(24 days)
Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy . Integrated Endoscopy's Nuvis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
Integrated Endoscopy's Battery Arthroscope is an optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's Battery Arthroscope has a 141mm working length, an outside diameter of 4mm, a field of view of 105 °, and a direction of 30 °. The Arthroscope is Battery Powered and three selectable light settings. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 141mm. The Arthroscope is supplied sterile and is for SINGLE USE ONLY. DO NOT REUSE OR RE-STERILIZE.
The provided document describes the FDA 510(k) premarket notification for the "Nuvis Battery Arthroscope" by Integrated Endoscopy, Inc. This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets novel acceptance criteria through a full-scale clinical study with extensive data analysis as typically seen for AI/ML-based medical devices.
The information primarily concerns the performance data summary for a medical device, specifically an arthroscope, and its comparison to a predicate device for FDA 510(k) clearance. It is not a study that proves an AI/ML device meets specific acceptance criteria in the sense of a multi-reader, multi-case study with AI assistance. Therefore, many of the requested points related to AI/ML device validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.
The document discusses "acceptance criteria" in terms of meeting design and performance requirements through bench testing, rather than clinical performance metrics in AI/ML validation.
Here's the information extracted from the provided text as it pertains to the device's validation:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with specific quantitative thresholds met, but rather summarizes that the device "met all specified design and performance requirements" and "passed electromagnetic compatibility (EMC), electrical safety and biocompatibility testing requirements." Performance was demonstrated through direct comparison to the predicate device and established standards.
| Acceptance Criteria Category (General) | Reported Device Performance |
|---|---|
| Design and Performance Requirements | Met all specified design and performance requirements. |
| Electromagnetic Compatibility (EMC) | Passed EMC testing requirements. |
| Electrical Safety | Passed electrical safety testing requirements. |
| Biocompatibility | Passed biocompatibility testing requirements (Meets ISO 10993-1 requirements). |
| Visual Inspection | Performed and passed. |
| Leak and Condensation Test | Performed and passed. |
| Visual Image Check | Performed and passed. |
| Pointer/Direction Test | Performed and passed. |
| Distal Tip Smoothness | Performed and passed. |
| Scope Diameter/Cannula Interface Test | Performed and passed. |
| Angle of View (AOV) Measurement | Performed and passed (AOV: 30°). |
| Field of View (FOV) Measurement | Performed and passed (FOV: 105°). |
| Resolution Test | Performed and passed (Resolution: 1 to 5 times actual size, dependent on distance). |
| LED Light Intensity Verification | Performed and passed. |
| PX3 Liquid Penetration and Ingress Tests | Performed and passed (IPX3 for subject vs. IPX1 for predicate device enclosure). |
| Packaging Testing (Pouch seal, Transportation valuation) | Performed and passed. |
| Shelf Life Stability Testing | Performed and passed. |
| Electrical (Power Supply Output) | Consistent with predicate: variable output power of <1W at approximately 3VDC. |
| Optics Compliance | Meets ISO 8600-1, 8600-3, 8600-5 standards. |
| EMC/Electrical Safety Compliance | Meets IEC 60601-1, 60601-2-18, IEC 62471 standards. |
| Sterilization Compliance | Meets AAMI/ANSI/ISO 11135-1, AAMI/ANSI/ISO 10993-7. |
2. Sample size used for the test set and the data provenance
The document describes bench testing, simulations, and engineering analyses, not human study data from real-world patients. Therefore, specific "sample sizes" in the context of a clinical test set or "data provenance" (country of origin, retrospective/prospective) are not applicable. The device was tested post-sterilization to ensure functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. Ground truth, in the AI/ML sense, was not established by human experts for a test set. This was a physical device performance evaluation using laboratory tests and established engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No human adjudication of images or clinical data was involved in this type of device performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This was not an AI/ML device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an algorithm-based device. "Standalone performance" here refers to the physical device's characteristics against engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was established by adherence to voluntary safety and international agency standards (e.g., ISO, IEC, AAMI/ANSI standards) and bench testing results against specified physical and electrical design requirements. This is a technical and engineering-based evaluation, not a medical "ground truth" derived from patient data or expert consensus on clinical findings.
8. The sample size for the training set
Not Applicable. This device is not an AI/ML product, so there is no training set in the machine learning context.
9. How the ground truth for the training set was established
Not Applicable. As there is no AI/ML training set, this question does not apply.
Summary of the study that proves the device meets the acceptance criteria:
The study that proves the Nuvis Battery Arthroscope meets its acceptance criteria is a series of bench tests and engineering analyses. These tests were conducted on post-sterile devices to assess functionality and suitability for intended use. The performance evaluation primarily involved:
- Comparison to a predicate device: The Nuvis Battery Arthroscope's images and characteristics were compared to those of the legally marketed predicate device, the Integrated Endoscopy NuVis® Arthroscope (K140903).
- Adherence to recognized international and voluntary standards: The device was tested to ensure compliance with a comprehensive list of ISO, IEC, and AAMI/ANSI standards related to biological evaluation, electrical safety, electromagnetic compatibility, optical performance, and sterilization.
- Specific performance tests: The regimen included: visual inspection, leak and condensation, visual image check, pointer/direction, distal tip smoothness, scope diameter/cannula interface, angle of view (AOV) measurement, field of view (FOV) measurement, resolution, LED light intensity verification, PX3 Liquid Penetration and Ingress, biocompatibility, packaging, and shelf life stability.
The conclusion drawn from these studies was that the Nuvis Battery Arthroscope "met all specified design and performance requirements" and "can perform as intended," demonstrating substantial equivalence to the predicate device. No animal or clinical studies were performed or required for this 510(k) submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2019
Integrated Endoscopy, Inc. Dr. Albert Rego VP Regulatory & Quality 16 Technology Drive. Suite 165 Irvine, California 92618
Re: K191594
Trade/Device Name: Nuvis Battery Arthroscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: June 15, 2019 Received: June 17, 2019
Dear Dr. Rego:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191594
Device Name Nuvis® Battery Arthroscope
Indications for Use (Describe)
Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy . Integrated Endoscopy's Nuvis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
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) |
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Image /page/3/Picture/0 description: The image contains the logo for Integrated Endoscopy. The logo features the word "integrated" in a lowercase, sans-serif font, stacked above the word "endoscopy" which is also in a lowercase, sans-serif font. To the right of the text is a triangular shape with a gradient of purple and blue. The logo is clean and modern, suggesting a focus on technology and innovation in the field of endoscopy.
- l. SUBMITTER: Integrated Endoscopy 16 Technology Dr. Ste. 165 Irvine, CA
| Contact Person: | Albert Rego, Ph.D.Vice President Regulatory & Quality |
|---|---|
| Phone: | 949.632.8126Email: albert@iescope.com |
| Date Prepared: | July 5, 2019 |
|---|---|
| ---------------- | -------------- |
- ll. DEVICE:
III.
| Trade Name | Nuvis® Battery Arthroscope |
|---|---|
| Common/Classification Name: | Arthroscope, Class II |
| Regulation Number/Name: | 21 CFR §888.1100, Arthroscope (Performance Standards) |
| Review Panel: Product Code: | Orthopedic/HRX, Arthroscope |
| PREDICATE DEVICE: |
510(k) Number:K140903 Product Name: Nuvis® Arthroscope Manufacturer: Integrated Endoscopy
IV. DEVICE DESCRIPTION:
Integrated Endoscopy's Battery Arthroscope is an optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's Battery Arthroscope has a 141mm working length, an outside diameter of 4mm, a field of view of 105 °, and a direction of 30 °. The Arthroscope is Battery Powered and three selectable light settings. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 141mm. The Arthroscope is supplied sterile and is for SINGLE USE ONLY. DO NOT REUSE OR RE-STERILIZE.
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Image /page/4/Picture/0 description: The image contains the logo for Integrated Endoscopy. The logo features the word "integrated" in a lowercase, sans-serif font, followed by the word "endoscopy" in a similar font but with a slightly bolder weight. To the right of the text is a stylized graphic element resembling a triangle or sail, with a gradient that transitions from a light purple at the top to a blue at the bottom. The overall design is clean and modern.
INDICATIONS FOR USE: V.
Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Integrated Endoscopy's NuVis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
VI. INTENDED USE:
The Nuvis® Battery Arthroscope is intended to be used as an endoscope in arthroscopic procedures performed on the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release) to view the surgical site.
TECHNOLOGY CHARACTERISTICS: VII.
The fundamental scientific technology of the previously cleared predicate device, Integrated Endoscopy NuVis® Arthroscope (K140903) is the same. The Nuvis® Battery Arthroscope utilizes an LED mounted on the inside the long tube of the scope to illuminate the surgical site, which is powered by a non-reusable battery placed within the surgical field.
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison of features and operation principles between Nuvis® Battery Arthroscope and NuVis®Arthroscope from Integrated Endoscopy is listed to below:
| Table 13A. Comparison of Nuvis® Battery Arthroscope to Legally Marketed Predicate |
|---|
| Devices |
| FEATURES ANDSPECIFICATIONS | NUVIS® BATTERYARTHROSCOPE(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE(PREDICATE DEVICE) | SUBSTANTIALLYEQUIVALENT(YES/NO) |
|---|---|---|---|
| 510(k) # | K191594 | K140903 | |
| General Information | |||
| Name of Device | Nuvis Battery Arthroscope | Nuvis Arthroscope | YES |
| Manufacturer | Integrated Endoscopy | Integrated Endoscopy | YES |
| Device Description | Integrated Endoscopy's BatteryArthroscope is an opticalinstrument designed forillumination and visualization ofinternal anatomy of a patientwithin the knee, shoulder, andhip joint. IntegratedEndoscopy's Battery | Integrated Endoscopy's NuVis®Arthroscope is a non-deflectablerigid endoscopic opticalinstrument designed forillumination and visualization ofinternal anatomy of a patientwithin the knee, shoulder, andhip joint. Integrated | YES |
| FEATURES ANDSPECIFICATIONS | NUVIS® BATTERYARTHROSCOPE(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE(PREDICATE DEVICE) | SUBSTANTIALLYEQUIVALENT(YES/NO) |
| Arthroscope has a 141mmworking length, an outsidediameter of 4mm, a field ofview of 105°, and a direction ofview of 30°. The Arthroscope isBattery Powered and threeselectable light settings. TheArthroscope is designed to beused with a cannula compatiblewith a 4mm x 30° arthroscopewith a working length of141mm. The Arthroscope issupplied sterile and is forSINGLE USE ONLY. DO NOTREUSE OR RE-STERILIZE. | Endloscopy's NuVis®Arthroscope has a 140mmworking length, an outsidediameter of 4mm, a field of viewof 105°, and a direction of viewof 30°. The Arthroscope isdesigned to be used with acannula compatible with a 4mmx 30° arthroscope with aworking length of 140mm. TheArthroscope is supplied sterileand is for Single Use Only. It isnot intended to he re-used orre-sterilized. | ||
| Indications for Use | Integrated Endoscopy's BatteryArthroscope is an endoscopicdevice introduced into a patientto provide an internal view orimage of the interior of a jointfor examination, diagnosis,and/or therapy. IntegratedEndoscopy's BatteryArthroscope is indicated for usein arthroscopic proceduresperformed in the knee,shoulder, hip, wrist (carpeltunnel syndrome), temporalmandibular joint, ankle, elbow,and feet (plantar fascia release). | Integrated Endoscopy's NuVis®Arthroscope is an endoscopicdevice introduced into a patientto provide an internal view orimage of the interior of a jointfor examination, diagnosis,and/or therapy. IntegratedEndoscopy's NuVis®Arthroscopes are indicated foruse in arthroscopic proceduresperformed in the knee,shoulder, hip, wrist (carpeltunnel syndrome), temporalmandibular joint, ankle, elbow,and feet (plantar fascia release). | YES(Identical exceptfor name) |
| Intended Use | The Nuvis Battery Arthroscopeis intended to be used as anendoscope in arthroscopicprocedures performed on theknee, shoulder, hip, wrist(carpel tunnel syndrome),temporal mandibular joint,ankle, elbow, and feet (plantarfascia release) to view thesurgical site. | The Nuvis Arthroscope isintended to be used as anendoscope in arthroscopicprocedures performed on theknee, shoulder, hip, wrist(carpel tunnel syndrome),temporal mandibular joint,ankle, elbow, and feet (plantarfascia release) to view thesurgical site. | YES(Identical exceptfor name) |
| Working Channel Length | 141mm | 140mm | YES |
| Diameter of WorkingChannel | 4mm | 4mm | YES |
| FEATURES ANDSPECIFICATIONS | NUVIS® BATTERYARTHROSCOPE(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE(PREDICATE DEVICE) | SUBSTANTIALLYEQUIVALENT(YES/NO) |
| Field of View (FOV) | 105° | 105° | YES |
| Direction/Angle of View(AOV) | 30° | 30° | YES |
| Principle of Operation | The Nuvis Battery Arthroscopeis essentially a long tubecontaining a series of opticaland electrical components. Atthe distal end, the primary lens(lens 1) captures the image ofthe object at a 30° angle andwith the aid of two mirrorstransfers the image though aseries of lenses inside the longtube to the clinician's eye pieceat the proximal end. The imagecan be viewed at the Eye Pieceor by a Camera Monitor Systemattached to the Eye Piece. | The operation principle ofthe NuVis® Arthroscope issimilar to arthroscopescurrently on the market usedfor the same indications foruse and intended use. Themajor difference is in howthe surgical site isilluminated. The NuVis®Arthroscope utilizes an inbuilt LED that provides lightto illuminate the surgical sitebeing viewed. MostArthroscopes on the markettoday incorporate a fiberbundle that carries the lightfrom an external light sourceconnected to it, to thesurgical site. The LED of theNuVis® Arthroscope isenergized by a custom powersupply located outside thesurgical field as describedearlier in this section. TheLED is connected to thepower supply by means of 10feet power cable. | YES |
| Method of Operation | The long tube of the endoscopeis inserted into the bodythrough a surgical incision andthe tip of the scope is placedabove the site that the clinicianwants to visualize. The surgicalsite is illuminated by an LEDinside the long tube at thedistal end. | The NuVis® Arthroscope isessentially a long tubecontaining a series of opticaland electrical components. Atthe distal end, the primary lens(lens 1) captures the image ofthe object at a 30 ° angle andwith the aid of two mirrorstransfers the image though aseries of lenses inside the longtube to the clinician's eye pieceat the proximal end. The imagecan be viewed at the Eye Piece | YES |
| FEATURES ANDSPECIFICATIONS | NUVIS® BATTERYARTHROSCOPE(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE(PREDICATE DEVICE) | SUBSTANTIALLYEQUIVALENT(YES/NO) |
| or by a Camera Monitor Systemattached to the Eye Piece. | |||
| Sterilization | Supplied Sterile, EO sterilization | Supplied Sterile, EO sterilization | YES |
| Reusable | No, Single Use | No, Single Use | YES |
| General Specifications | |||
| Resolution (Naked Eye) | 1 to 5 times actual sizedepending on distance of distaltip from site being visualized. | 1 to 5 times actual sizedepending on distance of distaltip from site being visualized. | YES |
| Resolution (CameraMonitor System) | Dependent on capability of theCamera Monitor System | Dependent on capability of theCamera Monitor System | YES |
| Materials of Construction | Stainless Steel, Copper, Glass,Sapphire, Medical gradeplastics, adhesives | Stainless Steel, Copper, Glass,Sapphire, Medical gradeplastics, adhesives | YES |
| Biocompatibility ofMaterials | Meets ISO 10993-1requirements | Meets ISO 10993-1requirements | YES |
| Electrical | |||
| Light Source | LED | LED | YES |
| Power Supply | AA Alkaline Battery operates at<1W at approximately 3VDC | Input: 100-240VAC, 50-60HzOutput: variable output powerof < 1W at approximately 3VDC | YES(Identical DCfeed at LED) |
| Environment | |||
| Operating Temperature | 10°C to 40°C | 10°C to 40°C | YES |
| Storage Temperature | 10°C to 50°C | 10°C to 70°C | YES |
| Relative Humidity | 15% to 90%, Non-condensing | 10% to 90%, Non-condensing | YES |
| Output Interfaces | |||
| Cannula | Stryker | Stryker | YES |
| Camera Monitor System | Standard c-mount interfaceused for Endoscopes | Standard c-mount interfaceused for Endoscopes | YES |
| Output Interfaces | |||
| Cannula | Stryker | Stryker | YES |
| Camera Monitor System | Standard c-mount interfaceused for Endoscopes | Standard c-mount interfaceused for Endoscopes | YES |
| Compliance | |||
| Optics | Meets following standardsrequirements• ISO 8600-1 Third edition2013- 03-01• ISO 8600-3 First edition1997- 07-01• ISO 8600-5 First edition2005- 03-15 | Meets following standardsrequirements• ISO 8600-1 Third edition2013- 03-01• ISO 8600-3 First edition1997- 07-01• ISO 8600-5 First edition 2005-03-15 | YES |
| Output Interfaces | |||
| Cannula | Stryker | Stryker | YES |
| FEATURES ANDSPECIFICATIONS | NuVis® BATTERYARTHROSCOPE(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE(PREDICATE DEVICE) | SUBSTANTIALLYEQUIVALENT(YES/NO) |
| Camera Monitor System | Standard C-mount interfaceused for Endoscopes | Standard C-mount interfaceused for Endoscopes | YES |
| Compliance | |||
| Optics | Meets following standardsrequirements• ISO 8600-1 Third edition2013-03-01• ISO 8600-3 First edition1997-07-01• ISO 8600-5 First edition2005-03-15 | Meets following standardsrequirements• ISO 8600-1 Third edition2013-03-01• ISO 8600-3 First edition1997-07-01• ISO 8600-5 First edition2005-03-15 | YES |
| EMC Compliance | Meets following standardsrequirements• IEC 60601-1:2005,Edition 3.0• IEC 60601-2-18Edition 3.0IEC 62471 First Edition | Meets following standardsrequirements• IEC 60601-1:2005,Edition 3.0• IEC 60601-2-18 Edition3.0IEC 62471 First Edition | YES |
| Electrical Safety | Meets following standardsrequirements• IEC 60601-1:2005,Edition 3.0• IEC 60601-2-18Edition 3.0IEC 62471 First Edition | Meets following standardsrequirements• IEC 60601-1:2005,Edition 3.0• IEC 60601-2-18 Edition3.0IEC 62471 First Edition | YES |
| Degree of Protection-Arthroscope | Type BF-Applied Part | Type BF-Applied Part | YES |
| Enclosure Degree ofProtection - Power Supply | IPX3 | IPX1 | YES |
| Disposal of Medical Device | Compliant with WEEE, RoHS,REACH, and Latex Free.Arthroscope discarded after asingle use per hospitalprocedure for medical wastedisposal and in accordance tonational and local regulationsand laws | Compliant with WEEE, RoHS,REACH, and Latex Free.Arthroscope discarded after asingle use per hospitalprocedure for medical wastedisposal and in accordance tonational and local | YES |
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Image /page/5/Picture/0 description: The image shows the logo for Integrated Endoscopy. The words "integrated endoscopy" are written in gray, with "integrated" on top of "endoscopy". To the right of the words is a triangle that is purple at the top and fades to blue at the bottom.
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Image /page/6/Picture/0 description: The image shows the logo for Integrated Endoscopy. The words "integrated endoscopy" are written in a sans-serif font, with "integrated" on top and "endoscopy" on the bottom. To the right of the words is a triangular shape that is purple and blue.
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Image /page/7/Picture/0 description: The image shows the logo for Integrated Endoscopy. The words "integrated endoscopy" are written in gray, with "integrated" on top of "endoscopy". To the right of the words is a triangle that is purple at the top and fades to blue at the bottom.
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Image /page/8/Picture/0 description: The image shows the logo for Integrated Endoscopy. The words "integrated endoscopy" are written in a gray sans-serif font, with "integrated" on top and "endoscopy" below. To the right of the text is a triangle shape that is colored with a gradient from purple to blue.
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Image /page/9/Picture/0 description: The image shows the logo for Integrated Endoscopy. The words "integrated endoscopy" are written in a sans-serif font, with "integrated" on the top line and "endoscopy" on the bottom line. To the right of the words is a triangular shape that is purple at the top and fades to blue at the bottom. The logo is simple and modern.
PERFORMANCE DATA SUMMARY: IX.
The Nuvis® Battery Arthroscope was subjected to and passed electromagnetic compatibility (EMC), electrical safety and biocompatibility testing requirements. The Nuvis® Battery arthroscope met all specified design and performance requirements. The performance testing included comparison of images taken by the Integrated Endoscopy Nuvis® Battery Arthroscope and its predicate, the Integrated Endoscopy NuVis® Arthroscope.
Testing was performed on post-sterile devices to ensure device functionality and suitability for its intended use. The test regimen consisted of the following: visual inspection, leak and condensation test, visual image check, pointer/direction test, distal tip smoothness, scope diameter/cannula interface test, angle of view (AOV) measurement, field of view (FOV) measurement, resolution test, and LED light intensity verification, and PX3 Liquid Penetration and Ingress tests, biocompatibility testing, packaging testing (pouch seal and transportation valuation testing, and shelf life stability testing.
All requirements were met for the Nuvis® Battery Arthroscope. Performance bench testing demonstrated the Nuvis® Battery Arthroscope can perform as intended.
ANIMAL
Animal studies were not performed nor required.
CLINICAL STUDIES
Clinical studies were not performed nor required.
X. VOLUNTARY SAFETY AND INTERNATIONAL AGENCY STANDARDS:
The following voluntary and international agency standards and guidelines were reviewed and are followed in the development of the Nuvis® Battery Arthroscope to ensure its safety and suitability for its intended use:
- . AAMI/ANSI/JSO I 0993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
- . AAMI/ANSI ES60601-I :2005/(R) 2012 and A 1:2012, medical electrical equipment -Part 1: general requirements for basic safety and essential performance.
- . AAMI / ANSI/IEC 60601-1-2:2007/(R) 2012, Medical Electrical Equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- . IEC 60601-2-18 Edition 3.0 2009-08, Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment.
- . IEC 62471 First Edition 2006-07, Photobiological Safety of Lamps and Lamp Systems.
- . ISO 8600-I Third edition 2013-03-0 I, Endoscopes -- Medical endoscopes and
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Image /page/10/Picture/0 description: The image shows the logo for Integrated Endoscopy. The logo consists of the words "integrated" and "endoscopy" stacked on top of each other. The word "integrated" is in a gray sans-serif font, while the word "endoscopy" is in a smaller, bolder, gray sans-serif font. To the right of the words is a stylized triangle shape that is colored with a gradient from blue to purple.
endotherapy devices -- Part 1: General requirements.
- . ISO 8600-3 First edition I 997-07-01, Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics.
- . ISO 8600-5 First edition 2005-03-15, optics and photonics - medical endoscopes and endotherapy devices - part 5: Determination of optical resolution of rigid endoscopes with optics.
- . AAMI/ANSI/ISO 11135-1:2007, Sterilization of health care products -- Ethylene oxide --Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.
- . AAMI /ANSI/ ISO 10993-7:2008(R) 2012, Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals.
XI. CONCLUSION
The information in this 510(k) submission demonstrated the Nuvis® Battery Arthroscope is substantially equivalent to its predicate device.
The Nuvis® Battery Arthroscope and the NuVis® Arthroscope are both orthopedic medical devices that are used during arthroscopic surgical procedures. The indications for use are the same for both subject and predicate devices. The safety and performance of the Nuvis® Battery Arthroscope has been validated through bench testing. These studies and tests demonstrated the subject device is at least as safe and effective as the predicate device. The difference in power sources between the subject and predicate devices do not pose new concerns for safety or effectiveness.
Integrated Endoscopy, Inc. believes that the Nuvis® Battery Arthroscope has similar benefits and no more risk of harm to the patient when compared to the predicate device. The information provided demonstrates the subject device is substantially equivalent to the predicate device.
§ 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.