(154 days)
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No
The description focuses on a manual surgical instrument with an integrated light source and protective features, with no mention of AI or ML capabilities.
No
The device is a surgical instrument used to cut ligaments or other tissue, which is a surgical tool, not a therapeutic device designed to treat a condition.
No
The device is a surgical instrument used for release of ligaments or other tissue, not for diagnosing medical conditions. Its integrated light source and protective retractors are for improved visualization and protection during surgery, not for diagnostic purposes.
No
The device description clearly states it is a "manual surgical instrument" and a "sterile, single use, completely disposable ligament and tissue release knife with an integrated light source." This indicates a physical hardware device, not software only.
No, 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 patient's body. It's a tool for cutting and releasing tissue during surgery.
The description clearly states its intended use is for surgical procedures on ligaments and other tissues, and it's a manual surgical instrument used in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
The Stryker Knifelight is a manual surgical instrument used for the release of ligaments or other tissue including, but not limited to, the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site. The Stryker Knifelight allows for a minimally open technique with minimal disturbance of surrounding tissue.
Product codes
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 light source 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 surgical blade has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. A standard elevator may be available with the device to facilitate ligament or tissue division.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
carpal tunnel
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
22
510K Summary
961122
Device Name:
| Classification Name: | Surgical Knife, 79 EMF, Class I
Surgical Instrument Light, 79 FSQ,
Class II |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Lighted Knife |
| Proprietary Name: | Stryker Knifelight |
| Device Sponsor: | Stryker Corporation
Instruments Division
4100 East Milham Avenue
Kalamazoo, MI 49001
Registration No: 1811755 |
Regulatory Class:
Class II
Summary of Safety and Effectiveness:
The Stryker Knifelight is a manual surgical instrument used for the release of ligaments or other tissue including, but not limited to, the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site. The Stryker Knifelight allows for a minimally open technique with minimal disturbance of surrounding tissue.
The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The light source 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 surgical blade has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. A standard elevator may be available with the device to facilitate ligament or tissue division.
1
The Stryker Knifelight is equivalent to existing marketed products by companies such as Biomet and Medtronic. Intended use, function, and safety risks are all substantially equivalent.
The Stryker Knifelight does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Therefore, the Stryker Knifelight is substantially equivalent to these existing devices.
Diane Davis
Diane Davis Regulatory Affairs Representative Stryker Instruments