MB 105 MILLENNIUM BLADES

K041110 · Millennium Biomedical, Inc. · HNO · Oct 13, 2004 · Ophthalmic

Device Facts

• Record ID: K041110
• Device Name: MB 105 MILLENNIUM BLADES
• Applicant: Millennium Biomedical, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Oct 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MB 105 Millennium blade is intended to be used as a replacement blade for the Moria M2 Non-Disposable Microkeratome.

Device Story

MB 105 Millennium Blade is a single-use, disposable replacement blade for Moria M2 Non-Disposable Microkeratome; used in ophthalmic surgery to create corneal flaps; stainless steel construction; device functions as a mechanical cutting instrument; operated by ophthalmologists in clinical/surgical settings; provides consistent cutting performance for refractive surgery; benefits patient by ensuring sterile, sharp cutting edge for each procedure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, disposable stainless steel blade; designed for compatibility with Moria M2 Non-Disposable Microkeratome; mechanical cutting principle; non-powered; sterile.

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 Non-Disposable Microkeratome (K002191)
• Med-Logics Microkeratome Blade, Model 7050clb (K022982)
• Disposable M2-Pe Microkeratome Blades (K030401)
• Prizm Keratome Blade, Model Mk8512m2 (K033236)

Submission Summary (Full Text)

{0}------------------------------------------------

OCI I 3 2004

May 22, 2001 Premarket Notification

Millennium Biomedical Inc. MB 105 Millennium Blades

K041110

## 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]
Jerry Kaeni Contact Person: b. President

April 22, 2004 Date Summary Prepared: C.

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

| a. | Trade/Proprietary Name: | Millennium Blades, Model MB 105 |
|----|-------------------------|------------------------------------|
| b. | Classification Name: | Keratome, AC-Powered, and/or Blade |

### Identification of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:

| Company | Device | 510(k) No. | Date Cleared |
|--------------------|-----------------------------------------------------|-----------------|--------------|
| Moria S.A | Moria M2 Non-<br>Disposable<br>Microkeratome | K002191 (blade) | 10-12-2000 |
| Med-Logics, Inc | Med-Logics<br>Microkeratome<br>Blade, Model 7050clb | K022982 | 11-15-2002 |
| Oasis Medical, Inc | Disposable M2-Pe<br>Microkeratome<br>Blades | K030401 | 06-19-2003 |

{1}------------------------------------------------

Millennium Biomedical Inc. MB 105 Millennium Blades

| Surgin Surgical<br>Instrumentation, Inc | Prizm Keratome<br>Blade, Model<br>Mk8512m2 | K033236 | 03-26-2004 |
|-----------------------------------------|--------------------------------------------|---------|------------|
|-----------------------------------------|--------------------------------------------|---------|------------|

## 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 105 Millennium Blade is a replacement blade designed to be used with the Moria M2 Non Disposable Microkeratome. The MB 105 Millennium Blade is a single-use only, disposable device. The Blade material is similar to that used in predicate devices (stainless steel).

#### A statement of intended use: న్.

The MB 105 Millennium blade is intended to be used as a replacement blade for the Moria M2 Non-Disposable Microkeratome.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

OCT 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Millennium Biomedical, Inc. c/o Mr. Jerry Kaeni President 306 East Bonita Avenue Pomona, CA 91767

Re: K041110

Trade/Device Name: MB 105 Millennium Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Kertatome Regulatory Class: Class I Product Code: HNO Dated: September 24, 2004 Received: September 28, 2004

Dear Mr. Kaeni:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications ferenced above and nave actering on and one marketed predicate devices marketed in interstate for use stated in the enclosure) is regard actual to the Medical Device Amendments, or to commerce proof to may 20, 1978, are eccordance with the provisions of the Federal Food, Drug, devices that have been recalsmod in asses approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, increfore, market the act include requirements for annual registration, listing of gencral controls provisions of the 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 classinod (500 abor of als. Existing major regulations affecting your device can inay oc subject to such address, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc activities and I Dr. Brassian that your device complies with other requirements of the Act that I DI Has Intact and regulations administered by other Federal agencies. You must or any I cuttar statures the equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), laborning (21 cegulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

# Page 2- Mr. Jerry Kaeni

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 Kalpi 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

{4}------------------------------------------------

Millennium Biomedical Inc. MB 105 Millennium Blade

April 22, 2004 Premarket Notification

| 510(k) Number (if known): | K 041110 |
|---------------------------|----------|
|---------------------------|----------|

MB 105 Millennium Blade Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The MB 105 Millennium blade is intended to be used as a replacement blade for the Moria M2 Non-Disposable Microkeratome.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ML Nicholas

Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use _ x x

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)