(248 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and clinical performance of a replacement blade, with 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 treat or prevent a disease or condition; it is a component of a surgical instrument.
No
The device is a surgical blade used during eye surgery (replacement blade for a microkeratome), not a device that diagnoses a condition.
No
The device description explicitly states it is a "replacement blade" and a "single-use only, disposable device" made of "stainless steel," indicating it is a physical hardware component.
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 ophthalmology. This is a surgical device, not a diagnostic device.
- Device Description: The description focuses on the physical characteristics and intended use within a surgical procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to perform tests on samples to aid in diagnosis.
- Anatomical Site: The anatomical site is the cornea, which is consistent with a surgical procedure on the eye.
- Intended User: The intended user is surgeons, which aligns with a surgical device.
Therefore, the MB 103 Millennium Blade is a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.
Product codes
HNO
Device Description
The MB 103 Millennium Blade is a replacement blade designed to be used with the Moria CB Microkeratome. The MB 103 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)
The performance of the MB 103 Millennium Blades was found to be acceptable by rne perfermanate from the market field study conducted in Korea and China. The positive roombile intended use and there were no adverse events reported when used according to the Moria CB microkeratome manufacturers' instructions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 103 Millennium Blades
FEB 1 5 2002
May 22, 2001 Premarket Notification K011833
Section 16
Summary of Safety and Effectiveness
1
Millennium Biomedical Inc. MB 103 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: 909)-621-7556 Fax:
Contact Person: b.
Jerry Kaeni President
May 22, 2001
Date Summary Prepared: C.
Name of device, including trade name and classification name: 2.
| a. | Trade/Proprietary Name: | MB 103 Millennium Blades |
|---|---|---|
| ---- | ------------------------- | -------------------------- |
- Keratome, AC-Powered, and/or Blades Classification Name: b.
- 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 | |||
| (Plancon | |||
| Instruments) | Moria CB Blade | K980924 | 04-15-1998 |
| Surgical Specialties | |||
| Corp. | Precision Edge | ||
| Microkeratome | |||
| Blade | K002849 | 10-18-2000 |
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 103 Millennium Blade is a replacement blade designed to be used with the Moria CB Microkeratome. The MB 103 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: 5.
The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.
3
Millennium Biomedical Inc
MB 103 Millennium Blades
May 22, 2001
Premarket Notification
- A statement of how the technological characteristics of the device compare to those of the predicate or legally
marketed devices: 9
| CHARACTERISTICS | MORIA CB BLADE
(PREDICATE DEVICE) | MBI MB 103
MILLENNIUM BLADE |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for use with the Moria
CB 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 Moria CB
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
illennium Biomedical I
May 22, 2001
Premarket Notification
MENSIONAL EQUIVALENCY CHA
| IILLENNIUM BLA
MB 103 | 0.4600" ±0.002" | 0.316" ± 0.001"
1 | .
010" ± 0.0003" | 130 | 2800" ± 0.0010" |
0.0860" ± 0.0010" | Clinically tested and verific | |
|--------------------------|-----------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| REDICATE DEVICE) MEASUR | 0.45975 | 0.31570 | 0.1015
: | 이 대한민국 대학교 대학교 대학교 대학교
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
13°
: | 0.2810 | 1
0.0861 | :
1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | : 上一篇:
and the comments of the comments of
: |
| TRIBUT | Length | Width | ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ
Thicknes | ar of the p
and and the comments of the count
Bevel | Mounting hole length | 产品 2017
Aounting hole width | arpness verification | and the production of the count |
・・・・・・・・・・・
: 上一篇:
서로 이용된 사람들이 보
5
7. Brief summary of clinical tests and results
The performance of the MB 103 Millennium Blades was found to be acceptable by rne perfermanate from the market field study conducted in Korea and China. The positive roombile intended use and there were no adverse events reported when used according to the Moria CB microkeratome manufacturers' instructions.
. RET 2016 01/05/2000 09/04/2008 1
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Public Health Service
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: K011833
Trade/Device Name: MB 103 Millennium Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HNO Dated: December 1, 2001 Received: December 7, 2001
Dear Mr. Kaeni:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2 - Mr. Jerry Kaeni, President
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the 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 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. 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
8
Millennium Biomedical Inc. MB 103 Millennium Blade
May 22, 2001 Premarket Notification
| 510(k) Number (if known): | K011833 |
|---|---|
| Device Name: | MB 103 Millennium Blade |
| Indications for Use: |
The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Denise L. McCarthy
(Division Sign-Up)
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number K011833
Prescription Use _
(Per 21 CFR 801.109)
Over-The-Counter Use _ OR