COLONOSIGHT MODEL 510B

K032688 · Sightline Technologies , Ltd. · FDF · Mar 5, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K032688
• Device Name: COLONOSIGHT MODEL 510B
• Applicant: Sightline Technologies , Ltd.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Mar 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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 standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.

Device Story

ColonoSight Model 510B is a colonoscope system providing visualization and therapeutic access to the lower GI tract. The system comprises an EndoSight, camera control unit, hydro-pump, and a disposable ColonoSleeve with integrated channels for suction and therapeutic interventions. The device is introduced rectally; intubation is facilitated by an 'air-assisted push technology.' Visualization is displayed on a video monitor for the clinician. The disposable sleeve acts as a microbiological barrier. The device is used in clinical settings by physicians to perform colonoscopies, aiding in the diagnosis and treatment of large bowel conditions. It functions similarly to standard video colonoscopes, with the primary benefit of using disposable components to manage hygiene and cross-contamination risks.

Clinical Evidence

Clinical trials were performed to evaluate the ColonoSight system. The device functioned as intended and performed as expected in all instances. Supporting data included microbiological barrier bench tests (laboratory and animal) and biocompatibility/pyrogenicity testing.

Technological Characteristics

System includes EndoSight, camera control unit, hydro-pump, and disposable ColonoSleeve/Hub. Features air-assisted push technology for intubation. Disposable channels provided for suction and therapeutic interventions. Microbiological barrier provided by disposable sleeve. Biocompatibility and pyrogenicity testing performed.

Indications for Use

Indicated for adult patients requiring visualization and therapeutic access to the lower gastrointestinal tract, including the large bowel.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Pentax Video Colonoscopes (K961570, K961563, K951579)
• Fellax Video Colonoscopes (K990354, K012543, K021344)
• VSI C-F100 Colonoscope (K943895)
• Sightline RectoSight (K994130, K011782)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with three faces in profile, with flowing lines representing hair or clothing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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 [phone] or [phone] 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 [phone] or [phone] 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 | <div style="display:inline-block; vertical-align:middle;"><img src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/AyUYwogBYgFgRgFiRkYABMgBqccC4QMwAAAABJRU5ErkJggg==" style="width:5px; height:5px; vertical-align:middle;"/></div> | 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: [phone] Facsimile: [phone]

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: [phone] Facsimile: [phone]

## Common or Usual Name

Colonoscope and Accessories

#### Classification Name

Colonoscope and Accessories

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K032688
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#### 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 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.

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.