FLEXLITE CAMERA

K122134 · Spine View, Inc. · HRX · Dec 27, 2012 · Orthopedic

Device Facts

• Record ID: K122134
• Device Name: FLEXLITE CAMERA
• Applicant: Spine View, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The FlexLite™ Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Device Story

FlexLite™ Camera is a reusable, flexible arthroscope for endoscopic visualization during spinal procedures. Device inputs include optical images captured via distal tip CCD sensor and fiber-optic illumination bundles. It operates by connecting to a Vision-Sciences DPU-5050 Video Processor Unit, which handles image display and transfer. Used in surgical settings by physicians, the device provides real-time visualization of the spinal surgical area, assisting in diagnostic or interventional tasks like discectomy, nucleotomy, and foraminotomy. It benefits patients by enabling minimally invasive access to the spine. The device is non-sterile and requires user cleaning and sterilization (STERRAD®) between uses.

Clinical Evidence

Bench testing only. Testing included dimensional, performance, durability, environmental, electrical/thermal safety, EMC, biocompatibility, design validation, cleaning validation, and sterilization validation. Results demonstrated the device performs according to its intended use and meets all applicable specifications.

Technological Characteristics

Reusable, flexible arthroscope; 2 mm diameter; 1163 mm working length. Features fiber-optic illumination bundles, integrated LED light source in handle, and distal tip CCD image sensor. Supports NTSC/PAL video formats. Designed for use with Vision-Sciences DPU-5050 Video Processor. Sterilization via STERRAD®. No software or firmware.

Indications for Use

Indicated for endoscopic visualization in the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures (discectomy, nucleotomy, foraminotomy).

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

• Vision-Sciences ENT-5000 flexible endoscope (K102733, K072073)
• Spine View SpineVu MiniScope (K081051)

Submission Summary (Full Text)

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## 510(k) Summary

# DEC 2 7 2012

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

- A. Name and Address of Applicant Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: [phone] Fax:, [phone]
#### B. Contact Person

Mbithi Muthini Director Quality and Regulatory [phone] [e-mail]

Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant [phone] [e-mail]

#### C. Date Prepared

November 30, 2012

#### D. Device Name

| Trade Name: | FlexLite™ Camera |
|----------------------|------------------|
| Common Name: | Arthroscope |
| Classification Name: | Arthroscope |

#### E. Device Classification

| Classification: | 21 CFR §888.1100 |
|-----------------|------------------|
| Product Code: | HRX |
| Device Class: | Class II |

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#### F. Predicate Device

Spine View, Inc. submits that the subject FlexLite™ Camera is substantially equivalent to the predicates, Vision-Sciences ENT-5000 flexible endoscope (K102733, K072073) and the Spine View SpineVu MiniScope (K081051).

#### G. Device Description

The Spine View FlexLite™ Camera is a flexible, reusable arthroscope designed for endoscopic visualization during diagnostic or interventional spinal procedures with access to the target area established through a surgical opening. The device includes fiber-optic illumination bundles with an integrated LED light source in the handle and a distal tip CCD image sensor with associated electronics. The camera is offered to support NTSC and PAL video formats. The FlexLite™ Camera is designed for use with the commercially available Vision-Sciences DPU-5050 Video Processor Unit (K102733, K072073) for image display and transfer. The FlexLite™ Camera contains neither software nor firmware. The FlexLite™ Camera is provided non-sterile to the customer and must be cleaned and sterilized by the user prior to each use.

#### H. Intended Use

The FlexLite™ Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

#### . Technological Comparison

The Spine View FlexLite™ Camera has similar features as compared to the predicate devices as shown in the tables below:

| Manufacturer<br>Model Name<br>510(k) Number | Spine View, Inc.<br>FlexLite™ Camera<br>TBD | Vision-Sciences, Inc.<br>ENT-5000 Surgical<br>Videoscope<br>K102733, K072073 | Spine View, Inc.<br>SpinVu Miniscope<br>K081051 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21CFR888.1100<br>HRX, Class II | 21CFR888.1100 &<br>21CFR874.4760<br>HRX& EOB, Class II | 21CFR888.1100<br>HRX, Class II |
| Indications for<br>Use | The FlexLite™ Camera<br>is indicated for use for<br>endoscopic visualization<br>in the surgical area of the<br>cervical, thoracic, or<br>lumbar spine during | The ENT-5000 is intended<br>for use in flexible<br>endoscopic examination of<br>the upper airway, vocal<br>cords and/or nasal<br>passages; and for use<br>diagnostic arthroscopic and | The SpineVu<br>Endoscopic Spine<br>System (SESS) and<br>SpinVu MiniScope are<br>indicated for use for<br>endoscopic access and<br>visualization in the |
| | diagnostic or<br>interventional spinal<br>procedures such as<br>discectomy, nucleotomy | endoscopic procedures to<br>provide illumination and<br>visualization of an interior<br>cavity of the body through | surgical area of the<br>cervical, thoracic, or<br>lumbar spine and are<br>accessorized with |

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Spine View, Inc.

| Manufacturer<br>Model Name<br>510(k) Number | Spine View, Inc.<br>FlexLite™ Camera<br>TBD | Vision-Sciences, Inc.<br>ENT-5000 Surgical<br>Videoscope<br>K102733, K072073 | Spine View, Inc.<br>SpinVu Miniscope<br>K081051 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | and foraminotomy. | either a natural or surgical<br>openings. | surgical and coagulation<br>tools for interventional<br>spinal procedures such<br>as discectomy,<br>nucleotomy and<br>foraminatomy |
| Design | A reusable, flexible,<br>video endoscope with no<br>channel; for use with the<br>Vision-Sciences Digital<br>Video Processor with<br>integrated LCD monitor. | A reusable, flexible, video<br>endoscope with no channel;<br>optional single-use, sterile,<br>disposable sheath (various<br>models and channel sizes);<br>for use with the Vision-<br>Sciences Digital Video<br>Processor with integrated<br>LCD monitor. | A reusable, flexible,<br>video endoscope with no<br>channel; with eyepiece<br>on proximal end having<br>port for illumination<br>cable. |
| Diameter | 2 mm | 3.4 mm | 0.8 mm |
| Working<br>Length | 1163 mm | 320 mm | ~11 inches (280mm) |
| Single Use? | Reusable (STERRAD®) | Reusable (EtO or<br>Glutaraldehyde) (optional<br>single-use sterile sheath) | Reusable (STERIS®) |

The technological characteristics and principals of operation of the FlexLite™ Camera are substantially equivalent to the named predicate devices.

#### J. Non-Clinical Performance Data

The following non-clinical testing was conducted to support a determination of substantial equivalence to the predicate device.

| • Dimensional Testing | • Biocompatibility Testing |
|---------------------------------------|-----------------------------|
| • Performance Testing | • Design Validation Testing |
| • Durability Testing | • Cleaning Validation |
| • Environmental Testing | • Sterilization Validation |
| • Electrical Safety, Thermal Safety & | |
| • EMC Testing | |

The above testing confirmed that the FlexLite™ Camera performs according to the stated intended use. All data fell well within product specifications and external standard requirements. Results of non-clinical testing demonstrated that the Spine View FlexLite™ Camera is substantially equivalent to the predicate devices for its intended use.

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#### K. Conclusions

The Spine View FlexLite™ Camera has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, nonclinical testing was conducted to validate the performance of the device and ensure the FlexLite™ Camera functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device for its intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping shapes that form the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all caps and appears to be in a sans-serif font.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter dated: December 27, 2012

Spine View, Incorporated % Mbithi Muthini Director, Quality and Regulatory 48810 Kato Road, Suite 100E Fremont, California 94538

Re: K122134

Trade/Device Name: FlexLite™ Camera Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 30, 2012 Received: December 03, 2012

### Dear Mbithi Muthini:

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. 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

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forth in the quality systems (QS) 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Mark N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Spine View, Inc.

Traditional 510(k) FlexLite™ Camera

## Indications for Use Statement

510(k) Number (if known): K_ 22 13 4

FlexLite™ Camera Device Name:

### Indications for Use:

The FlexLite™ Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ × Or (per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2012.12.27 08:02:33 -05'00'

os Min (Division Sign-Off) Division of Surgical Devices 510(k) Number K 122134