(588 days)
Here are the Reference Device(s) K/DEN numbers from the text, in a comma-separated list:
Not Found
No
The document describes a surgical instrument (scissors) and the robotic system it is used with. There is no mention of AI, ML, or any image processing or data analysis that would suggest the use of such technologies. The focus is on mechanical control and dexterity.
Yes
The device is described as a surgical instrument used for cutting, cauterizing, coagulation, manipulating, and blunt dissection of tissue during surgical procedures, which are all therapeutic actions.
No
The device is an instrument (scissors) used for surgical procedures like cutting, cauterizing, and manipulating tissue, not for diagnosing conditions.
No
The device description clearly outlines a physical instrument with housing, shaft, wrist, and tip, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical instrument used for cutting, cauterizing, coagulation, manipulating, and blunt dissection of tissue during surgical procedures on patients. This is an in-vivo application (within a living organism).
- Device Description: The description reinforces its use as a surgical tool for manipulating tissue in a minimally invasive environment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing biological samples outside of the body to provide diagnostic information. This device is used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, coagulation, manipulating and blunt dissection of tissue.
The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping. cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2. and for benign base of tonque resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The 8mm Monopolar Scissors of this submission are for use only with the Intuitive Si System (Endoscopic Instrument Control System).
Product codes
QSM, NAY
Device Description
The 8mm Monopolar Curved Scissors Instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile.
8mm Monopolar Curved Scissor Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for grecision when operating in a minimally invasive environment. EndoWrist 8mm Monopolar Curved Scissor Instruments, when used with the IS3000 system, are designed to support rapid and precise suturing, dissection and tissue manipulation in surgical procedures.
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
adult and pediatric use (except for transoral otolaryngology surgical procedures)
Intended User / Care Setting
trained physicians in an operating room 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)
Design verification and design validation were conducted on the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective. Tests included: Biocompatibility, Validation of Reprocessing, Functional Performance Testing, and Electrical Safety Testing. The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K180033, K050369, K081137, K123329, K170644
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter and a stylized image in the center. To the right, there is a blue rectangle with the letters "FDA" in white. Next to the rectangle, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
November 15, 2022
Iconocare Health Rick Ferreira President 7825 East Redfield Rd. Suite 103 Scottsdale, Arizona 85260
Re: K210478
Trade/Device Name: 8mm Monopolar Curved Scissors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY
Dear Rick Ferreira:
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 September 30, 2022. Specifically, FDA is updating this SE Letter as an administrative correction. The original SE letter did not include the 510(k) summary enclosure.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark Trumbore, OHT4: Office of Surgical and Infection Control Devices, 301-796-5436, Mark.Trumbore@fda.hhs.gov.
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2022.11.15 14:15:23 -05'00'
Mark Trumbore 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line. The logo is simple and professional, and it is easily recognizable.
September 30, 2022
Iconocare Health Rick Ferreira President 7825 East Redfield Rd. Suite 103 Scottsdale, Arizona 85260
Re: K210478
Trade/Device Name: 8mm Monopolar Curved Scissors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: QSM, NAY Dated: March 29, 2022 Received: March 31, 2022
Dear Rick Ferreira:
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 Mav 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
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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 (OS) 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/cdrl-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.
Digitally signed by Mark Mark Trumbore -S Trumbore -S Pate: 2022.09.30 16:32:31 -04'00'
Mark Trumbore 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
Submission Number (if known)
Device Name
8mm Monopolar Curved Scissors (420179)
Indications for Use (Describe)
The EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, coagulation, manipulating and blunt dissection of tissue.
The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping. cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2. and for benign base of tonque resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The 8mm Monopolar Scissors of this submission are for use only with the Intuitive Si System (Endoscopic Instrument Control System).
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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510(k) Summary
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | Iconocare Health | |
| Applicant Address | 7825 East Redfield Rd. Suite 103 Scottsdale AZ 85260 US | |
| Applicant Contact Telephone | 480-467-8517 | |
| Applicant Contact | Mr. Rick Ferreira | |
| Applicant Contact Email | rferreira@alliancehcpartners.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | 8mm Monopolar Curved Scissors (420179) | |
| Common Name | Endoscope and accessories | |
| Classification Name | Endoscope and Accessories | |
| Regulation Number | 21 CFR §876.1500 | |
| Product Code | QSM, NAY | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K180033 | 8mm Monopolar Curved Scissors | NAY |
| K050369 | Intuitive Surgical da Vinci Surgical System and Ednowrist Instruments | NAY |
| K081137 | Intuitive Surgical da Vinci Si Surgical System | NAY |
| K123329 | Intuitive Surgical® da Vinci®, da Vinci S® and da Vinci Si® Surgical | NAY |
| K170644 | Da Vinci S/Si EndoWrist Instruments And Accessories | NAY |
Device Description Summary
21 CFR 807.92(a)(4)
The 8mm Monopolar Curved Scissors Instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile.
8mm Monopolar Curved Scissor Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for grecision when operating in a minimally invasive environment. EndoWrist 8mm Monopolar Curved Scissor Instruments, when used with the IS3000 system, are designed to support rapid and precise suturing, dissection and tissue manipulation in surgical procedures.
Summary of Technological Characteristics:
The design, materials, and intended use of the 8mm Monopolar Curved Scissor Instruments, after an additional ten (10) reuse cycles are equivalent to the predicate device. The mechanism of the subject device is identical to the predicate device in that the same
5
standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation. The change in device specifications is to extend the useful life of the 8mm Monopolar Curved Scissor Instruments.
Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of modifications to the predicate device. Design verification and design vare conducted on the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective for its included the following tests: · Biocompatibility
- · Validation of Reprocessing
- · Functional Performance Testing
- · Electrical Safety Testing
The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue.
The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral procedures restricted to benign and malignant tumors classified as Tl and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by sicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The 8mm Monopolar Scissors of this submission are for use only with the Intuitive Si System (Endoscopic Instrument Control System),
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are the same as the predicate device.
Technological Comparison
The design, materials, and intended use of the 8mm Monopolar Curved Scissors Instruments, after an additional ten (10) reuse cycles are equivalent to the predicate device. The mechanism of the reusable device is identical to the predicate device in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of modifications to the predicate device. Design verification and design validation the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective for its included the following tests: · Biocompatibility
- · Validation of Reprocessing
- · Functional Performance Testing
- · Electrical Safety Testing
The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.