MSP M/K BLADE

K993122 · Medical Sterile Products, Inc. · HNO · Mar 16, 2000 · Ophthalmic

Device Facts

• Record ID: K993122
• Device Name: MSP M/K BLADE
• Applicant: Medical Sterile Products, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Mar 16, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MSP/MK Blade (#507-0028) is designed as a replacement blade for the Chiron Hansatome #507-0036-01 microkeratome for lamellar resection of the cornea.

Device Story

Disposable microkeratome blade; manufactured from surgical grade stainless steel; features either a prefixed plastic post or slot/holes for attachment to microkeratome instruments. Used as a replacement component in existing microkeratome machines (e.g., Chiron, Moria, Med-Logics, SCMD) for lamellar corneal resection. Operated by ophthalmic surgeons in clinical settings. Single-use; provided sterile via gamma radiation. Benefits include providing a sharp, sterile cutting edge for refractive surgery procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and functional comparison to existing, legally marketed microkeratome blades.

Technological Characteristics

Material: surgical grade stainless steel. Form factor: disposable blade with plastic post or slot/holes. Sterilization: gamma radiation. Packaging: plastic clamshell in Tyvek pouch. Connectivity: none (mechanical component).

Indications for Use

Indicated for lamellar resection of the cornea using the Chiron Hansatome microkeratome.

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

• Microspecialties, Inc. (K980510, K980508)
• Howard Instruments, Inc. (K972727)
• Med-Logics, Inc. (K962661)

Reference Devices

• Universal Refractive Instruments B. Graczyk, Inc.

Submission Summary (Full Text)

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K993122

510K Summary Medical Sterile Products Disposable Microkeratome Blades

Food and Drug Administration 510K Document Mail Center HFZ-401 Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850

FDA/CDRH/ODE/DMC
20 SEP 99 10 40
RECEIVED
sk-14

09/11/99

RE: 510K Submission - Microkeratome Blades from: Medical Sterile Products, Inc. Road 413 Km. 0.2 Rincon, Puerto Rico 00677

Submitter's Name: Gary C. Dionne

To: Document Control Clerk

Medical Sterile Products, Inc. is requesting 510k approval for its disposable microkeratome blades. The microkeratome blades are manufactured either with a prefixed plastic post or have a slot/holes in the blade. The plastic post fits into a slot within the microkeratome instrument and the slot/holes in the blade are used to affix the blades to a stainless steel post on the microkeratome. The steel used for the blade in either configuration is the same, as well as the packaging and sterilization method. The blades are designed to be used in pre-existing, on the market, microkeratomes that presently use comparable disposable microkeratome blades.

| Trade name : | MSP M/K BLADE |
|-------------------------------------|----------------------------------------------------------------------|
| Common name: | microkeratome blade |
| Classification : | keratome, or/and blade, surgical saw, general<br>and plastic surgery |
| Establishment Registration Number : | 2618676 |

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### Performance Standard:

The Medical Sterile Products disposable microkeratome blades are similar in design and function to those blades marketed by:

| Microspecialties, Inc.<br>16 Higgins Drive<br>Milford, CT 06460<br>510k Number : K980510<br>K980508 | (Releasable 510k details attached) |
|-----------------------------------------------------------------------------------------------------|------------------------------------|
| Howard Instruments, Inc.<br>4749 Appletree Lane<br>Tuscaloosa, AL 35405<br>510k Number : K972727 | (Releasable 510k details attached) |

Med-Logics, Inc. 9327 Blackley Street Temple City, CA 91780 510k Number : K962661 (Releasable 510k details attached)

Universal Refractive Instruments B. Graczyk, Inc. 61 Brookside Drive (Promotional information attached) Glendale, IL

#### Descriptive Comparison:

The Medical Sterile Products MSP M/K microkeratome blades are equivalent to those blades marketed by the above companies. The blades are designed to be used in existing microkeratome machines: Chiron, Moria, Med-Logics, SCMD.

## Characteristics :

The microkeratome blades are single-use disposable. The blades are packaged in a plastic clamshell case and the case is packaged in a tyvek pouch. The blades are provided sterile.

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# Certification of Safety and Effectiveness:

When used according to the microkeratome manufacturers' instructions, there are no adverse safety indications for either of the blades. The blades are manufactured from surgical grade stainless steel. The blades will be sterilized gamma radiation.

# Labeling:

The pouch will indicate Medical Sterile Products name, address, product identification, lot number, sterilization notes, disposable, and federal law requirements. Other companies could have the products relabeled with their company name.

# Sterilization:

### Gamma Radiation

Isomedix, Inc. Division STERIS Contract Services Vega Alta, Puerto Rico 00692

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2000

Mr. Gary Dionne Director Medical Sterile Products, Inc. RD. 413, KM. 0.2 Rincon, PR 00677

Re: K993122 Trade Name: MSP M/K Blade Regulatory Class: I Product Code: 86 HNO Regulation: 886.4370 Dated: February 24, 2000 Received: February 24, 2000

Dear Mr. Dionne:

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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Page 2 - Mr. Gary Dionne

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 [phone]. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl. 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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Page of of

K993122 510(k) Number (if known):_

Device Name:__________________________________________________________

Indications For Use:

The MSP/MK Blade (#507-0028) is designed as a replacement blade for the Chiron Hansatome #507-0036-01 microkeratome for lamellar resection of the cornea.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ODE/DOD/DSDB Concurrence of CDRH, Office of Device Evaluation (ODE)

Dkauf

ivision Sign-Off) vision of Ophthalmic Devices 10(k) Number_k 993122

(Optional Format 3-10-98)