(95 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on remote control and image capture, not intelligent analysis.
No
The device is described as a tool for wireless control of surgical and endoscopic devices, capturing images, and managing patient files. It is not directly used for treating or diagnosing medical conditions, but rather, it is a control system for other medical devices.
No
The device is described as a tool for wireless control of surgical and endoscopic devices, primarily for capturing images and managing patient files, and limited redundant control of medical devices. There is no indication that it is used to diagnose a disease, condition, or state of being.
Yes
The device is described as a "Tablet Application" and its function is to wirelessly control other medical devices and manage patient files. The description focuses solely on software functionalities and the performance studies listed are "Software Verification and Validation," with no mention of hardware components or hardware-specific testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "wireless control of compatible Smith & Nephew passive surgical and endoscopic devices including camera control unit and patient information system." This describes a device used during a surgical or endoscopic procedure to control other medical devices and manage patient information.
- Device Description: The description reinforces this by stating it acts as a "tool to remotely capture still and motion pictures, patient file management, and limited redundant control of medical devices."
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with patient specimens or any diagnostic function based on analyzing biological samples.
The device's function is related to controlling surgical equipment and managing patient data within a clinical setting, not performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes
QGY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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
2
Indications for Use
510(k) Number (if known) K190367
Device Name Tablet Application
Indications for Use (Describe)
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.
| 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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3
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
4
Endoscopy
Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810
USA
nenhew com
are smith&nephew
E. Description of Device
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.
F. Intended Use/Indications for Use:
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.
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).