K Number
K221740
Device Name
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
Date Cleared
2022-10-20

(127 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.
Device Description
The Smith & Nephew INTELLIO 4K CCU is a part of the Smith & Nephew visualization system. It is an all-in-one 4K imaging console and LED light source designed for endoscopic surgical procedures. The CCU is compatible with the LENS 4K Camera Head. The functional system level architecture of this device demonstrates multiple functions, that includes the illumination of surgical space and capturing of raw imaging data from the camera sensors. It also processes the imaging data and transfers it to the attached monitor for display. Apart from capturing still images and video during the procedure, the device also adjusts the visualization settings (brightness, line enhancement, color saturation/hue and image zoom) and allows optional communication to a medical tablet to facilitate centralized control of all tower devices from the tablet. The device contains of a Wi-Fi board that supports communication frequency of 2.4 GHz and 5.0 GHz. The device uses a LED light engine to illuminate the surgical space. The User Interface (UI) consists of buttons and LEDs that can be accessed on the front panel, which also contain the ports for camera head connector and USB slots for medical tablet and flash drive.
More Information

Not Found

No
The description focuses on standard image processing and hardware functionalities (4K imaging, LED light source, Wi-Fi, UI) without mentioning any AI/ML algorithms for image analysis, decision support, or automated adjustments beyond basic visualization settings. The lack of mention of AI/ML in the "Mentions AI, DNN, or ML" section and the absence of details about training/test sets further support this conclusion.

No
The device is described as an imaging console and LED light source for endoscopic surgical procedures, processing and displaying images, rather than directly treating a condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is intended for use in "diagnostic, and operative endoscopic surgical procedures".

No

The device description explicitly states it is an "all-in-one 4K imaging console and LED light source" and mentions hardware components like a Wi-Fi board, LED light engine, buttons, LEDs, and ports. It also includes hardware-related performance studies like Shock and Vibration, EMI/EMC, and Safety tests.

Based on the provided information, the Smith+Nephew INTELLIO 4K CCU is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states the device is for use in "diagnostic, and operative endoscopic surgical procedures." This refers to procedures performed on the patient's body, not on samples taken from the body.
  • Device Description: The description details a system for illuminating the surgical field, capturing and processing images from a camera head, and displaying them on a monitor. This is consistent with a surgical visualization system used during procedures.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine samples (like blood, tissue, or urine) outside of the body to diagnose a condition. IVD devices are specifically designed for testing biological samples in vitro (in glass or outside the living organism).

Therefore, the Smith+Nephew INTELLIO 4K CCU is a surgical visualization system, not an IVD device.

N/A

Intended Use / Indications for Use

The Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.

Product codes

GCJ

Device Description

The Smith & Nephew INTELLIO 4K CCU is a part of the Smith & Nephew visualization system. It is an all-in-one 4K imaging console and LED light source designed for endoscopic surgical procedures. The CCU is compatible with the LENS 4K Camera Head. The functional system level architecture of this device demonstrates multiple functions, that includes the illumination of surgical space and capturing of raw imaging data from the camera sensors. It also processes the imaging data and transfers it to the attached monitor for display. Apart from capturing still images and video during the procedure, the device also adjusts the visualization settings (brightness, line enhancement, color saturation/hue and image zoom) and allows optional communication to a medical tablet to facilitate centralized control of all tower devices from the tablet. The device contains of a Wi-Fi board that supports communication frequency of 2.4 GHz and 5.0 GHz. The device uses a LED light engine to illuminate the surgical space. The User Interface (UI) consists of buttons and LEDs that can be accessed on the front panel, which also contain the ports for camera head connector and USB slots for medical tablet and flash drive.

Mentions image processing

Yes

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

Prescription Use

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)

Non-Clinical Performance Data: The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has passed all acceptance criteria established by the predicate device, where applicable. The following bench tests have been submitted with the 510K application:

  • Shock and Vibration Tests
  • · EMI/EMC Test Report
  • · Safety Test Report
  • · Packaging Design Verification Test Report
    Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K191177

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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October 20, 2022

Smith and Nephew, Inc. Renesha Srivastava Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810

Re: K221740

Trade/Device Name: Smith & Nephew Intellio 4k Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4k Camera Control Unit, Non-network Enabled (72205448) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 13, 2022 Received: June 15, 2022

Dear Renesha Srivastava:

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.

1

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 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.

Jiantang Wang Acting 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) K221740

Device Name

SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)

Indications for Use (Describe)

The Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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INTELLIO 4K CAMERA CONTROL UNIT SMITH AND NEPHEW INC.

510K SUMMARY

Pursuant to Title 21 of Code of Federal Regulations, Subchapter H, section 807.92(a), the Traditional 510K Summary to seek clearance for the device INTELLIO 4K Camera Control Unit (CCU) is stated as follows:

  1. Submitter: Smith & Nephew Inc. Address: 150 Minuteman Road, Andover, Massachusetts, USA - 01810 Telephone Number: +1(978) 749-1000 Contact Person: Renesha Srivastava Date: 10/17/2022

  2. Device: SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT Trade Name and/or Proprietary Name: INTELLIO 4K Camera Control unit Common Name/Usual Name: Camera Control Unit Regulation and Product Code: 876.1500 / GCJ

3) Predicate Device: SMITH & NEPHEW LENS 4K SYSTEM

The INTELLIO 4K CCU is substantially equivalent to the Smith and Nephew LENS 4K System Camera Control Unit, cleared by the FDA under the Premarket Notification K191177. The INTELLIO 4K CCU has an updated Graphical User Interface (GUI) and can be operated by an optional accessory, the INTELLIO Tablet. The Wi-Fi network that can be supported by the device includes dual bandwidth of 2.4 GHz and 5.0 GHz.

Intended Use of INTELLIO 4K CCU: The Smith&Nephew INTELLIO 4K CCU is intended for illumination and visualization of endoscopic surgical procedures.

Indications for Use for INTELLIO 4K CCU: The Smith-Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.

Similarities between the subject and predicate devices:

  • a) Both the devices have similar Intended Use
  • b) Both the devices have similar Indications for Use
  • c) Both the devices have similar accessory input and output ports

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INTELLIO 4K CAMERA CONTROL UNIT SMITH AND NEPHEW INC.

  • d) Both the devices have the same integrated light source and light guide connector
  • e) Both the devices are compatible with the same LENS 4K Camera Head, used as an accessory, and cleared by the FDA (K191177)
  • f) The display resolution for both the devices are same
  • g) Both the devices can operate with the same electrical power input

Differences between the subject and the predicate device:

  • a) The INTELLIO 4K CCU supports an additional feature to enable a lavage trigger, that would allow the washing away of fluid from the surgical area.
  • b) The INTELLIO 4K CCU can operate on both 2.4 GHz and 5.0 GHz Wi-Fi enabled network system, as compared to the Predicate that can operate only on 2.4 GHz Wi-Fi enabled network system.
  • c) The INTELLIO 4K CCU has a reorganized enclosure and front panel, with mechanical buttons and an updated Graphical User Interface (GUI)
  • d) The INTELLIO 4K CCU can be controlled by the optional INTELLIO Tablet, which was not a feature on the predicate device
  • e) The INTELLIO 4K CCU has an updated chassis with a difference in overall size dimension and cover design (top cover) as compared to the Predicate device.

Device Description Summary: The Smith & Nephew INTELLIO 4K CCU is a part of the Smith & Nephew visualization system. It is an all-in-one 4K imaging console and LED light source designed for endoscopic surgical procedures. The CCU is compatible with the LENS 4K Camera Head. The functional system level architecture of this device demonstrates multiple functions, that includes the illumination of surgical space and capturing of raw imaging data from the camera sensors. It also processes the imaging data and transfers it to the attached monitor for display. Apart from capturing still images and video during the procedure, the device also adjusts the visualization settings (brightness, line enhancement, color saturation/hue and image zoom) and allows optional communication to a medical tablet to facilitate centralized control of all tower devices from the tablet. The device contains of a Wi-Fi board that supports communication frequency of 2.4 GHz and 5.0 GHz. The device uses a LED light engine to illuminate the surgical space. The User Interface (UI) consists of buttons and LEDs that can be accessed on the front panel, which also contain the ports for camera head connector and USB slots for medical tablet and flash drive.

Non-Clinical Performance Data: The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has passed all acceptance criteria established by the predicate device, where applicable.

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INTELLIO 4K CAMERA CONTROL UNIT SMITH AND NEPHEW INC.

The following bench tests have been submitted with the 510K application:

  • Shock and Vibration Tests
  • · EMI/EMC Test Report
  • · Safety Test Report
  • · Packaging Design Verification Test Report

Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.

Sterilization and Shelf Life

The INTELLIO 4K CCU is packaged in a double walled corrugated cardboard box with two endcaps that fit around the ends of the CCU. Shelf-Life for the Smith & Nephew INTELLIO 4K CCU is not applicable as the device is distributed non-sterile. Additionally, it's performance and materials do not degrade over the lifetime of the device.

Conclusion: The submission demonstrates that (1) any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed device is at least as safe and effective as the predicate. It is concluded that the information included in this summary supports substantial equivalence.