The Horus Laser Keratome is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Description

The Horus Laser Keratome is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Horus Laser Keratome is achieved through precise individual mirco-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vaccum.

AI/ML Overview

The provided text does NOT contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for the Horus Laser Keratome, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results with specific acceptance criteria.

However, I can extract the available information and indicate where data is missing.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify acceptance criteria for the Horus Laser Keratome in a numerical or categorical format with corresponding performance results. It broadly states:

Criterion	Reported Device Performance
Substantial Equivalence	"The Horus Laser Keratome was found to perform equivalently to the predicate device, the Hansatome Microkeratome, with respect to the creation of cornea resections."
Safety Standards	"The Horus Laser Keratome has been designed and tested to applicable safety standards."
Intended Use	The device is indicated for "creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea." This implies it successfully creates such flaps.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance (country of origin, retrospective/prospective): Not specified.
- The study is described as "extensive ex-vivo studies," suggesting it was conducted on excised tissue (likely animal or cadaveric) rather than live human patients.

3. Number of experts used to establish the ground truth for the test set and their qualifications

Not specified.

4. Adjudication method for the test set

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study is not mentioned. The study described is an "ex-vivo" comparison to a predicate device.

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

This device is a surgical laser, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" is not applicable in the way it would be for an AI diagnostic device. The performance mentioned ("creation of cornea resections") refers to the device's physical action.

7. The type of ground truth used

The text describes "extensive ex-vivo studies" comparing the device's performance in "creation of cornea resections" to a predicate device. The "ground truth" implicitly would be the physical characteristics and quality of the corneal resections created by both the Horus Laser Keratome and the predicate device, as evaluated by expert assessment (though the number and qualifications of experts are not specified). It is not pathology, expert consensus in a diagnostic sense, or outcomes data from human patients.

8. The sample size for the training set

This device is not an AI algorithm that undergoes a "training set." It is a physical medical device.

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

Not applicable, as it's not an AI algorithm.

Summary

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5. 510 (K) SUMMARY

K062314

510 (k) SUMMARY (per 21 CFR §807.92)

HORUS Laser Keratome

GENERAL INFORMATION

Manufacturer: Carl Zeiss Meditec AG Göschwitzer Strasse 51-52 07740 Jena Germany Est. Reg. No. 9615030 Contact Person: Michael Giebe RA-Manager U.S. Designated Agent: Kent W. Jones Vice President, RA/CA/Compliance Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 (925) 557-4353 (phone) (925) 557-4481 (fax) Classification name: Keratome Classification: Class II (acc. 21 CFR 878.4810) Product Code: GEX (21 CFR 878.4810) HNO (21 CFR 886.4370) Trade/Proprietary name: Horus PREDICATE DEVICE

Company:	IntraLase Corporation
Device:	IntraLase FS Laser (K013941)
Company:	Bausch & Lomb Surgical
Device:	Hansatome Microkeratome (K010260)

DEC 2 2 2006

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INTENDED USE

The Horus Laser Keratome is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Horus Laser Keratome has technological characteristics very similar to those of the IntraLase FS Laser, the laser predicate device, while the indication for use and the intended use are identical to those of the Hansatome Microkeratome.

SUMMARY

The Horus Laser Keratome has been designed and tested to applicable safety standards. In addition, the Horus Laser Keratome was found to perform equivalently to the predicate device, the Hansatome Microkeratome, with respect to the creation of cornea resections in extensive ex-vivo studies.

A statement of substantially equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA stated: "A determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. The determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2006

Carl Zeiss Meditec, Inc. c/o Kent Jones 5160 Hacienda Drive Dublin, CA 94568

Re: K062314

Trade/Device Name: Horus Laser Keratome Regulation Number: 21 CFR 878.4310 Regulation Name: Laser Instrument, Surgical, Powered Regulatory Class: Class II Product Codes: GEX; HNO Dated: December 21, 2006 Received: December 22, 2006

Dear Mr. Jones:

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M B Eychlmu Si WD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4.

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Ko6 2314

Device Name:

Horus Laser Keratome

Indications for Use:

The Horus Laser Keratome is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

ision of Ophthalmic Ea e and Throat Devis

510(k) Number

Prescription Use (Per 21 CFR 801.109)

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Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.