← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K020122
# MB 102 MILLENNIUM BLADES (K020122)
_Millennium Biomedical, Inc. · HNO · Feb 15, 2002 · Ophthalmic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K020122
## Device Facts
- **Applicant:** Millennium Biomedical, Inc.
- **Product Code:** [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO.md)
- **Decision Date:** Feb 15, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4370
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic
## 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.
## Regulatory 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](/device/K972808.md))
## 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
{1}------------------------------------------------
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: (909)-621-7556
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
(Bausch & Lomb) | Hansatome™
Microkeratome
which uses Bausch
& Lomb Accuglide™
blades | K972808 | 11-5-91 |
{2}------------------------------------------------
## 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
(PREDICATE DEVICE) | MBI MB 102
MILLENNIUM BLADE |
| Intended Use | Indicated for use with the
Hansatome™ Microkeratome by
surgeons to cut cornea in the form
of a hinged flap in LASIK
refractive surgery procedures. | Indicated for use as a replacement
blade for the Hansatome™
Microkeratome. |
| Operating Principle | The blade is held in the keratome
head and oscillates by means of
the turbine. The keratome head
adapts to the turbine by means of a
threaded part. The turbine motor
is gas powered. | The blade is held in the keratome
head and oscillates by means of
the turbine. The keratome head
adapts to the turbine by means of a
threaded part. The turbine motor
is gas powered. |
| Blade Design | Single edge blade with the plastic
blade holder | Single edge blade with the plastic
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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
---
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