(35 days)
The Photonics Coldlightsource PL3000 is indicated for use to provide illumination through light-conducting devices such as fiberoptic cables.
The Photonics Coldlightsource PL3000 is a lightsource for fiberoptic cables, with a 230/240 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.
This device is a light source for fiberoptic cables, specifically the Photonics Coldlightsource PL3000. The provided document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission generally focuses on comparisons of technical specifications and performance to an existing device rather than a comprehensive "study" in the sense of clinical trials or extensive performance testing found with novel devices or AI/ML-based systems.
Therefore, many of the requested fields, such as sample sizes for test sets, expert ground truth, MRMC studies, or training sets, are not applicable to this type of device and submission. The "study" here is essentially a comparison table to a predicate device and a statement of compliance with relevant standards.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly that the Photonics Model PL3000 performs comparably to or within acceptable limits of the predicate device (Luxtec Model 3150S) for the listed features. The reported device performance is presented as a direct comparison in the table.
| Feature | Acceptance Criteria (Predicate Device Performance - Luxtec Model 3150S) | Reported Device Performance (Photonics Model PL3000) |
|---|---|---|
| Power requirements | 115VAC 60 Hz | 115/230VAC 60 Hz |
| Power consumption | approx 200 W | approx 200 W |
| Lamp type | Halogen | Halogen |
| Lamp Wattage | 150 Watts | 150 Watts |
| Color Temperature | 3250° Kelvin | 3400° Kelvin |
| Light Intensity Control | Yes | Yes |
| Fiberoptic cable connection | Yes | Yes |
The "study" demonstrating this involves a comparison of technical specifications and functional capabilities against a legally marketed predicate device (Luxtec Model 3150S, K890716). The conclusion drawn is that the Model PL3000 is "substantially equivalent" to the predicate device. Additionally, the 230/240 volt version conforms to ENEC 11, EN60601, EN55011, and UL 2601, and the 120-volt version is manufactured to similar requirements.
The following questions are not applicable or cannot be determined from the provided 510(k) summary for this type of medical device (a light source). This summary focuses on establishing substantial equivalence based on technical specifications and indications for use, not on a clinical performance study with patient data or AI/ML algorithms.
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. This is a hardware device comparison based on specifications, not a test set of data.
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 in the context of diagnostic interpretation is established here. The "ground truth" is essentially the documented specifications and performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No expert adjudication of a test set is involved.
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 is a basic medical device (light source), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" is effectively the established performance and specifications of the predicate device and compliance with international standards mentioned (ENEC 11, EN60601, EN55011, UL 2601).
8. The sample size for the training set
- Not Applicable. This is a hardware device, not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. This is a hardware device, not a machine learning model.
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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 | PhotonicsModel PL3000 | LuxtecModel 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.
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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
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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
§ 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.