(313 days)
No
The summary describes a digital video arthroscope system with standard components for image capture and display. While it mentions "Video processing Software," there is no indication or mention of AI, ML, or advanced image analysis beyond basic processing for visualization. The performance testing focuses on physical and electrical characteristics, not algorithmic performance.
No
The device is used to provide an internal view or image for examination, diagnostic, and surgical procedures, but it does not directly treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to provide an internal view or image of the interior of a joint... during examination, diagnostic / operating, arthroscopic / endoscopic treatment procedures including examination, diagnostic & surgical procedures". The mention of "diagnostic" indicates its use in diagnosing conditions.
No
The device description clearly lists hardware components such as a Digital Video Arthroscope with CMOS Sensor & Built-in LEDs, a Single Use Outer Sheath/Cannula, and USB/HD Connecting Cables, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing an internal view or image of the interior of a joint during examination, diagnostic, and surgical procedures. It is used for visualization within the body.
- Device Description: The description details a system for capturing images inside a joint using a camera and light source. It's designed for direct visualization of internal structures.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform tests on samples outside the body.
The device is an arthroscope, which is a type of endoscope used for minimally invasive procedures within joints. It's an in vivo device, meaning it's used within a living organism.
N/A
Intended Use / Indications for Use
The Prosurg's Neo-Arthroscope TM -Digital Video Arthroscopic System (which includes Digital Video Arthroscope, Single use Outer Sheath is intended to provide an internal view or image of the interior of a joint through surgical opening during examination, diagnostic / operating, arthroscopic / endoscopic treatment procedures including examination, diagnostic & surgical procedures for treatment of knee, shoulder, ankle, elbow, Hip, wrist (Carpel Tunnel Syndrome), hand, TMJ (Temporal Mandibular Joint), Spine, Disc and feet (Planter fascia Release) using surgical devices and accessories.
Product codes
HRX
Device Description
The Single Use Digital Video Arthroscope design incorporates a CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end or in the sidewall, connecting wires along the length of the hollow tubular structure and a USB / HD Connector at the distal end of the Arthroscope containing CMOS sensor and LEDs / Fiber optic is protected by sealed, clear optical window. The Single Use Neo- Arthroscope is designed to be completely isolated from irrigation and suction fluid pathways. The design of sealed distal end and proximal end of the outer sheath / cannula also prevents any fluid or tissue contact with Neo-Arthroscope.
The Neo-Arthroscope ™ - Digital Video Arthroscopic System consists of four main components:
- (a) Digital Video Arthroscope with CMOS Sensor & Built-in LEDs / Fiber optic. (Patient Contact Item)
- (b) Single Use, Outer Sheath / Cannula with Suction / Irrigation, a separate, dedicated channel for insertion of video Arthroscope and /or Trocar for insertion. (Patient Contact Item)
- (c ) Laptop /Tablet computer with windows Operating System, TV monitor module and Video processing Software. (Commercially Available, Non patient Contact Item)
- (d) USB 2.0 / HD Connecting Cables. (Commercially Available, Non Patient Contact Item)
Mentions image processing
Video processing Software.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
Interior of a joint, knee, shoulder, ankle, elbow, Hip, wrist (Carpel Tunnel Syndrome), hand, TMJ (Temporal Mandibular Joint), Spine, Disc and feet (Planter fascia Release).
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Not Found.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Prosurg has conducted performance testing (Bench Test Evaluation- As per FDA Guidance Document) for of Neo-Arthroscope™ device to demonstrate Safety & effectiveness and its intended use.
The Following Testing was completed to demonstrate safety & effectiveness of the proposed device for its intended use.
- Dimensional Measurements (Outer Diameter, Working Length)
- Field of View (in air)
- Image Resolution (Number of Pixels)
- Direction of View
- LED Brightness, Voltage & Current measurement.
- USB / HD Connection compatibility with Laptop / Tablet / Monitor
- Electrical Safety Test (IEC 601-1)
- Electromagnetic Compatibility (IEC 601-1-2)
- Thermal (Heat) Temperature at the Distal Tip (LED)
- Product Labeling & IFU Requirements & Accuracy
- Packaging Integrity & Sterility Assurance Test
- Accelerated Aging Test (one Year)
- Sterilization Assurance Level (ISO 11135-1:2007)
- ETO Residual Levels (ISO 10993-7:2008)
- Biocompatibility (ISO 10993-1:2009)
The results of the performance testing demonstrate that proposed Neo- Arthroscope Single Use. Digital Video Arthroscopy system performs as well as predicate device and is considered safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an emblem of three stylized human profiles facing to the right. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2016
Prosurg, Inc Ashvin Desai Manager. Regulatory Affairs 2193 Trade Zone Blvd San Jose, California 95131
Re: K152511
Trade/Device Name: Neo - Arthroscope (rigid) 2.0mm/3.5mm, Outer Sheath/ Cannula, Outer Sheath/ Cannula W/ Handle, Trocar for Outersheath/ Cannula Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: June 24, 2016 Received: July 6, 2016
Dear Ashvin Desai:
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 of medical device
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -A
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K15211 |
|---|---|
| Device Name | Neo-Arthroscope ™ - Single Use Digital Video Arthroscopic System |
| Indications for Use (Describe) |
The Prosurg's Neo-Arthroscope TM -Digital Video Arthroscopic System (which includes Digital Video Arthroscope, Single use Outer Sheath is intended to provide an internal view or image of the interior of a joint through surgical opening during examination, diagnostic / operating, arthroscopic / endoscopic treatment procedures including examination, diagnostic & surgical procedures for treatment of knee, shoulder, ankle, elbow, Hip, wrist (Carpel Tunnel Syndrome), hand, TMJ (Temporal Mandibular Joint), Spine, Disc and feet (Planter fascia Release) using surgical devices and accessories.
| 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) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. |
| FOR FDA USE ONLY |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
13
3
Image /page/3/Picture/0 description: The image contains the word "ProSurg" in a stylized font. The "Pro" part of the word is in pink, while the "Surg" part is in blue. The letters in "Surg" have a horizontal striped pattern.
510K Summary # K15211 (Traditional 510K) Neo- Arthroscope ™ - Single Use Digital Video Arthroscopic System
| Submitter : | Prosurg, Inc
2193 Trade Zone Blvd San Jose CA 95131
Tel: 408 945 4044 Fax: 408 945 1390 | | |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------|
| Contact Person: | Ashvin Desai
Manager, Regulatory
Affairs Prosurg, Inc
2193 Trade Zone Blvd
San Jose CA 95131
Tel: 408 945 4044 Fax: 408 945 1390 | | |
| Date Summary Prepared : | Oct 12, 2015 | | |
| Device Trade Name: | Neo- ArthroscoopeTM - Digital Video
Arthroscopic System | | |
| Device common Name: | Arthroscope | | |
| Device Classification: | Class II | | |
| Regulation Number / Name: | 21 CFR 888.1100 | | |
| Arthroscope Product Code: | HRX, Arthroscope | | |
| Legally Marketed Devices | Manufacturer | Trade Name: | 510K# |
| 510K # to which the substantially
Equivalency is claimed | Integrated
Endoscopy System | NuVisTM
Arthroscope | K140903 |
Device Description :
The Single Use Digital Video Arthroscope design incorporates a CMOS imaging sensor and built-in
LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end or in the sidewall, connecting wires along the length of the hollow tubular structure and a USB / HD Connector at the distal
end of the Arthroscope containing CMOS sensor and LEDs / Fiber optic is protected by sealed, clear optical window. The Single Use Neo- Arthroscope is designed to be completely isolated from irrigation and suction fluid pathways. The design of sealed distal end and proximal end of the outer sheath / cannula also prevents
any fluid or tissue contact with Neo-Arthroscope.
4
The Neo-Arthroscope ™ - Digital Video Arthroscopic System consists of four main components:
- (a) Digital Video Arthroscope with CMOS Sensor & Built-in LEDs / Fiber optic. (Patient Contact Item)
- (b) Single Use, Outer Sheath / Cannula with Suction / Irrigation, a separate, dedicated channel for insertion of video Arthroscope and /or Trocar for insertion. (Patient Contact Item)
- (c ) Laptop /Tablet computer with windows Operating System, TV monitor module and Video processing Software. (Commercially Available, Non patient Contact Item)
- (d) USB 2.0 / HD Connecting Cables. (Commercially Available, Non Patient Contact Item)
Indications For Use:
The Prosurg's Neo-Arthroscope ™ -Digital Video Arthroscopic System , which includes Digital Video Arthroscope, Single use Outer Sheath is intended to provide an internal view or image of the interior of a joint through surgical opening during examination, diagnostic / operating, arthroscopic / endoscopic treatment procedures including examination, diagnostic & surgical procedures for treatment of knee, shoulder, ankle, elbow, Hip, wrist (Carpel Tunnel Syndrome), hand, TMJ (Temporal Mandibular Joint), Spine, Disc and feet (Planter fascia Release) using surgical devices and accessories.
Summary of Technological Characteristics in comparison Predicate devices:
The Single use, Neo -Arthroscope™ Digital Video Arthroscopic System -and Predicate device Single use, Nu Vis - Digital Arthroscope (K140903 ) are similar in design, Components, LED lighting, Outer tube Handle materials & connecting cable to power source. The Manufacturing & Assembly process, Product Packaging, Sterilization method & Recommendations for Single use are also identical.
The Neo- Arthroscope, is similar in design, materials, packaging, sterilization and construction to NeoScope Video Endoscopy system (K120766). Both devices have identical CMOS imaging sensor & LED mounted at the distal end tip and uses Laptop / Tablet computers to power imaging Sensor and LED for endoscopic procedure. The main difference between Neo-Arthroscopic System and Neoscope System is Indications for use, However, both devices are used for endoscopic procedures for diagnosis and treatment procedure. The difference between Neo-Arthroscope and Neoscope devices do not alter the suitability of the proposed device for its intended use.
The proposed Indications for Use for Neo-Arthroscope is based on Predicate device NuVis™ Arthroscope ( K 140903) marketed by Integrated Endoscopy Inc. The Neo - Arthroscope, Digital Video Arthroscopic System is substantially equivalent to NuVis™ Arthroscope in design, materials, construction and use of LED for Light source. The Recommended Single use and Indications for use are also identical. For details, please refer to Substantial Equivalence matrix summary comparing Physical & functional characteristics and Indications for use.
Performance Testing : (Bench Testing)
Prosurg has conducted performance testing (Bench Test Evaluation- As per FDA Guidance Document) for of Neo-Arthroscope™ device to demonstrate Safety & effectiveness and its intended use.
5
The Following Testing was completed to demonstrate safety & effectiveness of the proposed device for its intended use.
- . Dimensional Measurements (Outer Diameter, Working Length)
- Field of View (in air)
- Image Resolution (Number of Pixels)
- Direction of View
- LED Brightness, Voltage & Current measurement.
- USB / HD Connection compatibility with Laptop / Tablet / Monitor
- . Electrical Safety Test (IEC 601-1)
- Electromagnetic Compatibility (IEC 601-1-2)
- . Thermal (Heat) Temperature at the Distal Tip (LED)
- Product Labeling & IFU Requirements & Accuracy
- Packaging Integrity & Sterility Assurance Test
- Accelerated Aging Test (one Year)
- . Sterilization Assurance Level (ISO 11135-1:2007)
- ETO Residual Levels (ISO 10993-7:2008)
- . Biocompatibility (ISO 10993-1:2009)
Conclusion:
The results of the performance testing demonstrate that proposed Neo- Arthroscope Single Use. Digital Video Arthroscopy system performs as well as predicate device and is considered safe and effective for its intended use