CARRIAZO-PENDULAR MICROKERATOME

K082043 · Schwind Eye-Tech-Solutions GmbH & Co. KG · HNO · Aug 1, 2008 · Ophthalmic

Device Facts

• Record ID: K082043
• Device Name: CARRIAZO-PENDULAR MICROKERATOME
• Applicant: Schwind Eye-Tech-Solutions GmbH & Co. KG
• Product Code: HNO · Ophthalmic
• Decision Date: Aug 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

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

AC-powered microkeratome; utilizes pendulum motion to applanate cornea; creates homogeneous, predictable flap thickness with smooth edges. System includes console, cutting heads, suction rings, and foot switches. Surgeon operates device in clinical setting. Console controls cutting process; monitors and stores operational parameters. Monitoring software allows readout of stored data for quality assurance, process improvement, and analysis of potential complications. Output assists healthcare providers in evaluating cutting execution.

Clinical Evidence

Bench testing on pig eyes and clinical performance data on human eyes demonstrated that new cutting heads produce flaps similar to existing heads, with variations only in flap thickness. Functional testing, cleaning validation, and biocompatibility testing were performed.

Technological Characteristics

AC-powered microkeratome; pendulum motion cutting mechanism; convex cutting head/blade design. Includes console, suction rings, and foot switches. Software-based monitoring system for data storage and analysis. Sterilization process updated from predicate.

Indications for Use

Indicated for patients requiring corneal shaving prior to lamellar (partial thickness) transplant or creation of a corneal flap.

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-Pendular Microkeratome (K032910)
• BD K-4000 TM Microkeratome (K023092)
• INTRALASE FS Laser (K041893)

Submission Summary (Full Text)

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082043

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# 510(k) Summary

AUG - 1 2008

| Applicant: | SCHWIND eye-tech-solutions |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Address: | Mainparkstrasse 6-10<br>Germany 63801 Kleinostheim |
| Manufacturer: | SCHWIND eye-tech-solutions GmbH & Co.KG<br>Mainparkstrasse 6-10<br>Germany 63801 Kleinostheim<br>Registration Number: 8010873 |
| Telephone: | +49/6027 5080 |
| Fax Number: | +49/6027 508208 |
| Contact Person: | Mr. Rolf Schwind |
| Preparation Date:<br>(of the Summary) | May 2007 |
| Device Name: | Carriazo-Pendular Microkeratome |
| Common Name: | Keratome (microkeratome) |
| Classification: | 21 CFR 886.4370<br>Class I<br>Product Code: HNO<br>Panel: 86 |
| Predicated Devices: | Carriazo-Pendular Microkeratome (K032910)<br>BD K-4000 ^TM Microkeratome (K023092)<br>INTRALASE FS Laser (K041893) |

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## Device Description:

The Carriazo-Pendular is an AC powered microkeratome.

Cutting head and blade are designed in a convex form similar to the cornea itself. Due to the unique pendulum motion of the Carriazo-Pendular, the cornea becomes more applanated in the center than in the periphery. This technology provides a homogeneous and predictable flap thickness and smooth cutting edges.

The Carriazo-Pendular consists of:

| Carriazo-Pendular console: | The console controls and guards the cutting<br>process and guides the surgeon through the use<br>of the microkeratome. Additional parameters<br>will be saved for later analysis. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cutting heads: | Different heads are available in order to adjust<br>for different flap thicknesses. |
| Suction rings: | The suction ring is necessary to fixate the eye<br>during the cut. Different suction rings for<br>different flap diameters are available. The hinge<br>position can be freely selected (360 degrees). |
| Foot switches: | The foot switch starts the vacuum, and forward<br>and backward movement of the microkeratome. |
| Monitoring software: | The software was developed for read out of<br>relevant monitored data, which are stored<br>during the operation in the Carriazo-Pendular<br>console. These data can be used for quality<br>insurance, supporting the doctor in the process<br>of improving the cutting execution and analysis<br>of potential cut complications. |

#### 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.

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Image /page/2/Picture/0 description: The image shows the logo for SCHWIND eye-tech-solutions CARRAIAZO-PENDULAR. The text "SCHWIND" is in a bold, sans-serif font at the top of the image. Below that, the text "eye-tech-solutions" is in a smaller, sans-serif font. The text "CARRAIAZO-PENDULAR" is in a bold, sans-serif font at the bottom of the image.

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## Technological Characteristics:

The Carriazo-Pendular is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Carriazo-Pendular (K032910), amongst others.

The new Carriazo-Pendular has the following similarities compared to the predicate Carriazo-Pendular (K032910):

- . same intended use,
- same fundamental scientific technology and the same operating principle, .
- . same manufacturing processes,
- . construction of identical materials.

Compared to the predicated Carriazo-Pendular (K032910) the new Carriazo-Pendular differs in the following features:

- . additional cutting heads,
- . different sterilization process,
- . improved blade box,
- . Pendular Monitoring Software.

#### Performance tests/data:

Test on pig eyes and clinical performance data on human eyes shows that the new cutting heads perform flaps similar to the existing heads except for the different flap thicknesses.

Functional testing, cleaning validation and biocompatibility tests demonstrate that the device performs as intended.

#### Conclusion:

Based on the information in the notification, SCHWIND eye-tech-solutions believes that Carriazo-Pendular Microkeratome is substantially equivalent to the claimed predicate devices and does not raise new questions in terms of safety and effectiveness.

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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 stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG - 1 2008

SCHWIND eye-tech-solutions c/o Mr. Stefan Preiss TÜV SÜD America Inc. 1775 Old Highway 8 NW New Brighton, MN 55112-1891

Re: K082043

| Trade/Device Name: | Carriazo-Pendular Microkeratome |
|--------------------|--------------------------------------|
| Regulation Number: | 21 CFR 886.4370 |
| Regulation Name: | Keratome, AC-Powered (Microkeratome) |
| Regulatory Class: | I |
| Product Code: | HNO |
| Dated: | July 11, 2008 |
| Received: | July 18, 2008 |

Dear Mr. Preiss:

Wc 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Malvina B. Edwards, and

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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Page 1/1

# Indications for Use

510{k) Number (if known):

Device Name:

082043

Carriazo Pendular Microkeratrom

The Carriazo Pendular Microkeratom indicated for Indications for Use: shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea. Over-The-Counter Use OR Prescription Use × (Per 21 CFR 801.109) . . . . . . . PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED Cocurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number k092043