(98 days)
The 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 light source through a fiber optic cable and a scope.
LED Light Source (LLS-050 LED Illuminator)
The provided text is a 510(k) summary for the Sunoptic Technologies® LED Light Source (LLS-050 LED Illuminator). This document establishes the substantial equivalence of the LLS-050 to a legally marketed predicate device (Stryker L9000 LED Light Source, K082813).
The information requested pertains to the acceptance criteria and the study that proves a device meets those criteria. However, the provided 510(k) summary does not contain details of specific performance acceptance criteria or a study designed to directly prove the device meets these criteria in the context of clinical accuracy or diagnostic performance.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device by stating: "The technological differences between the LED Light Source (LLS-050) and the Styker LED Light Source (L9000) do not raise new questions of safety or effectiveness." It also mentions that the device will conform to voluntary safety and performance standards (UL60601-1, CAN/CSA C22.2 No.601.1 (SUP1+AM2), Medical EMC Stds. EN 60601-1-2).
Therefore, I cannot populate the requested table and sections with specific details about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test/training sets, expert qualifications, or ground truth methods, because such information is not present in the provided 510(k) summary. This type of detail is typically found in clinical study reports or validation documents, which are not part of this 510(k) summary.
Based on the provided document, here is what can be inferred or stated as "not applicable" given the nature of a substantial equivalence submission for an LED light source:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal: Substantial Equivalence to Predicate Device (Stryker L9000 LED Light Source, K082813) | "The technological differences between the LED Light Source (LLS-050) and the Styker LED Light Source (L9000) do not raise new questions of safety or effectiveness." |
| Conformance to Medical Safety Standards | Conforms to UL60601-1, CAN/CSA C22.2 No.601.1 (SUP1+AM2) |
| Conformance to Medical EMC Standards | Conforms to EN 60601-1-2 |
| Device Functionality | Used to illuminate the site of surgery during minimally invasive surgical procedures (arthroscopy, laparoscopy, endoscopy). Light transmitted via fiber optic cable and scope. |
| (Specific quantitative performance metrics like light output, color temperature stability, etc., are not detailed in this summary.) | Not Detailed in provided summary |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable, as this is a substantial equivalence submission for a light source, not a diagnostic device requiring a clinical test set for performance metrics like sensitivity/specificity. The evaluation focuses on engineering and safety comparisons.
- Data Provenance: Not applicable for a clinical test set. The submission is based on engineering design, performance specifications, and safety standard adherence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth establishment for a diagnostic test is not relevant for an LED light source substantial equivalence submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, which is not the function of an LED light source.
- Effect size of human reader improvement: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This device is a hardware component (light source), not an algorithm or AI system.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for a diagnostic or algorithmic "ground truth." The "truth" in this context revolves around engineering specifications, safety standards compliance, and functional performance as an illuminator, which are evaluated against a predicate device.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
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510 (k) Summary of Safety and Effectiveness Statement
Device Name:
Proprietary Name: Common and Usual Name: Classification Name:
LED Light Source (LLS-050 LED Illuminator) Light Source, Illuminator Light Source, Fiberoptic, Routine, CFR 21 § 876.1500
Manufacturer Information:
Sunoptic Technologies®, LLC 6018 Bowdendale Avenue Jacksonville, FL 32216 USA
MAR 1 8 2010
Establishment Registration Number: 1035968 FDA Device Classification
| Device Description: | Gastroenterology - Endoscope andAccessories |
|---|---|
| Medical Specialty: | General and Plastic Surgery |
| Product Code: | FCW |
| 510(k) Exempt? | No |
| Regulation Number: | 876.1500 |
Product Description:
Indications for Use: The 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 light source through a fiber optic cable and a scope.
Voluntary Safety and Performance Standards: The LED Light Source will conform to the Medical Safety Stds .: UL60601-1, CAN/CSA C22.2 No.601.1 (SUP1+AM2), Medical EMC Stds. EN 60601-1-2 and CE marked
Predicate Device:
The LED Light Source is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the predicate device Stryker L9000 LED Light Source (K082813).
Substantial Equivalence
The technological differences between the LED Light Source (LLS-050) and the Styker LED Light Source (L9000) do not raise new questions of safety or effectiveness. Therefore, the LED Light Source (LLS-050) is substantially equivalent to the predicate marketed device. Refer to section IV for a detailed comparison.
Contact:
Janice G. Lee
2/24/10
Date
Sunoptic Technologies®, LLC 6018 Bowdendale Avenue Jacksonville, FL 32216 USA 904 737 7611 (phone); 904 733 4832 (fax); or e-mail janice.lee@sunoptictech.com.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 1 8 2010
Sunoptic Technologies, LLC % Ms. Janice G. Lee Director, OA & Regulatory Affairs 6018 Bowdendale Avenue Jacksonville, Florida 32216-6042
Re: K093792
Trade/Device Name: LED Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FCW Dated: March 15, 2010 Received: March 16, 2010
Dear Ms. Lee:
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
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Page 2 - Ms. Janice G. Lee
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 (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.
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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours
Radiological Health
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and
Enclosure
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Indications for Use
510(k) Number (if known): K093792
Device Name: LED Light Source
Indications for Use: The 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 light source through a fiber optic cable and a 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)
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Uilal for Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093792 Page ① of ①
§ 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.