(140 days)
No
The device description focuses on the physical components and optical properties of a fiber-optic endoscope and associated accessories. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies described are related to the physical and material properties of the device, not algorithmic performance.
No.
This device is designed for visualization and illumination of internal body cavities during diagnostic and operative procedures, not for delivering therapy.
Yes
The Intended Use / Indications for Use states that the system is used "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." The explicit mention of "diagnostic" indicates its use for diagnosis.
No
The device description clearly outlines multiple hardware components including a rigid Fiberoptic scope, stainless steel shaft, cannula, dilator, needles, scalpel, guidewire, and hemostasis valve adapter. It also mentions coupling with a non-disposable system hand piece containing a light source and camera. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a system for providing "illumination and visualization of an interior cavity of the body through a natural or surgical opening." It's used for direct observation inside the body during procedures.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens. The device's function is purely visual and procedural.
Therefore, this device falls under the category of a surgical or endoscopic instrument, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
HRX, GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Interior cavity of the body, knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
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
NeedleView CH Scope 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 Performance Testing (HVA Fit and Leak Test), Guidewire Test (Guidewire Tensile Test, Guidewire Compression Test, Guidewire Flexural Test). Biocompatibility testing was completed utilizing ISO 10993-1:2009. Packaging, sterilization, distribution and accelerated aging testing were completed utilizing ISO 11607-2:2006, ASTM F2096:2011, ASTM F88:2009, ASTM F1886:2009, ANSI/AAMI/ISO 11135:2007 Part 1, EN 556:2006, AAMI TIR28:2009, ISO 10993-7:2008, ANSI/AAMI/ISO 11135-2:2008, ISO 11737-1:2006, ISO 11137-3:2004, ISTA 2A:2011, ASTM D4169:2009, ASTM F 1980:2007.
Key Metrics
Not Found
Predicate Device(s)
K082293, K051827, K083552, K082841, K973405
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
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.
1
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)
3
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 H |
| Golden, 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
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
4
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 | BioVision
SurgView™
Integrated
Visualization
System | Joimax
THESSYS
Multiscope | Hoogland
Spine Products
msxMorespine
Endoscope &
System | Blazejewski
MEDI-Tech
Spinal
Foraminoscope | Richard Wolf
Medical
Instruments Corp.
Endoscopic Spine
System Set (YESS) |
|-----------------------------------|-----------------------------------------------------------------|---------------------------------|---------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------|
| Similarities | | | | | |
| Intended
Use | X | X | X | X | X |
| Scope Shaft
Material | X | X | X | X | X |
| Labeling (Single
Use/Reusable) | X | X | X | X | |
| Differences | | | | | |
| Labeling (Single
Use/Resuable) | | X | X | X | X |
| Outer Diameter | X | | | X | |
| Number of
Channels | | 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.
6
- 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.