(28 days)
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.
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.
Here's a summary of the acceptance criteria and study information for the "SurgView™ Integrated Visualization System" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not detail specific performance acceptance criteria or report a direct comparison of the device's performance against such criteria using quantitative metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:
- Similarities in intended use, design, and materials, physical characteristics and geometry.
- Compliance with recognized electrical safety and electromagnetic compatibility (EMC) standards.
Therefore, instead of a direct performance table, the "acceptance criteria" are implied to be adherence to the design and safety characteristics of the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: For illumination and visualization of interior body cavities in diagnostic/operative arthroscopic/endoscopic procedures. | Confirmed to have the same Indications for Use as predicate devices. |
| Design and Materials: Similar technological characteristics to predicate devices. | "The SurgView™ Integrated Visualization System technological characteristics are similar to predicate devices." |
| Physical Characteristics & Geometry: Similar to predicate devices. | Stated for equivalence claim. |
| Electrical Safety: Compliance with medical electrical equipment standards. | Complies with UL/CSA/EN60601-1:1990 and UL/CSA/EN60601-2-18:1996. |
| Electromagnetic Compatibility (EMC): Compliance with relevant EMC standards. | Complies with EN60601-1-2, Group 2, Class B; and 47 CFR Part 15. |
Missing Information: It's important to note that this 510(k) summary does not provide specific quantitative performance metrics (e.g., resolution, light intensity, image fidelity) for the device, nor does it explicitly state acceptance thresholds for such metrics. The acceptance is based on demonstrating equivalence, primarily through non-clinical testing and adherence to standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The document states, "Clinical testing was not used to establish substantial equivalence to predicate devices." The evaluation was based on non-clinical testing and comparison to predicate devices, which typically does not involve a "test set" in the sense of clinical data.
- Data Provenance: Not applicable, as clinical testing was not performed for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical test set was used, and thus no ground truth established by experts in this context.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. The device is a visualization system (arthroscope/endoscope) and there is no mention of artificial intelligence (AI) or an MRMC study in the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is not an AI algorithm; it's a visualization system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for performance evaluation against a specific clinical ground truth. The "ground truth" for the submission is the established safety and performance of the listed predicate devices, and the device's compliance with relevant electrical and EMC standards.
8. The Sample Size for the Training Set
- Not applicable. The device is not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. The device is not an AI algorithm, and therefore there is no training set or associated ground truth establishment.
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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
2
Enclosure
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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)
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PAGE 2.1
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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 HGolden, Colorado 80401 |
| Telephone Number: | (303) 237-9608 |
| Facsimile Number: | (303) 237-0757 |
| Contact Person: | David SansoPresident |
| Proprietary Name: | SurgView™ Integrated Visualization System |
| Regulation Name: | ArthroscopeEndoscope |
| Regulation Number: | 21 CFR §888.1100, HRX21 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
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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
§ 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.