OVS1 VIDEO SYSTEM

K123359 · Olive Medical Corp. · FCW · Dec 19, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K123359
• Device Name: OVS1 VIDEO SYSTEM
• Applicant: Olive Medical Corp.
• Product Code: FCW · Gastroenterology, Urology
• Decision Date: Dec 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The OVS 1 Video 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 OVS1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable

Device Story

OVS1 Video System is a camera control unit (CCU) with integrated LED light source and 12.1" LCD display. Used in surgical environments by clinicians to view endoscopic images. Inputs include signals from compatible Olive Medical HD camera heads, endoscopes, and light cables. Device processes video signals for external display and provides illumination for the surgical site. System assists surgeons in visualizing interior body cavities during diagnostic and operative procedures. Benefits include integrated visualization and illumination in a single unit, facilitating endoscopic workflows.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via bench testing, including compliance with ISO 60601-1 (basic safety/essential performance) and ISO 60601-1-2 (electromagnetic compatibility).

Technological Characteristics

Integrated 12.1" LCD display; LED light source; 720 vertical line video resolution. Powered by external wall outlet. Materials similar to predicate devices. Connectivity via compatible camera head, endoscope, and light cable interfaces. Bench testing per ISO 60601-1 and ISO 60601-1-2.

Indications for Use

Indicated for patients undergoing diagnostic and operative endoscopic procedures requiring illumination and visualization of interior body cavities via natural or surgical openings.

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

• Tele Pack X (Not known)
• Image 1 Video Imaging System With Option (K070716)
• Inner Vue Diagnostic Scope System (K072879)
• Flexible Video Endoscope with Sheath and Video Processor (K102733)
• LED Light Source (K093792)

Reference Devices

• Lightsource or Illuminator (K961074)

Submission Summary (Full Text)

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KI23359

Olive Medical Corporation 2302 S Presidents Drive Ste. D SLC, UT 84120 +1. 866.300.1148 www.olivemedical.com

### 510(k) Summary

| DEC | 1 | 9 | 2012 |
|-----|---|---|------|
|-----|---|---|------|

Surgery

| 510(k) Submitter | Olive Medical Corp.<br>2302 South Presidents Dr. STE D<br>Salt lake City, UT 84120 |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Contact(s)<br>Telephone<br>Fax | Brian Dean<br>[phone]<br>[phone] |
| Date Prepared | October 26th, 2012 |
| Trade Name | OVS1 Video System |
| Common Name | Endoscope And/Or Accessories |
| Classification Name<br>Regulation Number<br>Product Code | Light Source, Fiberoptic, Routine; Laparoscope, General & Plastic<br>21 CFR 876.1500<br>FCW; GCJ |

# Predicate Devices

| Tele Pack X | Not known | Karl Storz Endoscopy- America, Inc |
|----------------------------------------------------------|-----------|------------------------------------|
| Image 1 Video Imaging System With Option | K070716 | Karl Storz Endoscopy- America, Inc |
| Inner Vue Diagnostic Scope System | K072879 | Biomet Sports Medicine |
| Flexible Video Endoscope with Sheath and Video Processor | K102733 | Vision-Sciences, Inc |
| LED Light Source | K093792 | Sunoptic Technologies, Inc. |

# Device Description:

The OVS I Video System is a Camera Control Unit with integrated LED Light Source and Video Display for use in a surgical environment to view endoscopic images when interfaced with the Olive Medical TCK I HD Camera Head, an endoscope, a light cable, and other accessory devices.

# Intended Use:

# Indications for Use:

The OVS 1 Video 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 OVS1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable

This Indications for Use statement is substantially equivalent to predicate devices.

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Section 5: 510(k) Summary

# General description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate:

The OVS I Video System is intended for use in endoscopic procedures without limit to the diseases or condition being treated by the treating surgeon.

### Patient Population for which the device is intended:

The OVS 1 Video System is intended for use with patients undergoing endoscopic procedures for which the treating surgeon desires external video display and/or illumination.

# Comparison of Technological Characteristics

The OVS1 Video System is substantially equivalent to predicate devices since the device technology and design are similar. The Indications for Use statements are similar to predicate devices, and no new issues of safety or effectiveness are raised. The minor differences between the OVS1 Video System and predicate devices have no negative effect on performance, function, or intended use of the device.

#### Device Comparison Tables:

| | Display<br>Technology | Display<br>Size | Video Output Resolution<br>(vertical lines) | Control Unit<br>Technology |
|------------------------------------------------------------------------------------------------|-----------------------|-----------------|---------------------------------------------|--------------------------------------------------|
| OVS1 Video System | Integrated LCD | 12.1" | 720 | Similar |
| Tele Pack X<br>Karl Storz Endoscopy- America, Inc<br>510(k) unknown | Integrated LCD | 15" | 494* | Similar |
| Image 1 Video Imaging System<br>With Option<br>Karl Storz Endoscopy- America, Inc<br>K070716 | N/A | N/A | N/A | Similar - no on-board display or<br>Light Source |
| InnerVue Diagnostic Scope<br>System<br>Biomet Sports Medicine<br>K072879 | Integrated LCD | 6.4" | 480 | Similar |
| Flexible Video Endoscope with<br>Sheath and Video Processor<br>Vision-Sciences, Inc<br>K102733 | Integrated LCD | 15" | 480 | Similar |
| LED Light Source<br>Sunoptic Technologies, Inc.<br>K093792 | N/A | N/A | N/A | N/A |
| Lightsource or Illuminator<br>Sunoptic Technologies, Inc.<br>K961074 | N/A | N/A | N/A | N/A |

*Output resolution unknown. Vertical lines of input listed

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# Section 5: 510(k) Summary

| | Light Source<br>Technology | Light Source Safety |
|------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------|
| OVS1 Video System | LED | LED Module and output identical to LED Light Source,<br>K093792 |
| Tele Pack X<br>Karl Storz Endoscopy- America, Inc<br>510(k) unknown | Metal Halide | Light Source Safety demonstrated in 510(k) submission |
| Image 1 Video Imaging System<br>With Option<br>Karl Storz Endoscopy- America, Inc<br>K070716 | N/A | N/A |
| InnerVue Diagnostic Scope<br>System<br>Biomet Sports Medicine<br>K072879 | Xenon Arc | Light Source Safety demonstrated in 510(k) submission |
| Flexible Video Endoscope with<br>Sheath and Video Processor<br>Vision-Sciences, Inc<br>K102733 | LED | Light Source Safety demonstrated in 510(k) submission |
| LED Light Source<br>Sunoptic Technologies, Inc.<br>K093792 | LED | Light Source Safety demonstrated in 510(k) submission |
| Lightsource or Illuminator<br>Sunoptic Technologies, Inc.<br>K961074 | Xenon | Light Source Safety demonstrated in 510(k) submission |

| | Performance<br>Comparison | Target Population<br>and Anatomical Site | Reuse<br>durability | Skill Level<br>Required |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------|---------------------|-------------------------|
| OVS1 Video System | Similar | Similar | Similar | Similar |
| Tele Pack X<br>Karl Storz Endoscopy- America, Inc<br>510(k) unknown | Equivalent | Similar | Similar | Similar |
| Image 1 Video Imaging System<br>With Option<br>Karl Storz Endoscopy- America, Inc<br>K070716 | Similar, no on-<br>board display or<br>light source | Similar | Similar | Similar |
| InnerVue Diagnostic Scope System<br>Biomet Sports Medicine<br>K072879 | Similar | Similar | Similar | Similar |
| Flexible Video Endoscope with<br>Sheath and Video Processor<br>Vision-Sciences, Inc<br>K102733 | Similar | Similar | Similar | Similar |
| LED Light Source<br>Sunoptic Technologies, Inc.<br>K093792 | Identical light<br>output | Similar | Similar | Similar |
| Lightsource or Illuminator<br>Sunoptic Technologies, Inc.<br>K961074 | Similar | Similar | Similar | Similar |

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| | Energy Source | Materials | Biocompatibility | Sterility |
|-------------------------------------------------------------------------------------------------|------------------------|----------------------------------------------|------------------|-----------|
| OVS1 Video System | External - wall outlet | Similar | N/A | N/A |
| Tele Pack X<br>Karl Storz Endoscopy- America,<br>Inc<br>510(k) unknown | External - wall outlet | Similar | N/A | N/A |
| Image 1 Video Imaging System<br>With Option<br>Karl Storz Endoscopy- America,<br>Inc<br>K070716 | External - wall outlet | Similar - no onboard display or light source | N/A | N/A |
| InnerVue Diagnostic Scope<br>System<br>Biomet Sports Medicine<br>K072879 | External - wall outlet | Similar | N/A | N/A |
| Flexible Video Endoscope with<br>Sheath and Video Processor<br>Vision-Sciences, Inc<br>K102733 | External - wall outlet | Similar | N/A | N/A |
| LED Light Source<br>Sunoptic Technologies, Inc.<br>K093792 | External - wall outlet | Similar - no onboard display | N/A | N/A |
| Lightsource or Illuminator<br>Sunoptic Technologies, Inc.<br>K961074 | External - wall outlet | Similar - no onboard display | N/A | N/A |

# Non-Clinical Testing:

The OVS 1 Video System demonstrates substantial equivalence in safety by tested compliance with ISO 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; and ISO 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

#### Clinical Testing:

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

# Substantial Equivalence Rationale:

The OVS 1 Video System fulfills criteria regarding substantial equivalence with the Predicate Devices listed for the following reasons:

- 1. The intended use of the OVS1 Video System is equivalent to the Tele Pack X, 510(k) unknown; Image 1 Video Imaging System, K070716; and InnerVue Diagnostic Scope System, K072879
- 2. The Indications for Use statements are equivalent to the indications for use of the InnerVue Diagnostic Scope System, K072879, and the Flexible Endoscope Sheath and Video Processor, K102733
- 3. The Technologic characteristics of the OVS I Video System are equivalent to Predicate Devices as follows:

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- Video Processing System Equivalence: Tele Pack X, 510(k) unknown; Image 1 a. Video Imaging System, K070716; InnerVue Diagnostic Scope System, K072879; and Flexible Endoscope Sheath and Video Processor, K102733
- b. Light Source Similarity: Tele Pack X, 510(k) unknown; Flexible Video Endoscope with Sheath and Video Processor, K102733, Lightsource or Illuminator, K961074
- c. Light Source Identical: LED Light Source, K093792
- d. Display Equivalence: Tele Pack X, 510(k) unknown; InnerVue Diagnostic Scope System, K072879; and Flexible Endoscope Sheath and Video Processor, K102733
- 4. Performance data show no new safety concerns for the OVS1 Video System
- 5. Performance of the OVS1 Video System demonstrates equivalent ability to Predicate Devices to illuminate the surgical site, process video, and display video

### 510(k) Summary Final Criteria Checklist

- > The summary includes only information that is also covered in the body of the 510(k).
- > The summary does not contain any puffery or unsubstantiated labeling claims.
- A The summary does not contain any raw data, i.e., contains only summary data.
- > The summary does not contain any trade secret or confidential commercial information.
- A The summary does not contain any patient identification information.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

December 19, 2012

Olive Medical Corp. % Mr. Brian Dean VP, RA/QA 2302 South Presidents Dr. STE D SALT LAKE CITY UT 84120

Re: K123359

Trade/Device Name: OVS1 Video System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCW, GCJ Dated: October 29, 2012 Received: October 31, 2012

Dear Mr. Dean:

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.

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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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Herbert R. Lerner

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

12-335

510(k) Number (if known):

Device Name:

OVS1 Video System

# Indications For Use:

The OVS 1 Video 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 OVS1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable

Prescription Use XX (Part 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Herbert P. Lerner**

Reproductive, Gastro-Renal, and ) Number