NeedleCam HD Visualization System
Device Facts
| Record ID | K143705 |
|---|---|
| Device Name | NeedleCam HD Visualization System |
| Applicant | Biovision Technologies, LLC |
| Product Code | HRX · Orthopedic |
| Decision Date | Feb 20, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
Indications for Use
The NeedleCam HD™ Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
Device Story
System comprises image capture box, camera handpiece with integrated LED light source, and external power supply; connects to BioVision surgical endoscopes via quick-release optical connector. Used in hospital or clinic settings by physicians for diagnostic and operative arthroscopic/endoscopic procedures. Captures still images and video; outputs to external monitor; stores data via USB. LED light source replaces predicate Xenon source; digital format replaces analog. Provides illumination and visualization of interior body cavities; assists physician in surgical navigation and documentation. Benefits include improved light source efficiency and modern data storage/connectivity.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing, design comparison, and software validation.
Technological Characteristics
Components: Image capture box, camera handpiece, fiberoptic scope. Materials: Plastic enclosure, stainless steel scope shaft, fiber optics. Illumination: Internal 1W LED (20,000-hour life). Camera: 1/4" CCD sensor, 768x494 resolution, 480 lines interlaced. Connectivity: USB storage, external monitor output. Safety: ANSI/AAMI ES 60601-1:2005 (3rd edition).
Indications for Use
Indicated for use by trained physicians for illumination and visualization of interior body cavities during diagnostic and operative arthroscopic and endoscopic procedures. Applicable to knee, shoulder, ankle, elbow, wrist, TMJ, spinal, ophthalmic, ENT, and cervical procedures.
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
- BioVision Technologies SurgView™ Integrated Visualization System (K082293)
Reference Devices
- BioVision NeedleView CH 3.4mm Scope Kit (K141326)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
BioVision Technologies, LLC Mr. David Sanso President 221 Corporate Circle, Unit H Golden, Colorado 80401
Re: K143705
Trade/Device Name: NeedleCam HD" Visualization System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, GCJ Dated: January 29, 2015 Received: January 30, 2015
Dear Mr. Sanso:
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 contact the Division of Industry and Consumer Education 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. 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
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You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
# Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K143705
Device Name NeedleCam HDTM Visualization System
Indications for Use (Describe) NeedleCam HDTM Visualization System
Indications for Use: The NeedleCam HD™ Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
This is the same intended use as for a previously cleared device - the BioVision Technologies SurgView™ Integrated Visualization System (K082293).
| Mother France<br>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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Visualizing Better Care
Image /page/3/Picture/1 description: The image shows the logo for BioVision Technologies, LLC. The logo features the word "BIO" in gray, with an eye symbol incorporated into the "O". Below "BIO" is the word "VISION" in teal, underlined with a teal line. To the right of "VISION" is the text "Technologies, LLC" in a smaller font, also in teal.
221 Corporate Circle, Suite Golden, Colorado 80401 USA Phone: 303-237-9608 • Fax: 303-237-0757 www.biovisiontech.com
## Needle Cam HD™ Visualization System Special 510(k) Submission
# SPECIAL 510(k) SUMMARY
#### Submission Information
- Date Prepared: December 22, 2014 Applicant: BioVision Technologies, LLC. Address: 221 Corporate Circle Unit H
- Telephone Number: 303-237-9608
- Submitter's Contact: David Sanso, President
### Device Information
| Proprietary Name: | NeedleCam HD™ Visualization System |
|----------------------|------------------------------------------------|
| Common Name: | Arthroscope/Endoscope |
| Classification Name: | Arthroscope / Endoscope and Accessories |
| Regulation Number: | 21 CFR §888.1100, HRX<br>21 CFR §876.1500, GCJ |
| Regulatory Class: | II |
Golden, Colorado 80401
# Predicate Device
BioVision Technologies SurgView™ Integrated Visualization System (K082293)
### Device Description
Name of the Device: NeedleCam HD™ Visualization System
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NeedleCam HDTM Visualization System is comprised of an Image Capture Box, a Camera Handpiece (including an LED light source) that captures still images and full resolution video, and External Power Supply. The camera has a quick-release optical connector that adapts to a wide variety of Bio Vision Technologies' surgical endoscopes. The device is used with an endoscope to visualize and illuminate an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures.
The BioVision endoscopes and supplemental instruments that were approved with the predicate SurgView Visualization System have not been changed.
# Statement of Intended Use
The system is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
# NeedleCam HD System Components and Accessories
The NeedleCam HD Visualization System is intended to be used with BioVision endoscopes. The following is a listing of the current compatible scopes, along with the applicable 510(k) clearance numbers.
| Part Number | Description | 510(k) Number |
|----------------|-----------------------------------------------------------------------------------------------------|---------------|
| BVTKIT72-0L065 | OnPoint 0 deg, 65mm Scope kit (including scope, cannula, obturator, trocar and plug) | K082293 |
| BVTKIT72-0L165 | BioVision NeedleView 0 deg, 65mm Scope kit (including scope, cannula, obturator, trocar and plug) | K082293 |
| BVTKIT72-0L1A0 | BioVision NeedleView 0 deg, 100mm Scope kit (including scope, cannula, obturator, trocar and plug) | K082293 |
| BVTKIT72-1R165 | BioVision NeedleView 10 deg, 65mm Scope kit (including scope, cannula, obturator, trocar and plug) | K082293 |
| BVTKIT72-1R1A0 | BioVision NeedleView 10 deg, 100mm Scope kit (including scope, cannula, obturator, trocar and plug) | K082293 |
| BVTKIT72-1R265 | InnerVue II 10 deg, 65mm Scope kit (including scope, cannula, obturator, trocar and plug) | K082293 |
| BVTKIT72-1R2A0 | InnerVue II 10 deg, 100mm Scope kit (including scope, cannula, obturator, trocar and plug) | K082293 |
It is the responsibility of the user to verify that this copy is of the latest revision. This document is maintained on electronic media, the current revision of this document is located on BioVision Technologies' network.
This document is the property of BioVision Technologies and is proprietary and confidential. Distribution of external copies must have prior consent from BioVision Technologies.
X: Master Documents BVT Device Master Records(97)Hydra\Regulatory Documents\a Special 510 (k) for Needle Cam HD\Needle CamHD Special 510 K Summary.docx 12/23/14
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| BVTKIT75-3R165 | BioVision NeedleView 30 deg, 65mm Scope kit<br>(including scope, cannula, obturator, trocar and plug) | K082293 |
|----------------|------------------------------------------------------------------------------------------------------------------------|---------|
| BVTKIT75-3R1A0 | BioVision NeedleView 30 deg, 100mm Scope kit<br>(including scope, cannula, obturator, trocar and plug) | K082293 |
| BVTKIT82-34001 | BioVision NeedleView CH 3.4mm Scope Kit<br>(including scope, cannula, dilator, tuohy needles,<br>scalpel and guidewire | K141326 |
# Comparison to Predicate Device
The table below shows relevant similarities and differences between the NeedleCam HD™ Visualization System and its predicate device - SurgView™ Integrated Visualization System (K082293).
| APPLICANT DEVICE: | NeedleCam HD™ Visualization System |
|-------------------|---------------------------------------------------------------------------------------------------------------------|
| PREDICATE DEVICE: | SurgView™ Visualization System (K082293) |
| NOTE: | <b>Relevant similarities are identified in bold text.</b><br>Relevant differences are identified in underlined text |
| | I. GENERAL CHARACTERISTICS | | PREDICATE DEVICE |
|-----------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ITEM | FEATURE | NeedleCam HD Visualization System | SurgView™ Visualization System K082293 |
| 1 | Device Description | NeedleCam HD Visualization System is a<br>video endoscope/arthroscope imaging system<br>consisting of the following components:<br><br>1. An Image Capture Box that includes image<br>processor and external power supply)<br><br>2. Camera handpiece including a LED light<br>source.<br><br>3. A semi-rigid Fiberoptic Scope in a variety<br>of diameters, lengths, and viewing angles.<br>Supplemental instruments include a<br>cannula, trocar, obturator, and cannula<br>plug.<br><br>4. Media Capture USB System<br><br>5. Video Outputs for external monitor | The SurgView™ Visualization System is a<br>video endoscope/arthroscope imaging system<br>consisting of the following components:<br><br>1. A Light Source/Display/Image Capture<br>device that includes an internal monitor,<br>image processor, Xenon light source and<br>internal power supply.<br><br>2. Camera handpiece.<br><br>3. A semi-rigid Fiberoptic Scope in a variety<br>of diameters, lengths, and viewing angles.<br>Supplemental instruments for the scope<br>include a cannula, trocar, obturator, and<br>cannula plug.<br><br>4. Media Capture CF Card System<br><br>5. Video output for external monitor. |
| 2 | Intended Use | Needle Cam HD™ Visualization System is<br>indicated to be used by a trained physician to<br>provide illumination and visualization of an<br>interior cavity of the body through a natural<br>or surgical opening in diagnostic and<br>operative arthroscopic and endoscopic<br>procedures. Examples of surgical use include<br>but are not limited to procedures on the<br>knee, shoulder, ankle, elbow, wrist, shoulder,<br>temporomandibular joint (TMJ), spinal,<br>ophthalmic, ENT, and cervix. | The SurgView™ Visualization System is<br>indicated to be used by a trained physician to<br>provide illumination and visualization of an<br>interior cavity of the body through a natural<br>or surgical opening in diagnostic and<br>operative arthroscopic and endoscopic<br>procedures. Examples of surgical use include<br>but are not limited to procedures on the<br>knee, shoulder, ankle, elbow, wrist, shoulder,<br>temporomandibular joint (TMJ), spinal,<br>ophthalmic, ENT, and cervix. |
| 3 | Materials Used | Plastic enclosure, media capture board,<br>plastic camera cable.<br>Scopes & instruments - Stainless Steel for<br>Scope Shaft; Fiber Optics for light<br>transmission | Plastic enclosure, metal plate, media capture<br>board, plastic camera cable, and fiber optic<br>cable.<br>Scopes & instruments - Stainless Steel for<br>Scope Shaft; Fiber Optics for light<br>transmission |
| 4 | Labeling (Single<br>Use/Reusable) | Image capture box and camera handpiece:<br>Reusable.<br>Scopes & instruments: Sterile, Single Use | Image capture box and camera handpiece:<br>Reusable.<br>Scopes & instruments: Sterile, Single Use |
| 5 | Image acquisition | Image acquisition is achieved through an<br>endoscope attached to a camera handpiece.<br>The endoscope is in the sterile field while the<br>handpiece remains non-sterile. A barrier is<br>provided to preserve the sterile field. | Image acquisition is achieved through an<br>endoscope attached to a camera handpiece.<br>The endoscope is in the sterile field while the<br>handpiece remains non-sterile. A barrier is<br>provided to preserve the sterile field. |
| 6 | Connectivity | The endoscope, camera handpiece, cable,<br>illumination source and image processor<br>connections allow functional coupling of the<br>components while providing safe and reliable<br>connections, in particular those related to<br>electrical safety for the user and patient. The<br>endoscope attached to the camera handpiece<br>using a quick release connection. The LED<br>light source is included in the camera<br>handpiece. The camera cable connects to the<br>image capture device using a single electrical<br>connector. | The endoscope, camera handpiece, cable,<br>illumination source and image processor<br>connections allow functional coupling of the<br>components while providing safe and reliable<br>connections, in particular those related to<br>electrical safety for the user and patient. The<br>endoscope attached to the camera handpiece<br>using a quick release connection. The<br>fiberoptic bundle is integrated with the camera<br>cable. The camera cable connects to the light<br>source/image capture device using a single<br>hybrid (electrical/optical) connector. |
| 7 | Image processing | The image is digitally processed to allow<br>further manipulation, capture, printing, and<br>multiple displays. | The image is digitally processed to allow<br>further manipulation, capture, printing, and<br>multiple displays. |
| 8 | Image display (s) | External monitor connection | Internal monitor display with external monitor<br>connection. |
| 9 | Data Entry | Session information entered via external<br>keyboard | Session information entered via external<br>keyboard |
| 10 | Data storage | Image and video storage to USB device | Image and video storage to Compact Flash™ cards. |
| 11 | Where used | Hospital / Doctor's office | Hospital / Doctor's office |
| II. CHARACTERISTICS OF THE LIGHT SOURCE | | | |
| ITEM | FEATURE | NeedleCam HD™ Visualization System | SurgView™ Visualization System K082293 |
| 1 | Illumination | Illumination is achieved via an internal LED light source. The LED light source is an integral part of the device. The LED is internal to the camera handpiece. LED and Xenon usable light output is equivalent. | Illumination is achieved via a fiberoptic bundle attached to the endoscope. The Xenon light source is an integral part of the device. The Xenon light source is internal to the image capture box. LED and Xenon usable light output is equivalent. |
| 2 | Type of light source | LED | Xenon |
| 3 | Lamp power rating | 1W | 35W |
| 4 | Rated lamp life | 20,000 hours | 3,000 hours |
| 5 | Luminous intensity as measured at scope output | 4-6 lumens | 4-6 lumens |
| III. CHARACTERISTICS OF THE CAMERA | | | |
| ITEM | FEATURE | NeedleCam HD™ Visualization System | SurgView™ Visualization System |
| 1 | Camera sensor | ¼" CCD | ¼" CCD |
| 2 | Sensor resolution | 768(H) x 494(V) pixels | 768(H) x 494(V) pixels |
| 3 | Camera resolution | 480 lines, interlaced | 480 lines, interlaced |
| 4 | Camera sterility | Non sterile. Drape is used for sterile field preservation. | Non sterile. Drape is used for sterile field preservation. |
| 5 | Endoscope coupler | Built-in | Built-in |
# PREDICATE COMPARISON CHART
It is the responsibility of the user to verify that this copy is of the latest revision. This document is mantained on electronic media, the current revision of this document is located on BioVision Technologies' network.
This document is the property of BioVision Technologies and is proprietary and confidential. Distribution of external copies must have prior consent from BioVision Technologies.
X:\Master_Documents_BVT\Device_Master_Records\(97)Hydra\Regulatory Documents\a Special 510 (k) for Needle Cam HD\Needle CamHD Special 510 K Summary.docx 12/23/14
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It is the responsibility of the user to verify that this copy is of the latest revision. This document is maintained on electronic media. the current revision of this document is located on BioVision Technologies' network.
This document is the property of BioVision Technologies and is proprietary and confidential. Distribution of external copies must have prior consent from BioVision Technologies.
X: Master Documents BVT Device Master Records(97)Hydra\Regulatory Documents\a Special 510 (k) for Needle Cam HD\Needle CamHD Special 510 K Summary.docx 12/23/14
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Conclusion: Based on the evaluation of the performance characteristics, construction, manufacturing processes, and indications of use, BioVision Technologies has concluded that the BioVision NeedleCam HD ™ Visualization System is substantially equivalent to the predicate device listed in this submission.
The upgrades were completed to incorporate the improved light source options provided by LED lighting. The industry standard for media storage has moved from CF cards to USB technology. Additionally, analog television technology has been replaced by digital television technology.
It is the responsibility of the user to verify that this copy is of the latest revision. This document is maintainedia, the current revision of this document is located on BioVision Technologies' network.
This document is the property of BioVision Technologies and is proprietary and confidential. Distribution of external opies must have prior consent from BioVision Technologies.
X:\Master_Documents_BVT\Device_Master_Records\(97)Hydra\Regulatory Documents\a Special 510 (k) for Needle Cam HD\Needle CamHD Special 510 K Summary.docx 12/23/14
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## Summary of Technologies
The technological characteristics of the Bio Vision NeedleCam HD™ Visualization System are similar to its predicate device - BioVision SurgView™ Visualization System (K082293). The indications and contraindications listed in this submission are in congruence between these devices. The modifications are incremental changes to the predicate image capture box and camera handpiece that do not affect safety and effectiveness of the modified device. The modifications are the following:
- 1) Update the image capture box to the current standard USB storage device;
- 2) Update the existing video format to the current digital format.
- 3) The camera handpiece has been upgraded with an LED light source.
We believe these modifications are eligible for the Special 510 (k) process since they have the same fundamental scientific technology and intended use as the predicate device.
### Performance Testing
Establishment of equivalence is based on similarities of intended use, design, physical characteristics and geometry between the BioVision NeedleCam HD™ Visualization System and its predicate device -BioVision SurgView™ Visualization System (K082293).
Safety testing was completed to ANSI/AAMI ES 60601-1:2005 (3™ edition) on the BioVision NeedleCam HD™ Visualization System. Additionally software validation was completed on the system.
### Clinical Testing
Clinical testing was not used to prove substantial equivalence. Establishment of equivalence is based on similarities of intended use, design, physical characteristics and geometry between the BioVision Needle Cam HD and its predicate device.
### Conclusion
Based on the evaluation of the performance characteristics, construction, manufacturing processes, and indications of use, Bio Vision Technologies has concluded that the BioVision Needle Cam HD™ Visualization System is substantially equivalent to the predicate device listed above. In all cases, the characteristics of this device are identical or similar to the predicate device as they relate to the intended uses or application. BioVision Technologies has also determined that the modification is an incremental change to the existing device that does not affect safety and effectiveness of the device.
It is the responsibility of the user to verify that this copy is of the latest revision. This document is maintainedia, the current revision of this document is located on BioVision Technologies' network.
This document is the property of BioVision Technologies and is proprietary and confidential. Distribution of external copies must have prior consent from BioVision Technologies.
X: Master Documents BVT Device Master Records (97)Hydra\Regulatory Documents\a Special 510 (k) for Needle Cam HD\Needle CamHD Special 510 K Summary.docx 12/23/14
