(29 days)
RapiScope™ Manual Light Source
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No
The device description and performance studies focus on basic illumination technology and physical properties, with no mention of AI or ML.
No
Explanation: The device is described as an illumination source for endoscopes, which are used for visualization. Its function is to provide light, not to treat or diagnose a medical condition.
No
The device is described as an illumination source for endoscopes, providing light for visualization during procedures, not for diagnosing conditions.
No
The device description clearly outlines a physical, hand-held illumination device with hardware components like batteries, a lamp, and a means of attachment. There is no mention of software as the primary or sole component.
Based on the provided information, the Clarus Model 5197 SightLite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as an "illumination source for endoscopes." This is a device used in vivo (within the body) to provide light for visualization during endoscopic procedures.
- Device Description: The description details a hand-held illumination device that attaches to an endoscope. This aligns with the function of a light source for internal examination.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, tissue samples, etc. IVDs are designed to analyze these types of samples to provide diagnostic information.
Therefore, the Clarus Model 5197 SightLite is a medical device used for illumination during endoscopic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Clarus Model 5197 SightLite is intended as an illumination source for endoscopes. These endoscopes would be legally marketed Clarus Medical Systems devices. The SightLite is intended for multiple use. It is sold non-sterile.
Product codes
78 FTI
Device Description
The Clarus Model 5197 SightLite is a hand held illumination device for endoscopy. The device has a means of attaching a legally marketed optical assembly manufactured by Clarus Medical Systems that is sold separately. The image connector on the endoscope attaches to the optical assembly. The male illumination receptacle on the endoscope attaches to the female receptacle on the Model 5197 SightLite. The power source is four 1.5 volt AA lithium batteries. The illumination source is a Tungsten Halogen lamp.
The SightLite is intended for multiple use. It is sealed for cleaning and disinfecting.
The optical assembly used with the SightLite endoscopic light source is a separate, legally marketed, Clarus Medical Systems device that can be attached to the SightLite by means of a machined clasp that is an intrical part of the SightLite.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was performed on all exposed materials used in the construction of the SightLite. All materials passed biocompatibility testing and are suitable for this application.
Other testing included cold disinfectant (glutaraldehyde) exposure testing, liquid leak testing, battery life testing, dimensional measurements and visual examination for workmanship. All testing of the product yielded acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
RapiScope™ Manual Light Source
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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K97145
pg. 1 of 2
510(k) Summary
Model 5197 SightLite
MAY 20 1997
General Information
Classifications: Class II
Clarus Model 5197 SightLite Trade Name:
- Clarus Medical Systems, Inc. Submitter: 1000 Boone Avenue North #100 Minneapolis, Minnesota 55427
- Dale Sappenfield Contact: Vice President Engineering and Quality (612) 525-8400
Substantially Equivalent and Predicate Devices
RapiScope™ Manual Light Source, manufactured by Cook Critical Care
Device Description
The Clarus Model 5197 SightLite is a hand held illumination device for endoscopy. The device has a means of attaching a legally marketed optical assembly manufactured by Clarus Medical Systems that is sold separately. The image connector on the endoscope attaches to the optical assembly. The male illumination receptacle on the endoscope attaches to the female receptacle on the Model 5197 SightLite. The power source is four 1.5 volt AA lithium batteries. The illumination source is a Tungsten Halogen lamp.
The SightLite is intended for multiple use. It is sealed for cleaning and disinfecting.
1
K971455
pg. 2 of 2
The optical assembly used with the SightLite endoscopic light source is a separate, legally marketed, Clarus Medical Systems device that can be attached to the SightLite by means of a machined clasp that is an intrical part of the SightLite.
Intended Use
The Clarus Model 5197 SightLite is intended as a illumination source for endoscopes. These endoscopes would be legally marketed Clarus Medical Systems devices. The SightLite is intended for multiple use. It is sold non-sterile.
Testing
Biocompatibility testing was performed on all exposed materials used in the construction of the SightLite. All materials passed biocompatibility testing and are suitable for this application.
Other testing included cold disinfectant (glutaraldehyde) exposure testing, liquid leak testing, battery life testing, dimensional measurements and visual examination for workmanship. All testing of the product yielded acceptable results.
Summary of Substantial Equivalence
The Clarus Model 5197 SightLite is indicated for use as an illumination source for endoscopes. These endoscopes would be legally marketed Clarus endoscopes. The Clarus SightLite is intended for multiple use.
The Clarus SightLite is substantially equivalent to the Cook Critical Care RapiScope Manual Light Source due to the design, method of use, materials used and methods of construction. The size and packaging are also equivalent. Additionally, the Cook Critical Care RapiScope is manufactured by Clarus Medical Systems for Cook.
Due to the similarity of materials, test results and methods of use to the predicate device, Clarus believes this product does not raise any new safety or effectiveness issues.
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 representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Mr. Dale Sappenfield Vice President, Engineering and Quality ... ................................. Clarus Medical Systems, Inc. 1000 Boone Avenue North, #100 Minneapolis, Minnesota 55427
Re: K971455
MAY 20 1997
Clarus SightLite Model #5197 ---------Dated: March 17, 1997 Received: April 21, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 FTI
Dear Mr. Sappenfield:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result 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 Compliance at (301) 594-4616. 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/dsmamain.html".
Sincerely yours,
Lilliae Yiu, Ph.D.
Lillian Yin, Ph.D Director. Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K971455 510(k) Number (if known):
5127 Sach 1641 Device Name: CLADUS
Indications For Use:
SOURCE CLARUS ENDOSCOPES For ILLUMINATION
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Stallings/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1197145 510(k) Number __
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)