(27 days)
Not Found
No
The description focuses on mechanical and electronic controls for a powered surgical instrument, with no mention of AI/ML capabilities or data processing for decision-making or analysis.
Yes
The device is described for orthopedic applications such as abrasion arthroplasty and synovectomy, which are therapeutic procedures used to treat medical conditions.
No
Explanation: The device is described as an arthroscopic shaver system used for surgical procedures like abrasion arthroplasty and synovectomy, which are interventional treatments, not diagnostic processes.
No
The device description clearly outlines multiple hardware components including a Control Console, Remote Control, Footswitch, and Shaver Handpiece, indicating it is a hardware-based system with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Power Tek II shaver system is a surgical instrument used directly on the patient's body during orthopedic procedures. It cuts and shaves tissue within joints.
- Intended Use: The intended use clearly describes surgical applications (abrasion arthroplasty, synovectomy, cutting, shaving) within specific anatomical sites. It does not mention analyzing biological samples.
The device is a surgical tool, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Power Tek II shaver system is a powered instrument for orthopedic applications including abrasion arthroplasty, synovectomy or intra-articular cutting and shaving. The device is intended for use in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.
Product codes
HRX
Device Description
The Arthrotek Power Tek II arthroscopic shaver system is intended to provide a shaver unit that will meet the surgeon's needs and patient's needs for abrasion arthroplasty, synovectomy or intra-articular cutting and shaving. The system consists of four pieces. The Control Console houses the microprocessor, shaver driver, mode and speed controls, and operator display. A Remote Control allows the user to access all controls from the surgical field. The Footswitch allows the surgeon easy on/off and forward/reverse/oscillate selection and control. The Shaver Handpiece is capable of running from 400 to 12,000 rpm's, with linear suction control for debris aspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.
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)
Non-Clinical Testing: Validation testing included IEC 601-1 Safety Testing, UL certification, and Electromagnetic Compatibility as well as software validation and clearing and sterilization validation.
Clinical Testing: None provided as a basis of substantial equivalence.
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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APR 0 3 2002
Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are bold and outlined in black, giving them a three-dimensional appearance. The overall design is simple and modern.
CORPORATE DOUARTERS H E A
Summary of Safety and Effectiveness
Applicant or Sponsor:Arthrotek. Inc.
(A wholly owned subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0578
| Contact Person: | Patricia Sandborn Beres
Biomet Orthopedics Inc.
Phone: (574) 267-6639
FAX: (574) 372-1683 |
| ----------------- | ---------------------------------------------------------------------------------------------------- |
|---|
Proprietary Name: Power Tek II
Arthroscopic shaver console and handpiece Common Name:
Classification Name: Surgical instrument motors and accessories/attachments (21 CFR 878.4820)
Legally Marketed Devices to which Substantial Equivalence is Claimed: The Integrated Endoscopy System 1000 (K920800)
Device Description: The Arthrotek Power Tek II arthroscopic shaver system is intended to provide a shaver unit that will meet the surgeon's needs and patient's needs for abrasion arthroplasty, synovectorny or intra-articular cutting and shaving. The system consists of four pieces. The Control Console houses the microprocessor, shaver driver, mode and speed controls, and operator display. A Remote Control allows the user to access all controls from the surgical field. The Footswitch allows the surgeon easy on/off and forward/reverse/oscillate selection and control. The Shaver Handpiece is capable of running from 400 to 12,000 rpm's, with linear suction control for debris aspiration.
Intended Use: The Power Tek II shaver system is a powered instrument for orthopedic applications including abrasion arthroplasty, synovectomy or intra-articular cutting and shaving. The device is intended for use in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.
Summary of Technologies: The materials, process and design of the Power Tek II are similar to the predicate device.
Non-Clinical Testing: Validation testing included IEC 601-1 Safety Testing, UL certification, and Electromagnetic Compatibility as well as software validation and clearing and sterilization validation.
Clinical Testing: None provided as a basis of substantial equivalence.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
일
OFFICE
219.267.6639
FAX 219.267.8137
000137
E-MAIL biomet@biomet.com
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 · Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K020761
Trade/Device Name: Power Tek II Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 6, 2002 Received: March 7, 2002
APR 0 3 2002
Dear Ms. Beres:
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.
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Page 2 - Ms. Patricia Sandborn Beres
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) 594-4659. 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.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ KO2O761
Device Name: Power Tek II
Indications For Use:
The Power Tek II shaver system is a powered instrument for orthopedic applications including abrasion arthroplasty, synovectorny or intra-articular cutting and shaving. The device is intended for use in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020761
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
************* Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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