(447 days)
The Nuvis Wireless HD Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body.
The Nuvis Wireless HD Camera System (or "System" or "Nuvis-2K") consists of two wireless reusable camera heads that can be paired to a wireless base station. When the camera head is attached to an arthroscope/light source (using a C-mount coupler) AND the wireless base station is attached to a clinic supplied video system, arthroscopic examinations can be viewed and pertinent data recorded. A tablet with NuvisCon Application (APP) can be connected to the wireless base station to enter patient and case data. The System can transmit uncompressed video content from the camera head to the wireless base station up to 5 meters (15 feet) away. Recorded video and snapped pictures are saved to an internal storage drive in the wireless base station.
N/A
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
November 20, 2025
Integrated Endoscopy, Inc.
Albert Rego
Vice President Regulatory & Quality
16 Technology Drive Suite 165
Irvine, California 92618
RE: K242606
Trade/Device Name: Nuvis® Wireless HD Camera System (Nuvis-2K)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: November 19, 2025
Received: November 20, 2025
Dear Albert 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K242606 - Albert Rego Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts, are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K242606 - Albert Rego Page 3
Sincerely,
Colin Kejing Chen, Ph.D.
Acting 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
Digitally signed by Colin K. Chen -S
Date: 2025.11.20 08:47:36 -05'00'
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242606
Device Name: Nuvis® Wireless HD Camera System
Indications for Use (Describe):
The Nuvis Wireless HD Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body.
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)
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."
Page 5
Integrated Endoscopy, Inc.
Nuvis Wireless HD Camera System
K242606 510(K) Summary
I. SUBMITTER
Integrated Endoscopy, Inc.
16 Technology Drive, Suite 165
Irvine, CA 92618
ESTABLISHMENT Number: 3011401113
Contact Person: Albert Rego, Ph.D.
Vice President Regulatory & Quality
Phone: 949-632-8126
Email: albert@iescope.com
Date Prepared: November 19, 2025
II. DEVICE
Trade Name: Nuvis® Wireless HD Camera System
Regulation Number and Name: 21 CFR 876.1500 Endoscope and accessories.
Regulation Class: Class II
Product Code and Review Panel: GCJ; General and Plastic Surgery
III. Predicate Device
510(K) Number: K213860
Product Name: ArthroFree Wireless Surgical Camera System
Manufacturer: Lazurite Holdings LLC
Page 6
IV. DEVICE DESCRIPTION
The Nuvis Wireless HD Camera System (or "System" or "Nuvis-2K") consists of two wireless reusable camera heads that can be paired to a wireless base station. When the camera head is attached to an arthroscope/light source (using a C-mount coupler) AND the wireless base station is attached to a clinic supplied video system, arthroscopic examinations can be viewed and pertinent data recorded.
A tablet with NuvisCon Application (APP) can be connected to the wireless base station to enter patient and case data.
The System can transmit uncompressed video content from the camera head to the wireless base station up to 5 meters (15 feet) away.
Recorded video and snapped pictures are saved to an internal storage drive in the wireless base station.
V. INDICATIONS FOR USE
The Nuvis Wireless HD Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison of features and operation principles between Nuvis Wireless HD Camera System and the ArthroFree Wireless Surgical Camera System are listed below:
Substantial Equivalence Comparison
| Subject Device | Predicate Device | Substantially Equivalent |
|---|---|---|
| 510(K) | TBD | 510(K) K213860 |
| Manufacturer | Integrated Endoscopy, Inc. | Lazurite Holdings LLC |
| Device Name | NuVis Wireless HD Camera System | ArthroFree Wireless Surgical Camera System |
| Product Code | GCJ | GCJ |
| Regulation Number | 876.1500 | 876.1500 |
| Indications for Use | The Nuvis Wireless Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body | The ArthroFree System is indicated for use in arthroscopy, general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery or wherever a laparoscope /endoscope/ arthroscope is indicated for use. The users of the camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons, and urologists. The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and |
Page 7
| supplying visualization of an interior cavity of the body. | visualization of an interior cavity of the body. Examples of common general endoscopic surgeries are listed below. • laparoscopic cholecystectomy • laparoscopic hernia repair • laparoscopic appendectomy • laparoscopic pelvic lymph node dissection • laparoscopically assisted hysterectomy • laparoscopic and thoracoscopic anterior spinal fusion • anterior cruciate ligament reconstruction • knee arthroscopy • shoulder arthroscopy • small joint arthroscopy • decompression fixation • wedge resection • lung biopsy • pleural biopsy • dorsal sympathectomy • pleurodesis • internal mammary artery dissection for coronary artery bypass • coronary artery bypass grafting where endoscopic visualization is indicated • examination of the evacuated cardiac chamber during performance of valve replacement | ||
|---|---|---|---|
| System Components | -Wireless Camera Head with Battery & Battery Charger -Receiver (wireless base station) -Sterilization Tray -Cables | -Wireless Camera Head Battery & Battery Charger -Receiver -Sterilization Tray -Cables | YES. |
| Camera Battery | Rechargeable | Rechargeable | YES |
| Reusable | Yes | Yes | YES |
| Cleanable | Yes | Yes | YES |
| Camera Head Control Buttons | Yes | Yes | YES |
| Sterilization (camera head) | Established Sterilization Method: Vaporized Hydrogen Peroxide | Established Sterilization Method: Vaporized Hydrogen Peroxide | YES |
| Principle of Operation | Wireless o FCC (Federal Communications Commission) Compliance o Wireless Co-Existence | Wireless o FCC (Federal Communications Commission) Compliance o Wireless Co-Existence | YES |
| Transmission distance | 5 meters (15 feet) | Within 10 feet | YES |
Page 8
| Compliance | |||
|---|---|---|---|
| Electrical Safety | IEC 60601-1 IEC 60601-2-18 | IEC 60601-1 IEC 60601-2-18 | YES |
| EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 | YES |
| Rechargeable Batteries | IEC 62133-2 compliant | IEC 62133-2 compliant | YES |
| Usability | IEC 60601-1-6 EN 62366 | IEC 60601-1-6 | YES |
| Wireless Compliance | FCC Wireless Co-Existence | FCC Wireless Co-Existence | YES |
| Software Documentation Level | Basic (per "Content of Premarket Submissions for Device Software Functions" Guidance issued on June 14, 2023) | Moderate (per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005) | YES. The FDA Software classifications were revised in 2023. |
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Nuvis Wireless HD Camera System has comparable technological characteristics (e.g., design, principle of operation, and energy source) as the predicate device (Lazurite ArthroFree Wireless Surgical Camera System).
Page 9
IX. PERFORMANCE DATA SUMMARY
Performance Tests included:
| Test | Test Summary |
|---|---|
| Electrical/thermal | IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance was conducted by a third party and passed. |
| Electromagnetic Compatibility | IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests was conducted by a third party and passed. |
| Essential Performance | IEC 60601-2-18 Endoscopic basic safety and essential performance was conducted by a third party and passed |
| Cleaning Validation | Cleaning Validation (ANSI/AAMI ST98: 2022) was conducted by a third party and passed. |
| Sterilization Validation | Sterilization Validation (ISO 22441: 2022 Sterilization of health care products-Low temperature vaporized Hydrogen Peroxide) was conducted by a third party and passed. |
| Camera Resolution Tests | Air Force Resolution Chart images obtained from the system were checked for Resolution, and the resolution was found to be at least 1920x1080 p. |
| Wireless Range Tests | With the camera head transmitter partially and fully covered, the wireless base station could receive data from the enabled camera head at a distance of 15 feet. |
| Battery Life/Durability Tests | The camera head rechargeable battery was charged to various charging levels and the length of time for imaging was measured. The length of time for imaging at various camera head charging levels was acceptable. |
| Wireless Coexistence | ANSI C63.27 Wireless Co-existence was conducted by a third party and passed. |
| Software | IEC 62304 Software Life Cycle Process was reviewed by a third party and passed. |
| Transportation | ISTA 3 Transportation/Packaging Tests was conducted by a third party and passed. |
| Usability | IEC 62366-1 Usability was reviewed by a third party and passed. |
| Communications | FCC Part 15 Compliance testing was conducted by a third party and passed. |
Page 10
FDA Recognized Consensus Standards Utilized
| FDA Recognition Number | Description |
|---|---|
| 19-49 | IEC 60601-1 Ed. 3.2 en:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 19-36 | IEC 60601-1-2 Edition 4.1 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| 9-114 | IEC 60601-2-18 Ed. 3.0 b:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| 5-129 | IEC 62366-1 Ed. 1.1 b:2020 Medical devices - Part 1: Application of usability engineering to medical devices |
| 13-79 | IEC 62304 Ed. 1.1 b:2015 Medical device software - Software life cycle processes |
| 5-126 | ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
| 19-48 | IEEE/ANSI C63.27-2021 American National Standard for Evaluation of Wireless Coexistence |
| 19-22 | AAMI TIR69:2017/(R2020) Risk management of radio-frequency wireless coexistence for medical devices and systems for wireless co-existence. |
| 14-583 | ANSI/AAMI ST98: 2022; Cleaning Validation of Health Care Products— Requirements for Development and Validation of a Cleaning Process for Medical Devices |
| 14-578 | EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
| 14-586 | ISO 22441: 2022 Sterilization of health care products-Low temperature vaporized hydrogen peroxide-Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 5-125 | EN ISO 14971:2019 Medical devices – Application of risk management to medical devices (ISO 14971:2019) |
Page 11
FDA Guidance Documents Utilized
"Electronic Submission Template for Medical Device 510(k) Submissions" Guidance for Industry and Food and Drug Administration Staff. Document issued on October 2, 2023.
"Content of Premarket Submissions for Device Software Functions" Guidance for Industry and Food and Drug Administration Staff. Document issued on June 14, 2023.
"Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" Guidance for Industry and Food and Drug Administration Staff. Document issued on: March 17, 2015.
"Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" Guidance for Industry and Food and Drug Administration Staff. Document issued on September 27, 2023.
"Radio Frequency Wireless Technology in Medical Devices" Guidance for Industry and Food and Drug Administration Staff. Document issued on: August 14, 2013.
"Electromagnetic Compatibility (EMC) of Medical Devices" Guidance for Industry and Food and Drug Administration Staff. Document issued on June 6, 2022.
XI CONCLUSION
The Nuvis Wireless HD Camera System has the same intended use as the predicate device (Lazurite ArthroFree Wireless Surgical Camera System) and similar technological characteristics to the predicate device, including comparable design, principle of operation, and energy source. The subject device incorporates additional features (tablet availability, storage ability, and increased battery life) that enhance convenience and functionality without altering the intended use or safety profile relative to the predicate device.
Based on the comparison of technological characteristics and performance data, the Nuvis Wireless HD Camera System (subject device) is substantially equivalent to the Lazurite ArthroFree Wireless Surgical Camera System (K213860).
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.