(28 days)
K07287, K04339, K03009, K00293, K02031
Not Found
No
The summary describes a standard video endoscope/arthroscope imaging system with components like a light source, display, image capture, and scope. While it mentions "image processor," this is a common component in digital imaging systems and does not inherently indicate AI/ML. There is no mention of AI, ML, deep learning, or any related terms, nor is there any description of training or test data sets which are typical for AI/ML device submissions.
No.
The device is used to provide illumination and visualization of interior body cavities during diagnostic and operative procedures, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "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." The key word here is "diagnostic," indicating that the device aids in the diagnosis of medical conditions.
No
The device description explicitly lists multiple hardware components including a Light Source/Display/Image Capture device, a fiberoptic scope, and supplemental instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body (in vitro).
- SurgView™ Function: The SurgView™ Integrated Visualization System is used to provide illumination and visualization inside the body during surgical and diagnostic procedures. It is a tool for direct observation of internal structures.
The device's intended use, description, and the procedures it's used for clearly indicate it's an in vivo (within the living body) visualization system, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The SurgView™ Integrated 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX, GCJ
Device Description
The SurgView™ Integrated Imaging System is a video endoscope/arthroscope imaging system consisting of the following components:
- A Light Source/Display/Image Capture device that includes a monitor, image processor, Xenon light source, camera unit, and a camera hand piece with integrated fiberoptic cable.
- A semi-rigid Fiberoptic Scope designed for one time use, in a variety of diameters, lengths, and viewing angles.
- Supplemental Instruments that can be used interchangeably throughout the procedure. They include a cannula, trocar, obturator, and cannula plug.
- Procedural Kit that contains a variety of sterile items used to aid in the procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Establishment of equivalence is based on similarities of intended use, design, and materials, physical characteristics and geometry between the SurgView™ Integrated Visualization System and predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
Performance and Safety Testing: The SurgView™ Integrated Visualization System complies with UL/CSA/EN60601-1:1990 Medical electrical equipment - Part 1. General requirements for safety; UL/CSA/EN60601-2-18:1996 Medical electrical equipment -Part 2. Particular requirements for the safety of endoscopic equipment; EN60601-1-2, Group 2, Class B. Collateral standard electromagnetic compatibility; 47 CFR Part 15.
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.
K07287, K04339, K03009, K00293, K02031
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.
Not Found
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an emblem of an eagle with its wings stylized into three curved lines.
SEP 0 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioVision Technologies, LLC % TÜV SÜD America Inc. Ms. Dawn Tibodeau 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891
Re: K082293
Trade/Device Name: SurgView™ Integrated Visualization System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, GCJ Dated: August 22, 2008 Received: August 25, 2008
Dear Ms. Tibodeau:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Dawn Tibodeau
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device. to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark. N. Millerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
2
Ko82293
Indications for Use
510(k) Number (if known): K082293
Device Name: SurgView™ Integrated Visualization System
Indications for Use:
The SurgView™ Integrated 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.
Daniel Krane for Nixon
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082293
Prescription Use ✔ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Page 1 of 1
PAGE 2.1
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Image /page/3/Picture/1 description: The image shows the logo for BioVision Technologies, LLC. The logo is in black and white and features the word "BIOVISION" in a stylized font. The word "Technologies, LLC" is written in a smaller font to the right of "BIOVISION" and is underlined. The logo is simple and professional.
510(k) Summary of Safety and Effectiveness SurgView™ Integrated Visualization System
| Date: | June 3, 2008 |
|---|---|
| Applicant/Sponsor: | BioVision Technologies, L.L.C. |
| Address: | 221 Corporate Circle Unit H |
| Golden, Colorado 80401 | |
| Telephone Number: | (303) 237-9608 |
| Facsimile Number: | (303) 237-0757 |
| Contact Person: | David Sanso |
| President | |
| Proprietary Name: | SurgView™ Integrated Visualization System |
| Regulation Name: | Arthroscope |
| Endoscope | |
| Regulation Number: | 21 CFR §888.1100, HRX |
| 21 CFR §876.1500, GCJ |
Regulatory Class: II
Information on devices to which substantial equivalence is claimed:
| COMPANY | DEVICE | 510(k) |
|---|---|---|
| Biomet Sports Medicine | InnerVue Diagnostic Scope System | K07287 |
| Smith & Nephew | Video Arthroscope | K04339 |
| Arthrex, Inc | Arthrex Arthroscopes | K03009 |
| Medtronic Sofamor Danek | METRx System | K00293 |
| Davlite Technologies | Davlite Microendoscope | K02031 |
Device Description:
The SurgView™ Integrated Imaging System is a video endoscope/arthroscope imaging system consisting of the following components:
-
- A Light Source/Display/Image Capture device that includes a monitor, image processor, Xenon light source, camera unit, and a camera hand piece with integrated fiberoptic cable.
- A semi-rigid Fiberoptic Scope designed for one time use, in a variety of diameters, lengths, and viewing angles.
All trademarks are property of BioVision Technologies, LLC
4
-
Supplemental Instruments that can be used interchangeably throughout the procedure. They include a cannula, trocar, obturator, and cannula plug.
-
Procedural Kit that contains a variety of sterile items used to aid in the procedure.
Indications for Use: The SurgView™ Integrated 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 are included but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, shoulder, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, cervix, and the urethra.
Summary of Technologies: The SurgView™ Integrated Visualization System technological characteristics are similar to predicate devices.
Non-Clinical Testing: Establishment of equivalence is based on similarities of intended use, design, and materials, physical characteristics and geometry between the SurgView™ Integrated Visualization System and predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
Performance and Safety Testing: The SurgView™ Integrated Visualization System complies with UL/CSA/EN60601-1:1990 Medical electrical equipment - Part 1. General requirements for safety; UL/CSA/EN60601-2-18:1996 Medical electrical equipment -Part 2. Particular requirements for the safety of endoscopic equipment; EN60601-1-2, Group 2, Class B. Collateral standard electromagnetic compatibility; 47 CFR Part 15.
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510(K) SUMMARY PAGE 2.2