LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
K153606 · Smith & Nephew · GCJ · Jun 2, 2016 · Gastroenterology, Urology
Device Facts
Record ID
K153606
Device Name
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
Applicant
Smith & Nephew
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Jun 2, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Lens Integrated system and LENS Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs and canals. Additionally, the LENS Integrated System and Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope. The LENS Application, when used in conjunction with the LENS Integrated System WiFi version, is indicated for capture of still and motion pictures, patient file management and limited redundant control of the LENS camera control unit within articular cavities, body cavities, hollow organs, canals and the thoracic cavity.
Device Story
Integrated system combining camera, LED light source, and image management in single console; supports arthroscopic/endoscopic visualization. Input: optical signals from surgical site via camera head/coupler/endoscope. Processing: FPGA-based video processing. Output: still/motion images displayed/managed via console or optional tablet application. Used in OR/clinical settings by surgeons/staff. Tablet app allows remote image capture, patient file management, and redundant camera control via Wi-Fi. Benefits: centralized visualization, illumination, and documentation workflow; enables remote data sharing/annotation.
Clinical Evidence
Bench testing only. Included light output, performance, thermal, and ship testing. Software verified per IEC 62304. Sterilization validated per AAMI TIR 12.
Technological Characteristics
Integrated console with LED light source, camera control, and image management. Single-chip camera head. FPGA-based video processing. Wi-Fi connectivity for tablet application. Reusable components. Sterilization per AAMI TIR 12.
Indications for Use
Indicated for diagnostic and operative arthroscopic and endoscopic procedures, including thoracic cavity procedures (with thoracoscope), to provide illumination and image capture within articular cavities, body cavities, hollow organs, and canals.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
VisionScope High Definition Endoscopy Camera System (K101734)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2016
Smith & Nephew Ms. Janice Haselton Principal Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K153606
Trade/Device Name: Lens Camera Control Unit-WiFi. Lens Camera Unit-Non-WiFi. Lens Camera Head, Camera Coupler, Tablet Application Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, HRX Dated: May 3, 2016 Received: May 4, 2016
Dear Ms. Haselton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K153606
Device Name
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler and Tablet Application
Indications for Use (Describe)
The Lens Integrated system and LENS Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs and canals.
Additionally, the LENS Integrated System and Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
The LENS Application, when used in conjunction with the LENS Integrated System WiFi version, is indicated for capture of still and motion pictures, patient file management and limited redundant control of the LENS camera control unit within articular cavities, body cavities, hollow organs, canals and the thoracic cavity.
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.
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}------------------------------------------------
Endoscopy
T 978 749 1000 978 749 1599 w.smith-nephew.com
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
# Smith & Nephew LENS Integrated System and LENS Camera head
Date Prepared: December 15, 2015
### A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road, Andover, MA 01810
## B. Company Contact
Janice Haselton Principal Regulatory Affairs Specialist Phone: (978) 749-1494
## C. Device Name
| Trade Name: | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS Camera Head, Camera Coupler and Tablet Application |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name: | LENS Camera System |
| Classification Name: | Endoscopes and Accessories per 876.1500. |
| Pro codes: | GCJ, HRX |
# D. Predicate Devices
The Smith & Nephew LENS Integrated System and LENS camera head are substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: Primary: VisionScope High Definition Endoscopy Camera System, K101734
Secondary: 560 High Definition Camera System, K070266.
#### Description of Device E.
The Smith & Nephew LENS Integrated System is an integrated camera/ LED light source/ image management device that provides visualization, illumination and image capture combined in a single console. The LENS Integrated System control units will be offered in two versions, Wi-Fi and Non-Wi-Fi. The LENS Integrated system works in conjunction with the LENS camera head, appropriate light guides, couplers and endoscopes.
The optional LENS application acts as a tool to remotely capture still and motion pictures, patient file management and limited redundant control of the LENS control unit wirelessly from the LENS camera system.
{4}------------------------------------------------
Endoscopy Smith & Nenhew. Inc 150 Minuteman Road Andover. MA 01810
smith-nephew.com
The application provides the ability to view and annotate by voice or graphics or to text captured patient data and sharing of patient data via a USB storage device, email, or printing to the local tablet camera roll. The application is downloaded from the Apple APP store to a surgeon's tablet.
#### F. Intended Use
The LENS Integrated System and LENS camera head are intended to provide illumination, visualization and still and motion pictures of surgical sites. In addition the LENS Application is intended to capture still and motion pictures, and provide patient file management and limited redundant control of camera features.
Indications for Use
The Lens Integrated System and LENS Camera Head are indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs and canals.
Additionally, Lens Integrated System and LENS Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
The LENS Application, when used in conjunction with the LENS Integrated System Wi-Fi version, is indicated for capture of still and motion pictures, patient file management and limited redundant control of the LENS camera control unit within articular cavities, body cavities, hollow organs, canals and the thoracic cavity.
# G. Comparison of Technological Characteristics
The Smith & Nephew LENS Integrated System and LENS camera head are substantially equivalent in design, materials, technological characteristics, intended use, and indications for use to the currently marketed predicate device, VisionScope High Definition Endoscopy Camera System K101734 in that:
- The proposed and predicate devices both have the same intended use and indications for use.
- Both the predicate and proposed devices have the same functional requirements.
- Video formats are similar.
- Both the proposed and predicate device use single chip technology.
- Both the proposed and predicate device utilize LED technology
{5}------------------------------------------------
Endoscopy
smith-nephew.com
The similarities between the Smith & Nephew LENS Integrated System and Lens Camera Head and the 560 High Definition Camera Head are:
- Both the proposed and the predicate are constructed out of the same materials.
- . Both the proposed and predicate device have the same FPGA based video processing.
- Both the proposed and predicate device have similar indications for use. ●
- . Both the prosed and predicate device camera heads are CF rated for thoracic surgery.
The major differences between the proposed LENS Integrated System and LENS camera head to the predicate devices VisionScope High Definition Endoscopy Camera System are:
- . The VisionScope High Definition Endoscopy Camera System offers sterile procedure kits. The LENS Integrated System does not offer sterile procedure kits.
- The Lens System is not for use in a doctor's office and the VisionScope High . Definition Endoscopy Camera System can be used in the operating room and a doctor's office.
- . The LENS system offers an optional APP feature that can be downloaded from the APP store to a surgeons tablet to remotely capture video recordings and image files from the LENS camera control unit. The VisionScope High Definition Endoscopy Camera System does not offer a tablet APP but communicates and transfers patient images and information only to a remote source over WIFI. Additionally the LENS provides redundant remote control for camera control unit function
The major differences between the proposed LENS Integrated System and LENS camera head to the secondary predicate devices 560 High Definition Camera system are:
- The 560 does not have image management or an LED light source . incorporated into the control unit. The LENS Integrated System incorporates an LED light source, image management function and camera functionality within the control unit.
- . The 560 High Definition Camera head utilizes 3 chip technology and the LENS camera head offers 1 chip technology.
- . The 560 High Definition Camera System does not provide Wi-Fi functionality.
- . The 560 High Definition Camera System does not offer an optional APP feature.
{6}------------------------------------------------
We are smith&nephew
mith & Nenhew. Inc 50 Minuteman Road 978 749 1000 78 749 1599 w.smith-nephew.com
### H. Summary Performance Data
Software was developed, tested and verified per FDA guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304: 2006 -Medical Device Software-Software Life Cycle Processes. The software for this device is considered a moderate level of concern.
Sterilization validation activities were performed in accordance with AAMI TIR 12-Designing, testing, and labeling reusable medical devices for reprocessing in Health Care facilities: A guide for medical device manufactures.
Bench testing was conducted to ensure that devices functioned as intended and met design specifications and acceptance criteria. Bench testing included light output testing, performance testing, thermal testing and ship testing.
In conclusion, based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Smith & Nephew LENS Integrated System raises no new questions of safety and effectiveness as compared to the predicate device Visionscope High Definition Endoscopy Camera System cleared in K101734 and the 560 High Definition Camera System, cleared in K070266 and are substantially equivalent to the predicate device in safety, effectiveness and performance.
