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.

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.

AI/ML Overview

This is a summary of the provided text, focusing on the acceptance criteria and study details for the Clarus Model 5197 SightLite.

Device Description:
The Clarus Model 5197 SightLite is a handheld illumination device for endoscopy. It attaches to a legally marketed optical assembly (sold separately) from Clarus Medical Systems. The device is intended for multiple use, is sealed for cleaning and disinfecting, and is sold non-sterile. It uses four 1.5 volt AA lithium batteries and a Tungsten Halogen lamp as its illumination source.

Intended Use:
The Clarus Model 5197 SightLite is an illumination source for legally marketed Clarus Medical Systems endoscopes and is intended for multiple use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria/Methodology	Reported Device Performance
Material Safety	Biocompatibility Testing	All exposed materials used in construction must pass biocompatibility testing.	All materials passed biocompatibility testing and are suitable for this application.
Durability/Sterilization	Cold Disinfectant Exposure Testing	Tested for exposure to glutaraldehyde (a common cold disinfectant).	Acceptable results.
Integrity	Liquid Leak Testing	Not specified, but implies testing for fluid ingress/egress.	Acceptable results.
Functionality	Battery Life Testing	Not specified, but implies measuring the operational duration of the batteries.	Acceptable results.
Manufacturing Quality	Dimensional Measurements and Visual Examination	Verification of physical dimensions and visual inspection for workmanship.	All testing yielded acceptable results.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document mentions "all exposed materials" for biocompatibility and "the product" for other tests, implying a representative sample of the device was used for each test, but specific numbers are not provided.
Data Provenance: Not specified, but implied to be internal testing conducted by Clarus Medical Systems, Inc. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not applicable/not mentioned. The testing described primarily involves engineering and material science tests, not clinical or diagnostic assessments requiring expert consensus on ground truth for medical imaging or diagnostics.
Qualifications of Experts: Not applicable/not mentioned.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The tests performed are objective measurements and evaluations (e.g., passing/failing biocompatibility, acceptable liquid leak results, acceptable battery life). There is no mention of a human adjudication process for interpreting these engineering test results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study Done: No. The provided document is for a medical device (illumination source) and does not describe any MRMC comparative effectiveness study, nor does it address human reader performance with or without AI assistance. This type of study is not relevant to the evaluation of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study Done: No. This device is not an AI algorithm but a physical illumination device. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

Type of Ground Truth: The ground truth for the performance criteria is based on established engineering and materials testing standards (e.g., "passed biocompatibility testing," "acceptable results" for physical and functional tests). There is no clinical "ground truth" (like pathology, outcomes data, or expert consensus on a diagnosis) as the device itself does not make a diagnosis or produce diagnostic images to be interpreted.

8. Sample Size for the Training Set:

Sample Size: Not applicable. This device is a physical product and does not involve machine learning algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment: Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

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 SightLite is intended for multiple use. It is sealed for cleaning and disinfecting.

{1}------------------------------------------------

K971455
pg. 2 of 2

Intended Use

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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.