NeedleCam HD™ 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.

Device Description

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.

AI/ML Overview

The BioVision NeedleCam HD™ Visualization System submitted a Special 510(k) and did not conduct a study to prove the device meets acceptance criteria, but rather demonstrated substantial equivalence to a predicate device (BioVision SurgView™ Integrated Visualization System K082293) based on similarities in intended use, design, physical characteristics, and geometry, as well as modifications that are considered incremental changes and do not affect safety and effectiveness.

Here’s a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a direct comparison of such metrics against predefined thresholds. Instead, it relies on a comparison of technological characteristics to a predicate device, arguing that the new device is "substantially equivalent."

The table below summarizes the key comparisons made between the applicant device (NeedleCam HD™ Visualization System) and the predicate device (SurgView™ Visualization System K082293), highlighting similarities and differences. The implied "acceptance criteria" here are that the new device's characteristics are either identical or demonstrably equivalent/improved without compromising safety and effectiveness.

Feature	Predicate Device (SurgView™ Visualization System K082293)	Applicant Device (NeedleCam HD™ Visualization System)	Comparison / Implied Performance
I. GENERAL CHARACTERISTICS
Device Description	Video endoscope/arthroscope imaging system with Light Source/Display/Image Capture device (internal monitor, image processor, Xenon light source, internal power supply), Camera handpiece, Semi-rigid Fiberoptic Scope, Media Capture CF Card System, Video output.	Video endoscope/arthroscope imaging system with Image Capture Box (image processor, external power supply), Camera handpiece (with LED light source), Semi-rigid Fiberoptic Scope, Media Capture USB System, Video Outputs.	Similar core function, updated components.
Intended Use	Illumination and visualization of interior body cavities in diagnostic and operative arthroscopic/endoscopic procedures (e.g., knee, shoulder, ankle, elbow, wrist, TMJ, spinal, ophthalmic, ENT, cervix).	Identical: Illumination and visualization of interior body cavities in diagnostic and operative arthroscopic/endoscopic procedures (e.g., knee, shoulder, ankle, elbow, wrist, shoulder, TMJ, spinal, ophthalmic, ENT, cervix).	Identical
Materials Used	Plastic enclosure, metal plate, media capture board, plastic camera cable, fiber optic cable. Scopes & instruments: Stainless Steel for Scope Shaft; Fiber Optics for light transmission.	Plastic enclosure, media capture board, plastic camera cable. Scopes & instruments: Stainless Steel for Scope Shaft; Fiber Optics for light transmission.	Similar, minor difference in enclosure description.
Labeling (Single Use/Reusable)	Image capture box and camera handpiece: Reusable. Scopes & instruments: Sterile, Single Use.	Identical: Image capture box and camera handpiece: Reusable. Scopes & instruments: Sterile, Single Use.	Identical
Image acquisition	Endoscope attached to a camera handpiece. Endoscope in sterile field, handpiece non-sterile with barrier.	Identical: Endoscope attached to a camera handpiece. Endoscope in sterile field, handpiece non-sterile with barrier.	Identical
Connectivity	Endoscope, camera handpiece, cable, illumination source, image processor connections; safe and reliable. Endoscope to camera handpiece via quick release. Fiberoptic bundle integrated with camera cable. Camera cable to light source/image capture with single hybrid (electrical/optical) connector.	Endoscope, camera handpiece, cable, illumination source, image processor connections; safe and reliable. Endoscope to camera handpiece via quick release. LED light source in camera handpiece. Camera cable to image capture device with single electrical connector.	Similar function, updated light source integration.
Image processing	Digitally processed for manipulation, capture, printing, multiple displays.	Identical: Digitally processed for manipulation, capture, printing, multiple displays.	Identical
Image display	Internal monitor display with external monitor connection.	External monitor connection.	Difference: no internal monitor, relies on external.
Data Entry	Session information entered via external keyboard.	Identical: Session information entered via external keyboard.	Identical
Data storage	Image and video storage to Compact Flash™ cards.	Image and video storage to USB device.	Difference: updated storage medium (USB).
Where used	Hospital / Doctor's office.	Identical: Hospital / Doctor's office.	Identical
II. CHARACTERISTICS OF THE LIGHT SOURCE
Illumination	Fiberoptic bundle attached to endoscope. Xenon light source internal to image capture box. LED and Xenon usable light output is equivalent.	Internal LED light source, integral to camera handpiece. LED and Xenon usable light output is equivalent.	Similar output, different technology/location.
Type of light source	Xenon	LED	Difference: updated technology (LED).
Lamp power rating	35W	1W	Difference: lower power (LED efficiency).
Rated lamp life	3,000 hours	20,000 hours	Difference: significantly increased lamp life.
Luminous intensity at scope output	4-6 lumens	Identical: 4-6 lumens	Identical
III. CHARACTERISTICS OF THE CAMERA
Camera sensor	¼" CCD	Identical: ¼" CCD	Identical
Sensor resolution	768(H) x 494(V) pixels	Identical: 768(H) x 494(V) pixels	Identical
Camera resolution	480 lines, interlaced	Identical: 480 lines, interlaced	Identical
Camera sterility	Non sterile. Drape is used for sterile field preservation.	Identical: Non sterile. Drape is used for sterile field preservation.	Identical
Endoscope coupler	Built-in	Identical: Built-in	Identical

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical testing was not used to prove substantial equivalence." Therefore, there was no test set of clinical data, no sample size, and no data provenance relevant to clinical performance. The evaluation was primarily based on engineering and design comparisons.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical testing was performed, no ground truth was established by experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a visualization system (hardware), not an AI-assisted diagnostic tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a hardware device; there is no standalone algorithm performance to evaluate in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical test set requiring ground truth was used. Substantial equivalence was based on technological similarity to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. No algorithm or machine learning component is described that would require a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 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 FranceType 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, HRX21 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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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(including scope, cannula, obturator, trocar and plug)	K082293
BVTKIT75-3R1A0	BioVision NeedleView 30 deg, 100mm Scope kit(including scope, cannula, obturator, trocar and plug)	K082293
BVTKIT82-34001	BioVision NeedleView CH 3.4mm Scope Kit(including scope, cannula, dilator, tuohy needles,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:	Relevant similarities are identified in bold text.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 avideo endoscope/arthroscope imaging systemconsisting of the following components:1. An Image Capture Box that includes imageprocessor and external power supply)2. Camera handpiece including a LED lightsource.3. A semi-rigid Fiberoptic Scope in a varietyof diameters, lengths, and viewing angles.Supplemental instruments include acannula, trocar, obturator, and cannulaplug.4. Media Capture USB System5. Video Outputs for external monitor	The SurgView™ Visualization System is avideo endoscope/arthroscope imaging systemconsisting of the following components:1. A Light Source/Display/Image Capturedevice that includes an internal monitor,image processor, Xenon light source andinternal power supply.2. Camera handpiece.3. A semi-rigid Fiberoptic Scope in a varietyof diameters, lengths, and viewing angles.Supplemental instruments for the scopeinclude a cannula, trocar, obturator, andcannula plug.4. Media Capture CF Card System5. Video output for external monitor.
2	Intended Use	Needle Cam HD™ Visualization System isindicated to be used by a trained physician toprovide illumination and visualization of aninterior cavity of the body through a naturalor surgical opening in diagnostic andoperative arthroscopic and endoscopicprocedures. Examples of surgical use includebut are not limited to procedures on theknee, shoulder, ankle, elbow, wrist, shoulder,temporomandibular joint (TMJ), spinal,ophthalmic, ENT, and cervix.	The SurgView™ Visualization System isindicated to be used by a trained physician toprovide illumination and visualization of aninterior cavity of the body through a naturalor surgical opening in diagnostic andoperative arthroscopic and endoscopicprocedures. Examples of surgical use includebut are not limited to procedures on theknee, shoulder, ankle, elbow, wrist, shoulder,temporomandibular joint (TMJ), spinal,ophthalmic, ENT, and cervix.
3	Materials Used	Plastic enclosure, media capture board,plastic camera cable.Scopes & instruments - Stainless Steel forScope Shaft; Fiber Optics for lighttransmission	Plastic enclosure, metal plate, media captureboard, plastic camera cable, and fiber opticcable.Scopes & instruments - Stainless Steel forScope Shaft; Fiber Optics for lighttransmission
4	Labeling (SingleUse/Reusable)	Image capture box and camera handpiece:Reusable.Scopes & instruments: Sterile, Single Use	Image capture box and camera handpiece:Reusable.Scopes & instruments: Sterile, Single Use
5	Image acquisition	Image acquisition is achieved through anendoscope attached to a camera handpiece.The endoscope is in the sterile field while thehandpiece remains non-sterile. A barrier isprovided to preserve the sterile field.	Image acquisition is achieved through anendoscope attached to a camera handpiece.The endoscope is in the sterile field while thehandpiece remains non-sterile. A barrier isprovided to preserve the sterile field.
6	Connectivity	The endoscope, camera handpiece, cable,illumination source and image processorconnections allow functional coupling of thecomponents while providing safe and reliableconnections, in particular those related toelectrical safety for the user and patient. Theendoscope attached to the camera handpieceusing a quick release connection. The LEDlight source is included in the camerahandpiece. The camera cable connects to theimage capture device using a single electricalconnector.	The endoscope, camera handpiece, cable,illumination source and image processorconnections allow functional coupling of thecomponents while providing safe and reliableconnections, in particular those related toelectrical safety for the user and patient. Theendoscope attached to the camera handpieceusing a quick release connection. Thefiberoptic bundle is integrated with the cameracable. The camera cable connects to the lightsource/image capture device using a singlehybrid (electrical/optical) connector.
7	Image processing	The image is digitally processed to allowfurther manipulation, capture, printing, andmultiple displays.	The image is digitally processed to allowfurther manipulation, capture, printing, andmultiple displays.
8	Image display (s)	External monitor connection	Internal monitor display with external monitorconnection.
9	Data Entry	Session information entered via externalkeyboard	Session information entered via externalkeyboard
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;
1. Update the existing video format to the current digital format.
1. 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.

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

Regulation Number and Section

§ 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.