← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K011833 # MB 103 MILLENNIUM BLADES (K011833) _Millennium Biomedical, Inc. · HNO · Feb 15, 2002 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K011833 ## 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 - **Attributes:** Therapeutic ## Intended Use The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome. ## Device Story MB 103 Millennium Blade is a single-use, disposable stainless steel blade designed for use with the Moria CB Microkeratome. The blade is held in the keratome head and oscillates via a gas-powered turbine. It is used by surgeons during refractive surgery procedures. The device functions as a mechanical cutting tool to create corneal flaps. Clinical performance was verified through field studies in Korea and China, demonstrating acceptable performance with no reported adverse events when used according to manufacturer instructions. ## Clinical Evidence Clinical performance was evaluated via a market field study conducted in Korea and China. No adverse events were reported when the device was used according to the Moria CB microkeratome manufacturer's instructions. The study confirmed the device's performance was acceptable for its intended use. ## Technological Characteristics Single-use disposable blade; material: stainless steel; blade holder material: Delrin; hardness: 52 Rockwell C; operating principle: mechanical oscillation via gas-powered turbine; sterilization: Cobalt 60 radiation. ## 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 - Moria CB Blade ([K980924](/device/K980924.md)) - Precision Edge Microkeratome Blade ([K002849](/device/K002849.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 K011833 #### 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K011833](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K011833) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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