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).

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Millennium Biomedical Inc. MB 105 Millennium Blades. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with detailed acceptance criteria and performance data like those found in a PMA (Premarket Approval) application.

Therefore, the document does not contain the requested information regarding specific acceptance criteria for device performance, or a study proving the device meets said criteria in the way a clinical trial report would.

Here's why and what can be inferred from the document:

Type of Device: The MB 105 Millennium Blade is a replacement blade for a microkeratome, a Class I device (regulated under 21 CFR 886.4370 as a Keratome). Class I devices typically have lower risk and do not require extensive clinical data for market clearance.
510(k) Process: The 510(k) pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device characteristics (design, materials, intended use, performance testing, etc.) rather than conducting de novo clinical trials to establish safety and effectiveness against explicit performance criteria.
Content of the Document: The summary focuses on:
- Identifying the submitter and device.
- Listing predicate devices.
- Describing basic physical and performance characteristics (blade material is stainless steel, similar to predicates).
- Stating the intended use (replacement blade for a specific microkeratome).
- The FDA's decision letter confirming substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text. The document does not describe:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or data provenance.
Number/qualifications of experts for ground truth.
Adjudication methods.
MRMC studies or effect sizes.
Standalone algorithm performance.
Types of ground truth used.
Sample size for training sets.
How ground truth for training sets was established.

The absence of this information is typical for a 510(k) submission for a Class I device where substantial equivalence is demonstrated through non-clinical means (e.g., material testing, mechanical testing) rather than extensive clinical efficacy or diagnostic performance studies.

Summary

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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: (909)-621-7556
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-DisposableMicrokeratome	K002191 (blade)	10-12-2000
Med-Logics, Inc	Med-LogicsMicrokeratomeBlade, Model 7050clb	K022982	11-15-2002
Oasis Medical, Inc	Disposable M2-PeMicrokeratomeBlades	K030401	06-19-2003

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Millennium Biomedical Inc. MB 105 Millennium Blades

Surgin SurgicalInstrumentation, Inc	Prizm KeratomeBlade, ModelMk8512m2	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):

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.

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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.

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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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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

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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)

Regulation Number and Section

§ 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.