(27 days)
Not Found
No
The summary describes a system for visualization and access during spine surgery. While it mentions digital image processing, there is no mention of AI, ML, or any related concepts like training or test sets for algorithms. The performance studies focus on substantial equivalence through standard engineering and safety testing.
No.
The device is used to provide access and visualization of the surgical area during minimally invasive spine surgery, it does not provide any therapeutic function.
No
Explanation: The Voyant System is described as an access and visualization device used during minimally invasive spine surgery. Its function is to provide access to the surgical area and display a live video image, but it does not perform any diagnostic function such as identifying diseases or conditions.
No
The device description clearly outlines multiple hardware components including a sheath, imager, image control box, and cables, which are integral to its function.
Based on the provided information, the Voyant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide "minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine." This describes a surgical tool used during a procedure to aid the surgeon, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details a system for accessing and visualizing the surgical site, including a sheath, imager, and control box. This aligns with surgical instrumentation.
- Anatomical Site: The device is used on the "spine," which is a part of the patient's body, not a biological sample.
- Input Imaging Modality: The image acquisition is through an "integrated camera external to the surgical opening," which is used for direct visualization of the surgical field.
- Performance Studies: The performance studies focus on demonstrating substantial equivalence to a predicate device for surgical access and visualization, not on the accuracy of diagnostic measurements or interpretations of biological samples.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Voyant System's function is to facilitate a surgical procedure by providing access and visualization in vivo (within the body).
N/A
Intended Use / Indications for Use
The Voyant System is indicated to provide minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine.
Product codes (comma separated list FDA assigned to the subject device)
HRX
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:
- 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.
Mentions image processing
The image is digitally processed.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Electrical Safety, Applicable Test Standard: IEC 60601-1
Test/Document Description: Electromagnetic Emissions and Immunity, Applicable Test Standard: IEC 60601-1-2
Test/Document Description: Software, Applicable Test Standard: IEC 62304
Test/Document Description: Risk Management, Applicable Test Standard: EN ISO 14971
Test/Document Description: Design Verification Testing, Applicable Test Standard: N/A
The results demonstrate that the subject Voyant System is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Camera resolution: 1080p
Sensor resolution: 3280 x 2464 pixels
Camera sensor: 1/4" CMOS
Tubular retractor compressive force: ≥ 100N
Image resolution: ≥ 11 lp/mm at 80mm
Working length: 4-13cm
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.
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.
Not Found
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
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (949) 662-3959 ext. 106 Facsimile: (949) 581-4761
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
Number | Package Contents** | | |
|---------------------------------------|-----------------|--------------------------|---------------|---------|
| | | Voyant Sheath | Voyant Imager | |
| Sterile, Single-use,
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,
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
Voyant System | SUBJECT DEVICE
Voyant System |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K181885 | K191579 |
| Product Code | HRX | Same |
| Indications for Use | The Voyant System is indicated to provide
minimally invasive access, visualization,
illumination, and magnification of the
surgical area of the spine. | Same |
| Intended Use | Visualization of surgical area. | Same |
| Design | The Voyant System is an access and
visualization system designed to provide
illumination and magnification of the
surgical area during minimally invasive
spine surgery.
The system consists of the Voyant Sheath
and the Voyant Imager and Accessories.
The Voyant Sheath is a tubular retractor
used to provide access to the surgical area.
The Voyant Imager is an external camera
with LED light source that attaches to the
Voyant Sheath. Accessories to the Voyant
Imager include an Image Control Box (ICB)
with connecting cables.
The Image Control Box is a portable
accessory used to control the image output
of the Voyant Imager, which is displayed on
a connected operating room HD monitor. | Same |
| Patient Contacting
Materials (Tubular
Retractor) | Anodized 6061-T6 Aluminum and medical
grade plastic and adhesive | Parylene coated 6061-T6
Aluminum and medical grade
adhesive |
| Feature | PREDICATE DEVICE | SUBJECT DEVICE |
| | Voyant System | Voyant System |
| Labeling (Single
use/Reusable) | Voyant Sheath and Voyant Imager:
Sterile, Single use
Image Control Box and Connecting
Cables: Non-sterile, Reusable | Same |
| Surgical Site Access
Device | Tubular retractors | Same |
| Image Acquisition | Image acquisition is achieved through an
integrated camera external to the surgical
opening | Same |
| Image Processing | The image is digitally processed. | Same |
| Image Display | External monitor connection. | Same |
| Illumination | Illumination is achieved via direct
transmission using an LED light source. | Same |
| Sterilization | Voyant Sheath and Voyant Imager:
• Supplied sterile by Ethylene Oxide
(EtO) to a sterility assurance level of
$10^{-6}$ , for single use
Image Control Box: Supplied non-sterile
and reusable. | Same |
| Performance
Characteristics | Camera resolution: 1080p
Sensor resolution: 3280 x 2464 pixels
Camera sensor: 1/4" CMOS
Tubular retractor compressive force: $\geq$ 100N
Image resolution: $\geq$ 11 lp/mm at 63mm
Working length: 6-13cm | Camera resolution: Same
Sensor resolution: Same
Camera sensor: Same
Tubular retractor compressive
force: Same
Image resolution: $\geq$ 11 lp/mm at
80mm
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.