate Device Performance (Eyetech Refractive Set K954058)	SE?
Indications for Use	Keratoplasty & corneal harvesting; Microlamellar keratoplasty	Same	Yes
Method of cut	Automatic - Step motor controlled 0.1 to 3.0mm/sec.	Manual advance - micrometer-type dial	Yes
Sterilization Method	Autoclave	Same	Yes
Blade Oscillation	Adjustable, with preset default	Fixed	Yes
Materials	Stainless Steel, Plastic, Glass, Natural Diamond	Same	Yes
Manufacturer	Gebauer GMBH	Same	Yes

Explanation: The "acceptance criteria" here are that the new device's features and indications for use are either identical to the predicate device or do not raise new questions of safety and effectiveness despite differences (e.g., automatic vs. manual cut, adjustable vs. fixed blade oscillation). The document simply states "Yes" for Substantial Equivalence for each feature, implying that the differences are considered acceptable.

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

The document does not describe a specific clinical or performance test set with human subjects or derived data for the Summit Krumeich-Barraquer Microkeratome. The submission focuses on technical and descriptive comparison to the predicate device.

Given this is a 510(k) for a Class I device and the emphasis is on substantial equivalence based on device design and function, a formal clinical study with a detailed test set may not have been required or submitted for this particular premarket notification.

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

Not applicable, as no described "test set" with ground truth determination is provided in the document.

4. Adjudication Method for the Test Set:

Not applicable, as no described "test set" with ground truth determination is provided in the document.

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

No MRMC study is mentioned or implied. The device is a surgical instrument, not an AI diagnostic tool, so this type of study would not be relevant in this context.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

Not applicable. This is a surgical microkeratome, not an AI algorithm. Its performance is inherent to its mechanical and electronic function, intended for human-in-the-loop use by a surgeon.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" in this submission is the established safety and effectiveness of the predicate device, which the new device aims to be substantially equivalent to, rather than an independent measure of performance against a specific metric.

8. Sample Size for the Training Set:

Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a machine learning algorithm.

In Summary:

The provided document is a 510(k) premarket notification for a Class I medical device (keratome). The primary "study" that proves the device meets "acceptance criteria" is the comparative analysis demonstrating substantial equivalence (SE) to a legally marketed predicate device (Eyetech Barraquer-Krumeich-Swinger Refractive Set, K954058).

The acceptance criteria are implicitly that the new device's design, indications for use, and technological characteristics (even if improved, like automatic cutting and adjustable oscillation) do not raise new questions of safety or effectiveness compared to the predicate device. No formal clinical trial data, test set performance metrics, or explicit quantitative acceptance criteria are provided in this specific submission. The FDA's letter states they "determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This determination is the "proof" that the device meets the regulatory acceptance criteria for market entry under the 510(k) pathway.

Summary

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980675
December 15, 1998

Summary of Safety and Summit Krumeich-Barraquer Microkeratome
Effectiveness Information

et Notification, Section 510(k) Regulatory Authority: Safe Medical Devices Act of 1990,
4|21 CFR 807.92

1. Device Name: Summit Krumeich-Barraquer Microkeratome Trade Name: Electronic Microkeratome Common Name: Keratome Classification Name: KERATOME, AC-POWERED
1. Establishment Name & Registration Number: Summit Technology, Inc. Name: Number: 1287364
1. Classification: & 886.4370 Keratome.

$ 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. [55 FR 48443, Nov. 20, 1990]

Device Class: Class I Classification Panel: Ophthalmic devices panel Product Code: 86HNO

Special Controls: 4. Not applicable to this device.
1. Labeling:

Federal (United States) Law restricts this device to sale by or on the order of a physician.

The warnings, cautions for the device are presented here. The balance of the product labeling is found in Appendix I.

Image /page/0/Picture/13 description: The image shows four warning signs with accompanying text. The first sign is a triangle with an exclamation point inside, labeled "Danger", and the text warns of the danger of cutting oneself during installation or removal of the cutting blade. The second sign is a triangle with a lightning bolt inside, and the text warns not to remove the cover of the electronic part of the instrument. The third sign is an "i" inside a square, and the text states that the instrument complies with safety regulations. The fourth sign is a triangle with an exclamation point inside, labeled "Caution", and the text describes the microkeratome as a precision instrument and warns of damage if the instrument falls.

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K980675

Fauivalent / Predicate Device: 6.

Evetech Barraquer-Krumeich-Swinger Refractive Set, K954058 .

7. Device Description:

The Microkeratome is a medical "instrument" exclusively designed for use in ophthalmic surgery. This instrument should only be installed, used and serviced by suitably qualified personnel. The speed of forward movement during cutting and the frequency of oscillation of the blade can be individually set and controlled by the operator. The instrument will remain programmed until the data is overwritten by new data. For safety reasons the instrument is equipped with an electrical energy and vacuum reserve which is maintenance free. There is enough reserve energy and vacuum stored that in the event of an electrical failure or loss of main voltage at an inconvenient point in the procedure, the procedure can still be completed.

The primary function of this instrument is to make a thin anterior corneal lamellar section leaving the cornea attached nasally by means of a hinge or to remove or harvest the cornea completely. The suction ring is responsible for positioning the microkeratome over the eye. The microkeratome has an oscillating blade, which, with a defined advancing speed (0.1 to 3.0mm/sec.) is guided over the cornea of the patient. The frequency of oscillation and the advancing speed of the blade greatly influence the quality of the cut surface.

Indications.

. Keratoplasty & corneal harvesting
. Microlamellar keratoplasty

The instrument consists of 4 components:

Service Terminal, Microcomputer and Vacuum-Pump .
Motor for oscillating blade and Step Motor for Forward Movement .
. Microkeratome
Suction Ring with Vacuum Connection .

Elements of the Instrument:

1. LCD Display
Service keys and LED 2.
1. Vacuum tubing to suction ring
1. Manometer, pressure indicator of vacuum container
1. Water separator
Button for forward movement of microkeratome drive steel leaf 6.
Stepper motor for microkeratome advancement 7.
1. Foot pedal for vacuum
1. Foot pedal for cutting, start, stop function
1. Button to position microkeratome drive steel leaf
1. Microkeratome drive steel leaf of stepper motor for forward movement
1. Pin guide for forward movement of microkeratome drive steel leaf
1. Coupling clip for microkeratome drive steel leaf
1. Suction ring

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December 15, 1998

K980675

1. Suction ring handle
1. Microkeratome
1. Motor for blade oscillation

8. Modified Device Data:

The Summit Krumeich-Barraquer Microkeratome is an improved model of a previously reviewed substantially equivalent device, the Eyetech-Barraquer-Krumeich-Swinger Refractive Set, covered by K954058.

1. Applicant Name & Address: Summit Technology, Inc. 21 Hickory Drive Waltham, MA 02451

10. Submission Correspondent:

Eric P. Ankerud Vice President, Quality, Regulatory and Clinical Affairs Summit Technology, Inc. 21 Hickory Drive Waltham, MA 02451 Ph: 781-672-0570 Fax: 781-890-6316

11. Manufacturing Facility:

At the present time, the Summit Krumeich-Barraquer Microkeratome is manufactured by GEBAUER GMBH., MONBACHSTR. 7/1, 75242 NEUHAUSEN - ENZKREIS. GEBAUER GMBH, is a registered medical device manufacturing facility located in Germany.

12. Feature Comparison Table:

FEATURE	Summit K-BMicrokeratome	Eyetech RefractiveSet K954058	SE?
Indications for Use(s):	Keratoplasty & cornealharvesting; Microlamellarkeratoplasty	Same	Yes
Method of cut	Automatic - Step motorcontrolled 0.1 to 3.0mm/sec.	Manual advance -micrometer-type dial	Yes
Sterilization Method:	Autoclave	Same	Yes
Blade Oscillation	Adjustable, with presetdefault	Fixed	Yes
Materials:	Stainless Steel, Plastic, Glass,Natural Diamond	Same	Yes
Manufacturer:	Gebauer GMBH	Same	Yes

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is black against a white background, providing high contrast and readability.

Image /page/3/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1998

Eric Ankerud, J.D. Vice President, Quality, Regulatory and Clinical Affairs Summit Technology, Inc. 21 Hickory Drive Waltham, Massachusetts 02451

Re: K980675 Trade Name: Summit Krumeich - Barraquer Microkeratome Regulatory Class: I Product Code: 86 HNO Dated: December 15, 1998 Received: December 16, 1998

Dear Mr. Ankerud:

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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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 (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" (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 1980 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Robert 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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510(k) Number (if known): K980675

Device Name: Summit Krumeich-Barraquer Microkeratome

Indications For Use:

Keratoplasty & corneal harvesting ●
Microlamellar keratoplasty .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ementt Beens

of Onhthalmic Devices 510(k) Number

ل Prescription Use

Over-The-Counter Use _

(Per 21 CFR 801.109)

(Optional format 1-2-96)

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.