(39 days)
Not Found
No
The summary describes a light source accessory for endoscopes and does not mention any AI/ML capabilities or image processing.
No.
The "Intended Use" states it provides illumination for examination, diagnostic, and therapeutic applications, but the "Device Description" clarifies it is an accessory to endoscopes that require an external light source. The "therapeutic applications" are enabled by the endoscope, not by the light source itself which only provides illumination.
No
The device description indicates it provides illumination for examination, diagnostic, and therapeutic applications. While it aids in diagnostic procedures by providing light, it does not perform the diagnosis itself. It is explicitly described as an "accessory to endoscopes and other devices that require an external light source," rather than a diagnostic tool.
No
The device description explicitly states it is a "stand-alone, portable, detachable adaptation of the light source embedded into the ENTity NasoView Fiberscope," indicating it is a physical hardware device providing illumination.
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 illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy." This describes a device used to visualize internal structures, not to perform tests on samples taken from the body (which is the core of IVD).
- Device Description: The description confirms it's a light source accessory for endoscopes and other devices requiring external illumination. This aligns with a visualization tool, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis based on laboratory tests
The device's function is purely to provide light for visual examination, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
Product codes
NTN
Device Description
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.
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)
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. Performance testing demonstrates that the PLS is as safe and as effective as the predicate device.
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
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
1
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.
2
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
3
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
4
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