(266 days)
Not Found
No
The device description and intended use focus solely on providing light for endoscopic devices using traditional optical and electrical components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
Explanation: The device provides light for endoscopic devices, which are diagnostic or surgical tools. It does not directly treat or prevent a disease or condition.
No
Explanation: The device is a light source for endoscopic devices, not a diagnostic tool that interprets or analyzes patient data or physiological parameters. Its function is to illuminate, not to diagnose.
No
The device description explicitly details hardware components such as lamps, electronic ballasts, mirrors, lenses, filters, and fiber light guides, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide light for endoscopic devices." This is a function related to visualization during medical procedures, not for examining specimens in vitro (outside the body) to diagnose diseases or conditions.
- Device Description: The description details a light source with lamps, ballasts, and optical components to focus light for transmission via fiber guides to endoscopes. This aligns with a device used for illumination during endoscopy, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, this device is a medical device used for illumination during endoscopic procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FFS, GCT, FCW
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.
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)
No performance data is required for this Class II device nor requested by FDA (ODE).
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.
K983714, K001698, K022384, K052979, K991572, K991208
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
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 endoscopic | ||
| fiber cable | K001698 | II, FFS&KOD 876.1500 | |
| II, HBI&FST, 878.4580 | |||
| Isolux America | 1300 XSBP | K022384 | II, HET, 884.1720 |
| Isolux America | 1125 XSB | K052979 | II, HBI, 878.4580 |
| I, EAZ, 872.4630 | |||
| Isolux America | Fiber optic surgical | ||
| headlight | 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
Page 2 of 2
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.
2
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".
3
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
4
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
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