(32 days)
Not Found
No
The summary describes a replacement surgical blade and makes no mention of AI or ML.
No.
The device is a replacement blade for a microkeratome, which is a surgical tool. The blade itself does not directly perform a therapeutic function but is a component of a device that is used during a therapeutic procedure (corneal surgery).
No
Explanation: The device is a replacement blade for a surgical instrument (microkeratome) used in ophthalmic procedures, not for diagnosing a condition. Its function is to cut tissue, which is a therapeutic action.
No
The device is a physical blade, a hardware component, intended for use with a microkeratome. It is not software.
Based on the provided information, the MB 102 Millennium blade is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to be a replacement blade for a surgical microkeratome used on the cornea. This is a surgical tool used directly on a patient's tissue.
- Device Description: It's described as a disposable blade made of stainless steel, designed for a surgical instrument.
- Anatomical Site: The cornea is a part of the human body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The MB 102 Millennium blade is a surgical accessory used during a procedure on a patient, not a device used to analyze samples outside of the body.
N/A
Intended Use / Indications for Use
The MB 102 Millennium blade is intended to be used as a replacement blade for the Hansatome™ Microkeratome.
Product codes
HNO
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4370 Keratome.
(a)
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.(b)
Classification. Class I.
0
Millennium Biomedical Inc. MB 102 Millennium Blades
: 201
December 26, 2001 Premarket Notification
FEB 1 5 2002
Section 16
Summary of Safety and Effectiveness
1
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:
-
- 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.
3
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 |
4
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.
5
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.
6
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
7
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)