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 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.

AI/ML Overview

The Olive Medical OVS1 Video System is a surgical video system that includes a Camera Control Unit with an integrated LED Light Source and Video Display. It is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body.

Here's an analysis of the provided information regarding its acceptance criteria and the study proving it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided documentation does not explicitly list quantitative acceptance criteria in the typical sense (e.g., minimum resolution, specific light output intensity). Instead, the acceptance criteria are implicitly defined by demonstrating substantial equivalence to existing predicate devices. The "reported device performance" is a comparative qualitative assessment against these predicates, highlighting similarities in technology and function.

Acceptance Criteria (Implicit)	Reported Device Performance (vs. Predicates)
Intended Use Equivalence	The intended use of the OVS1 Video System is equivalent to the Tele Pack X (unknown 510(k)), Image 1 Video Imaging System (K070716), and InnerVue Diagnostic Scope System (K072879). The Indications for Use statements are equivalent to the InnerVue Diagnostic Scope System (K072879) and the Flexible Endoscope Sheath and Video Processor (K102733).
Technological Characteristics Equivalence	Display Technology: OVS1 Integrated LCD (12.1", 720 vertical lines) similar to Tele Pack X (15", 494* vertical lines input). InnerVue Diagnostic Scope System (6.4", 480 vertical lines), Flexible Video Endoscope (15", 480 vertical lines). Image 1 Video Imaging System (no on-board display). Light Source Technology: OVS1 LED, identical to LED Light Source (K093792). Similar to Flexible Video Endoscope (LED), Lightsource or Illuminator (Xenon). Different from Tele Pack X (Metal Halide) and InnerVue Diagnostic Scope System (Xenon Arc). Control Unit Technology: Similar to all listed predicate devices. Light Source Safety: LED Module and output identical to LED Light Source, K093792. Predicates demonstrated their own light source safety.
Performance Data	Performance data show no new safety concerns for the OVS1 Video System. Performance demonstrates equivalent ability to Predicate Devices to illuminate the surgical site, process video, and display video. This is a general statement of equivalence rather than specific metrics.
Safety Testing	Compliance with ISO 60601-1 (general requirements for basic safety and essential performance) and ISO 60601-1-2 (electromagnetic compatibility).
Target Population & Anatomical Site	Similar to predicate devices.
Reuse Durability	Similar to predicate devices.
Skill Level Required	Similar to predicate devices.
Energy Source	External - wall outlet, similar to all predicate devices.
Materials	Similar to predicate devices (with variations for those without on-board displays or light sources).

Note: The document states "Output resolution unknown. Vertical lines of input listed" for Tele Pack X, implying the 494 lines is an input spec, not necessarily output resolution.

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

The document explicitly states: "No comparison of clinical performance data was used for demonstration of substantial equivalence." This means there was no "test set" in the context of clinical data for performance evaluation. The substantial equivalence was based on comparison of technological characteristics and non-clinical safety testing against predicates.

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

N/A. As no clinical performance data was used, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

N/A. No clinical test set.

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:

N/A. This device is an endoscopic video system, not an AI-powered diagnostic tool. No MRMC study was performed, and the concept of "human readers improving with AI" is not applicable here.

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

N/A. This device is hardware for visualization, not a standalone algorithm.

7. The type of ground truth used:

N/A. As no clinical performance data was used, no ground truth was established for a clinical test set. The "ground truth" for demonstrating substantial equivalence was effectively the established safety and performance records of the predicate devices and compliance with relevant electrical and EMC standards.

8. The Sample Size for the Training Set:

N/A. This device is not an AI/ML algorithm that requires a training set.

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

N/A. No training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Olive Medical OVS1 Video System demonstrates it meets acceptance criteria (which are defined implicitly by substantial equivalence) through a non-clinical comparative study and safety testing:

Comparative Assessment: The primary "study" was a detailed comparison of the OVS1 Video System's technological characteristics (display, light source, control unit, resolution) and intended use against several legally marketed predicate devices (Tele Pack X, Image 1 Video Imaging System, InnerVue Diagnostic Scope System, Flexible Video Endoscope, LED Light Source, Lightsource or Illuminator). The study concluded that the OVS1 is "substantially equivalent" because its technology and design are similar, its indications for use are similar, and differences do not negatively affect performance, function, or intended use.
Non-Clinical Testing: The device underwent compliance testing with recognized international standards for medical electrical equipment:
- ISO 60601-1: General requirements for basic safety and essential performance.
- ISO 60601-1-2: Electromagnetic compatibility (EMC) requirements and tests.

These non-clinical tests and the detailed comparative analysis against predicate devices established that the OVS1 Video System is as safe and effective as the already-marketed devices, thus meeting the requirements for its 510(k) clearance. No clinical trials or human performance studies were conducted or required to demonstrate substantial equivalence for this type of device.

Summary

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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
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Surgery

510(k) Submitter	Olive Medical Corp.2302 South Presidents Dr. STE DSalt lake City, UT 84120
Contact(s)TelephoneFax	Brian Dean(801) 953-0559(801) 823-2238
Date Prepared	October 26th, 2012
Trade Name	OVS1 Video System
Common Name	Endoscope And/Or Accessories
Classification NameRegulation NumberProduct Code	Light Source, Fiberoptic, Routine; Laparoscope, General & Plastic21 CFR 876.1500FCW; 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:

Intended Use:

Indications for Use:

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:

	DisplayTechnology	DisplaySize	Video Output Resolution(vertical lines)	Control UnitTechnology
OVS1 Video System	Integrated LCD	12.1"	720	Similar
Tele Pack XKarl Storz Endoscopy- America, Inc510(k) unknown	Integrated LCD	15"	494*	Similar
Image 1 Video Imaging SystemWith OptionKarl Storz Endoscopy- America, IncK070716	N/A	N/A	N/A	Similar - no on-board display orLight Source
InnerVue Diagnostic ScopeSystemBiomet Sports MedicineK072879	Integrated LCD	6.4"	480	Similar
Flexible Video Endoscope withSheath and Video ProcessorVision-Sciences, IncK102733	Integrated LCD	15"	480	Similar
LED Light SourceSunoptic Technologies, Inc.K093792	N/A	N/A	N/A	N/A
Lightsource or IlluminatorSunoptic Technologies, Inc.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 SourceTechnology	Light Source Safety
OVS1 Video System	LED	LED Module and output identical to LED Light Source,K093792
Tele Pack XKarl Storz Endoscopy- America, Inc510(k) unknown	Metal Halide	Light Source Safety demonstrated in 510(k) submission
Image 1 Video Imaging SystemWith OptionKarl Storz Endoscopy- America, IncK070716	N/A	N/A
InnerVue Diagnostic ScopeSystemBiomet Sports MedicineK072879	Xenon Arc	Light Source Safety demonstrated in 510(k) submission
Flexible Video Endoscope withSheath and Video ProcessorVision-Sciences, IncK102733	LED	Light Source Safety demonstrated in 510(k) submission
LED Light SourceSunoptic Technologies, Inc.K093792	LED	Light Source Safety demonstrated in 510(k) submission
Lightsource or IlluminatorSunoptic Technologies, Inc.K961074	Xenon	Light Source Safety demonstrated in 510(k) submission

	PerformanceComparison	Target Populationand Anatomical Site	Reusedurability	Skill LevelRequired
OVS1 Video System	Similar	Similar	Similar	Similar
Tele Pack XKarl Storz Endoscopy- America, Inc510(k) unknown	Equivalent	Similar	Similar	Similar
Image 1 Video Imaging SystemWith OptionKarl Storz Endoscopy- America, IncK070716	Similar, no on-board display orlight source	Similar	Similar	Similar
InnerVue Diagnostic Scope SystemBiomet Sports MedicineK072879	Similar	Similar	Similar	Similar
Flexible Video Endoscope withSheath and Video ProcessorVision-Sciences, IncK102733	Similar	Similar	Similar	Similar
LED Light SourceSunoptic Technologies, Inc.K093792	Identical lightoutput	Similar	Similar	Similar
Lightsource or IlluminatorSunoptic Technologies, Inc.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 XKarl Storz Endoscopy- America,Inc510(k) unknown	External - wall outlet	Similar	N/A	N/A
Image 1 Video Imaging SystemWith OptionKarl Storz Endoscopy- America,IncK070716	External - wall outlet	Similar - no onboard display or light source	N/A	N/A
InnerVue Diagnostic ScopeSystemBiomet Sports MedicineK072879	External - wall outlet	Similar	N/A	N/A
Flexible Video Endoscope withSheath and Video ProcessorVision-Sciences, IncK102733	External - wall outlet	Similar	N/A	N/A
LED Light SourceSunoptic Technologies, Inc.K093792	External - wall outlet	Similar - no onboard display	N/A	N/A
Lightsource or IlluminatorSunoptic Technologies, Inc.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
1. 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
1. 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
1. Performance data show no new safety concerns for the OVS1 Video System
1. 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 (800) 638-2041 or (301) 796-7100 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:

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

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.