The Canady Flex RoboWrist is intended for grasping, mobilization, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

Device Description

The Canady Flex RoboWrist is a motorized, hand-held laparoscopic surgery instrument available with hook, scissors, or needle holder end-effectors. The device includes a connector for an electrosurgical generator, which allows the option of using the mono scissors or hook for electrosurgery. The Canady Flex RoboWrist primarily intended for dissection, and/or suturing of tissue under direct and endoscopic visualization in minimally invasive surgical procedures for interventions such as laparoscopic (urologic, gynecologic) or thoracic surgeries.

The Canady Flex RoboWrist is composed of an instrument (with end-effectors) and a control unit, which provides power to the instrument. Three models of instruments are available: needle-holder, monopolar hook and monopolar scissors. An electrical cable is provided to connect the instrument to the control unit. It is also provided with a sterilization tray.

AI/ML Overview

The provided text is a 510(k) summary for the Canady Flex RoboWrist, an endoscopic instrument. This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study that evaluates the device's performance against specific clinical or diagnostic metrics, as would be expected for an AI/ML-driven device with performance claims.

Instead, the document focuses on non-clinical performance data to demonstrate safety and effectiveness for a surgical instrument. The key takeaway is that this is not an AI/ML device and therefore the questions about AI-specific performance criteria, ground truth, expert adjudication, and MRMC studies are not applicable.

Here's an analysis based on the provided text, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in the typical sense for a medical device with performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests that were performed to evaluate conformance to product specifications.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Passed testing per ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Intracutaneous reactivity), ISO 10993-11 (Acute systemic toxicity, Material-mediated pyrogenicity)
Electrical Safety	Passed testing per IEC 60601-1
Electromagnetic Compatibility	Passed testing per IEC 60601-1-2
Cleaning and Sterilization	Validations per ISO 17665-1
Human Factors/Usability	Testing per IEC 62366
Functionality	Passed testing including manipulating, cutting, and suturing

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The "test set" here refers to physical components of the device and its performance in a lab setting, not a dataset of patient images or clinical outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is an endoscopic surgical instrument, not an AI/ML diagnostic or prognostic tool. "Ground truth" for this device would relate to engineering specifications, material properties, and functionality demonstrations performed by engineers and technicians, not clinical experts establishing diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no clinical test set requiring adjudication in the context of an AI/ML device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a surgical instrument operated by a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the requirements and specifications of the referenced ISO and IEC standards (e.g., a material is cytotoxic or not based on ISO 10993-5 criteria; electrical safety is met if measurements are within IEC 60601-1 limits). For functionality, it's whether the device can successfully manipulate, cut, and suture tissue as intended.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.

December 7, 2022

US Medical Innovations, LLC % Stuart Goldman Senior Regulatory Consulant Emergo Global Consulting, LLC 2500 Bee Cave Rd, Bldg 1, Suite 300 Austin, Texas 78746

Re: K212736

Trade/Device Name: Canady Flex RoboWrist Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, GEI

Dear Stuart Goldman:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 11/22/2022. Specifically, FDA is updating this SE Letter for a typo in the contact name on Page 2 as an administrative correction (Michael Siano should be replaced by Stuart Goldman).

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Long Chen, OHT4: Office of Surgical and Infection Control Devices, Long.Chen@fda.hhs.gov, 301-796-6389.

Sincerely.

Jessica Carr -S

for Long Chen, PhD 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

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food & 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. The text is stacked, with "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

11/22/2022

US Medical Innovations, LLC % Stuart Goldman Senior Regulatory Consulant Emergo Global Consulting. LLC 2500 Bee Cave Rd, Bldg 1, Suite 300 Austin, Texas 78746

Re: K212736

Trade/Device Name: Canady Flex RoboWrist Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ. GEI Dated: October 20, 2022 Received: October 24, 2022

Dear Stuart Goldman:

We have reviewed vour 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

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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 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 Carr -S

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

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Indications for Use

510(k) Number (if known) K212736

Device Name Canady Flex RoboWrist™

Indications for Use (Describe)

The Canady Flex RoboWrist is intended for grasping, mobilization, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

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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510(k) Summary Canady Flex RoboWrist™

1. Submission Sponsor

US Medical Innovations, LLC 6930 Carroll Avenue, Suite 1000 Takoma Park, MD 20912-4467 United States Contact: Dr. Jerome Canady Title: CEO (301) 270-0147

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Stuart R. Goldman Title: Senior Regulatory Consultant 512.327.9997

3. Date Prepared

November 22, 2022

4. Device Identification

Trade/Proprietary Name:	Canady Flex RoboWrist™
Common/Usual Name:	Endoscopic Instrument
Classification Name:	Endoscope and accessories
Regulation Number:	876.1500
Product Code:	GCJ, GEI
Class:	Class II
Classification Panel:	Gastroenterology/Urology

5. Legally Marketed Predicate and Reference Devices

Predicate Device: Novare Surgical Systems, Inc. - RealHand High Dexterity Instruments (K072715) Reference Devices: Covidien, LLC – iDrive System (K102325) Covidien, LP - SILS™ (K091869)

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6. Indication for Use Statement

The Canady Flex RoboWrist is intended for grasping, mobilization, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

7. Device Description

8. Substantial Equivalence Discussion

The following table compares the Canady Flex RoboWrist to the predicate device forming the basis for the determination of substantial equivalence.

	Subject Device (K212736)	Predicate Device (K072715)	Comparison
Tradename	Canady Flex RoboWrist™	RealHand™ High Dexterity Instruments	Different
Manufacturer	US Medical Innovations, LLC	Novare Surgical Systems, Inc.	Different
Class	II	II	Same
Product Code	GCJ	GCJ	Same
RegulationNumber	876.1500	876.1500	Same
Indications forUse	The Canady Flex RoboWrist isintended for grasping,mobilization, dissection,transection, suturing, and/orelectrocautery of tissue underdirect and endoscopicvisualization.	The RealHand High Dexterity (HID)instruments are intended for grasping,mobilization, dissection, transection,suturing, and/or electrocautery of tissueunder direct and endoscopic visualization.	Same
Conditions ofUse	Rx Only; Clinical environment	Rx Only; Clinical environment	Same
Principle ofOperation	The Canady Flex RoboWristconsists of an articulatedmotorized needle holder,scissors and hook that isdesigned to allow access todifficult areas to reach in theabdomen. The devic includesmotorization of twomovements for accessingsurgical sites and laparoscopicsuturing. The user managesthese movements using the	RealHand™ High Dexterity Instrumentsconsist of a handle, jaws, and a shaft whichincludes distal and proximal articulatingsections. The instrument jaws are activatedby compressing and releasing the handle. Thehandle can include a ratchet and ratchetrelease which allow the instrument jaws tobe locked in place, a rotation control wheeland articulation lock.	Different

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	control ring over the instrument.
	Designcharacteristics	Instrument composed of ahand-held handle, a shaft andan end effector that can bejaws/ scissors/hook.Instrument is articulated(shaft) and can rotate (distalsection of the shaft) and islockable.	Instrument composed of a hand-held handle,a shaft and an end effector that can bejaws/scissors/hook/dissector. Instrument isarticulated (shaft), can rotate (distal sectionof the shaft) and is lockable.
Power Source	Electrical energy	Manual	Different
Sterility	User sterilized	Sterile	Similar
SterilizationMethod	Moist Heat	Irradiation	Different
SingleUse/reusable	Reusable	Single use	Different
Performance	Product testing was conductedto evaluate conformance toproduct specification. Testingincluded manipulating, cuttingand suturing of tissue.	Product testing was conducted to evaluateconformance to product specification.Testing included grasping, manipulating,cutting and suturing of tissue.	Different

9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of the Canady Flex RoboWrist and to show substantial equivalence to the predicate device, the following non-clinical tests were performed. Results confirm that the design inputs and performance specifications for the device are met. The device passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

Cytotoxicity testing per ISO 10993-5
Sensitization testing per ISO 10993-10
Intracutaneous reactivity testing per ISO 10993-10
Acute systemic toxicity testing per ISO 10993-11
Material-mediated pyrogenicity testing per ISO 10993-11
. Electrical safety testing per IEC 60601-1
. Electromagnetic Compatibility per IEC 60601-1-2
Cleaning and sterilization validations per ISO 17665-1
Human Factors/Usability testing per IEC 62366
. Functionality testing including manipulating, cutting and suturing

10. Statement of Substantial Equivalence

The subject device has the same indications for use as the predicate device. Differences in the technological characteristics have been evaluated through appropriate safety and performance testing, which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, Canady Flex RoboWrist has been determined to be substantially equivalent to RealHand High Dexterity (HD) Instrument (the predicate device).

Regulation Number and Section

§ 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.