(142 days)
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No
The document describes a software application for remote control of surgical devices via Wi-Fi and does not mention AI, ML, or related concepts.
No
The device is a software application for wireless control of surgical and endoscopic device parameters, not for direct therapeutic intervention on a patient.
No
The device is described as a software application that provides wireless control of parameter settings for surgical and endoscopic devices. It functions as a remote control for other medical devices, rather than acquiring, processing, or analyzing physiological data or images for diagnostic purposes.
Yes
The device is described as a "software application" that provides wireless control of compatible surgical and endoscopic devices. While it interacts with hardware, the device itself is explicitly stated to be software and the description focuses on its software functionality and validation.
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 used to "provide wireless control of parameters settings for compatible Smith & Nephew surgical and endoscopic devices within the operating room". This describes a device used to control surgical equipment, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces this by stating it's a "software application that provides a Wi-Fi connection between compatible medical devices" and offers "limited remote control". This is consistent with controlling surgical equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any other activity typically associated with IVD devices.
Therefore, the Smith & Nephew Tablet Application is a device used for controlling surgical equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of parameters settings for compatible Smith & Nephew surgical and endoscopic devices within the operating room including cameralcamera control unit, patient information system, DYONICS POWER II Control Unit and the Werewolf Controller.
Product codes (comma separated list FDA assigned to the subject device)
ODA
Device Description
The Smith & Nephew Tablet Application is a software application that provides a Wi-Fi connection between compatible medical devices. Once connected the Tablet Application has the ability to provide limited remote control to the connected devices.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Operating Room
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing demonstrated that the Smith & Nephew Tablet Application has met the performance specifications and required Cybersecurity testing therefore, is substantially equivalent to the predicate device cleared in K190367.
The following Software validations were conducted:
- Software verification
- Software validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew Ms. Janice Haselton Principal Regulatory Affairs Specialist 150 Minuteman Rd Andover, Massachusetts 01810
Re: K192876
Trade/Device Name: INTELLIO Tablet Application Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODA Dated: October 7, 2019 Received: October 8, 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/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 medical devices and radiation-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,
Jessica Mavadia-Shukla Acting Assistant 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) K192876
Device Name INTELLIO Tablet Application
Indications for Use (Describe)
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of parameters settings for compatible Smith & Nephew surgical and endoscopic devices within the operating room including cameralcamera control unit, patient information system, DYONICS POWER II Control Unit and the Werewolf Controller.
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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T 978-749-1496 F 978-749-1443 www.smith-nephew.com
Image /page/3/Picture/2 description: The image shows the Smith & Nephew logo. The logo consists of a flower-like symbol in orange, followed by the text "We are smith&nephew". The text "We are" is in gray, while "smith&nephew" is in orange.
K192876 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: Smith & Nephew Tablet Application
Date Prepared: February 26, 2020
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: INTELLIO Tablet Application Common Name: Application Classification Name: Endoscopes and Accessories, 876.1500 Regulatory class: II Product Code: ODA
D. Predicate Devices
The Smith & Nephew Tablet Application presented in this submission is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device currently in commercial distribution: Smith & Nephew Tablet Application cleared in K190367.
4
T 978-749-100
01810 USA
F 978-749-1443
www.smith-
are smith&nephew
E. Description of Device
The Smith & Nephew Tablet Application is a software application that provides a Wi-Fi connection between compatible medical devices. Once connected the Tablet Application has the ability to provide limited remote control to the connected devices.
F. Intended Use and Indications for Use
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of parameters settings for compatible Smith & Nephew surgical and endoscopic devices within the operating room including camera control unit, patient information system, DYONICS POWER II Control Unit and the Werewolf Controller.
G. Comparison of Technological Characteristics
The Smith & Nephew Tablet Application has the following similarities as the predicate device, Smith & Nephew Tablet Application, cleared in K190367.
Both Applications utilizes Wi-Fi capability for connection with compatible Wi-Fi devices.
The difference between the proposed Smith & Nephew Tablet Application and the currently cleared predicate Tablet Application (190367) is the addition of two new medical devices which communicate with the Tablet Application.
H. Performance Data
Testing demonstrated that the Smith & Nephew Tablet Application has met the performance specifications and required Cybersecurity testing therefore, is substantially equivalent to the predicate device cleared in K190367.
The following Software validations were conducted:
- Software verification
- Software validation ●
5
T 978-749-1000
Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA
F 978-749-1443 www.smith-
Image /page/5/Picture/4 description: The image contains the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of "We are", the text "smith&nephew" is written in orange.
Conclusion:
The Smith & Nephew Tablet Application has met all specified criteria and does not raise new safety or effectiveness questions. The substantial equivalence of the modified device is based on the same fundamental technology. Based on the similarities to the predicate device cleared in K190367, the Smith & Nephew Tablet Application, the proposed Smith & Nephew Tablet is substantially equivalent to its predicate cleared in K190367.