M2 COMPATIBLE MICROKERATOME BLADE

K033457 · Micro Specialties, Inc. · HNO · May 25, 2004 · Ophthalmic

Device Facts

• Record ID: K033457
• Device Name: M2 COMPATIBLE MICROKERATOME BLADE
• Applicant: Micro Specialties, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191.

Device Story

The M2 Compatible Microkeratome Blade is a single-use, sterile, stainless steel replacement blade designed for the Moria M2 Microkeratome. It functions as a mechanical cutting instrument during ophthalmic surgery. The device is intended for use by trained ophthalmic surgeons in a clinical or surgical setting. It is supplied sterile via gamma radiation. The blade is physically and functionally equivalent to the predicate Moria M2 blade, ensuring compatibility with the existing microkeratome system. Its use allows for corneal resections with accuracy and variability comparable to the predicate device, facilitating standard microkeratome-assisted procedures.

Clinical Evidence

Bench testing only. Non-clinical testing on porcine eyes demonstrated that corneal resections performed with the subject blade had similar accuracy and variability to the predicate device. Physical measurements, sharpness, and fit were also confirmed to be comparable to the predicate.

Technological Characteristics

Material: 400 series stainless steel. Form factor: Replacement blade for Moria M2 microkeratome. Sterilization: Gamma radiation to SAL 10^-6 per EN 552. Single-use, disposable.

Indications for Use

Indicated for use as a replacement blade for the Moria M2 non-disposable microkeratome in ophthalmic surgical procedures.

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

• Moria M2 Microkeratome blade (K002191)

Submission Summary (Full Text)

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K033457

Ref: 510(k) Premarket Notification Summary

MAY 25 2004

To: Document Control clerk

This is to notify you of the intention of MICROspecialties, Inc. to manufacture and market the following device:

Disposable M2 Compatible Microkeratome Blades

## Establishment registration number: 1226074

This 510(k) summary of safety and effectiveness for the MICROspecialties, Inc. Microkeratome blade is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF §807.92, and follows the Office of Device Evaluation guidance concerning the presentation and content of a 510(k) summary.

- Submitter's name, address, telephone number, contact person, and date the 1. summary was prepared:
- Applicant: MICROspecialties, Inc. a. 264 Quarry Road Milford, CT 06460
- (203)-874-1832 b. Telephone number:
- c. Contact Person: Leigh S. Ayres (Director, Regulatory and Quality)
- d. Date summary prepared: 10/23/03
- Name of the device, including trade name, the common or usual name, and the 2. classification
- M2 Compatible Microkeratome Blade a. Trade/Proprietary name:
- Microkeratome blade b. Common/Usual Name:
- c. Classification: Keratome (blade only) - 21CFR §886.4370
- 86 HNO d. Product code:
- e. Classification panel: Ophthalmic
- 3. Identification of legally marketed devices to which equivalence is being claimed:

The MICROspecialties, Inc. disposable M2 Compatible Microkeratome blade is substantially equivalent in design, material, and function to the devices as marketed by:

Company: Moria S. A. Device: Moria M2 Microkeratome blade 510(k) number: K002191

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K033457

- Description of the device: 4.
The MICROspecialties, Inc. disposable M2 compatible Microkeratome blade is a replacement stainless steel blade for the Moria M2 Microkeratome blade. Both blades are made of 400 series stainless steel and they are packaged and shipped using the same methods. Both blades are single-use, sterile, and disposable blades.

#### Certification of safety and effectiveness:

When used according to the Microkeratome manufacturer's instructions, there are no adverse safety indications for the M2 compatible Microkeratome blade.

### Sterilization Methodology:

All blades are sterilized by exposure to gamma radiation to a Sterilization Assurance Level (SAL) of 10-6 with a validated process to EN 552.

### Labeling:

The pouch will indicate MICROspecialties, Inc. name, address, product identification, lot number, sterilization notes, single use, and federal law statements.

#### 5. Intended Use for the Device:

The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191.

#### Summary of the Technological Characteristics of the Submitted Device 6. Compared to the Predicate device (§807.92(a)(6) - K002191):

| CHARACTERISTICS | M2 Compatible Blade | M2 Blade |
|-------------------|----------------------------|----------|
| Intended use | As indicated | Same |
| Target population | As indicated | Same |
| Performance | Comparable to the M2 Blade | Same |
| Blade Material | Low carbon stainless steel | Same |
| Blade dimensions | Comparable to the M2 blade | Same |

Performance Tests and Conclusions:

- 1. The physical measurements of the M2 compatible Microkeratome blade is the same as the predicate device made by Moria S. A.
- 2. The sharpness of the predicate blade made by Moria S. A. and the M2 Compatible Microkeratome blade are comparable.
- 3. The fit of the predicate blade made by Moria S. A. and the M2 Compatible Microkeratome blade are the same.
- 4. Non-clinical testing on porcine eves resulted in corneal resections that had similar accuracy and variability.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 2004

Micro Specialties, Inc. c/o Leigh S. Ayres 264 Quarry Road Milford, CT 06460

Re: K033457

Trade/Device Name: M2 Compatible Microkeratome Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: 86 HNO Dated: April 27, 2004 Received: April 29, 2004

Dear Ms. Ayres :

We have reviewed your Section 510(k) premarket notification of intent to market the device w f na re reviewe 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 prov to that if the 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- Ms. Leigh Ayres

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 Kaligi 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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# Indications for Use

510(k) Number (if known):

Device Name: M2 Compatible Microkeratome Blade (Model 700700)

Indications For Use:

The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191

Prescription Use (Part 21 CFR 801 Subparl D)

AND/OR

Qver-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Don Kevin

(Division sign-om)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(K) Number K0334157

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