(449 days)
No
The description focuses on the mechanical and electrical components of a motorized surgical instrument and does not mention any AI or ML capabilities.
No
The device is a surgical instrument used to manipulate, cut, and suture tissue, rather than to treat or cure a disease or condition. It is a tool for performing therapeutic procedures, not a therapeutic device itself.
No
The device is described as a surgical instrument for grasping, mobilization, transection, suturing, and electrocautery, which are all interventional procedures, not diagnostic ones.
No
The device description explicitly states it is a "motorized, hand-held laparoscopic surgery instrument" with physical components like end-effectors, a control unit, and cables, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, the Canady Flex RoboWrist is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Canady Flex RoboWrist's Intended Use: The intended use of the Canady Flex RoboWrist is for surgical procedures involving grasping, mobilization, transection, suturing, and electrocautery of tissue within the body under direct and endoscopic visualization. It is a surgical instrument used during a procedure, not for analyzing samples outside the body.
Therefore, the Canady Flex RoboWrist falls under the category of a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Canady Flex RoboWrist is intended for grasping, mobilization, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, GEI
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.
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
Rx Only; Clinical environment
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)
Product testing was conducted to evaluate conformance to product specification. Testing included manipulating, cutting and suturing of tissue. 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
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.
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.
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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
1
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
2
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
3
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)
5
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
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.
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 |
| Regulation | |||
| Number | 876.1500 | 876.1500 | Same |
| Indications for | |||
| Use | The Canady Flex RoboWrist is | ||
| intended for grasping, | |||
| mobilization, dissection, | |||
| transection, suturing, and/or | |||
| electrocautery of tissue under | |||
| direct and endoscopic | |||
| visualization. | The RealHand High Dexterity (HID) | ||
| instruments are intended for grasping, | |||
| mobilization, dissection, transection, | |||
| suturing, and/or electrocautery of tissue | |||
| under direct and endoscopic visualization. | Same | ||
| Conditions of | |||
| Use | Rx Only; Clinical environment | Rx Only; Clinical environment | Same |
| Principle of | |||
| Operation | The Canady Flex RoboWrist | ||
| consists of an articulated | |||
| motorized needle holder, | |||
| scissors and hook that is | |||
| designed to allow access to | |||
| difficult areas to reach in the | |||
| abdomen. The devic includes | |||
| motorization of two | |||
| movements for accessing | |||
| surgical sites and laparoscopic | |||
| suturing. The user manages | |||
| these movements using the | RealHand™ High Dexterity Instruments | ||
| consist of a handle, jaws, and a shaft which | |||
| includes distal and proximal articulating | |||
| sections. The instrument jaws are activated | |||
| by compressing and releasing the handle. The | |||
| handle can include a ratchet and ratchet | |||
| release which allow the instrument jaws to | |||
| be locked in place, a rotation control wheel | |||
| and articulation lock. | Different |
6
| control ring over the instrument. | |||
|---|---|---|---|
| Design | |||
| characteristics | Instrument composed of a | ||
| hand-held handle, a shaft and | |||
| an end effector that can be | |||
| jaws/ scissors/hook. | |||
| Instrument is articulated | |||
| (shaft) and can rotate (distal | |||
| section of the shaft) and is | |||
| lockable. | Instrument composed of a hand-held handle, | ||
| a shaft and an end effector that can be | |||
| jaws/scissors/hook/dissector. Instrument is | |||
| articulated (shaft), can rotate (distal section | |||
| of the shaft) and is lockable. | |||
| Power Source | Electrical energy | Manual | Different |
| Sterility | User sterilized | Sterile | Similar |
| Sterilization | |||
| Method | Moist Heat | Irradiation | Different |
| Single | |||
| Use/reusable | Reusable | Single use | Different |
| Performance | Product testing was conducted | ||
| to evaluate conformance to | |||
| product specification. Testing | |||
| included manipulating, cutting | |||
| and suturing of tissue. | Product testing was conducted to evaluate | ||
| conformance 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).