(86 days)
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 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 provided text describes a 510(k) submission for the Stryker LED Light Source (L9000). A 510(k) submission establishes substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, many of the requested details such as acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not available in the provided document. The document focuses on regulatory approval based on demonstrating equivalence, not on a detailed clinical performance study with specific metrics as one would find for a novel device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not provide specific performance acceptance criteria or quantitative performance results from a study. It states the device "will conform to the voluntary standards listed in section 5.1" (which is not provided) and that "The technological differences... do not raise new questions of safety or effectiveness." This implies equivalence in performance rather than meeting new, specific metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Available: This type of information is related to a clinical performance study, which is not detailed in this 510(k) summary. The submission primarily relies on demonstrating substantial equivalence to a predicate device rather than conducting a new, independent clinical assessment with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Available: Ground truth establishment by experts is typically part of a clinical validation study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available: Adjudication methods are relevant for studies involving human interpretation and ground truth establishment, which are not detailed in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No: No MRMC study is mentioned. This device is a light source, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The Stryker LED Light Source is a physical illuminator, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available: As no clinical study results are presented with a "test set," no ground truth type is mentioned. The primary "ground truth" for a 510(k) is the performance of the legally marketed predicate device.
8. The sample size for the training set
- Not Applicable/Not Available: "Training set" is a term relevant to machine learning or AI models, which this device is not. No equivalent concept applies to a light source in this context.
9. How the ground truth for the training set was established
- Not Applicable/Not Available: As above, this concept doesn't apply to this device.
Summary of available information:
The provided document describes a 510(k) submission for the Stryker LED Light Source (L9000). The key to its acceptance is demonstrating substantial equivalence to a predicate device, the Stryker Quantum 5000 Light Source (K961971).
- Intended Use: To illuminate the site of surgery during minimally invasive surgical procedures (arthroscopy, laparoscopy, endoscopy).
- Regulatory Basis: The device is deemed substantially equivalent to the predicate device, meaning "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."
- Acceptance Criteria (Implied): Conformance to voluntary safety and performance standards (not explicitly listed in the provided text but mentioned as "section 5.1"). The primary "acceptance criterion" for a 510(k) is meeting the standard for substantial equivalence to a legally marketed predicate device.
- Study Proving Acceptance: The "study" is the submission itself, which compares the new device to the predicate device in terms of technology, intended use, and safety/effectiveness data available for the predicate. No new clinical performance study with specific device metrics is detailed. The FDA review determined that the information provided (including presumably technical comparisons and adherence to standards) was sufficient to demonstrate substantial equivalence.
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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
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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.
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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
§ 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.