Who is the manufacturer of Nuvis Battery Arthroscope?

Integrated Endoscopy, Inc. filed the 510(k) submission for Nuvis Battery Arthroscope (K191594).

What is the FDA product code for Nuvis Battery Arthroscope?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Nuvis Battery Arthroscope?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Nuvis Battery Arthroscope?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Nuvis Battery Arthroscope

K191594 · Integrated Endoscopy, Inc. · HRX · Jul 11, 2019 · Orthopedic

Device Facts

Record ID	K191594
Device Name	Nuvis Battery Arthroscope
Applicant	Integrated Endoscopy, Inc.
Product Code	HRX · Orthopedic
Decision Date	Jul 11, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.1100
Device Class	Class 2

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.

Device Story

Nuvis Battery Arthroscope is a single-use, sterile, rigid optical instrument for joint visualization. It features a 141mm working length, 4mm diameter, 105° field of view, and 30° direction of view. The device incorporates an internal LED for illumination, powered by an integrated AA alkaline battery, eliminating the need for external light sources or fiber bundles. It is inserted into the joint via a cannula; the clinician views the surgical site directly through an eyepiece or via an attached camera monitor system. The device is used by surgeons in clinical settings to facilitate minimally invasive orthopedic procedures. By providing integrated, battery-powered illumination, it simplifies the surgical setup and reduces equipment requirements compared to traditional fiber-optic arthroscopes. It is discarded after a single use, mitigating cross-contamination risks.

Clinical Evidence

No clinical data was performed or required. Substantial equivalence was established through bench testing, including visual inspection, leak/condensation tests, image quality checks, AOV/FOV measurements, resolution tests, LED intensity verification, liquid ingress (IPX3), biocompatibility (ISO 10993-1), and sterilization validation.

Technological Characteristics

Rigid endoscope; materials include stainless steel, copper, glass, sapphire, medical-grade plastics, and adhesives. Features an internal LED light source powered by a 3VDC AA alkaline battery. Dimensions: 141mm length, 4mm diameter. Optical specs: 105° FOV, 30° AOV. Connectivity: standard C-mount interface for camera systems. Sterilization: Ethylene Oxide (EO). Complies with IEC 60601-1, IEC 60601-2-18, IEC 62471, and ISO 8600 series.

Indications for Use

Indicated for arthroscopic procedures in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release) to provide internal visualization for examination, diagnosis, and/or therapy.

Regulatory Classification

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.

Predicate Devices

Nuvis® Arthroscope (K140903)

Related Devices

K140903 — NUVIS ARTHROSCOPE · Integrated Endoscopy, Inc. · Jul 17, 2014
K152511 — Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula · Prosurg, Inc. · Jul 11, 2016
K162475 — mi-eye 2, mi-eye 2 monitor · Trice Medical · Sep 16, 2016
K960805 — ARTHOSCOPE · United States Surgical, A Division of Tyco Healthc · Apr 10, 1996
K133941 — MITEK ARTHROSCOPES · Medos International SARL · Apr 18, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {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 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 {2}------------------------------------------------ # 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ 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: | 949.632.8126 Email: 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. {4}------------------------------------------------ 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 AND SPECIFICATIONS | NUVIS® BATTERY ARTHROSCOPE (SUBJECT DEVICE) | NuVis™ ARTHROSCOPE (PREDICATE DEVICE) | SUBSTANTIALLY EQUIVALENT (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 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 | Integrated Endoscopy's NuVis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated | YES | | FEATURES AND SPECIFICATIONS | NUVIS® BATTERY ARTHROSCOPE (SUBJECT DEVICE) | NuVis™ ARTHROSCOPE (PREDICATE DEVICE) | SUBSTANTIALLY EQUIVALENT (YES/NO) | | | Arthroscope has a 141mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view 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. | Endloscopy's NuVis® Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for Single Use Only. It is not intended to he re-used or re-sterilized. | | | Indications for Use | Integrated Endoscopy's 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 Battery Arthroscope is 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 NuVis® 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® 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). | YES (Identical except for name) | | 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. | The Nuvis 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. | YES (Identical except for name) | | Working Channel Length | 141mm | 140mm | YES | | Diameter of Working Channel | 4mm | 4mm | YES | | FEATURES AND SPECIFICATIONS | NUVIS® BATTERY ARTHROSCOPE (SUBJECT DEVICE) | NuVis™ ARTHROSCOPE (PREDICATE DEVICE) | SUBSTANTIALLY EQUIVALENT (YES/NO) | | Field of View (FOV) | 105° | 105° | YES | | Direction/Angle of View (AOV) | 30° | 30° | YES | | Principle of Operation | The Nuvis Battery Arthroscope is essentially a long tube containing a series of optical and electrical components. At the distal end, the primary lens (lens 1) captures the image of the object at a 30° angle and with the aid of two mirrors transfers the image though a series of lenses inside the long tube to the clinician's eye piece at the proximal end. The image can be viewed at the Eye Piece or by a Camera Monitor System attached to the Eye Piece. | The operation principle of the NuVis® Arthroscope is similar to arthroscopes currently on the market used for the same indications for use and intended use. The major difference is in how the surgical site is illuminated. The NuVis® Arthroscope utilizes an in built LED that provides light to illuminate the surgical site being viewed. Most Arthroscopes on the market today incorporate a fiber bundle that carries the light from an external light source connected to it, to the surgical site. The LED of the NuVis® Arthroscope is energized by a custom power supply located outside the surgical field as described earlier in this section. The LED is connected to the power supply by means of 10 feet power cable. | YES | | Method of Operation | The long tube of the endoscope is inserted into the body through a surgical incision and the tip of the scope is placed above the site that the clinician wants to visualize. The surgical site is illuminated by an LED inside the long tube at the distal end. | The NuVis® Arthroscope is essentially a long tube containing a series of optical and electrical components. At the distal end, the primary lens (lens 1) captures the image of the object at a 30 ° angle and with the aid of two mirrors transfers the image though a series of lenses inside the long tube to the clinician's eye piece at the proximal end. The image can be viewed at the Eye Piece | YES | | FEATURES AND SPECIFICATIONS | NUVIS® BATTERY ARTHROSCOPE (SUBJECT DEVICE) | NuVis™ ARTHROSCOPE (PREDICATE DEVICE) | SUBSTANTIALLY EQUIVALENT (YES/NO) | | | | or by a Camera Monitor System attached 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 size depending on distance of distal tip from site being visualized. | 1 to 5 times actual size depending on distance of distal tip from site being visualized. | YES | | Resolution (Camera Monitor System) | Dependent on capability of the Camera Monitor System | Dependent on capability of the Camera Monitor System | YES | | Materials of Construction | Stainless Steel, Copper, Glass, Sapphire, Medical grade plastics, adhesives | Stainless Steel, Copper, Glass, Sapphire, Medical grade plastics, adhesives | YES | | Biocompatibility of Materials | Meets ISO 10993-1 requirements | Meets ISO 10993-1 requirements | YES | | Electrical | | | | | Light Source | LED | LED | YES | | Power Supply | AA Alkaline Battery operates at <1W at approximately 3VDC | Input: 100-240VAC, 50-60Hz Output: variable output power of < 1W at approximately 3VDC | YES (Identical DC feed 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 interface used for Endoscopes | Standard c-mount interface used for Endoscopes | YES | | Output Interfaces | | | | | Cannula | Stryker | Stryker | YES | | Camera Monitor System | Standard c-mount interface used for Endoscopes | Standard c-mount interface used for Endoscopes | YES | | Compliance | | | | | Optics | Meets following standards requirements • ISO 8600-1 Third edition 2013- 03-01 • ISO 8600-3 First edition 1997- 07-01 • ISO 8600-5 First edition 2005- 03-15 | Meets following standards requirements • ISO 8600-1 Third edition 2013- 03-01 • ISO 8600-3 First edition 1997- 07-01 • ISO 8600-5 First edition 2005- 03-15 | YES | | Output Interfaces | | | | | Cannula | Stryker | Stryker | YES | | FEATURES AND SPECIFICATIONS | NuVis® BATTERY ARTHROSCOPE (SUBJECT DEVICE) | NuVis™ ARTHROSCOPE (PREDICATE DEVICE) | SUBSTANTIALLY EQUIVALENT (YES/NO) | | Camera Monitor System | Standard C-mount interface used for Endoscopes | Standard C-mount interface used for Endoscopes | YES | | Compliance | | | | | Optics | Meets following standards requirements • ISO 8600-1 Third edition 2013-03-01 • ISO 8600-3 First edition 1997-07-01 • ISO 8600-5 First edition 2005-03-15 | Meets following standards requirements • ISO 8600-1 Third edition 2013-03-01 • ISO 8600-3 First edition 1997-07-01 • ISO 8600-5 First edition 2005-03-15 | YES | | EMC Compliance | Meets following standards requirements • IEC 60601-1:2005, Edition 3.0 • IEC 60601-2-18 Edition 3.0 IEC 62471 First Edition | Meets following standards requirements • IEC 60601-1:2005, Edition 3.0 • IEC 60601-2-18 Edition 3.0 IEC 62471 First Edition | YES | | Electrical Safety | Meets following standards requirements • IEC 60601-1:2005, Edition 3.0 • IEC 60601-2-18 Edition 3.0 IEC 62471 First Edition | Meets following standards requirements • IEC 60601-1:2005, Edition 3.0 • IEC 60601-2-18 Edition 3.0 IEC 62471 First Edition…