This 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

The NeedleView CH is a rigid Fiberoptic scope with a working channel designed for single use. The product consists of a 17,000 pixel coherent silica fiber bundle, 30um diameter light fibers and a stainless steel channel encased in a stainless steel shaft. The effective field of view is 80° in air and 62° in water. The direction of view is 0°. The scope has retaining groves to incorporate a drape that will cover the camera and cord that connects to the Surg View System. The NeedleView CH Scope Kit consists of a fiber-optic based micro-endoscope (3.4mm Outer Diameter, 1.85mm Working Channel, 160mm Working Length), 12F Cannula (4mm Inner Diameter), 12F Dilator(4mm Diameter), 14Gx127mm Tuohy Needle, 18Gx152mm Tuohy Needle, #11 Scalpel, Guidewire (70cm Length), Hemostasis Valve Adapter (HVA), and a sterile drape. All of these items are disposable and for single-use only. The micro-endoscope is made to couple with a non-disposable system hand piece that contains a light source and camera, which is available separately.

AI/ML Overview

This document is a 510(k) summary for the NeedleView CH™ Scope Kits, a medical device for arthroscopic and endoscopic procedures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, thereby eliminating the need for extensive clinical trials.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on non-clinical performance and biocompatibility testing to demonstrate substantial equivalence. It does not provide specific numerical "acceptance criteria" or "reported device performance" in the format of a clinical trial outcome with metrics like sensitivity, specificity, or accuracy. Instead, it lists the types of performance tests conducted for various components of the NeedleView CH™ Scope Kit and states that these tests were "completed" or "utilized" specific standards. This implies that the device met the requirements of these standards for each test.

Since no specific numerical performance criteria or results are detailed in the provided text, a table like the one requested cannot be fully constructed with explicit numerical values. However, we can infer the categories of acceptance based on the tests conducted.

Category of Test	Implicit Acceptance Criteria (based on standards)	Reported Device Performance (Summary)
NeedleView CH Scope	Scope performance standards	Performance Testing and Accelerated Aging Performance Testing were completed successfully.
Tuohy Needle	Flexural strength, buckling, puncture resistance	Flexural Test (14G, 18G), Buckling Test (18G), and Puncture Test Summary were completed successfully.
Cannula	Insertion/withdrawal, leak, bending, crushing, tensile strength	Insertion and Withdrawal Test (with dilator), Leak Test, Bending Test, Crushing Test, and Tensile Test were completed successfully.
HVA (Hemostasis Valve Adapter)	Fit and leak integrity	Fit and Leak Test was completed successfully.
Guidewire	Tensile, compression, flexural strength	Tensile Test, Compression Test, and Flexural Test were completed successfully.
Biocompatibility	ISO 10993-1:2009 standards	Biocompatibility testing was completed utilizing ISO 10993-1:2009.
Packaging & Sterilization	Integrity, sterility, accelerated aging	Packaging, sterilization, distribution, and accelerated aging testing were completed utilizing relevant ISO and ASTM standards (e.g., ISO 11607-2:2006, ASTM F2096:2011, ANSI/AAMI/ISO 11135:2007).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for any of the performance tests. The data provenance is also not explicitly stated beyond the fact that these tests were performed by BioVision Technologies, LLC, for their device. This is typical for 510(k) submissions focusing on substantial equivalence through non-clinical bench testing, where detailed sample sizes for each specific test component are often included in the full test reports, not generally in the summary document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This submission relies on performance testing against established engineering and biocompatibility standards, not on expert-adjudicated "ground truth" for diagnostic or clinical outcomes. There were no human experts evaluating the performance in a clinical context for the purpose of establishing ground truth for a test set in the way one would for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As the tests described are physical, mechanical, and biological evaluations against standards, there is no "adjudication method" involving human reviewers in the context of clinical interpretation or diagnosis. The results of the tests would be pass/fail based on the specified standard's criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

No. A MRMC comparative effectiveness study was not performed. This device is a physical medical instrument (an arthroscope/endoscope), not an AI-assisted diagnostic or interpretative system. The submission explicitly states: "Clinical testing was not used to prove substantial equivalence."

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

No. This device is a physical instrument for visualization, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used:

For the performance and biocompatibility testing, the "ground truth" used is implicitly the established scientific and engineering standards (e.g., ISO 10993-1, ASTM F2096, ISO 11607-2, etc.). The device's components had to meet the performance specifications outlined in these standards. There is no pathology, outcomes data, or expert consensus serving as "ground truth" in the clinical sense for this type of submission.

8. The Sample Size for the Training Set:

Not applicable. Since this is not an AI/machine learning device, there is no "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

October 8, 2014

BioVision Technologies, LLC Mr. David Sanso President 221 Corporate Circle, Unit H Golden, Colorado 80401

Re: K141326

Trade/Device Name: NeedleView CH™ Scope Kits Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, GCJ Dated: August 22, 2014 Received: September 2, 2014

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.

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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 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/Resourcesfor You/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 vours.

Binita S. Ashar -S 2014.10.08 12:36:21 -04'00'

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

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INDICATIONS FOR USE

510(k) Number (if known): _ K141326

Device Name: NeedleView CH™ Scope Kits

Indications for Use: This 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use N/A (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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NeedleView CH™ Scope Kits Traditional 510(k) Submission

510(k) SUMMARY

Submission Information

Date:	October 7, 2014
Applicant:	BioVision Technologies, LLC.
Address:	221 Corporate Circle Unit HGolden, Colorado 80401
Telephone Number:	303-237-9608
Submitter's Contact:	David Sanso, President

Device Information

Proprietary Name:	NeedleView CH Scope Kit
Regulation Number:	21 CFR 888.1100
Regulation Name:	Arthroscope / Endoscope
Regulatory Class:	II
Product Codes(s):	HRX, GCJ
Predicate Devices	BioVision SurgView™ Integrated Visualization System (K082293)Joimax THESSYS Multiscope (K051827)Hoogland Spine Products maxMorespine Endoscope (K083552)Blazejewski MEDI-Tech Spinal Foraminoscope (K082841)Richard Wolf Medical Instruments Corp. Endoscopic Spine System Set(YESS) (K973405)

Device Description

Name of Device: NeedleView CH™ Scope Kit

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Needle, #11 Scalpel, Guidewire (70cm Length), Hemostasis Valve Adapter (HVA), and a sterile drape. All of these items are disposable and for single-use only. The micro-endoscope is made to couple with a non-disposable system hand piece that contains a light source and camera, which is available separately.

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.

Comparison to Predicate Devices

The table below shows relevant similarities and difference between the NeedleView CH Table 1: and its predicate devices.

Feature	BioVisionSurgView™IntegratedVisualizationSystem	JoimaxTHESSYSMultiscope	HooglandSpine ProductsmsxMorespineEndoscope &System	BlazejewskiMEDI-TechSpinalForaminoscope	Richard WolfMedicalInstruments Corp.Endoscopic SpineSystem Set (YESS)
Similarities
IntendedUse	X	X	X	X	X
Scope ShaftMaterial	X	X	X	X	X
Labeling (SingleUse/Reusable)	X	X	X	X
Differences
Labeling (SingleUse/Resuable)		X	X	X	X
Outer Diameter	X			X
Number ofChannels		X		X	X

Summary of Technologies

The technological characteristics of the BioVision NeedleView CH are similar to those of the predicate devices listed.

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Performance Testing

The following performance tests were completed on the BioVision NeedleView CH Kit.

NeedleView CH Scope Performance Testing

NeedleView CH Performance Testing ●
NeedleView CH Accelerated Aging Performance Testing .

Tuohy Needle Performance Testing

. Flexural Test for 14G Tuohy Needle
Flexural Test for 18G Tuohy Needle ●
18G Tuohy Needle Buckling Test .
. Tuohy Needle Puncture Test Summary

Cannula Performance Testing

Cannula Insertion and Withdrawal Test including the 12F dilator ●
Cannula Leak Test ●
Cannula Bending Test .
Cannula Crushing Test ●
. Cannula Tensile Test

HVA

. HVA Fit and Leak Test

Guidewire Test

Guidewire Tensile Test ●
Guidewire Compression Test ●
. Guidewire Flexural Test

Biocompatibility testing was completed utilizing the following standard:

ISO 10993-1:2009, Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process.
Packaging, sterilization, distribution and accelerated aging testing were completed utilizing the following standards:
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: . Validation requirements for forming , sealing and assembly processes
ASTM F2096:2011, Standard Test Method for Detecting Gross Leaks in Medical . Packaging by Internal Pressurization (Bubble Test)
ASTM F88:2009, Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1886:2009, Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
ANSI/AAMI/ISO 11135:2007 Part 1, Sterilization of health care products Ethylene . oxide - Part 1 : Requirements for development, validation and routine control of a sterilization process for medical devices.

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EN 556:2006, Sterilization of medical devices Requirements for terminally-sterilized ● medical devices to be labeled "Sterile"
AAMI TIR28:2009, Product adoption and process equivalency for ethylene oxide ● sterilization
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide ● sterilization residuals
ANSI/AAMI/ISO 11135-2:2008, Guidance on the application of 11135-1 ●
ISO 11737-1:2006. Determination of a population of microorganisms on products
ISO 11137-3:2004. Guidance on evaluation and interpretation of bioburden data
ISTA 2A:2011, Partial-Simulation Performance Test Procedure: Packaged-Products ● 150lb (68 kg) or Less
. ASTM D4169:2009. Standard Practice for Performance Testing of Shipping Containers and Systems
. ASTM F 1980:2007. Guide to Accelerated Aging of Sterile Medical Device Packages

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 NeedleView CH and predicate devices.

Conclusion

Based on the evaluation of the performance characteristics, construction, manufacturing processes, and indications of use, Bio Vision Technologies has concluded that the BioVision NeedleView CH is substantially equivalent to the predicate devices listed. In all cases, the characteristics of this device are identical or similar to the predicate devices as they relate to the intended uses or application. The indications and contraindications of this device and those of the predicates listed in this submission are in congruence between devices. BioVision Technologies has also determined that the differences in characteristics indicated in this evaluation do not adversely affect the safety and effectiveness of the BioVision NeedleView CH.

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.