(87 days)
Not Found
No
The description focuses on the device's mechanical function and integrated light source, with no mention of AI or ML capabilities.
No.
The device is a surgical instrument used to cut the carpal tunnel ligament, but it does not directly treat a disease or condition itself. Its function is to facilitate a surgical procedure, not to provide therapy.
No
The device is a surgical instrument used to release the carpal tunnel ligament and illuminate the surgical site, not to diagnose a condition.
No
The device description clearly states it is a "manual surgical instrument" and a "completely disposable ligament and tissue release knife with an integrated light source," indicating it is a physical hardware device.
Based on the provided information, the Stryker Knifelight is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue samples, etc., to provide information about a person's health.
- The Stryker Knifelight is a surgical instrument used directly on the human body. Its purpose is to cut and illuminate tissue during surgery, not to analyze samples taken from the body.
The description clearly states it's a "manual surgical instrument used for the release of the carpal tunnel ligament" and is used "inside areas with restricted view due to small incisions." This is a direct surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.
Product codes (comma separated list FDA assigned to the subject device)
79 EMF, 79 FSQ
Device Description
The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The device is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery.
The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Carpal tunnel ligament, carpal ligament, median nerve, functional ligaments and tendons.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
510(k) Summary of Safety and Effectiveness: Labeling Change Being Effected: Stryker Knifelight
| Proprietary Name: | Stryker Knifelight | JUN 2 5 20 |
|---|---|---|
| Common Name: | Lighted Knife | |
| Classification Name and Reference: | 21 CFR 878.4800 | |
| Manual Surgical Instrument for General Use | ||
| 21 CFR 878.4580 | ||
| Surgical Lamp | ||
| Proposed Regulatory Class: | Class I (Surgical Instrument) & Class II (Surgical | |
| Lamp) | ||
| Product Codes: | 79 EMF (Surgical Instrument), 79 FSQ (Surgical | |
| Lamp) | ||
| For Information contact: | Avital Merl-Margulies | |
| Regulatory Affairs Specialist | ||
| Howmedica Osteonics Corp. | ||
| 325 Corporate Drive | ||
| Mahwah, NJ 07430 | ||
| Phone: (201) 831-6365 Fax: (201) 831-3365 | ||
| Date Prepared: | June 23, 2010 |
Description:
The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The device is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery.
The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.
Indications for Use:
The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.
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1
Proposed Modification:
The purpose of this premarket notification is to document the legal manufacturer location change and add disposal information, additional warnings & new contraindications to the package insert for the Stryker Knifelight device.
Predicate Device:
The subject Stryker Knifelight device is substantially equivalent to the predicate Stryker Knifelight device cleared under K961122.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation % Ms. Avital Merl-Margulies Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
JUN 2 5 2010
Re: K100884
Trade/Device Name: The Stryker Knifelight Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: March 24, 2010 Received: March 30, 2010
Dear Ms. Merl-Margulies:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
. .
3
Page 2 - Ms. Avital Merl-Margulies
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely your
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Stryker Knifelight
Change Being Effected 510(k)
. Indications for Use
510(k) Number (if known): _K/00 884
The Stryker Knifelight is a manual surgical instrument used for the release of the samal The Stryker Knitenght is a manual surgicul minute to illuminate the surgical site which
tunnel ligament. It features an integrated light source of surrounding tissue tunnel itgament. It reatures an integrated itgitt bears in the minimal disturbance of surrounding tissue.
Over-The-Counter Use X Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (Patt 21 CFR 801 Subpar 27)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Neil R.P. Ogden for nxm
Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Division of Surges and Restorative Devices
510(k) Number. K100884
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