(86 days)
Not Found
No
The 510(k) summary describes a standard LED light source for surgical illumination and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
Explanation: The device is used to illuminate the surgical site, which is a supportive function rather than directly treating or diagnosing a condition.
No
The device is an LED Light Source used to illuminate the surgical site, which is an ancillary function for surgery rather than a diagnostic one. It does not gather information for the purpose of identifying a medical condition.
No
The device description explicitly states it is a "LED Light Source" and describes the transmission of light through an optical cable and scope, indicating it is a hardware device.
Based on the provided information, the Stryker LED Light Source is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "illuminate the site of surgery during minimally invasive surgical procedures." This is a direct surgical aid, not a device used to examine specimens (like blood, tissue, or urine) outside the body to diagnose or monitor a condition.
- Device Description: The description reinforces its function as a light source for surgical procedures, transmitting light through an optical cable and scope. This is consistent with a surgical illumination device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body. The Stryker LED Light Source is used in vivo (within the living body) to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
The Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
The light source is an integral component of a visualization system which consists of a video camera, video monitor, video recorder, video printer, light cable and scope.
Product codes (comma separated list FDA assigned to the subject device)
FCW
Device Description
Stryker LED Light Source (L9000)
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): 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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521
DEC 1 9 2008
Endoscopy
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name Proprietary Name: Common and Usual Names: Classification Name:
Stryker LED Light Source (L9000) Light Source, illuminator Light Source, Fiberoptic, Routine, CFR 21 § 876.1500
Product Description:
Intended Use: The Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
Voluntary Safety and Performance Standards: The Stryker LED Light Source will conform to the voluntary standards listed in section 5.1.
Predicate Devices: The Stryker LED Light Source is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the Stryker Quantum 5000 Light Source (K961971).
Substantial Equivalence: The technological differences between the LED Light Source (L9000) and the Stryker Quantum 5000 Light Source do not raise new questions of safety or effectiveness. Therefore, the Stryker LED Light Source (L9000) is substantially equivalent to the predicate marketed device. Refer to Section 7.0 for a detailed comparison.
Contact:
23 September 2008
Date:
Desiree Crisolo Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Phone: 408-754-2784 Fax: 408-754-2521 Email: desiree.crisolo(@stryker.com
STRYKER LED LIGHTSOURCE 510(K) SUBMISSION
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle, indicating the department's name and national affiliation.
Public Health Service
MAR 2 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Corporation % Ms. Desiree Crisolo Sr. Regulatory Representative 5900 Optical Court San Jose, California 95138
Re: K082813
Trade/Device Name: Stryker LED Lightsource Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCW Dated: December 19, 2008 Received: November 14, 2008
Dear Ms. Crisolo:
This letter corrects our substantially equivalent letter of December 19, 2008.
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 (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 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.
2
Page 2 - Ms. Desiree Crisolo
This letter will allow you to continue 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INTENDED USE
Device Name: Stryker LED Light Source (L9000)
K0828 510(k) Number if known:
The Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
The light source is an integral component of a visualization system which consists of a video camera, video monitor, video recorder, video printer, light cable and scope.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilke Adan firmkn
Division of General. Restorative. ological Devices
510(k) Number K02813
STRYKER LED LIGHTSOURCE 510(K) SUBMISSION