(103 days)
Not Found
No
The summary describes a wireless camera system for endoscopic procedures that transmits and processes video for display. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on standard video transmission and processing for visualization.
No
The device is a camera system used for visualization during surgical procedures, not for treating or rehabilitating a medical condition.
No.
The device is a camera system for endoscopic procedures, which can be used for both diagnostic and operative purposes. However, it does not interpret or analyze medical images to provide a diagnosis; it merely supplies illumination and visualization of an interior cavity.
No
The device description explicitly states it is a "high-definition wireless camera system" and mentions hardware components like a "light engine" and "battery." The performance studies also include hardware-related testing such as "Electrical Safety and Electromagnetic Compatibility" and "Wireless Performance."
Based on the provided information, the ArthroFree System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "diagnostic and operative endoscopic procedures, supplying illumination and visualization of an interior cavity of the body." This involves direct visualization of internal body structures during surgical procedures.
- Device Description: The description reinforces this by stating it's a "high-definition wireless camera system intended to transmit live video from a surgical site to a patient data console and surgical display during endoscopic surgical procedures."
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The ArthroFree System is used inside the body for visualization during surgery.
The ArthroFree System is a surgical imaging device used for visualization during endoscopic procedures.
N/A
Intended Use / Indications for Use
The ArthroFree System is indicated for use in arthroscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery or wherever a laparoscope is indicated for use. The users of the camera are general surgeons, gynecologists, cardiac 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 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 thorascopic 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
Product codes
GCJ
Device Description
The ArthroFree System is a high-definition wireless camera system intended to transmit live video from a surgical site to a patient data console and surgical display during endoscopic surgical procedures. The ArthroFree System also enables the capture of still images and video from the live video stream by transmitting instructions for such capture to a patient data console when indicated by the user. The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and visualization of an interior cavity of the body.
Mentions image processing
Light is projected to illuminate a body cavity. The image data is processed to provide a video stream sent to a display unit for viewing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Interior cavity of the body.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was performed on the ArthroFree System.
- Sterilization and Cleaning Validations
- Software Verification and Validation
- Electrical Safety and Electromagnetic Compatibility
- Performance Verification and Validation
- Light Engine Optical Output Validation
- Extended High Level Functional Validation
- Measured On-Screen Indicator Validation
- Power Connector Validation
- Video Signal and Battery Swap Time Validation
- Wireless Latency Validation
- Receiver Remote Trigger Validation
- Firmware Functionality Validation
- Battery Life Validation
- Usability Validation
- Wireless Performance
- FCC (Federal Communications Commission) Compliance
- Wireless Co-Existence
- Human Factors and Usability Testing
Testing of the ArthroFree System indicated no new risks and demonstrated substantial equivalence in performance compared to the legally marketed predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Precision HD Camera System (K142603)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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March 23, 2022
Lazurite Holdings LLC % Mike Goodson Director, Regulatory Affairs MCRA, LLC 803 7th Street NW, 3rd Floor Washington DC 20001
Re: K213860
Trade/Device Name: ArthroFree Wireless Surgical Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: December 9, 2021 Received: December 10, 2021
Dear Mike Goodson:
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/cfpm/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 (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
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Indications for Use
510(k) Number (if known) K213860
Device Name
ArthroFree Wireless Surgical Camera System
Indications for Use (Describe)
The ArthroFree System is indicated for use in arthroscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery or wherever a laparoscope is indicated for use. The users of the camera are general surgeons, gynecologists, cardiac 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 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 thorascopic 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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
510(k) Summary
| Device Trade Name: | ArthroFree™ Wireless Surgical Camera System | |
|---|---|---|
| Manufacturer: | Lazurite Holdings LLC | |
| 5000 Euclid Avenue, Suite 206 | ||
| Cleveland, OH 44103 | ||
| Contact: | Mike Goodson | |
| Director, Regulatory Affairs | ||
| MCRA, LLC | ||
| 202.552.5817 | ||
| Prepared by: | MCRA, LLC | |
| 803 7th Street NW, 3rd Floor | ||
| Washington, DC 20001 | ||
| Office: 202.552.5800 | ||
| Date Prepared: | December 10, 2021 | |
| Classifications: | Endoscope and accessories (21 CFR 876.1500) | |
| Class: | II | |
| Product Codes: | GCJ | |
| Primary Predicate: | Stryker Precision HD Camera System (K142603) |
Indications For Use:
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 camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons, and urologists.
The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and 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 .
5
- anterior cruciate ligament reconstruction ●
- knee arthroscopy
- shoulder arthroscopy
- small joint arthroscopy
- decompression fixation
- wedge resection
- lung biopsy
- pleural biopsv
- 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
Device Description:
The ArthroFree System is a high-definition wireless camera system intended to transmit live video from a surgical site to a patient data console and surgical display during endoscopic surgical procedures. The ArthroFree System also enables the capture of still images and video from the live video stream by transmitting instructions for such capture to a patient data console when indicated by the user. The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and visualization of an interior cavity of the body.
Predicate Device:
Stryker Precision HD Camera System (K142603)
Performance Testing Summary:
The following testing was performed on the ArthroFree System.
- Sterilization and Cleaning Validations ●
- Software Verification and Validation
- Electrical Safety and Electromagnetic Compatibility ●
- Performance Verification and Validation ●
- Light Engine Optical Output Validation O
- о Extended High Level Functional Validation
- Measured On-Screen Indicator Validation O
- Power Connector Validation O
- Video Signal and Battery Swap Time Validation O
- Wireless Latency Validation O
- Receiver Remote Trigger Validation O
- Firmware Functionality Validation O
- Battery Life Validation O
- Usability Validation O
6
- . Wireless Performance
- o FCC (Federal Communications Commission) Compliance
- Wireless Co-Existence O
- Human Factors and Usability Testing .
Testing of the ArthroFree System indicated no new risks and demonstrated substantial equivalence in performance compared to the legally marketed predicate.
Substantial Equivalence:
The subject and predicate devices have the same indications for use and have similar technological characteristics. Both include reusable components intended to be sterilized before use by the end-user and components that are reusable and not intended to be resterilized. Comparative information and data presented in the 510(k) demonstrate substantial equivalence of the ArthroFree System to the Stryker Precision HD Camera System (K142603).
| Subject Device | Predicate Device (K142603) | |
|---|---|---|
| Device Name | ArthroFree Wireless Surgical | |
| Camera System | Stryker Precision HD Camera | |
| System | ||
| Manufacturer | Lazurite | Stryker |
| Regulatory Information | ||
| Classification | II | II |
| Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code | GCJ | GCJ |
| Clinical Characteristics | ||
| Indications | 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 visualization of an | ||
| interior cavity of the body. | ||
| Examples of common general | ||
| endoscopic surgeries are listed below. | ||
| • laparoscopic cholecystectomy | ||
| • laparoscopic hernia repair | The Stryker Precision HD Camera | |
| System is indicated for use in | ||
| general laparoscopy, | ||
| nasopharyngoscopy, ear | ||
| endoscopy, sinuscopy, and plastic | ||
| surgery wherever a | ||
| laparoscope/endoscope/arthroscope | ||
| is indicated for use. | ||
| A few examples of the more | ||
| common endoscopic surgeries are | ||
| listed below. | ||
| • laparoscopic cholecystectomy | ||
| • laparoscopic hernia repair | ||
| • laparoscopic appendectomy | ||
| • laparoscopic pelvic lymph node | ||
| dissection | ||
| • laparoscopically assisted | ||
| hysterectomy | ||
| • laparoscopic and thorascopic | ||
| anterior spinal fusion | ||
| Device Name | Subject Device | |
| ArthroFree Wireless Surgical | ||
| Camera System | Predicate Device (K142603) | |
| Stryker Precision HD Camera | ||
| System | ||
| 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 | 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 The users of the camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. | |
| Technical Characteristics | ||
| System Components | Wireless Camera Head | |
| Battery & Battery Charger | ||
| Receiver | ||
| Sterilization Tray | ||
| Cables | Camera Head and Coupler | |
| Camera Control Unit (CCU) | ||
| Cables | ||
| Imaging System | High definition | Same as subject device |
| Compatible With | ||
| Most Endoscopes | ||
| Via C-Mount | Yes | Same as subject device |
| Principles of | ||
| Operation | Light is projected to illuminate a body cavity. The image data is processed to provide a video stream sent to a display unit for viewing. | Same as subject device |
| Camera Head | ||
| Control Buttons | Yes | Same as subject device |
| Software Level of | Moderate | Same as subject device |
| Subject Device | Predicate Device (K142603) | |
| Device Name | ArthroFree Wireless Surgical | |
| Camera System | Stryker Precision HD Camera | |
| System | ||
| Safety Standards | AIM 7351731 Rev. 2.00 | |
| IEC 60601-1 | ||
| IEC 60601-1-2 | ||
| IEC 60601-1-6 | ||
| IEC 60601-2-18 | ||
| IEC 60825-1 | ||
| IEC 62133-2 | ||
| IEC 62471 | ANSI/AAMI ES60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-18 | ||
| IEC 60825-1 | ||
| Light Source | Built-in | Some models use a built-in light |
| source, and some models use an | ||
| external light source | ||
| Laser Safety | ||
| Classification | Class 1 | Same as subject device |
| Sterilization Characteristics | ||
| Sterilization Status | Provided non-sterile to end-user | Same as subject device |
| Sterilization Method | ||
| for Components | ||
| Requiring | ||
| Sterilization | Vaporized Hydrogen Peroxide (VHP) | Steam |
| Includes | ||
| Components not | ||
| Intended to be | ||
| Sterilized | Yes | Same as subject device |
| Biological Characteristics | ||
| Patient Contacting | Non-patient contacting | Same as subject device |
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8
*Per FDA guidance - Content of Premarket Submissions for Software Contained in Medical Devices (2005)