The ColonoSight Model 510B is intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract. The lower gastrointestinal tract includes, but is not restricted to, the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.

Device Description

The ColonoSight is a colonoscope covered with a disposable protective sheath and incorporating disposable channels for protective oncain and suction/therapeutic interventions. Intubation, is perfomed using an "air assisted push technology". The main components are: EndoSight, Camera Contol Unit, Hydro-The main componentie t; disposable ColonoSleeve and disposable Hub.

AI/ML Overview

The provided text describes the Sightline Technologies ColonoSight Model 510B, a colonoscope system. However, the document is a 510(k) summary (a premarket notification), which primarily focuses on demonstrating substantial equivalence to existing legally marketed devices. It does not contain the detailed acceptance criteria and a study dedicated to proving the device meets those specific acceptance criteria in the way typically expected for a detailed performance study report.

Instead, it lists types of performance data that were collected to demonstrate functionality and safety for the 510(k) submission. Therefore, I can extract information regarding the types of tests done and general statements about performance, but I cannot fulfill many of the specific requests regarding predefined acceptance criteria and a detailed study proving performance against them from this document.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document as a table of acceptance criteria with corresponding performance data against those criteria. The document states that various tests were performed and that the device "functioned as intended and performed as expected."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for any of the tests mentioned (microbiological, functional, optical, or clinical trials). The document only mentions "clinical trials" were performed.
Data Provenance: The manufacturer is based in Israel (Haifa), suggesting the studies likely occurred there, but this is not explicitly stated for all tests. The nature of the studies (retrospective/prospective) is not specified.

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)

This information is not provided. As this is a medical device for direct visualization, the "ground truth" for clinical performance would typically involve comparison to other colonoscopies or subsequent pathology. However, the document does not detail this.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

MRMC study: Highly unlikely and not mentioned. This device is a colonoscope providing visualization and therapeutic access, not an AI-assisted diagnostic imaging interpretation system. Therefore, an MRMC study related to "human readers improving with AI vs without AI assistance" is not applicable to the function of this device as described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone algorithm performance: No, this is not a software algorithm-only device. It is a physical colonoscope. The document describes "functional tests," "optical performance tests," and "clinical trials" of the system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "clinical trials" mentioned, the specific type of ground truth used is not specified. For a colonoscope, positive findings would typically be confirmed by pathology, and visualization quality by expert assessment.

8. The sample size for the training set

Training Set Sample Size: Not applicable and not provided. The device is a physical medical instrument, not a machine learning model that undergoes a "training phase" on a dataset in the conventional sense.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable and not provided. See above.

Summary of available performance data from the document:

The document broadly states that the following performance data was collected as part of the 510(k) submission:

Microbiological barrier bench tests: Performed on the ColonoSleeve component, both in a laboratory and in animals.
Functional tests: The ColonoSight system was tested for functionality.
Optical performance tests: Performed both with and without the ColonoSleeve, reported to meet needs.
Biocompatibility and pyrogenicity tests: Performed.
Clinical trials: Performed, with "no adverse events reported." In all instances, the device "functioned as intended and performed as expected."

Conclusion from the Document:

The provided 510(k) summary asserts that the ColonoSight Model 510B is substantially equivalent to predicate devices and that various tests confirmed its functionality and safety, with "no adverse events reported" in clinical trials. However, it does not provide the granular detail of acceptance criteria, specific sample sizes for tests, expert qualifications, or adjudication methods that would be found in a comprehensive study report definitively proving performance against predefined criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Sightline Technologies. Ltd. % Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street. N.W. Washington, DC 20004-1109

JUL 2 7 2015

Re: K032688 Trade/Device Name: ColonSight® Model 510B Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated (Date on orig SE ltr): November 24, 2003 Received (Date on orig SE ltr): December 8, 2003

Dear Mr. Kahan,

This letter corrects our substantially equivalent letter of March 5, 2004.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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 forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number (if known): KO326 88

Device Name: ColonoSight Model 510B

ColonoSight provides visualization and Indications for use: The therapeutic access to the lower gastrointestinal tract. Visualization is provided via a video monitor. The lower gastrointestinal tract includes, but is not restricted to, the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the a requirement for the procedure are observed in adult patient populations.

(PLEASE DO NOT WRITE: BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		Or	Over-The-Counter
Use
(Per 21 C.F.R. 801.109)			(Optional Format 1-
2-96)

Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K032488
---------------	---------

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MAR - 5 2004

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510(k) SUMMARY

Sightline Technologies' ColonoSight Model 510B

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Sightline Technologies Ltd. Advanced Technology Center 31905 Haifa ISRAEL

Phone: +972-4-855-0447 Facsimile: +972-4-855-0164

Sharon Goldfarb-Albak Contact Person:

Date Prepared:

Name of Device and Name/Address of Sponsor

ColonoSight Model 510B

Sightline Technologies Ltd. Advanced Technology Center 31905 Haifa ISRAEL

Phone: +972-4-855-0447 Facsimile: +972-4-855-0164

Common or Usual Name

Colonoscope and Accessories

Classification Name

Colonoscope and Accessories

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K032688
page 2 of 2

Predicate Devices

ate Devices
Pentax Video Colonoscopes (K961570, K961563, and K951579). Fellax Video Co. 990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130, K011782).

Intended Use

The ColonoSight Model 510B is intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract. The lower gastrointestinal tract includes, but is not restricted to, the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any and subsystems of the large bo weating consistent with the requirement for the procedure are observed in adult patient populations.

Technological Characteristics and Substantial Equivalence

The ColonoSight is substantially equivalent to the other currently marketed Colonoscopes which are referenced above. The ColonoSight and its predicate devices are Colonoscopes. Thus, the ColonoSight and no production of safety or effectiveness.

Performance Data

Microbiological barrier bench tests were performed on the ColonoSleeve component both in a laboratory and in animals. The ColonoSight system was tested for funtionality. Optical Colonooight System this reformed both with and without the I cromance todes needs. Biocompatibility and pyrogenicity tests were performed. In addition, clinical trials were performed with no were portonment on all instances, the ColonoSight functioned as intended and performed as expected.

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.