(57 days)
Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.
The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.
Light Projector AUTO LP 5123 uses a xenon arc lamp to provide illumination for an endoscope via a light guide which is connected to the projector's light port. The illumination level is automatically controlled by video.
The provided document is a 510(k) summary for the Auto LP 5123 Xenon Light Projector. It focuses on establishing substantial equivalence to a predicate device and safety through compliance with electrical standards. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/ML medical device.
Based on the document, I can provide the following, noting where information is explicitly not present for the type of device described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as performance criteria but implied by testing) | Reported Device Performance (Implied by compliance) |
|---|---|
| Safety and Effectiveness for intended use (general) | "Designed and tested to guarantee safety and effectiveness" |
| Compliance with IEC601-1 amendment 1 and 2 | Tested and found compliant by independent laboratories |
| Compliance with IEC601-1-1 | Tested and found compliant by independent laboratories |
| Compliance with IEC601-2-18 | Tested and found compliant by independent laboratories |
| Electrical Safety (Type CF applied part) | Classified as Type CF applied part per IEC601-1 |
| Color temperature of 180W xenon arc lamp | About 5600 K |
| Service life of xenon arc lamp | Approximately 500 hours |
2. Sample size used for the test set and the data provenance
- Not Applicable. This device is a xenon light projector, not an AI/ML device that processes data for diagnostic or prognostic purposes. The performance data refers to electrical safety and performance standards, not analysis of a data test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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. This is not an AI/ML device. No MRMC study was conducted. The document explicitly states "No clinical tests performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware device; there is no "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this device, "ground truth" pertains to engineering standards and specifications (e.g., electrical parameters, light output, lifespan) rather than clinical outcomes or diagnostic classifications.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets acceptance criteria, as presented in this 510(k) summary, consists of independent laboratory testing against specified international electrical safety and performance standards.
- Standards Tested: IEC601-1 amendment 1 and 2, IEC601-1-1, and IEC601-2-18.
- Conclusion: The testing led to the conclusion that the device is "designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." This implies compliance with the standards, although specific test results are not detailed in this summary.
- Clinical Testing: The document explicitly states, "No clinical tests performed." This is common for predicate-based 510(k) submissions for devices like light sources, where safety and effectiveness are primarily demonstrated through compliance with recognized electrical and performance standards and comparison to a legally marketed predicate device.
- Substantial Equivalence: The main argument for market clearance is "substantial equivalence" to existing 510(k) devices (specifically K952696 from Richard Wolf M.I.C.), asserting that "The new technological characteristics have not diminished safety or effectiveness."
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353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488
RICHARD MEDICAL INSTRUMENTS C
510(k) Summary of Safety and Effectiveness
| Submitter | |
|---|---|
| Company / Institution name: | Richard Wolf Medical Instruments Corp. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP/Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation | October 13, 1998 |
| FDA establishment regulation number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| Product Information: | |
| Trade name: | Auto LP 5123 Xenon Light Projector |
| Model number: | 5123.011 |
| Common name: | Xenon Light Source |
| Classification Name: | Xenon Light Source |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K952696 | 1 Xenon Light Source | 1 Richard Wolf M.I.C. |
| 2 | 2 | 2 |
| 3 | 3 | 3 |
1.0 Description
Light Projector AUTO LP 5123 uses a xenon arc lamp to provide illumination for an endoscope via a light guide which is connected to the projector's light port. The illumination level is automatically controlled by video.
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K 983628
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2.0 Intended Use
Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.
The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.
Technological Characteristics 3.0
The color temperature of the 180 W xenon arc lamp is about 5600 K. The service life is approximately 500 hours and will decline with time due to the number of starts. The light projector is a type CF applied part per IEC601-1.
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety and effectiveness as existing devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf.
5.0 Performance Data
Independent laboratories tested the Xenon Light Source 5123 according to specified standards IEC601-1 amendment 1 and 2, IEC601-1-1, and IEC601-2-18. The certifications for UL and CE compliance are pending.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.
By: Robert J. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Oct 12 98
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K983628 Auto LP 5123 Xenon Light Projector Dated: October 13, 1998 Received: October 15, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 GCT
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrf/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ndication
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__Light Projector AUTO LP 5123
Intended Use:
Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.
The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac svstem.
(PI.E.ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concursence of CDRH Office of Device Evaluation (ODE)
Voriel a. Seymon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
§ 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.