8X-10-XXXX Camera System

K152513 · Santa Barbara Imaging Systems · GCJ · Dec 15, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152513
• Device Name: 8X-10-XXXX Camera System
• Applicant: Santa Barbara Imaging Systems
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The 8X-10-XXXX Camera System, with optional integrated LED light source and image/video capture, is to be used when performing a variety of minimally invasive surgical procedures and for general medical visualization and video archive applications. The 8X-10-XXXX Camera System incorporates a remote camera head which displays the image, as presented through an endoscope, microscope, integrated or coupled optics, onto a viewing monitor. Displayed images and videos may be captured and stored internally or transferred or transmitted via a variety of means, controlled through the device's integrated touch panel or an optional secondary remote control mobile device. The 8X-10-XXXX is intended to be used in a controlled operating room environment with compatible devices by qualified medical personnel. The camera heads are provided non-sterile. The endoscopic camera head may be sterilized by steam autoclave or other prescribed sterilization methods. The system has a 3 year expected service life.

Device Story

High-definition camera system captures still/video images during endoscopic/general surgical procedures; includes console and compatible camera head; optional internal LED light source with turret light guide adapter. Used in controlled operating room environments by qualified medical personnel. System displays images from endoscopes/microscopes onto monitors; supports internal storage, transfer, or transmission of captured media. Controlled via integrated touch panel or optional secondary remote mobile device. Provides visualization of interior body cavities to assist clinical decision-making; benefits patient through minimally invasive surgical support.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via bench testing and compliance with international medical device safety standards (IEC 60601 series).

Technological Characteristics

High-definition endoscopic camera system; console and camera head configuration. Features optional integrated LED light source with turret light guide adapter. Connectivity via integrated touch panel or optional remote mobile device. Sterilization: camera heads compatible with steam autoclave. Standards compliance: IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (Endoscopic equipment).

Indications for Use

Indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Used with compatible 8X-10-XXXX Camera Head, endoscope, optical coupler, and light cable.

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

• OVS I Video System (K123359)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

December 15, 2015

Santa Barbara Imaging Systems James Candy Director 340 Storke Road, Suite 101 Goleta, California 93117

Re: K152513

Trade/Device Name: 8X-10-XXXX Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 30, 2015 Received: November 5, 2015

Dear James Candy:

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. 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 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for 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

510(k) Number (if known) K152513

Device Name 8X-10-XXXX Camera System

#### Indications for Use (Describe)

The 8X-10-XXXX Camera System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The 8X-10-XXXX Camera System is indicated for use with a compatible 8X-10-XXXX Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image contains the logo for Santa Barbara Imaging Systems. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of four blue and yellow arrow-like shapes pointing towards the center. The text "Santa Barbara" is in a larger, teal font, and "IMAGING SYSTEMS" is in a smaller, teal font below it.

340 Storke Road, Suite 101 Goleta, CA 93117 USA

August 28. 2015 Traditional 510(k) Summary

#### 510(k) Summary 5

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Santa Barbara Imaging Systems, Incorporated is hereby submitting this 510(k) summary.

# Submitter [510(k) owner]

Santa Barbara Imaging Systems, Incorporated.

340 Storke Road, Suite 101

Goleta, CA 93117

## Company Contact

James Candy Director, Research and Development P 805.770.2110 F 805.770.2093 [e-mail]

## Submitted Device Information

Trade Name: 8X-10-XXXX Camera System Common Name: Endoscope And Accessories Classification Name: Laparoscope, General & Plastic Surgery

## Classification Information

Classification: Class II Classification Regulation: 21 CFR 876.1500 Classification Product Code: GCJ

# Legally Marketed Predicate Devices

The 8X-10-XXXX Camera System manufactured by Santa Barbara Imaging Systems (SBIS) is substantially equivalent to the following device currently in commercial use:

| Device: | OVS I Video System |
|----------------|---------------------------------------------------------------|
| Manufacturer: | Olive Medical Corporation |
| Address: | 2302 S Presidents Drive, Suite D, Salt Lake City, Utah, 84120 |
| 510(k) number: | K123359 |

## Submitted Device Description

The 8X-10-XXXX Camera System is a high-definition camera used to capture still and video images of endoscopic or general surgications. The system also incorporates an optional internal light source featuring a Turret Light Guide Adapter which accepts various light guides. The 8X-10-XXXX Camera System consists of a console and a compatible 8X-10-XXXX camera head.

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Image /page/4/Picture/0 description: The image shows the logo for Santa Barbara Imaging Systems. The logo consists of a blue and yellow geometric shape on the left, followed by the text "Santa Barbara" in blue, and "IMAGING SYSTEMS" in a smaller font size below it. The address "340 Storke Road, Suite 101" is printed below the logo.

Goleta, CA 93117 USA

# Intended Use

The 8X-10-XXXX Camera System, with optional integrated LED light source and image/video capture, is to be used when performing a variety of minimally invasive surgical procedures and for general medical visualization and video archive applications. The 8X-10-XXXX Camera System incorporates a remote camera head which displays the image, as presented through an endoscope, microscope, integrated or coupled optics, onto a viewing monitor. Displayed images and videos may be captured and stored internally or transferred or transmitted via a variety of means, controlled through the device's integrated touch panel or an optional secondary remote control mobile device.

The 8X-10-XXXX is intended to be used in a controlled operating room environment with compatible devices by qualified medical personnel. The camera heads are provided non-sterile. The endoscopic camera head may be sterilized by steam autoclave or other prescribed sterilization methods. The system has a 3 year expected service life.

### Indications for Use:

The 8X-10-XXXX Camera System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The 8X-10-XXXX Camera System is indicated for use with a compatible 8X-10-XXXX Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.

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Goleta, CA 93117 USA

# Substantial Equivalence

The 8X-10-XXXX Camera System is substantially equivalent to the predicate device. The 8X-10-XXXX Camera System does not raise any new questions of safety or effectiveness.

The following table summarizes the characteristics of the 8X-10-XXXX Camera System (SBIS Subject Device) and the OVS1 Video System (Predicate Device) that were evaluated.

| SBIS 8X-10-XXXX Camera System | OVS I Video System (K123359) | Comparison |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------|
| Device Description | Device Description | Substantially<br>Equivalent |
| Indications for Use | Indications for Use | Same |
| Intended Use | Intended Use | Substantially<br>Equivalent |
| Skill Level Required for User | Skill Level Required for User | Same |
| Configuration | Configuration | Same |
| Primary Device Functions | Primary Device Functions | Substantially<br>Equivalent |
| Primary Device Controls (via integrated<br>Front Panel Display or Camera Head<br>Buttons) | Primary Device Controls (via integrated<br>Front Panel Display or Camera Head<br>Buttons) | Substantially<br>Equivalent |
| Secondary Device Functions | Secondary Device Functions | Substantially<br>Equivalent |
| Compatible Equipment/Accessories | Compatible Equipment/Accessories | Substantially<br>Equivalent |
| Technology | Technology | Substantially<br>Equivalent |
| Performance | Performance | Substantially<br>Equivalent |
| Material | Material | Substantially<br>Equivalent |
| Energy Source | Energy Source | Same |
| How Supplied | How Supplied | Same |
| Safety Standard | Safety Standard | Same |
| Biocompatibility | Biocompatibility | Same |
| Sterility | Sterility | Same |

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Image /page/6/Picture/0 description: The image contains the logo for Santa Barbara Imaging Systems. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of four blue triangles pointing towards the center, with yellow diamonds in the center. The text "Santa Barbara" is in a larger, bolder font, while "IMAGING SYSTEMS" is in a smaller font below it.

August 28. 2015 Traditional 510(k) Summary

340 Storke Road, Suite Goleta, CA 93117 USA Non-Clinical Testing:

The 8X-10-XXXX Camera System demonstrates substantial equivalence in safety by tested compliance with:

- IEC 60601 -1: Medical electrical equipment -Part 1: General requirements for basic safety . and essential performance; and
- . IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.

Bench testing of performance specifications were completed and demonstrate that the device met all requirements. Bench comparison testing between the predicate device and the 8X-10-XXXX Camera System demonstrated that the devices are substantially equivalent.

#### Clinical Testing:

No comparison of clinical performance data was used for demonstration of substantial equivalence.

## Equivalence Standards Compliance

The 8X-10-XXXX Camera System has been tested and found to comply with the relevant international Medical Device Standards for Safety.

- IEC 60601-1 Medical Electrical Equipment, General Standards ●
- IEC 60601-1-2 Medical Electrical Equipment, Requirements for Electromagnetic Compatibility
- IEC 60601-2-18 Medical Electrical Equipment, Particular Requirements for Endoscopic Equipment

James Candy Director, Research and Development 340 Storke Road, Suite 101 Goleta, CA 93117 P 805.770.2110 F 805.770.2093