(49 days)
No
The summary describes a standard endoscopic video system with image processing capabilities, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
No
The device is indicated for "illumination and visualization" in diagnostic and operative endoscopic procedures, which points to a diagnostic and observation role rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "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." The term "diagnostic" directly indicates its use for diagnosis.
No
The device description explicitly states it is a "Camera Control Unit with integrated LED Light Source and Video Display," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body". This describes a device used during a medical procedure to directly visualize internal structures, not a device used to test samples (like blood, urine, or tissue) outside the body.
- Device Description: The description confirms it's a "Camera Control Unit with integrated LED Light Source and Video Display for use in a surgical environment to view endoscopic images". This aligns with a device used for direct visualization during surgery or diagnostic endoscopy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide visual access to the inside of the body.
N/A
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
Product codes (comma separated list FDA assigned to the subject device)
FCW; GCJ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interior cavity of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No comparison of clinical performance data was used for demonstration of substantial equivalence
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K070716, K072879, K102733, K093792
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
2302 South Presidents Dr. STE D
Salt lake City, UT 84120 |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Contact(s)
Telephone
Fax | 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 Name
Regulation Number
Product Code | Light Source, Fiberoptic, Routine; Laparoscope, General & Plastic
21 CFR 876.1500
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.
1
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
Technology | Display
Size | Video Output Resolution
(vertical lines) | Control Unit
Technology |
|------------------------------------------------------------------------------------------------|-----------------------|-----------------|---------------------------------------------|--------------------------------------------------|
| OVS1 Video System | Integrated LCD | 12.1" | 720 | Similar |
| Tele Pack X
Karl Storz Endoscopy- America, Inc
510(k) unknown | Integrated LCD | 15" | 494* | Similar |
| Image 1 Video Imaging System
With Option
Karl Storz Endoscopy- America, Inc
K070716 | N/A | N/A | N/A | Similar - no on-board display or
Light Source |
| InnerVue Diagnostic Scope
System
Biomet Sports Medicine
K072879 | Integrated LCD | 6.4" | 480 | Similar |
| Flexible Video Endoscope with
Sheath and Video Processor
Vision-Sciences, Inc
K102733 | Integrated LCD | 15" | 480 | Similar |
| LED Light Source
Sunoptic Technologies, Inc.
K093792 | N/A | N/A | N/A | N/A |
| Lightsource or Illuminator
Sunoptic Technologies, Inc.
K961074 | N/A | N/A | N/A | N/A |
*Output resolution unknown. Vertical lines of input listed
2
Section 5: 510(k) Summary
| | Light Source
Technology | Light Source Safety |
|------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------|
| OVS1 Video System | LED | LED Module and output identical to LED Light Source,
K093792 |
| Tele Pack X
Karl Storz Endoscopy- America, Inc
510(k) unknown | Metal Halide | Light Source Safety demonstrated in 510(k) submission |
| Image 1 Video Imaging System
With Option
Karl Storz Endoscopy- America, Inc
K070716 | N/A | N/A |
| InnerVue Diagnostic Scope
System
Biomet Sports Medicine
K072879 | Xenon Arc | Light Source Safety demonstrated in 510(k) submission |
| Flexible Video Endoscope with
Sheath and Video Processor
Vision-Sciences, Inc
K102733 | LED | Light Source Safety demonstrated in 510(k) submission |
| LED Light Source
Sunoptic Technologies, Inc.
K093792 | LED | Light Source Safety demonstrated in 510(k) submission |
| Lightsource or Illuminator
Sunoptic Technologies, Inc.
K961074 | Xenon | Light Source Safety demonstrated in 510(k) submission |
| | Performance
Comparison | Target Population
and Anatomical Site | Reuse
durability | Skill Level
Required |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------|---------------------|-------------------------|
| OVS1 Video System | Similar | Similar | Similar | Similar |
| Tele Pack X
Karl Storz Endoscopy- America, Inc
510(k) unknown | Equivalent | Similar | Similar | Similar |
| Image 1 Video Imaging System
With Option
Karl Storz Endoscopy- America, Inc
K070716 | Similar, no on-
board display or
light source | Similar | Similar | Similar |
| InnerVue Diagnostic Scope System
Biomet Sports Medicine
K072879 | Similar | Similar | Similar | Similar |
| Flexible Video Endoscope with
Sheath and Video Processor
Vision-Sciences, Inc
K102733 | Similar | Similar | Similar | Similar |
| LED Light Source
Sunoptic Technologies, Inc.
K093792 | Identical light
output | Similar | Similar | Similar |
| Lightsource or Illuminator
Sunoptic Technologies, Inc.
K961074 | Similar | Similar | Similar | Similar |
.
ノ・
·
.
3
| Energy Source | Materials | Biocompatibility | Sterility | |
|---|---|---|---|---|
| OVS1 Video System | External - wall outlet | Similar | N/A | N/A |
| Tele Pack X | ||||
| Karl Storz Endoscopy- America, | ||||
| Inc | ||||
| 510(k) unknown | External - wall outlet | Similar | N/A | N/A |
| Image 1 Video Imaging System | ||||
| With Option | ||||
| Karl Storz Endoscopy- America, | ||||
| Inc | ||||
| K070716 | External - wall outlet | Similar - no onboard display or light source | N/A | N/A |
| InnerVue Diagnostic Scope | ||||
| System | ||||
| Biomet Sports Medicine | ||||
| K072879 | External - wall outlet | Similar | N/A | N/A |
| Flexible Video Endoscope with | ||||
| Sheath and Video Processor | ||||
| Vision-Sciences, Inc | ||||
| K102733 | External - wall outlet | Similar | N/A | N/A |
| LED Light Source | ||||
| Sunoptic Technologies, Inc. | ||||
| K093792 | External - wall outlet | Similar - no onboard display | N/A | N/A |
| Lightsource or Illuminator | ||||
| Sunoptic 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:
-
- The Technologic characteristics of the OVS I Video System are equivalent to Predicate Devices as follows:
4
- 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
-
- Performance data show no new safety concerns for the OVS1 Video System
-
- 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.
5
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.
6
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
7
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