(26 days)
No
The document describes a surgical instrument and system for controlling it, focusing on mechanical and electrical functions. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as assisting in surgical procedures for tissue manipulation, including cutting, grasping, and suturing, and in the delivery and placement of ablation probes, which are all therapeutic interventions.
No
The device is described as a surgical instrument (scissors) used for cutting, cauterizing, and manipulating tissue during surgical procedures, not for diagnostic purposes.
No
The device description explicitly details physical components like housing, shaft, wrist, and tip, indicating it is a hardware instrument, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system and instruments used for manipulating tissue during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a surgical instrument with mechanical components for interacting directly with patient tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is to perform surgical tasks.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's purpose is surgical intervention, not diagnostic testing.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System. Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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, gynecological laparoscopic surgical 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 pediatic use. It is intended to be used by tramed physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The EndoWrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
The Intuitive Surgical EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS4000 da Vinci Xi Surgical System or IS4200 da Vinci X Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.
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
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 testing were conducted.
Design Verification: Bench testing on a da Vinci Surgical System. Verified mechanical and electrical requirements, including instrument reliability and durability, leakage, electrical safety, and general and physical requirements for compatibility with the system and tip cover accessory.
Design Validation: Validated functional and interaction (compatibility) requirements for the subject device, addressing how features meet user needs and intended use.
Biocompatibility Testing: Performed in accordance with ISO 10993-1 and ASTM standards. Determined that the device met the requirements of recognized biocompatibility standards.
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.
0
Image /page/0/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 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.
Intuitive Surgical, Inc. Gayle Perry Sr. Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K220023
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 Dated: January 4, 2022 Received: January 5, 2022
Dear Gayle Perry:
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
1
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 (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 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,
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name 8mm Monopolar Curved Scissors
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System. Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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 laparoscopic surgical 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 pediatic use. It is intended to be used by tramed physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
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510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact: | Gayle Perry
Senior Regulatory Affairs Engineer
Cell Number: 650-867-9347
Email: gayle.perry@intusurg.com |
| Date Summary Prepared: | January 4, 2022 |
| Trade Name: | 8mm Monopolar Curved Scissors |
| Common Name: | Endoscope and accessories |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Device: | K131861 – 8mm Monopolar Curved Scissors |
Device Description
The Intuitive Surgical EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS4000 da Vinci Xi Surgical System or IS4200 da Vinci X Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.
Intended Use/Indications for Use:
The EndoWrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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
Image /page/3/Picture/9 description: The image shows the word "INTUITIVE" in all capital letters. The text is in a dark blue color. There is a small circle above the letter "I".
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cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical 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. 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.
Technological Characteristics:
The subject 8mm Monopolar Curved Scissors is very similar to its predicate device originally cleared under K131861 for use with the IS4000 da Vinci Xi System, and subsequently cleared under K171294 for use with the IS4200 da Vinci X System. It has the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device. The modification to the device consists of a material change to the main tube.
Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of modification to the predicate device. Design verification and design validation testing were conducted on the subject device to confirm that the design output meets design input requirements and that the device is safe and effective for its intended use.
Design Verification:
The bench testing with the subject device was performed on a da Vinci Surgical System. The design verification summarized in this submission verifies mechanical and electrical requirements for the subject instrument, such as:
- instrument reliability and durability, ●
- leakage,
- electrical safety,
- general and physical requirements to ensure compatibility with the system and tip cover . accessory.
Design Validation:
The design validation summarized in this submission validates functional and interaction (compatibility) requirements for the subject device. Design validation addresses how the features of the instrument meet the user needs and intended use as documented in the product requirements document.
Biocompatibility Testing
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Biocompatibility tests on the subject device were performed in accordance with ISO 10993-1 and ASTM standards. Based upon the toxicological assessment, the established biocompatibility of the device for its intended clinical use, and the provisions of the current harmonized standard ISO 10993-1:2018, it was determined that the subject device met the requirements of the recognized biocompatibility standards for its intended clinical use.
Summary:
Based on the intended use, indications for use, technological characteristics, performance data, and biocompatibility, the subject 8mm Monopolar Curved Scissors is substantially equivalent to the predicate device.
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