(266 days)
The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.
The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a small diameter of typically 1.5-4mm. Fiber light guides (single or bundles) transmit the light to the application such as endoscopes.
The provided text is a 510(k) summary for a medical device called the "PS series" light source with fiber. This submission focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance through a clinical study with acceptance criteria.
Therefore, the document explicitly states: "No performance data is required for this Class II device nor requested by FDA (ODE)."
This means most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this particular 510(k) submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A | N/A |
| (No specific performance criteria or data were required or provided in this 510(k) submission.) | (The submission asserts effectiveness based on components and design similarities to predicate devices, stating the device produces white light similar to sunlight and improves focusing of light into fibers due to an extra short arc lamp, similar to the predicate device.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set performance data was provided or required for this 510(k) submission.
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. No ground truth establishment was performed as no test set data was provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set data was provided for adjudication.
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
- Not applicable. This device is a light source, not an AI-powered diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a light source, not an algorithm. No standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as no performance study was conducted.
8. The sample size for the training set
- Not applicable. No training set was used as this device is a light source, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth was used for this device.
Summary of Device Safety and Effectiveness Demonstration:
Instead of performance criteria, the submission focuses on demonstrating safety and effectiveness through:
- Substantial Equivalence: Comparing the PS series to legally marketed predicate devices (Isolux and Cogent/WelchAllyn light sources and cables) in terms of use, design, and function.
- Safety Standards Compliance: The device is designed to and fully meets several international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, UL2601-1, CAN/CSA-C22.2 No. 601-1-M90, 47 CFR Ch.1 Part 15 (FCC), IEC 60601-2-41).
- Technological Characteristics: Describing the components (short arc metal-halide or xenon lamps, electronic ballasts, optical components) and how they function to focus white light into fiber light guides for endoscopic applications. The short arc lamp is cited as improving effectiveness of focusing, similar to the predicate device.
The conclusion states that the technological differences to the predicate devices do not affect the safety or efficacy of the submitted devices, leading to the determination of substantial equivalence.
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K061622
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510(k) Summary of Safety and Effectiveness
Submitter
Photonic Optische Geräte GesmbH & CoKG Seeböckgasse 59 A-1160 Vienna, Austria Mr. Dieter Feger (GM) phone: +43(1)4865691-0 prepared: 13th March 2006
MAR 0 5 2007
Device Submitted
Xenon/Metal halide light source with fiber
Proprietary Name
PS series
Common Name
Light source
Predicate Devices
| Applicant | Predicate Device | 510(k) | class, code, 21CFR |
|---|---|---|---|
| Cogent/WelchAllyn | Solartec Source ST270(CL300) | K983714 | II, FFS, 876.1500 |
| Cogent/WelchAllyn | Micro Link endoscopicfiber cable | K001698 | II, FFS&KOD 876.1500II, HBI&FST, 878.4580 |
| Isolux America | 1300 XSBP | K022384 | II, HET, 884.1720 |
| Isolux America | 1125 XSB | K052979 | II, HBI, 878.4580I, EAZ, 872.4630 |
| Isolux America | Fiber optic surgicalheadlight | K991572 | II, FST, 878.4580 |
| Isolux America | fiberoptic cable | K991208 | II, HBI, 878.4580 |
Device Description
The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a small diameter of typically 1.5-4mm. Fiber light guides (single or bundles) transmit the light to the application such as endoscopes.
Intended Use
The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.
Technological Characteristics Similarities
The light sources PS series with fibers are similar in use, design and function to those from Isolux and Cogent (WelchAllyn).
Performance Data
No performance data is required for this Class II device nor requested by FDA (ODE).
Safety
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K061622
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The device is designed for and fully meets following international safety standards:
- · IEC 60601-1:1988 +A1:1991 +A2:1995
- · IEC 60601-1-2:2001
- · IEC 60601-2-18:1996 +A1:2000
- · UL2601-1:1997
- · CAN/CSA-C22.2 No. 601-1-M90
- · 47 CFR Ch.1 Part 15 (FCC)
- · IEC 60601-2-41:2000 (in accordance to UV measurements)
Effectiveness
Metal halide or xenon arc lamps produce white light similar to sunlight. All light transmitting elements such as mirrors, lenses, filters and coatings are determined not to change the color temperature of the system.
This device uses an extra short arc lamp, which improves the effectiveness of focusing the light with the help of optics into a small fiber (single or bundle) with diameters typically between 1.5-4mm as the predicate device.
Conclusion
The technological differences to the predicate devices do not affect the safety or efficacy of the submitted devices, therefore leads to the conclusion, that the cold light series PS including fibers are substantial equivalent to the Predicate Devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Photonic Optische Geräte GesmbH & CoKG c/o Mr. Stefan Preiss TPR Program Manager TÜV Product Service, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
MAR 05 2001
K061622 Re:
Trade/Device Name: PS series with fiber light guide Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FFS, GCT and FCW Dated: January 23, 2007 Received: January 29, 2007
Dear Mr. Preiss:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a black and white circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "PA" are in the center of the seal in a bold font. The word "Centennial" is below the letters "PA". Three stars are below the word "Centennial".
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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.
This letter will allow you to begin 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K061622 510(k) Number (if known):
Device Name: PS series with fiber light guide
Indications For Use:
The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.
Prescription Use: YES
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
cy Broodon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiolasiמ
and Radiological Devices
510(k) Number
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.