(71 days)
The Bioplate® Battery Powered Drill is intended to be used to drill pilot holes to facilitate the insertion of self-tapping bone screws in surgical procedures on a patient's skull.
The Bioplate® Battery Powered Drill is not intended for bone cutting or bone shaping indications.
The Bioplate® Battery Powered Drill is comprised of a metal housing, containing the motor, designed to withstand steam sterilization. Two forward speeds are activated using control buttons on the body of the unit. There is no reverse. The operating portion of the instrument has a quick release mechanism that is designed to hold stainless steel drill bits for drilling pilot holes into bony tissue prior to insertion of self-tapping bone screws. Four (4) AAA batteries (sterile, unitized or non-sterile) are inserted into the back portion of the handle prior to use.
This document is a 510(k) premarket notification for a medical device submitted to the FDA in 2002. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as requested in the prompt.
The document primarily focuses on establishing "substantial equivalence" of the Bioplate® Battery Powered Drill to existing predicate devices. This type of regulatory submission in 2002 generally relies on comparing the new device's technical characteristics and intended use to already legally marketed devices, rather than presenting a standalone clinical study with detailed performance metrics and acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone algorithm performance study.
- The type of ground truth used.
- Sample size for a training set or how ground truth for a training set was established.
The "Summary of Safety and Effectiveness" section within the 510(k) summary for this type of device typically just states that the device is substantially equivalent to predicates and that any minor differences raise no new issues of safety and effectiveness, based on comparison of technical specifications rather than clinical trial data meeting predefined acceptance criteria.
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BIOPLATE, INC. 6911 Melrose Ave. Los Angeles, California 90038 Tel: (323) 549-9500, FAX: (323) 935-0110
NOV 1 9 2002
Summary of Safety and Effectiveness - K022986
Submitter's name, address, telephone number and contact person:
Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 (323) 549-9500 (323) 935-0110 (fax)
Contact Person: Carol E. Jones
Trade Name of Device
The Bioplate® Battery Powered Drill
Common name
Battery powered drill
Classification name
Electric cranial drill motor
Device Classification
84HBC (21CFR - 882.4360)
Predicate Devices
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Anspach eMax Drill System K011444
- (4) Aesculap, Inc. Microspeed EC Motorsystem K003612
- Linvatec Corporation (5) Advantage™ Drive System K002523
- Medicon, E.G. (6) Servotronic EC100 System K972857
Description of the device
The Bioplate® Battery Powered Drill is comprised of a metal housing, containing the motor, designed to withstand steam sterilization. Two forward speeds are activated using control buttons on the body of the unit. There is no reverse. The operating portion of the instrument has a quick release mechanism that is designed to hold stainless steel drill bits for drilling pilot holes into bony tissue prior to insertion of self-tapping bone screws. Four (4) AAA batteries (sterile, unitized or non-sterile) are inserted into the back portion of the handle prior to use.
Intended used of the device
The Bioplate® Battery Powered Drill is intended to be used to drill pilot holes to facilitate the insertion of self-tapping bone screws in surgical procedures on a patient's skull.
The Bioplate® Battery Powered Drill is not intended for bone cutting or bone shaping indications.
Comparison of the device's technological characteristics with those of predicate devices
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The Bioplate® Battery Powered Drill has similar indications for use as the predicate devices marketed by Sodem Systems, Linvatec Corporation, Aesculap, Inc., Anspach Inc. and Medicon, E. G. The technical characteristics of The Bioplate® Battery Powered Drill are substantially equivalent to the corresponding characteristics of the predicate devices for the same application, and any minor differences raise no new issues of safety and efficacy.
Revised 11/1/02 Carol E. Jones Bioplate, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2002
Bionlate Inc. Bruce F. Mackler c/o Heller, Ehrman, White & McAuliffe 815 Connecticut Avenue, NW Washington, D.C. 20006-4004
Re: K022986
Trade/Device Name: Bioplate® Battery Powered Drill Regulation Number: 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC Dated: September 9, 2002 Received: September 9, 2002
Dear Mr. Mackler:
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
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Page 2 – Mr. Bruce F. Mackler
quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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) 594-4659. 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Bioplate Inc. APPLICANT:
510(k) NUMBER: (if known): K022786
Bioplate® Battery Powered Drill DEVICE NAME:
INDICATIONS FOR USE:
The Bioplate® Battery Powered Drill is intended to be used to drill pilot holes to facilitate the insertion of self-tapping bone screws in surgical procedures on a patient's skull.
The Bioplate® Battery Powered Drill is not intended for bone cutting or bone shaping indications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter-
Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022986
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).