Voyant System

K191579 · Viseon, Inc. · HRX · Jul 11, 2019 · Orthopedic

Device Facts

• Record ID: K191579
• Device Name: Voyant System
• Applicant: Viseon, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jul 11, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The Voyant System is indicated to provide minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine.

Device Story

Voyant System is a sterile, single-use minimally invasive spine surgery access and visualization device. It consists of a tubular retractor (Voyant Sheath) and an external camera (Voyant Imager) with an LED light source. The Imager attaches to the Sheath and connects via HDMI to an Image Control Box (ICB). The ICB powers the Imager, processes video data, and outputs a live feed to an external HD monitor in the operating room. Surgeons use the system to visualize the surgical site during spinal procedures. The device provides magnification and illumination to assist in surgical decision-making and procedural execution. The system is intended for use by physicians in an operating room setting.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance verification testing, including design verification, software validation, electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

System comprises a tubular retractor (Parylene coated 6061-T6 Aluminum, medical grade adhesive) and an external CMOS camera (1/4" sensor, 3280x2464 resolution, 1080p output). Illumination via integrated LED. Connectivity via HDMI to an external Image Control Box. Sterilization of single-use components via Ethylene Oxide (EtO) to 10^-6 SAL. Complies with IEC 60601-1, IEC 60601-1-2, IEC 62304, and EN ISO 14971.

Indications for Use

Indicated for patients undergoing minimally invasive spine surgery requiring access, visualization, and magnification of the surgical area.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Voyant System (K181885)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

July 11, 2019

Viseon, Inc. Cora Sim Regulatory Affairs Manager 13900 Alton Parkway, Suite 125 Irvine, California 92618

Re: K191579

Trade/Device Name: Voyant System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: June 13, 2019 Received: June 14, 2019

Dear Cora Sim:

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. You must comply with all the Act's

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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-regulatory-information/postmarketing-safety-reportingcombination-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191579

Device Name Voyant System

Indications for Use (Describe)

The Voyant System is indicated to provide minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine.

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)

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Image /page/3/Picture/0 description: The image shows the logo for VISEON INC. The logo consists of a stylized V shape in teal and blue, followed by the word "VISEON" in blue, block letters. Below the word "VISEON" is the word "INC." in smaller, blue letters.

## Voyant System 510(k) Summary - K191579

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

#### A. Submitted by:

Cora Sim Regulatory Affairs Manager Viseon, Inc. 13900 Alton Parkway, Suite 125 Irvine, CA 92618 Telephone: [phone] ext. 106 Facsimile: [phone]

Date Prepared: July 1, 2019

#### B. Device Name:

| Trade or Proprietary Name: | Voyant System |
|----------------------------|-------------------|
| Common or Usual Name: | Arthroscope |
| Classification Name: | Arthroscope |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.1100 |
| Product Code: | HRX |

#### C. Predicate Device:

The subject Voyant System is substantially equivalent to the predicate device, Voyant System (K181885).

#### D. Device Description:

The Voyant System is composed of the Voyant Sheath and Voyant Imager, and Accessories which includes an Image Control Box (ICB) and connecting cables. The Voyant Sheath and Voyant Imager are supplied sterile by ethylene oxide (EtO) while the ICB and connecting cables are supplied non-sterile and are The Voyant System is used in minimally invasive spine surgery to provide access and reusable. visualization of the surgical area of the spine.

The Voyant System is a sterile, single-use access and visualization device consisting of a Sheath for access to the spine and an Imager for illumination and visualization of the surgical area. The Sheaths are available in multiple diameters and lengths to accommodate a variety of patient anatomies and spinal surgical procedures. Likewise, the Voyant Imager is available in corresponding diameters to attach to the Voyant Sheath. The Voyant Imager connects to the Image Control Box (ICB) via an HDMI cable and live video image is displayed to a connected external HD monitor in the operating room. The ICB functions to power the Voyant Imager, process video data from the Voyant Imager to display live video image to the connected third-party HD Monitor.

The purpose of this submission is to implement design changes to the predicate Voyant System (K181885) to create a product line extension which includes the Voyant Imager, and Accessories. These modifications to the Voyant System do not change the indications for use of the device, nor do they change the fundamental scientific technology of the device. Specifically, the following design and labeling modifications are described in this submission:

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Image /page/4/Picture/0 description: The image contains a logo on the left and the word "Spec" on the right. The logo consists of a blue letter N and the word "INC." written below it. The word "Spec" is written in a serif font and is positioned to the right of the logo.

- Design modifications to the Voyant Sheath including additional diameters and lengths ●
- Material change of the patient contacting components of the Voyant System
- Design modifications to the Voyant Imager .
- Design modifications to the Image Control Box (ICB) .
- Labeling changes to include updated images and instructions based upon the modified subject device ● and additional warning based upon the improved performance of the subject device.

The models for the subject device are listed in the table below:

### Voyant System Models:

| | Model<br>Number | Package Contents** | | |
|---------------------------------------|-----------------|--------------------------|---------------|---------|
| | | Voyant Sheath | Voyant Imager | |
| Sterile, Single-use,<br>Voyant System | VSY-1640 | 16mm OD | 40mm length | 16mm OD |
| | VSY-1650 | | 50mm length | |
| | VSY-1660 | | 60mm length | |
| | VSY-1670 | | 70mm length | |
| | VSY-1680 | | 80mm length | |
| | VSY-1840 | 18mm OD | 40mm length | 18mm OD |
| | VSY-1850 | | 50mm length | |
| | VSY-1860 | | 60mm length | |
| | VSY-1870 | | 70mm length | |
| | VSY-1880 | | 80mm length | |
| | VSY-2040 | 20mm OD | 40mm length | 20mm OD |
| | VSY-2050 | | 50mm length | |
| | VSY-2060 | | 60mm length | |
| VSY-2070 | 70mm length | | | |
| VSY-2080 | 80mm length | | | |
| VSY-2240 | 22mm OD | 40mm length | | 22mm OD |
| VSY-2250 | | 50mm length | | |
| VSY-2260 | | 60mm length | | |
| VSY-2270 | | 70mm length | | |
| VSY-2280 | | 80mm length | | |
| VSY-2640 | 26mm OD | 40mm length | | 26mm OD |
| VSY-2650 | | 50mm length | | |
| VSY-2660 | | 60mm length | | |
| VSY-2670 | | 70mm length | | |
| VSY-2680 | | 80mm length | | |
| Non-sterile, Reusable,<br>Accessories | ICB-02*** | Voyant Image Control Box | | |

** One Voyant Sheath of specified diameter (OD) and length and one Voyant Imager of corresponding diameter (OD) are packaged together

***VLBL08-002 Operator's Manual

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Image /page/5/Picture/0 description: The image shows the logo for VISEON INC. The logo features a stylized "V" shape in teal and blue, followed by the word "VISEON" in a blue, sans-serif font. Below the word "VISEON" is the word "INC." in a smaller, sans-serif font.

#### E. Indications for Use:

The Voyant System is indicated to provide minimally invasive access, visualization, and magnification of the surgical area of the spine.

#### F. Comparison of Technological Characteristics with the Predicate Device:

As was established in this submission, the subject Voyant System is substantially equivalent to the predicate Voyant System (K181885) previously cleared by FDA for commercial distribution in the United States. There have been no design changes to the devices previously cleared in the predicate 510(k). The subject device has been shown to be substantially equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, principles of operation, materials, and function.

| Feature | PREDICATE DEVICE<br>Voyant System | SUBJECT DEVICE<br>Voyant System |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K181885 | K191579 |
| Product Code | HRX | Same |
| Indications for Use | The Voyant System is indicated to provide<br>minimally invasive access, visualization,<br>illumination, and magnification of the<br>surgical area of the spine. | Same |
| Intended Use | Visualization of surgical area. | Same |
| Design | The Voyant System is an access and<br>visualization system designed to provide<br>illumination and magnification of the<br>surgical area during minimally invasive<br>spine surgery.<br>The system consists of the Voyant Sheath<br>and the Voyant Imager and Accessories.<br>The Voyant Sheath is a tubular retractor<br>used to provide access to the surgical area.<br>The Voyant Imager is an external camera<br>with LED light source that attaches to the<br>Voyant Sheath. Accessories to the Voyant<br>Imager include an Image Control Box (ICB)<br>with connecting cables.<br>The Image Control Box is a portable<br>accessory used to control the image output<br>of the Voyant Imager, which is displayed on<br>a connected operating room HD monitor. | Same |
| Patient Contacting<br>Materials (Tubular<br>Retractor) | Anodized 6061-T6 Aluminum and medical<br>grade plastic and adhesive | Parylene coated 6061-T6<br>Aluminum and medical grade<br>adhesive |
| Feature | PREDICATE DEVICE | SUBJECT DEVICE |
| | Voyant System | Voyant System |
| Labeling (Single<br>use/Reusable) | Voyant Sheath and Voyant Imager:<br>Sterile, Single use<br>Image Control Box and Connecting<br>Cables: Non-sterile, Reusable | Same |
| Surgical Site Access<br>Device | Tubular retractors | Same |
| Image Acquisition | Image acquisition is achieved through an<br>integrated camera external to the surgical<br>opening | Same |
| Image Processing | The image is digitally processed. | Same |
| Image Display | External monitor connection. | Same |
| Illumination | Illumination is achieved via direct<br>transmission using an LED light source. | Same |
| Sterilization | Voyant Sheath and Voyant Imager:<br>• Supplied sterile by Ethylene Oxide<br>(EtO) to a sterility assurance level of<br>$10^{-6}$ , for single use<br>Image Control Box: Supplied non-sterile<br>and reusable. | Same |
| Performance<br>Characteristics | Camera resolution: 1080p<br>Sensor resolution: 3280 x 2464 pixels<br>Camera sensor: 1/4" CMOS<br>Tubular retractor compressive force: $\geq$ 100N<br>Image resolution: $\geq$ 11 lp/mm at 63mm<br>Working length: 6-13cm | Camera resolution: Same<br>Sensor resolution: Same<br>Camera sensor: Same<br>Tubular retractor compressive<br>force: Same<br>Image resolution: $\geq$ 11 lp/mm at<br>80mm<br>Working length: 4-13cm |

### Design Comparison Table for Substantial Equivalence:

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Image /page/6/Picture/1 description: The image shows the logo for VISEON INC. The logo consists of a stylized letter V in two shades of blue, followed by the word "VISEON" in a sans-serif font, also in blue. Below the word "VISEON" is the abbreviation "INC." in a smaller font size and the same shade of blue.

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Image /page/7/Picture/0 description: The image shows the logo for VISEON Inc. The logo features a stylized letter "V" in two shades of blue, with the left side being a lighter teal color and the right side a darker blue. To the right of the "V" is the company name, "VISEON," in a bold, sans-serif font, also in the darker blue color. Below the "ON" portion of the name, "INC." is written in a smaller font size.

#### G. Performance Data

Non-clinical performance verification testing was performed to demonstrate that the subject Voyant System is substantially equivalent to the predicate device. Testing included design verification testing, software validation, electrical safety and electromagnetic emissions and immunity testing was performed in accordance with the following standards in order to establish equivalence to the predicate device:

| Test/Document Description | Applicable Test Standard |
|----------------------------------------|--------------------------|
| Electrical Safety | IEC 60601-1 |
| Electromagnetic Emissions and Immunity | IEC 60601-1-2 |
| Software | IEC 62304 |
| Risk Management | EN ISO 14971 |
| Design Verification Testing | N/A |

The results demonstrate that the subject Voyant System is substantially equivalent to the predicate.

#### H. Conclusions

Based on the indications for use, technological characteristics, non-clinical performance data, and a comparison to the predicate device, the subject Voyant System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.