(39 days)
To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
The PLS is a stand-alone, portable, detachable adaptation of the light source embedded into the ENTity NasoView Fiberscope. The PLS is an accessory to endoscopes and other devices that require an external light source.
The provided text describes a 510(k) premarket notification for a medical device called OPTIM's "PLS" Portable Light Source. This device is an LED light source intended to provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
Based on the information provided in the document, here's a breakdown of the requested criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics in the way one might expect for a diagnostic or AI-driven device (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance assessment is based on demonstrating compliance with recognized medical electrical equipment standards and substantial equivalence to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety & Effectiveness | "Performance testing demonstrates that the PLS is as safe and as effective as the predicate device." |
| Electrical Safety | Declaration of conformity to IEC Medical Electrical Equipment standards: - 60601-1:1998 - 60601-2-18:1996 - 60601-1-2:2001 |
| Intended Use | Same intended use as the predicate devices. |
| Fundamental Scientific Technology | Same fundamental scientific technology as the light engine embedded into the ENTity NasoView Fiberscope (a predicate device). |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of collected data (e.g., images, patient records). The performance evaluation here is based on engineering testing and confirmation of compliance with standards for the device itself, rather than a study involving patient data. Therefore, there is no information about sample size or data provenance in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth for a test set of data. The ground truth for device performance revolves around adherence to engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, there is no "test set" in the context of data requiring expert 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
No. This document pertains to a medical device (a portable light source), not an AI-driven system or a diagnostic tool that would involve human reader performance with or without AI assistance. Therefore, an MRMC study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device (a light source), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by its compliance with recognized industry standards for medical electrical equipment (IEC 60601 series) and demonstrating that its performance is equivalent to legally marketed predicate devices in terms of safety and effectiveness for its intended use. There is no biological or clinical ground truth like pathology or outcomes data mentioned for this specific device.
8. The sample size for the training set
Not applicable. This is a hardware device, not a machine learning model, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this hardware device.
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K091/829
510(k) SUMMARY
OPTIM's "PLS" Portable Light Source
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
JUL 2 8 2009
OPTIM Incorporated 64 Technology Park Road Sturbridge, MA 01566-1253
(508) 347-5100 Phone: Facsimile: (508) 347-2380
Robert Krupa Contact Person:
June 19, 2009 Date Prepared:
Name of Device and Name/Address of Sponsor
"PLS" Portable Light Source
OPTIM, Incorporated . 64 Technology Park Road Sturbridge, MA 01566-1253
Common or Usual Name
LED Light Source
Classification Name and Product Code
LED Light Source; NTN
Predicate Devices
ENTity NasoView Fiberscope, K080622 SOPRO 225 Dual Halogen Light Source, K072912
Purpose of the Abbreviated 510(k) Notice
The PLS is a modification of the light source embedded into the ENTity NasoView Fiberscope.
Page VI-1
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Intended Use / Indications for Use
It is intended to provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
Technological Characteristics
The PLS is a stand-alone, portable, detachable adaptation of the light source embedded into the ENTity NasoView Fiberscope. The PLS is an accessory to endoscopes and other devices that require an external light source.
Performance Data
In support of this Abbreviated 510(k), OPTIM has provided a declaration of conformity to IEC Medical Electrical Equipment standards 60601-1:1998, 60601-2-18:1996, and 60601-1-2:2001.
Substantial Equivalence
The PLS has the same intended use and fundamental scientific technology as the light engine embedded into the ENTity NasoView Fiberscope. Performance testing demonstrates that the PLS is as safe and as effective as the predicate device. The PLS also has the same intended us as the SOPRO 225 Dual Halogen Light Source. Thus, the PLS is substantially equivalent to legally marketed devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OPTIM, Inc. % Robert J. Krupa, Ph.D. Chief Scientist 64 Technology Park Road Sturbridge, Massachusetts 01566-1262
Re: K091829
Trade/Device Name: OPTIM's "PLS" Portable Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NTN Dated: June 19, 2009 Received: June 19, 2009
Dear Dr. Krupa:
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.
JUL 2 8 2009
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Robert J. Krupa, Ph.D.
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cholarboneln
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name:
OPTIM's "PLS" Portable Light Source
Indications for Use:
To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
Prescription Use X (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K091829
Page V-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.