(168 days)
Not Found
No
The summary describes a replacement blade for a microkeratome, a mechanical surgical device. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is a replacement blade for a microkeratome, which is a surgical tool. The blade itself does not directly provide a therapeutic effect; its function is to cut tissue as part of a surgical procedure performed by another device.
No
The device is described as a replacement blade for a microkeratome, which is a surgical instrument. Its intended use is to replace a part of a surgical device, not to diagnose a condition.
No
The device is a physical blade, a hardware component, intended for use with a microkeratome. The description explicitly states it is a "replacement blade" and a "single-use only, disposable device."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a replacement blade for a microkeratome, which is a surgical instrument used in ophthalmic procedures (specifically, likely for creating corneal flaps in refractive surgery). This is a surgical device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description confirms it's a surgical blade made of stainless steel, designed for a surgical instrument.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the MB 105 Millennium blade is a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MB 105 Millennium blade is intended to be used as a replacement blade for the Moria M2 Non-Disposable Microkeratome.
Product codes (comma separated list FDA assigned to the subject device)
HNO
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K002191, K022982, K030401, K033236
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCI I 3 2004
May 22, 2001 Premarket Notification
Millennium Biomedical Inc. MB 105 Millennium Blades
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- | ||
| Disposable | |||
| Microkeratome | K002191 (blade) | 10-12-2000 | |
| Med-Logics, Inc | Med-Logics | ||
| Microkeratome | |||
| Blade, Model 7050clb | K022982 | 11-15-2002 | |
| Oasis Medical, Inc | Disposable M2-Pe | ||
| Microkeratome | |||
| Blades | K030401 | 06-19-2003 |
1
Millennium Biomedical Inc. MB 105 Millennium Blades
| Surgin Surgical
Instrumentation, Inc | Prizm Keratome
Blade, Model
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 (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
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)