(94 days)
No
The summary explicitly states that the device does not include software and software verification and validation testing was not performed. There is no mention of AI, ML, or image processing capabilities.
No.
The device is specifically designed for "endoscopic diagnosis within the uterus," indicating a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "for endoscopic diagnosis within the uterus."
No
The device description and performance studies clearly indicate this is a hardware device (hysteroscope) used with other hardware components, and it explicitly states that software verification and validation testing was "Not applicable and not performed as the device does not include software."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis within the uterus." This involves directly visualizing the internal anatomy of the uterus using a video endoscope.
- Device Description: The device is described as an instrument used with a video system, light source, etc., for "endoscopic diagnosis within the uterus."
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device operates in vivo (inside the body) for direct visualization.
The device is a medical device used for direct visualization and diagnosis within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.
Product codes
HIH
Device Description
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
within the uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
-
Non-Clinical Bench Testing:
- Thermal Safety: HYF-V. Thermal safety performance test verified compliance to Protection against excessive temperature and other safety hazards of IEC 60601-2-18:2009-08.
- Photobiological Safety: HYF-V. The photobiological safety test verified compliance to IEC 32471:2006-07 and confirms the light emitted from subject devices connected to each light source is low enough not to cause injury to the skin and eye.
- Noise and Dynamic Range: HYF-V. The substantial equivalence of Noise and Dynamic range between the subject device and predicate device connected with Video System Center / Light Source was confirmed and verified compliant to ISO 15739:2017.
- Composite Durability: HYF-V. The durability test against composite stress of mechanical (angulation and wiping during reprocessing) and chemical stress demonstrates the subject device retains its safety and effectiveness against the stresses expected in its use-life.
- Color Performance: HYF-V. The color performance of the subject devices is confirmed as substantially equivalent to the predicate devices in the WLI.
- Image Intensity Uniformity: HYF-V. The image intensity uniformity of the subject devices is confirmed as substantially equivalent to the predicate devices.
- Resolution: HYF-V. The resolution of the subject device is confirmed as substantially equivalent to the predicate device.
- Direction of View: HYF-V. The direction of view test verified compliance to ISO 8600-1 and confirms that the subject device is consistent with the design specifications and does not introduce new questions related to safety and effectiveness.
- Field of View: HYF-V. The field of view test verified compliance to ISO 8600-1 and confirms that the subject device is consistent with the design specifications and does not introduce new questions related to safety and effectiveness.
-
Animal Test: Not applicable and not performed.
-
Biocompatibility Evaluation: Biocompatibility of the subject device was evaluated according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. The subject device passed testing for all applicable biocompatibility endpoints.
-
Sterilization, Shelf Life, Reprocessing: HYF-V and their reusable accessories are not sterilized before shipment. Before using these instruments for the first time and between patient use the endoscopes must be cleaned and high-level disinfected and sterilized as shown in the Instruction for Use. All cleaning, disinfection, and sterilization methods were validated pursuant to FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015. The reprocessing validation was conducted pursuant to the same FDA guidance document. HYF-V is validated as safe and effective for reprocessing with the following:
- Manual Cleaning
- Manual Disinfection with 2 - 3.5% glutaraldehyde
- OER-Pro (K103264)
- Sterilization with EO Gas
-
Electrical Safety and Electromagnetic Compatibility (EMC): The HYF-V was tested for electrical safety and electromagnetic compatibility inclusive of Essential Performance Requirements in accordance with FDA recognized standards for endoscopic equipment as listed below.
- IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 4)
-
Software Verification and Validation Testing: HYF-V does not include any software; thus, software testing was not applicable and not performed.
-
Risk Analysis: Risk analysis for the subject device was conducted in accordance with established in-house acceptance criteria based on ISO 14971. Design verification tests based on required risk mitigations, and their acceptance criteria were identified and performed as a result of this risk analysis assessment. These assessments confirmed that there was no unacceptable user-related residual risk for Visera Hysterovideoscope, HYF-V.
-
Clinical Testing: Not applicable and not performed.
Key Metrics
Not Found
Predicate Device(s)
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V K022445
Reference Device(s)
K111425, K051645, K954451, K102379, K103264
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 2, 2022
Olympus Medical Systems Corporation % Gary Brennan Regulatory Program Manager Olympus Corporation of the Americas 800 West Park Drive Westborough, MA 01581
Re: K221557
Trade/Device Name: VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V) Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: August 9, 2022 Received: August 11, 2022
Dear Gary Brennan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221557
Device Name VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V)
Indications for Use (Describe)
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ☑ | ☐ |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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K221557 Page 1 of 7
510(k) Summary
For
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V)
| General Information | |
|---|---|
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP. |
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan | |
| 192-8507 | |
| Phone: (+81) 42-642-2694 | |
| Fax: (+81) 42-642-2307 | |
| Establishment Registration Number: 8010047 | |
| Manufacturer: | Shirakawa Olympus Co., Ltd. |
| 3-1 Okamiyama, Odakura, Nishigo-mura, | |
| Nishishirakawa-gun, Fukushima 961-8061, | |
| Japan | |
| Phone: (+81) 248-27-2239 | |
| Fax: (+81) 248-27-2429 | |
| Establishment Registration Number: 3002808148 |
Aizu Olympus Co., Ltd.
500 Muranishi, Niidera, Monden-machi,
Aizuwakamatsushi, Fukushima 965-8520, Japan
Phone: (+81) 172-52-8511
Fax: (+81) 172-52-8515
Establishment Registration Number: 9614641 |
| 510(k) Submitter: | Olympus Corporation of the Americas
3500 Corporate Parkway
Center Valley, PA 18034-0610 |
| Establishment Registration Number: | 2429304 |
| Contact Person: | Gary Brennan
Regulatory Affairs Program Manager
Mobile : (315) 877-7298
Email : Gary.Brennan@olympus.com |
| Date Prepared: | September 1, 2022 |
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K221557 Page 2 of 7
Device Description
| Classification Name: | Hysteroscope and accessories |
|---|---|
| Generic/Common Name: | Hysteroscope |
| Trade Name: | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V |
| (HYF-V) | |
| Model Number: | HYF-V |
| Regulation Number: | 884.1690 |
| Regulatory Class: | Class II |
| Product Codes: | HIH |
| Review Panel: | Obstetrics/Gynecology |
Table 15-1. Predicate Device
| Predicate Device | 510(k) No. |
|---|---|
| VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V | K022445 |
The predicate device has not been subject to a design-related recall.
Product Description
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus.
Comparison of Technological Characteristics
Table 5-1 compares HYF-V to the predicate device with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
| Comparator | Subject Device | Predicate Device |
|---|---|---|
| Regulatory | ||
| Device Name (Model) | Same as predicate | Visera Hysterovideoscope (HYF-V) |
| Regulatory Decision | Same as predicate | K022445 |
| Product Code | Same as predicate | HIH |
| Regulation Number | Same as predicate | 884.1690 |
| Regulation Name | Same as predicate | Hysteroscope and accessories |
| Indications for use | VISERA | |
| HYSTEROVIDEOSCOPE | ||
| OLYMPUS HYF TYPE V | ||
| has been designed to be used | ||
| with an Olympus video | This instrument has been | |
| designed to be used with an | ||
| Olympus video system center, | ||
| light source, documentation | ||
| equipment, display monitor, and | ||
| Comparator | Subject Device | Predicate Device |
| system center, light source, | ||
| documentation equipment, | ||
| display monitor, and other | ||
| ancillary equipment for | ||
| endoscopic diagnosis within | ||
| the uterus. Do not use the | ||
| instrument for any | ||
| purpose other than its | ||
| intended use. | other ancillary equipment for | |
| endoscopic diagnosis within the | ||
| uterus, including: | ||
| • Abnormal uterine bleeding | ||
| • Amenorrhea | ||
| • Evaluation of abnormal | ||
| hysterosalpingogram | ||
| • Infertility and pregnancy | ||
| wastage | ||
| • Pelvic pain | ||
| Optical system parameters | ||
| Field of View | Same as predicate | 120° |
| Direction of View | Same as predicate | 0° (Forward viewing) |
| Depth of Field | Same as predicate | 2-50mm |
| (for all compatible light sources) | ||
| Imaging System | ||
| Noise | OTV-S190/ | |
| CLV-S190 | OTV-S7V/ | |
| CLV-S40 | ||
| Insertion Section | ||
| Insertion Flexible Tube | Same as predicate | 3. 6mm |
| Outer Diameter | Same as predicate | 3.8 mm |
| Distal End | Same as predicate | 240 mm |
| Working Length | Same as predicate | |
| Instrument Channel | ||
| Channel Inner Diameter | Same as predicate | 1.2 mm |
| Bending Section | ||
| Angulation Range | Same as predicate | Up 100° / Down 100° |
| Connection to Light Source | ||
| Configuration | Light Guide (LG) cable is not | |
| detachable | Light Guide (LG) cable is not | |
| detachable | ||
| Venting Connector | ||
| Position | Same as predicate | On LG connector |
| Sterilization | ||
| EO | Same as predicate | Available |
| Others | ||
| Total length | Same as predicate | 520mm |
| Suction Function | Same as predicate | Not provided |
| Compatible Video System Center/Light Source/Monitor/Reprocessor | ||
| Compatible Video System | ||
| Center | VISERA ELITE video | |
| system center, OTV-S190 | ||
| (K111425) | VISERA video system center, | |
| OTV-S7V (K051645) | ||
| Compatible Light Source | VISERA ELITE Xenon light | |
| source, CLV-S190 | ||
| (K111425) | VISERA light source, CLV-S40 | |
| (K954451) | ||
| EVIS universal light source, | ||
| CLV-U40 (K954451) | ||
| Compatible Monitor | OEV-262H (K102379) | OEV-141/201/142/ 202/143/203 |
| (K954451) | ||
| Comparator | Subject Device | Predicate Device |
| Compatible Reprocessor | OER-Pro (K093106) | Not available |
Table 5-1: Comparison of the technological characteristics of HYF-V to predicate device
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Indications for Use
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.
Compliance to Voluntary Standards
The following voluntary standards have been applied to the subject device respectively:
- . ANSI AAMI ES 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- . ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
- ISO 15739:2017 Photography Electronic still-picture imaging Noise measurements
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
- . ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicitv
- . ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
- . ISO 11135:2014 Sterilization of health care products - Ethylene Oxide - requirements for development, validation and routine control of a sterilization process for medical devices
- . ISO 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
- ISO 14971:2007 Medical Devices Application of risk management to medical devices
Device-Specific Guidance
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff
- FDA Guidance Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . FDA Guidance Hysteroscopes and Gynecologic Laparoscopes
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Summary of Performance Testing
The following performance testing was conducted in support of the substantial equivalence determination.
1. Non-Clinical Bench Testing
| Item | Applicable Device | Contents |
|---|---|---|
| Thermal Safety | HYF-V | Thermal safety performance test verified compliance to Protection against excessive temperature and other safety hazards of IEC 60601-2-18:2009-08. |
| Photobiological Safety | HYF-V | The photobiological safety test verified compliance to IEC 32471:2006-07 and confirms the light emitted from subject devices connected to each light source is low enough not to cause injury to the skin and eye. |
| Noise and Dynamic Range | HYF-V | The substantial equivalence of Noise and Dynamic range between the subject device and predicate device connected with Video System Center / Light Source was confirmed and verified compliant to ISO 15739:2017. |
| Composite Durability | HYF-V | The durability test against composite stress of mechanical (angulation and wiping during reprocessing) and chemical stress demonstrates the subject device retains its safety and effectiveness against the stresses expected in its use-life. |
| Color Performance | HYF-V | The color performance of the subject devices is confirmed as substantially equivalent to the predicate devices in the WLI. |
| Image Intensity Uniformity | HYF-V | The image intensity uniformity of the subject devices is confirmed as substantially equivalent to the predicate devices. |
| Resolution | HYF-V | The resolution of the subject device is confirmed as substantially equivalent to the predicate device. |
| Direction of View | HYF-V | The direction of view test verified compliance to ISO 8600-1 and confirms that the subject device is consistent with the design specifications and does not introduce new questions related to safety and effectiveness. |
| Field of View | HYF-V | The field of view test verified compliance to ISO 8600-1 and confirms that the subject device is consistent with the design specifications and does not introduce new questions related to safety and effectiveness. |
2. Animal Test
Animal testing was not applicable and not performed.
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K221557 Page 6 of 7
3. Biocompatibility Evaluation
Biocompatibility of the subject device was evaluated according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. The subject device passed testing for all applicable biocompatibility endpoints.
4. Sterilization, Shelf Life, Reprocessing
HYF-V and their reusable accessories are not sterilized before shipment. Before using these instruments for the first time and between patient use the endoscopes must be cleaned and high-level disinfected and sterilized as shown in the Instruction for Use. All cleaning, disinfection, and sterilization methods were validated pursuant to FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015. The reprocessing validation was conducted pursuant to the same FDA guidance document. HYF-V is validated as safe and effective for reprocessing with the following:
- . Manual Cleaning
- . Manual Disinfection with 2 - 3.5% glutaraldehyde
- . OER-Pro (K103264)
- Sterilization with EO Gas
5. Electrical Safety and Electromagnetic Compatibility (EMC)
The HYF-V was tested for electrical safety and electromagnetic compatibility inclusive of Essential Performance Requirements in accordance with FDA recognized standards for endoscopic equipment as listed below.
- . IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 4)
6. Software Verification and Validation Testing
HYF-V does not include any software; thus, software testing was not applicable and not performed.
7. Risk Analysis
Risk analysis for the subject device was conducted in accordance with established in-house acceptance criteria based on ISO 14971. Design verification tests based on required risk mitigations, and their acceptance criteria were identified and performed as a result of this risk analvsis assessment.
9
These assessments confirmed that there was no unacceptable user-related residual risk for Visera Hysterovideoscope, HYF-V.
8. Clinical Testing
Clinical testing was not applicable and not performed.
Substantial Equivalence Conclusion
HYF-V has the same intended use and has similar technological characteristics as the predicate device. Except for the differences summarized in Table 5-1, the technological characteristics, including principle of operation, materials, and directions for use are identical between the subject device and predicate device. The differences in technological characteristics between the subject and predicate do not raise different questions of safety and effectiveness.
The results of of non-clinical performance testing demonstrate that the Visera Hysterovideoscope, HYF-V is as safe and effective as the predicate device, and therefore is substantially equivalent to the predicate.