CARRIAZO PENDULAR

K032910 · Schwind Eye-Tech-Solutions GmbH & Co. KG · HNO · Aug 30, 2004 · Ophthalmic

Device Facts

• Record ID: K032910
• Device Name: CARRIAZO PENDULAR
• Applicant: Schwind Eye-Tech-Solutions GmbH & Co. KG
• Product Code: HNO · Ophthalmic
• Decision Date: Aug 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Carriazo Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

Device Story

The Carriazo Pendular Microkeratome is a surgical instrument used by ophthalmologists to create corneal flaps or shave the cornea for lamellar transplants. The device features a ball-shaped cutting head with a curved blade, guided by two separate mains, which moves in a pendular motion. It incorporates an adjustable vacuum system (up to 675 mm Hg) with a double-headed pump to secure the eye. The device includes electronic monitoring for cable breaks and automatic stop positioning. Compared to traditional straight-blade, single-pivot microkeratomes, the pendular design and dual-guide system aim to improve cutting stability and reduce stromal bed micro-scattering. The device is operated in a clinical or surgical setting to prepare the cornea for refractive or transplant procedures, providing consistent flap thickness and diameter as verified by clinical study.

Clinical Evidence

Clinical study conducted on 200 eyes to assess safety and effectiveness. An additional study focused on flap thickness, diameter, and hinge size across various cutting heads and suction rings. Results demonstrated consistent, predictable performance in meeting clinically-selected parameters and validated the labeled flap specifications. Clinical evidence supports that technical differences from predicates do not significantly alter clinical performance.

Technological Characteristics

Materials are biocompatible. Features include a ball-shaped cutting head, curved blade, and dual-guide rail system. Vacuum system is adjustable to 675 mm Hg with a double-headed pump. Includes electronic cable break detection and automatic stop positioning. Sterilization validated to a sterility assurance level of at least 10^-6. Conforms to EN standards and CE Mark requirements.

Indications for Use

Indicated for patients requiring corneal shaving prior to lamellar (partial thickness) transplant or corneal flap creation. Prescription use only.

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

• Carriazo Barraquer Microkeratome M2 (K981741)
• Hansatome Micro-keratome (K972808)
• Plancon Microlamellar Keratome (K980924)
• Hansatome Excellus (K021640)
• UltraShaper System (K990227)
• Visitone 20-10 Microkeratome (K014000)

Submission Summary (Full Text)

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K0329/0

# SECTION 11

### 510(k) SUMMARY

This 510(k) summary of safety and effectiveness for the SCHWIND eye-tech-solutions Cariazo Pendular Microkeratome is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | SCHWIND eye-tech-solutions |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Mainparkstrasse 6-10<br>Kleinostheim 63801<br>Germany |
| Manufacturer: | SCHWIND eye-tech-solutions GMBH & CO. KG<br>Mainparkstrasse 6-10<br>Kleinostheim<br>Germany 63801 |
| Registration Number: | 8010873 |
| Telephone: | +49/6027 508273 |
| Contact Person: | Mr. William T. Kelley |
| Telephone: | 949-292-8477 |
| Fax Number: | 509-479-4840. |
| Preparation Date:<br>(of the Summary) | August 2004 |
| Device Name: | Carriazo Pendular Microkeratome |
| Common Name: | Keratome (microkeratome) |
| Classification: | 21 CFR 886.4370<br>Class I<br>Product Code: HNO<br>Panel: 86 |
| Predicate devices: | Carriazo Barraquer Microkeratome M2 (K981741); Hansatome Micro-keratome (K972808); Plancon Microlamellar Keratome (K980924);<br>Hansatome Excellus (K021640); UltraShaper System (K990227); Visitone |

20-10 Microkeratome (K014000).

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The Carriazo Pendular Microkeratome is indicated for shaving the cornea Indications: prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

Performance Data: A clinical study in 200 eyes was conducted to collect data to primarily provide reasonable assurance of the safety and effectiveness of the Carriazo-Pendular Microkeratome in a clinical setting.

> Moreover, an additional study has been performed at another site (Dr. Maria Arbelaez) with special focus on flap thickness, flap diameter and hinge size with different cutting heads and suction rings as declared in the product specification. This study provides evidence of the validity of labeled flap thicknesses and diameters which the different cutting heads are capable of producing.

> The studies include the consistent and predictable performance of the device in meeting the clinically-selected parameters.

> The differences in specifications between the Carriazo-Pendular (CP) Microkeratome and its predicates (e.g., the Carriazo-Barraquer or CB) have been evaluated. Selected differences in specifications include head/ring coupling (the CP couples automatically; predicates use manual coupling); the CP vacuum is adjustable to 675 mm Hg; the predicates are constant at 625 mm Hg); the CP has a double-headed vacuum pump and the predicates single-headed vacuum pumps; the CP electronically detects and signals a cable break; the predicates lack this feature); shape of the blade (CP is curved: the predicates are straight); the CP has a ball-shaped cutting head; the predicates are straight; at the stop in final position - the CP is automatic; the predicates are not; the CP has right and left eye rings, the predicates do not; and the CP head is guided by two separate mains; the predicates by a single pivot on the ring only and the head can move up and down during the cut which can result in micro-scattering on the stromal bed). Manv specifications of the Carriazo-Pendular Microkeratome and its cited predicates are substantially the same, e.g., hinge width, diameter of the ring, conformance to EN standards and meeting CE Mark requirements.

> The tissue-contact materials used in the fabrication of the Carriazo-Pendular Microkeratome have been shown to be biocompatible and the sterilization methods have been validated to a sterility assurance level of at least 10° and the packaging has been tested to assure its performance in maintaining the sterility of the components supplied sterile.

#### Summary:

The claim of substantial equivalence of the SCHWIND Carriazo-Pendular Microkeratome is based on clinical studies, comparisons of its specifications, intended use, and other information with the claimed predicates.

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The results of clinical studies constitute valid scientific evidence (as described in 21 CFR 860.7) which provides reasonable assurance that the Carriazo-Pendular Microkeratome is safe and effective for its intended use. Moreover, the results of the studies also provide valid scientific evidence that the observed differences in specifications between the Carriazo-Pendular Microkeratome and its predicates are not significant in terms of the clinical performance of the device. Further, the results of clinical studies corroborate its claim of substantial equivalence to the cited predicate microkeratomes.

- Based on the information in this notification SCHWIND eye-tech-solutions CONCLUSION: believes that Carriazo Pendular Microkeratome is substantially equivalent to the claimed predicates under conditions of use described in the labeling of the Carriazo-Pendular Microkeratome.
rev. 8/2004

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2004

Schwind Eye-Tech-Solutions % William T. Kelley 23832 Via Monte Coto de Caza, CA 92679

Re: K032910

Trade/Device Name: Carriazo Pendular Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: September 18, 2003 Received: September 22, 2003

Dear Mr. Kelley:

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 -- William T. Kelley

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 [phone]. 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 [phone] or [phone] 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

Enclosure

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## SECTION 7

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ Ko32910

Device Name: Carriazo Pendular Microkeratome__________________________________________________________________________________________________________________________________

Indications for Use Statement:

The Carriazo Pendular Microkeratome is indicated for shaving the cornea The Carria20 Fondular (partial thickness) transplant or to create a flap in the cornea.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use V (Per 21 CFR 801.109) OR

Over-The Counter Use ________________________________________________________________________________________________________________________________________________________

Clay R. Buttner

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

510(k) Number K032910