MB 102 MILLENNIUM BLADES

K020122 · Millennium Biomedical, Inc. · HNO · Feb 15, 2002 · Ophthalmic

Device Facts

• Record ID: K020122
• Device Name: MB 102 MILLENNIUM BLADES
• Applicant: Millennium Biomedical, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Feb 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1

Intended Use

The MB 102 Millennium blade is intended to be used as a replacement blade for the Hansatome™ Microkeratome.

Device Story

MB 102 Millennium Blade is a single-use, disposable stainless steel replacement blade for the Hansatome™ Microkeratome. Used by surgeons in clinical settings during LASIK refractive surgery. The blade is held in the keratome head and oscillates via a gas-powered turbine to cut a hinged corneal flap. The device functions as a mechanical cutting instrument; it does not involve electronic processing, software, or AI. The blade's physical design, material (stainless steel), and hardness (52 Rockwell C) are identical to the predicate device, ensuring equivalent performance in creating corneal flaps for refractive correction.

Clinical Evidence

Bench testing only. Functional performance testing demonstrated that the MB 102 Millennium Blade is substantially equivalent to the predicate device.

Technological Characteristics

Single-use, disposable stainless steel blade with Delrin plastic holder. Hardness: 52 Rockwell C. Operating principle: mechanical oscillation via gas-powered turbine. Sterilization: Cobalt 60 radiation. No software or electronic components.

Indications for Use

Indicated for use as a replacement blade for the Hansatome™ Microkeratome in LASIK refractive surgery procedures to cut corneal hinged flaps.

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

• Hansatome™ Microkeratome (K972808)

Submission Summary (Full Text)

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Millennium Biomedical Inc. MB 102 Millennium Blades

: 201

December 26, 2001 Premarket Notification

K020122

FEB 1 5 2002

# Section 16

## Summary of Safety and Effectiveness

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K020122

Millennium Biomedical Inc. MB 102 Millennium Blades

December 26, 2001 Premarket Notification

## Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

- Submitter's name, address, telephone number, contact person, and data 1. summary prepared:
- Millennium Biomedical Inc. a. 360 East Bonita Avenue Pomona, California 91767 (909)-621-7646 Phone: Fax: [phone]

Contact Person: b.

Jerry Kaeni President

Date Summary Prepared: C.

December 26, 2001

## Name of device, including trade name and classification name: 2.

| a. Trade/Proprietary Name: | MB 102 Millennium Blades |
|----------------------------|--------------------------|
|----------------------------|--------------------------|

- Keratome, AC-Powered, and/or Blades b. Classification Name:
- 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| Company | Device | 510(k) No. | Date Cleared |
|----------------------------------|---------------------------------------------------------------------------------|------------|--------------|
| Chiron Vision<br>(Bausch & Lomb) | Hansatome™<br>Microkeratome<br>which uses Bausch<br>& Lomb Accuglide™<br>blades | K972808 | 11-5-91 |

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## A description of the device that is the subject of the 510(k), including 4. explanation of how device function, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

The MB 102 Millennium Blade is a replacement blade designed to be used with the Hansatome™ Microkeratome. The MB 102 Millennium Blade is a single-use only, disposable device. The blade material is similar to that used in predicate devices (stainless steel).

### 5. A statement of intended use:

The MB 102 Millennium blade is intended to be used as a replacement blade for the Hansatome™ Microkeratome.

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Millennium Biomedical Inc.

December 26, 2001
emarket Notificatio

# A statement of how the technological characteristics of the device compare to those of the predicate or legally
marketed devices: 9

# MMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVI

| CHARACTERISTICS | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | B&L Accuglide™ Blade<br>(PREDICATE DEVICE) | MBI MB 102<br>MILLENNIUM BLADE |
| Intended Use | Indicated for use with the<br>Hansatome™ Microkeratome by<br>surgeons to cut cornea in the form<br>of a hinged flap in LASIK<br>refractive surgery procedures. | Indicated for use as a replacement<br>blade for the Hansatome™<br>Microkeratome. |
| Operating Principle | The blade is held in the keratome<br>head and oscillates by means of<br>the turbine. The keratome head<br>adapts to the turbine by means of a<br>threaded part. The turbine motor<br>is gas powered. | The blade is held in the keratome<br>head and oscillates by means of<br>the turbine. The keratome head<br>adapts to the turbine by means of a<br>threaded part. The turbine motor<br>is gas powered. |
| Blade Design | Single edge blade with the plastic<br>blade holder | Single edge blade with the plastic<br>blade holder |
| Blade Hardness | 52 Rockwell C | 52 Rockwell C |
| Sterilization Method | Cobalt 60 radiation | Cobalt 60 radiation |
| Blade Material | Stainless steel | Stainless steel |
| Blade Holder Material | Delrin | Delrin |
| Patient Contact Portion of Device | Blade cutting edge | Blade cutting edge |

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## 7. Brief summary of clinical tests and results

The performance of the MB 102 Millennium Blades was found to be acceptable the test results of the functional performance testing. The results showed that the functional performance of the MB 102 Millennium Blades was substantially equivalent to that of the predicate blade.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2002

Mr. Jerry Kaeni President Millennium Biomedical Inc. 360 East Bonita Avenue Pomona, CA 91767

Re: K020122

Trade/Device Name: MB 102 Millennium Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HNO Dated: December 26, 2001 Received: January 14, 2001

Dear Mr. Kaeni:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) personalially equivalent (for the indications ferenced above and nave welling a would marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) actual to the Medical Device Amendments, or to commence prior to May 20, 1978, are excerdance with the provisions of the Federal Food, DNAA devices that have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (11ct) that to november to the general controls provisions of the Act. The You may, merciole, market the act include requirements for annual registration, listing of gencial controls provisions of are tice, 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 If your device is classified too a croy of als. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood on enents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of advised that I DT is issuation that your device complies with other requirements of the Act that I Drinas made a and regulations administered by other Federal agencies. You must of any I each statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, adoning (21 CFR 22000), 3
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by stems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 -- Mr. Jerry Kaeni, President

This letter will allow you to begin marketing your device as described in your Section 510(k) This leter will anow you to begin maing of substantial equivalence of your device to a legally promatics notification: "The starsification 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 0077. Additionally, for questions on the promotion and advertising of Complance at (301) 59 to 1010 office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general informational 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

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Millennium Biomedical Inc. MB 102 Millennium Blade

December 26, 2001 Premarket Notification

1020122 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

MB 102 Millennium Blade

Indications for Use:

The MB 102 Millennium blade is intended to be used as a replacement blade for the Chiron Hansatome™ Microkeratome.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Toris L. McCarthy

a and Throat Devisas

510(k) Number K020122

Prescription Use ____x

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

(Per 21 CFR 801.109)