(35 days)
Not Found
No
The 510(k) summary describes a basic light source for fiberoptic cables and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device provides illumination for fiberoptic cables used during medical procedures and does not directly deliver therapy.
No
The device provides illumination and acts as a light source for fiberoptic cables, which is an ancillary function to medical procedures, not a diagnostic one.
No
The device description explicitly states it is a "lightsource for fiberoptic cables" and mentions voltage versions and conformity to hardware-related standards (ENEC 11, EN60601, EN55011, UL 2601), indicating it is a physical hardware device.
Based on the provided information, the Photonics Coldlightsource PL3000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide illumination through light-conducting devices such as fiberoptic cables." This describes a device used for illumination during procedures, not for testing samples taken from the human body (which is the core function of an IVD).
- Device Description: The description focuses on the technical specifications of a light source and its compliance with safety and electrical standards. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims based on sample analysis
The device appears to be a medical device used for illumination during procedures, likely surgical or endoscopic, as indicated by the use of fiberoptic cables. The predicate device (Luxtec Model 3150 Light Source) also supports this interpretation, as Luxtec is known for surgical lighting systems.
N/A
Intended Use / Indications for Use
The Photonics Coldlightsource PL3000 is indicated for use to provide illumination through light-conducting devices such as fiberoptic cables.
Product codes
FCW
Device Description
The Photonics Coldlightsource is a lightsource for fiberoptic cables, with a 230/240 PL3000 volt version which conforms to ENEC 11, EN60601, EN55011, and UL 2601. The 120 volt version is manufactured to the same requirements of these standards, and has been submitted for approval. Approval is anticipated in the immediate future.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NUV - 5 1999
Appendix D 510 (k) Summary
September 23, 1999
l. Submitted for Photonics Optics GESMBH by the initial importer and distributor, Fiber Imaging Technologies, Inc., 326 Clark Street, Worcester, Massachusetts, 01606. Submission correspondent and contact: Mr. Joseph Ress, Medical Device Requlatory Consultants, 45 Pontiac Road, Newton, MA 02168, whose telephone and FAX number is (617) 965-7714.
- Trade Name of the Device: Coldsource PL3000
Common Name: Light source
Classification Name: Endoscope and Accessories, Product code: KOG (per 876.1500)
K890716, Luxtec Model 3150 Light Source 3. Predicate Device:
-
Description of the Device: The Photonics Coldlightsource is a lightsource for fiberoptic cables, with a 230/240 PL3000 volt version which conforms to ENEC 11, EN60601, EN55011, and UL 2601. The 120 volt version is manufactured to the same requirements of these standards, and has been submitted for approval. Approval is anticipated in the immediate future.
-
Intended Use: To provide illumination through lightconducting devices such as fiberoptic cables.
-
Comparison to Predicate Device:
| Feature | Photonics
Model PL3000 | Luxtec
Model 3150S |
|-----------------------------|---------------------------|-----------------------|
| Power requirements | 115/230VAC 60 Hz | 115VAC 60 Hz |
| Power consumption | approx 200 W | approx 200 W |
| Lamp type | Halogen | Halogen |
| Lamp Wattage | 150 Watts | 150 Watts |
| Color Temperature | 3400° Kelvin | 3250° Kelvin |
| Light Intensity Control | Yes | Yes |
| Fiberoptic cable connection | yes | yes |
- Conclusions: Photonics Optics GMBH believes that based upon the foreqoinq, the Model PL3000 is substantially equivalent to the predicate device (K890716) marketed by Luxtec Model 3150S.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, arranged in a stacked formation. The profiles are depicted in a simple, curved line style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Fiber Imaging Technologies, Inc. c/o Mr. Joseph Ress Medical Device Regulatory Consultants 45 Pontiac Road Newton, MA 02168
Re: K993300 Photonics Coldlightsource PL3000 Dated: September 24, 1999 Received: October 1, 1999 Regulatory Class: II 21 CFR §876.1500/Procode: 78 FCW
Dear Mr. Ress:
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 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). 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 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 regult 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 Compiiance 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/cdrh/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INDICATIONS FOR USE
Page 1 of l
510(K) Number: к 993300
Device Name: Photonics Coldlightsource PL3000
Indications for Use:
The Photonics Coldlightsource PL3000 is indicated for use to provide illumination through light-conducting devices such as fiberoptic cables.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrance of CDRH, Office of Device Evaluation (ODE)
Perscription Use yes
OR
Over-The-Counter Use NO
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number K993300