(67 days)
Not Found
No
The description focuses on remote control and data access, with no mention of AI/ML capabilities or related performance metrics.
No
The device is a remote control and monitoring system for other surgical devices; it does not directly perform any therapeutic function on a patient.
No
The device is described as providing remote control for surgical and endoscopic devices, adjusting parameter settings, and accessing device status and reports. It explicitly states its role in controlling devices and setting parameters, not in diagnosing patient conditions.
No
The device description explicitly states the software is "pre-installed upon a medical grade tablet," indicating it includes hardware (the tablet) as part of the medical device. The performance studies also include "Physical Verification" and "Electrical Safety Testing," which are typically associated with hardware components.
Based on the provided information, the Smith+Nephew INTELLIO Tablet is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "wired or wireless remote control of Smith+Nephew compatible surgical and endoscopic devices within the operating room". It focuses on controlling parameters of surgical equipment.
- Device Description: The description reinforces this by explaining how the tablet controls surgical devices like camera control units, fluid management systems, and RF coblation systems. It also mentions accessing data related to surgical procedures.
- 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 INTELLIO Tablet does not interact with patient specimens in this way. Its function is to control surgical equipment and manage data related to the surgical procedure itself.
Therefore, the INTELLIO Tablet falls under the category of a surgical device control system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smith+Nephew INTELLIO Tablet is indicated for use to provide wired or wireless remote 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 (comma separated list FDA assigned to the subject device)
ODA
Device Description
The INTELLIO Tablet application software is pre-installed upon a medical grade tablet that is used with compatible Smith + Nephew surgical and endoscopic device allows for control of parameters within the operating room, including camera control system, patient information system, mechanical resection system, Fluid Management system and RF Coblation system. The device also connects to the MY.INTELLIO™ cloud and provides access to medical device status, settings, images/videos, and reports before, during and after surgical procedures. Additionally, software updates are manually downloaded from the MY.INTELLIO cloud account via secured link and can be installed via the administrator account
The device is able to set parameters remotely for the Fluid management pumps, Mechanical Resection controller and RF Coblation controller by connecting to the Wifi connect device either separate (LINK box) or integrated with the individual pump or controller. It also provides a secondary control mechanism for all of these devices forming a connected system. The primary control for setting parameters are on the individual 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 INTELLIO Tablet has met the performance specifications, required Cybersecurity testing and therefore, is substantially equivalent to the predicate device cleared in K203566.
The following testing was performed:
- . Physical Verification
- . Software Verification and Validation
- Emissions and Immunity Testing ●
- Electrical Safety Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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
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September 6, 2022
Smith+Nephew Kathleen Solomon Principal Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K221929/S001
Trade/Device Name: Smith+Nephew INTELLIO Tablet Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODA Dated: June 30, 2022 Received: July 1, 2022
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
1
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,
for
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221929
Device Name Smith+Nephew INTELLIO Tablet
Indications for Use (Describe)
The Smith+Nephew INTELLIO Tablet is indicated for use to provide wired or wireless remote 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
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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 INTELLIO Tablet
Date Prepared: June 30, 2022
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 E Kathleen.solomon@smith-nephew.com
C. Device Name
Trade Name: Smith+Nephew INTELLIO Tablet Common Name: Tablet Application Classification Name: Endoscopes and Accessories, 876.1500 Regulatory class: II Product Code: ODA
D. Predicate Devices
The Smith+Nephew INTELLIO Tablet 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 K203566.
E. Description of Device
The INTELLIO Tablet application software is pre-installed upon a medical grade tablet that is used with compatible Smith + Nephew surgical and endoscopic device allows for control of parameters within the operating room, including camera control system, patient information system, mechanical resection system, Fluid Management system and RF Coblation system. The device also connects to the MY.INTELLIO™ cloud and provides access to medical device status, settings,
4
images/videos, and reports before, during and after surgical procedures. Additionally, software updates are manually downloaded from the MY.INTELLIO cloud account via secured link and can be installed via the administrator account
The device is able to set parameters remotely for the Fluid management pumps, Mechanical Resection controller and RF Coblation controller by connecting to the Wifi connect device either separate (LINK box) or integrated with the individual pump or controller. It also provides a secondary control mechanism for all of these devices forming a connected system. The primary control for setting parameters are on the individual devices.
F. Intended Use
Indication for Use:
The Smith+Nephew Tablet Application is indicated for use to provide wired or wireless remote 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 K203566. 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
- . Both the predicate and proposed devices allow for control of parameters within the operating room.
The differences between the proposed INTELLIO Tablet and the predicate device S+N Tablet Application are:
- The Intellio software application will be provided on an Android platform. The predicate platform is an Apple iOS.
- The Intellio software application is pre-installed on medial grade tablet. The predicate is downloaded from Apple store onto the surgeon's iPad.
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
5
Testing demonstrated that the Smith+Nephew INTELLIO Tablet has met the performance specifications, required Cybersecurity testing and therefore, is substantially equivalent to the predicate device cleared in K203566.
The following testing was performed:
- . Physical Verification
- . Software Verification and Validation
- Emissions and Immunity Testing ●
- Electrical Safety Testing
G. Conclusion:
The Smith+Nephew INTELLIO Tablet has met all specified criteria and does not raise new safety or effectiveness questions. The substantial equivalence of the modified device is based on similar indications for use, principal of operation and fundamental technology. Based on the similarities to the predicate device and the performance data, the Smith+Nephew INTELLIO Tablet Application is substantially equivalent to its predicate device cleared in K203566.