(157 days)
Not Found
No
The summary describes a software application for remote control of surgical devices, with no mention of AI/ML capabilities, image processing, or data analysis for decision support.
No
The device is a software application for wireless control of other surgical/endoscopic devices; it adjusts parameter settings and does not directly provide therapy.
No
Explanation: The device is described as providing wireless control and adjusting parameter settings of other surgical and endoscopic devices. It does not perform any diagnostic functions or analyze patient data to identify diseases or conditions.
Yes
The device is explicitly described as a "software application" that provides wireless control and limited remote control to compatible medical devices. The description focuses solely on the software's function and connectivity, without mentioning any accompanying hardware components developed or included as part of this specific device submission.
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 application is for providing wireless control of surgical and endoscopic devices within the operating room. This involves controlling the operation of medical devices used directly on or within a patient during a surgical procedure.
- Device Description: The description reinforces this by stating it provides a Wi-Fi connection and limited remote control to connected 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 diagnostic purposes.
The device is a software application designed to facilitate the control of surgical equipment, which falls under the category of medical devices used in a clinical setting for treatment or procedural support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of Smith & Nephew compatible surgical and endoscopic devices within the operating room including camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.
Product codes
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
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
Operating Room
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing demonstrated that the Smith & Nephew Tablet Application has met the performance specifications, compatibility to the Arthroscopic inflow/ outflow fluid management system and required Cybersecurity testing therefore, is substantially equivalent to the predicate device cleared in K192876.
The following Software validations were conducted:
- Software verification
- Software validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 13, 2021
Smith & Nephew Sean Reynolds Director, Regulatory Affairs Specialist 150 Minuteman Rd Andover, Massachusetts 01810
Re: K203566
Trade/Device Name: Tablet Application Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: ODA Dated: April 14, 2021 Received: April 15, 2021
Dear Sean Reynolds:
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
1
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 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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203566
Device Name Smith & Nephew Tablet Application 4.0
Indications for Use (Describe)
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of Smith & Nephew compatible surgical and endoscopic devices within the operating room including camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.
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: + 1 978 749 1000 T: + 1 800 343 8386 (USA toll free) www.smith-nephew.com
K203566
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: May 12, 2021
A. Submitter's Name:
Smith+Nephew, Inc., Endoscopy Division 150 Minuteman Road, Andover MA. 01810
B. Company Contact:
Sean Reynolds Director, Regulatory Affairs T 978-749-1173
C. Device Name
Trade Name: Smith+Nephew 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 equivalent in intended use and fundamental scientific technology to the following legally marketed device currently in commercial distribution: Smith+Nephew Tablet Application cleared in K192876.
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.
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F. Intended Use
Indication for Use:
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of Smith & Nephew compatible surgical and endoscopic devices within the operating room including camera/camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.
G. Comparison of Technological Characteristics
The Smith & Nephew Tablet Application has the following similarities as the predicate device, Smith & Nephew Tablet Application, cleared in K192876.
| Property | Proposed Device | Predicate Device K192876 |
|---|---|---|
| Intended Use | The Smith & Nephew Tablet | |
| Application is intended for use for | ||
| wireless control of compatible Smith | ||
| & Nephew surgical and endoscopic | ||
| devices. | The Smith & Nephew Tablet | |
| Application is intended for use for | ||
| wireless control of compatible Smith | ||
| & Nephew surgical and endoscopic | ||
| devices. | ||
| Indications for use | The Smith & Nephew Tablet | |
| Application is indicated for use to | ||
| provide wireless control of Smith & | ||
| Nephew compatible surgical and | ||
| endoscopic devices within the | ||
| operating room including | ||
| camera/camera control unit, patient | ||
| information system, mechanical | ||
| resection system, fluid management | ||
| system and RF coblation system. | ||
| These controls consist of adjusting | ||
| parameter settings only. | 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/camera control unit, patient | ||
| information system, DYONICS | ||
| POWER II Control Unit and the | ||
| Werewolf Controller. | ||
| Regulation Number | 876.1500 | 876.1500 |
| Classification | Class II | Class II |
| Pro Code | ODA | ODA |
| Device Name | Tablet Application 4.0 | INTELLIO Tablet Application |
| Software | 4.0 | 03.05.49 |
| WiFi | Yes | Yes |
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 (K192876) is the addition of arthroscopic inflow/ outflow fluid management system which communicates with the Tablet Application. These controls consist of adjusting parameter settings only.
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K203566
H. Performance Data
Testing demonstrated that the Smith & Nephew Tablet Application has met the performance specifications, compatibility to the Arthroscopic inflow/ outflow fluid management system and required Cybersecurity testing therefore, is substantially equivalent to the predicate device cleared in K192876.
The following Software validations were conducted:
- Software verification ●
- . Software validation
G. 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 K192876, the Smith & Nephew Tablet Application, the proposed Smith+Nephew Tablet is substantially equivalent to its predicate device cleared in K192876.