(168 days)
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.
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.
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.
The provided text is a 510(k) summary for the Smith & Nephew LENS Integrated System and LENS Camera Head. It outlines the device's characteristics, intended use, and comparison to predicate devices to establish substantial equivalence. However, it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and the study that proves the device meets them.
Specifically, the document states generally that "Bench testing was conducted to ensure that devices functioned as intended and met design specifications and acceptance criteria." It also mentions "light output testing, performance testing, thermal testing and ship testing." However, it does not provide:
- Specific acceptance criteria values (e.g., minimum light output intensity, specific performance metrics for image quality, thermal limits, etc.).
- Reported device performance values against those criteria.
- Details of the study methodology for these bench tests (sample sizes, ground truth establishment, expert involvement, etc.).
Therefore, many parts of your request cannot be answered from the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Light Output Tests: Specific criteria for light intensity, uniformity, color temperature, etc. (Not specified in text) | Performance values met design specifications and acceptance criteria (No specific values provided). |
| Performance Tests: Specific criteria for image resolution, clarity, frame rate, latency, color accuracy, etc. (Not specified in text) | Performance values met design specifications and acceptance criteria (No specific values provided). |
| Thermal Tests: Specific temperature limits for device components and patient contact surfaces. (Not specified in text) | Performance values met design specifications and acceptance criteria (No specific values provided). |
| Ship Tests: Criteria for device integrity and functionality after simulated shipping conditions (e.g., vibration, drop, shock resistance). (Not specified in text) | Performance values met design specifications and acceptance criteria (No specific values provided). |
| Software Functionality: Software operates as intended, meets specified requirements, and complies with IEC 62304 and FDA guidance document. | Software was "developed, tested and verified per FDA guidance documents... and IEC 62304." |
| Sterilization Validation: Device can be reprocessed according to AAMI TIR 12. | Sterilization validation activities were "performed in accordance with AAMI TIR 12." |
2. Sample size used for the test set and the data provenance: Not specified in the text. The document refers to "bench testing" generally, without detailing specific test sets or sample sizes used for performance validation. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. As the document mainly describes bench testing for technical specifications (light output, thermal, performance of hardware/software), there's no indication of clinical expert involvement for establishing "ground truth" in the way it would be for a diagnostic AI device analyzing medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable based on the information provided. This type of adjudication is typically for clinical studies involving human interpretation or performance, which is not detailed here for the "bench testing."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device described is an endoscope camera system, not an AI-assisted diagnostic tool that would typically involve human readers and MRMC studies. There is an "optional LENS application" that acts as a tool to remotely capture images and manage patient files and provide limited redundant control, but it's not presented as an AI for diagnostic improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the system as an "integrated camera/ LED light source/ image management device." The "LENS application" is described as a tool for remote capture, management, and control. This implies a human-in-the-loop system, as the camera is used by a surgeon. No "standalone algorithm" performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench testing, the "ground truth" would be the engineering specifications and design requirements (e.g., a light output sensor measuring a specific lumen value, a thermal sensor reading a specific temperature). No clinical ground truth (expert consensus, pathology, outcomes) is mentioned for the performance testing.
8. The sample size for the training set: Not applicable. The device is a camera system, not an AI algorithm that would typically involve a "training set" in the context of machine learning. The software development follows a life cycle process, not an AI training paradigm.
9. How the ground truth for the training set was established: Not applicable for the reasons stated above.
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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
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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
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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)
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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.
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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
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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.
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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.
§ 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.