(113 days)
The LENS 4K Camera Control Unit and LENS 4K Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of surgical sites within articular cavities, body cavites, hollow organs and canals. Additionally, the LENS 4K Camera Control Unit and LENS 4K Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
The Smith & Nephew LENS 4K System ( 4K Camera Control Unit (CCU) and LENS 4K Camera Head), is an integrated camera/ LED light source/ image management device that provides visualization, illumination and image/video capture combined in a single console. The LENS 4K CCU works in conjunction with a camera head, appropriate light guides, couplers and endoscopes. The LENS 4K CCU will be offered in two versions, one with Wi-Fi and one without Wi-Fi. The non-Wi-Fi version does not have the ability to communicate to a tablet but captures the data to an attached USB storage device or to the Smith & Nephew 660HD-E Image Management System, which is a Class 1 device per LMB for display and sharing for display and sharing. Additionally, the LENS 4K System will also work with an optional Tablet Application, which was cleared in K190367. The Tablet application, when downloaded to a mobile device, acts as a tool to remotely capture video recordings and image files wirelessly from the LENS 4K System. The application provides the ability to view and annotate by voice or graphics or to text. Sharing of patient data from the Tablet is provided via the ability to archive to a USB storage device on the CCU, email, printing, or export to the local tablet camera roll.
This FDA 510(k) summary for the Smith & Nephew LENS 4K System (K191177) describes a device that provides illumination, visualization, and image/video capture for arthroscopic and endoscopic procedures. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device (Smith & Nephew LENS Integrated System, K153606), rather than presenting a detailed study proving the LENS 4K System meets specific performance acceptance criteria found in a typical clinical trial.
However, based on the provided text, we can extract details related to performance testing and acceptance criteria to the extent possible.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" against which "device performance" is reported in a numerical table format, as would be common for a medical imaging AI product. Instead, it lists categories of testing performed to demonstrate that the device "met the established performance specifications." Therefore, the table below reflects the types of testing done and the general conclusion drawn, rather than specific numerical criteria and results.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Video Output | Met all specified criteria. |
| Camera Head Surface Temperature | Met all specified criteria. |
| Software Verification and Validation | Met all specified criteria. |
| Emissions and Immunity Testing | Met all specified criteria. |
| Electrical Safety Testing | Met all specified criteria. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing focuses on demonstrating substantial equivalence based on engineering and performance testing rather than clinical study data. There is no mention of a "test set" in the context of patient data or images.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As there is no mention of a test set involving patient data/images for which ground truth would be established by experts, this section is not applicable.
4. Adjudication Method for the Test Set
This information is not provided in the document. Not applicable given the absence of a clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed based on the provided document. The device is a camera system, not an AI-assisted diagnostic tool designed to improve human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an algorithm's diagnostic accuracy was not performed or mentioned. This device is a camera system for visualization during surgery, not an AI algorithm performing a diagnostic task. The "performance data" mentioned (video output, temperature, software V&V, etc.) refers to the engineering and functional performance of the hardware and associated software.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, expert consensus) is not applicable here. The performance testing described (Video Output, Camera Head Surface Temperature, Software V&V, Emissions, Electrical Safety) would rely on objective engineering measurements and verification against design specifications and relevant standards, rather than clinical ground truth derived from patient outcomes or expert interpretations.
8. Sample Size for the Training Set
This information is not provided in the document. The device is a hardware system with associated software, not a machine learning model that requires a training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Not applicable as there is no mention of a training set for an AI model.
Summary of Study Type:
The provided document describes a 510(k) premarket notification for a medical device (a 4K camera system for endoscopy). The 'study' referred to is a series of engineering and functional performance tests conducted on the device itself to ensure it meets established design specifications and relevant regulatory standards (e.g., electrical safety, emissions). The primary goal of the submission is to demonstrate substantial equivalence to an existing predicate device (Smith & Nephew LENS Integrated System, K153606) based on similar intended use, fundamental scientific technology, basic design, and comparable performance. It is not a clinical study evaluating diagnostic accuracy or physician performance, nor is it related to AI/ML software performance studies that would typically involve test sets, ground truth, and expert readers.
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Smith and Nephew, Inc. Kathleen Solomon Principal Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
August 23, 2019
Re: K191177
Trade/Device Name: LENS 4K Camera Control Unit - Wifi. LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, HRX Dated: July 25, 2019 Received: July 26, 2019
Dear Kathleen Solomon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R.P. Ogden, MS Assistant Director, THT4A4 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
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Indications for Use
510(k) Number (if known) K191177
Device Name Smith & Nephew LENS 4K System
Indications for Use (Describe)
The LENS 4K Camera Control Unit and LENS 4K Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of surgical sites within articular cavities, body cavites, hollow organs and canals. Additionally, the LENS 4K Camera Control Unit and LENS 4K Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
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) |
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Endoscopy
Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810
USA
mith-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 4K System (Camera Control Unit and Camera Head)
Date Prepared: August 19, 2019
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road, Andover MA. 01810
B. Company Contact:
Kathleen Solomon Principal Regulatory Affairs Specialist T 978-749-1605 F 978-749-1443
C. Device Name:
| Trade Name: | LENS 4K Camera Control Unit-Wifi, LENS 4K Camera Control Unit- Non-Wifi LENS 4K Camera Head |
|---|---|
| Common Name: | LENS 4K System (4K camera control unit and 4K camera head) |
| Classification Name: | Endoscopes and Accessories per 876.1500 |
| Regulatory class: | II |
| Product Code: | GCJ, HRX |
D. Predicate Devices
The Smith & Nephew LENS 4K is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: Smith & Nephew LENS Integrated System and LENS Camera Head, K153606.
E. Description of Device
The Smith & Nephew LENS 4K System ( 4K Camera Control Unit (CCU) and LENS 4K Camera Head), is an integrated camera/ LED light source/ image management device that provides visualization, illumination and image/video capture combined in a single console. The LENS 4K CCU works in conjunction with a camera head, appropriate light guides, couplers and endoscopes.
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Endoscopy
Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810
USA
smith-nephew.com
The LENS 4K CCU will be offered in two versions, one with Wi-Fi and one without Wi-Fi. The non-Wi-Fi version does not have the ability to communicate to a tablet but captures the data to an attached USB storage device or to the Smith & Nephew 660HD-E Image Management System, which is a Class 1 device per LMB for display and sharing for display and sharing.
Additionally, the LENS 4K System will also work with an optional Tablet Application, which was cleared in K190367. The Tablet application, when downloaded to a mobile device, acts as a tool to remotely capture video recordings and image files wirelessly from the LENS 4K System. The application provides the ability to view and annotate by voice or graphics or to text. Sharing of patient data from the Tablet is provided via the ability to archive to a USB storage device on the CCU, email, printing, or export to the local tablet camera roll
F. Intended Use
●
The LENS 4K Camera Control Unit and LENS 4K Camera Head are intended to provide illumination, visualization and capture of still and motion pictures of surgical sites.
Indications for Use:
The LENS 4K Camera Control Unit and LENS 4K Camera Head are used in diagnostic and operative procedures for 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, the LENS 4K Camera Control Unit and LENS 4K Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
G. Comparison of Technological Characteristics
The proposed Smith & Nephew LENS 4K Camera Control Unit and LENS 4K Camera Head has the following similarities as the predicate device cleared in K153606. In that:
- The proposed and predicate devices have similar indications for use/intended use.
- . Both the predicate and proposed utilizes the same principle of operation and fundamental scientific technology
- Incorporates the same basic design
- o Camera control unit utilizes the same chassis design (size and shape) and same material
- Camera head utilizes the same housing and silicone button design o
- Camera Control Unit incorporates the same material
- Video formats are similar in that both the LENS 4K and predicate use 1080p/1080i ● switchable formats.
- Both the predicate and the proposed are designed and compatible with the Tablet Application
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Endoscopy
Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810
USA
T 978-749-1000
F 978-749-1443
www.smith-nephew.com
The differences between the proposed LENS 4K System and the predicate device LENS Integrated System are:
- The LENS 4K System has 4K video technology whereas the LENS Integrated System is HD video.
- LENS 4K camera head is a 3-chip CMOS sensor comprised of 304L stainless steel housing. The predicate LENS camera heads is a single chip sensor and PEEK housing.
The differences between the proposed and predicate device do not constitute a new intended use, there are no differences in technological characteristics and does not introduce new types of safety or effectiveness questions.
H. Performance Data
The following testing was performed on the LENS 4K System to demonstrate that it has met the established performance specifications and therefore, is substantially equivalent to the predicate device cleared in K153606:
- Video Output ●
- Camera Head Surface Temperature ●
- Software Verification and Validation ●
- Emissions and Immunity Testing ●
- Electrical Safety Testing .
I. Conclusion:
The Smith & Nephew LENS 4K System met all specified criteria and did not raise new safety and/or effectiveness questions. The substantial equivalence of the proposed device is based on similar indications for use, fundamental technology including design, and operational principles. Based on the similarities to the predicate and the performance data, the Smith & Nephew LENS 4K System is substantially equivalent to its predicate (K153606).
§ 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.