The Smith & Nephew Tablet Application is indicated for wireless control of compatible Smith & Nephew passive surgical and endoscopic devices including camera control unit and patient information system.

Device Description

The Tablet Application acts as a tool to remotely capture still and motion pictures, patient file management, and limited redundant control of medical devices. The Tablet Application currently supports the LENS Integrated System and Integration Broker.

AI/ML Overview

The provided text describes the Smith & Nephew Tablet Application, which is indicated for wireless control of compatible Smith & Nephew passive surgical and endoscopic devices, including camera control units and patient information systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics. It generally states that "Testing demonstrated that the Tablet Application has met the performance specifications" and "met all specified criteria."

Acceptance Criteria (Implied)	Reported Device Performance
Device functions as intended for wireless control of compatible surgical/endoscopic devices.	"Testing demonstrated that the Tablet Application has met the performance specifications" and "met all specified criteria."
No new safety or effectiveness concerns are raised compared to the predicate device.	"did not raise new safety or effectiveness questions."
Software operates reliably and performs its specified functions.	"Software Verification and Validation" was conducted.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Software Verification and Validation" was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention an MRMC comparative effectiveness study, nor does it discuss an effect size of human readers improving with AI vs. without AI assistance. The device is for controlling surgical and endoscopic devices, not for diagnostic interpretation by human readers.

6. Standalone Performance Study

The document indicates that "Software Verification and Validation" was conducted, which implies evaluation of the algorithm's performance in a standalone context to ensure it meets its specifications. However, specific details of this standalone performance are not enumerated beyond the general statement of meeting criteria.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used. For a device intended for wireless control, the "ground truth" would likely involve objective measures of functionality, such as successful command execution, accurate data transfer, proper control of connected devices, and adherence to communication protocols, rather than expert consensus, pathology, or outcomes data typically associated with diagnostic or prognostic devices.

8. Sample Size for the Training Set

This information is not provided in the document. The device is a software application for control, so a "training set" in the machine learning sense may not be directly applicable, or if it involves configuration data, its size is not mentioned.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. As noted above, the concept of a "training set" might not be relevant in a conventional sense for this type of device. If there was a training phase for any adaptable components of the software, the method for establishing ground truth for that phase is not given.

Summary

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Smith & Nephew Ms. Janice Haselton Principal Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Mav 21, 2019

Re: K190367

Trade/Device Name: Smith & Nephew Tablet Application Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: QGY Dated: February 12, 2019 Received: February 22, 2019

Dear Janice 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. 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Stevenson, For Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190367

Device Name Tablet Application

Indications for Use (Describe)

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

nith-nenhew com

SECTION IV

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 Tablet Application

Date Prepared: February 5, 2019

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road, Andover MA. 01810

B. Company Contact:

Janice Haselton Principal Regulatory Affairs Specialist T 978-749-1494 F 978-749-1407

C. Device Name

Trade Name: Tablet Application

Common Name: APP

Classification Name: Mobile / tablet software application to control settings of surgical and endoscopic camera 876.1500

Regulatory class: 2

Product Code: QGY

D. Predicate Devices

The Tablet Application is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution:

Smith & Nephew LENS Integrated System APP cleared in K153606

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Endoscopy
Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810
USA

nenhew com

are smith&nephew

E. Description of Device

F. Intended Use/Indications for Use:

H. Comparison of Technological Characteristics

The modified Smith & Nephew Tablet Application has the following similarities as the predicate device cleared in K151326. In that:

Utilizes the same principle of operation and fundamental scientific technology
Incorporates the same basic software design ●

The differences between the currently cleared device and the proposed device are an expanded Intended Use and Indication for Use.

I. Performance Data

Testing demonstrated that the Tablet Application has met the performance specifications and therefore, is substantially equivalent to the predicate device cleared in K151326.

The following performance data and validations were conducted:

Software Verification and Validation ●

Conclusion:

The Smith & Nephew Tablet Application met all specified criteria and did not raise new safety or effectiveness questions. The substantial equivalence of the modified device is based on fundamental technology including software design and principles. Based on the similarities to the predicate and the performance data, the Smith & Nephew Tablet Application is substantially equivalent to its predicate (K151326).

Regulation Number and Section

§ 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.