(151 days)
Not Found
No
The description focuses on wireless communication and control of surgical instruments via a footswitch, with no mention of AI or ML technologies.
No
The device is an accessory used to control surgical instruments, not a therapeutic device itself.
No
The device is described as an accessory for controlling surgical instruments, specifically a footswitch that activates a drive console to power handpieces. Its function is to facilitate the operation of other medical devices, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it consists of a Wireless Footswitch (W1000) and a Wireless Footswitch Adapter (W1100), which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to control surgical instruments connected to power drive consoles. This is a surgical device, not a diagnostic one.
- Device Description: The description details how the footswitch and adapter control handpieces for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for controlling surgical equipment during a procedure.
N/A
Intended Use / Indications for Use
The ConMed Linvatec Zen™ Wireless Footswitch and Adapter is an accessory that is intended to interface with compatible ConMed Linvatec power drive consoles to selectively control ConMed Linvatec surgical instruments.
Product codes
HRX
Device Description
The ConMed Linvatec Zen™ Wireless Footswitch and Adapter consists of a Wireless Footswitch (W1000) and a Wireless Footswitch Adapter (W1100) used for control of handpieces connected to a compatible ConMed Linvatec drive console. The Wireless Footswitch is designed to receive a communication signal from the Wireless Footswitch Adapter and, when a footswitch pedal is depressed, activate the drive console accordingly to power a ConMed Linvatec handpiece.
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)
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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Image /page/0/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized graphic on the left, followed by the text "CONMED" in large, bold letters. Below "CONMED" is the text "LINVATEC" in smaller letters. The logo appears to be for a medical or surgical device company.
14311 Concept Boulevard • Largo, FL 33773-4908 • 727-393-6464 • www.llnvatec.com
510(k) SUMMARY ConMed Linvatec Zen™ Wireless Footswitch and Adapter
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number __________________________________________________________________________________________________________________________________________
A. Submitter
MAR 2 7 2009
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Sue F. Dauterman Regulatory Affairs Manager (727) 399-5321 Telephone (727) 399-5264 FAX
C. Device Name
ConMed Linvatec Zen™ Wireless Footswitch and Adapter Trade Name:
Common Name: Wireless Footswitch
Classification Name: Arthroscope, 888.1100
Proposed Class/Device: Class II
Product Code: HRX
D. Predicate/Legally Marketed Devices
| ConMed Linvatec 3-Pedal | 510(k) # K990524 | ConMed Linvatec Footswitch |
|---|---|---|
| Stryker Wireless Universal | 510(k) # K033135 | Stryker Endoscopy |
| Footswitch System | ||
| IR Wireless Footswitch System | 510(k) # K053510 | Linemaster Switch |
| Corporation |
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Image /page/1/Picture/0 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads 'K083161' and is written in a cursive style. The characters are black against a white background, and the image is slightly angled.
Image /page/1/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo features a stylized graphic to the left of the text "CONMED LINVATEC". The text is in a bold, sans-serif font, with "LINVATEC" appearing in a smaller font size below "CONMED".
11314 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.linvatec.com
510(k) SUMMARY ConMed Linvatec Zen™ Wireless Footswitch and Adapter
Device Description ய்
The ConMed Linvatec Zen™ Wireless Footswitch and Adapter consists of a Wireless Footswitch (W1000) and a Wireless Footswitch Adapter (W1100) used for control of handpieces connected to a compatible ConMed Linvatec drive console. The Wireless Footswitch is designed to receive a communication signal from the Wireless Footswitch Adapter and, when a footswitch pedal is depressed, activate the drive console accordingly to power a ConMed Linvatec handpiece.
F. Intended Use
The ConMed Linvatec Zen™ Wireless Footswitch and Adapter is an accessory that is intended to interface with compatible ConMed Linvatec power drive consoles to selectively control ConMed Linvatec surgical instruments.
Substantial Equivalence G.
The ConMed Linvatec Zen™ Wireless Footswitch and Adapter is substantially equivalent in intended use and design characteristics to the ConMed Linvatec 3-Pedal Footswitch.
The ConMed Linvatec Zen™ Wireless Footswitch and Adapter is substantially equivalent in technological characteristics to the Stryker Wireless Universal Footswitch System (Stryker Endoscopy), and IR Wireless Footswitch System (Linemaster Switch Corporation).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2009
ConMed Linvatec % Ms. Sue Dauterman Regulatory Affairs Manager 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K083161
Trade/Device Name: ConMed Linvatec Zen™ Wireless Footswitch and Adapter Regulation Number: 21 CFR 888,1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 10, 2009 Received: March 11, 2009
Dear Ms. Dauterman:
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
3
Page 2 - Ms. Sue Dauterman
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Aym. D. fr.
Mafk N. Melkerson 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):
Device Name: ConMed Linvatec Zen™ Wireless Footswitch and Adapter
Ko83161
Indications for Use:
The ConMed Linvatec Zen™ Wireless Footswitch and Adapter is an accessory that is intended to interface with compatible ConMed Linvatec power drive consoles to selectively control ConMed Linvatec surgical instruments.
Prescription Use_X AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krone for MXM 3/27/09
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083161