(211 days)
No
The summary describes a surgical instrument (grasper) for use with a robotic surgical system. It focuses on the mechanical and functional aspects of the instrument itself, its compatibility with the system, and validation through bench and animal/cadaver testing. There is no mention of AI, ML, image processing, or any data-driven algorithms for decision-making or control beyond the basic robotic manipulation.
No.
The device is an endoscopic instrument used for manipulation of tissue (grasping, retraction, blunt dissection, and approximation) during surgical procedures, not for therapeutic treatment itself.
No
The device is an endoscopic instrument intended for surgical manipulation of tissue, not for diagnostic purposes.
No
The device description explicitly states it is an "endoscopic instrument" and describes physical components like a shaft, distal tip, and connection to a manipulator arm. It also details bench testing for physical specifications and performance requirements related to hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that the Intuitive Surgical Endoscopic Instrument Control System and the EndoWrist 5mm Thoracic Grasper are used for surgical procedures involving the manipulation of tissue within the body. They are tools for performing surgery, not for analyzing samples taken from the body.
- Intended Use: The intended use describes surgical actions like grasping, cutting, dissection, suturing, etc., all performed directly on the patient's tissues during surgery.
- No Mention of Specimen Analysis: There is no mention of collecting, preparing, or analyzing any biological specimens.
Therefore, this device falls under the category of surgical instruments or systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Intuitive Surgical 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 laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI 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 trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The EndoWrist 5mm Thoracic Grasper is intended for endoscopic manipulation of tissue, including grasping, retraction, blunt dissection and approximation.
Product codes
NAY
Device Description
The EndoWrist 5mm Thoracic Grasper is an endoscopic instrument for use with the Intuitive Surgical da Vinci S Surgical System (K050369) or da Vinci Si Surgical System (K081137). The instrument is designed for atraumatic grasping, manipulation and blunt dissection of tissue while fitting through a 5mm instrument cannula. The EndoWrist 5mm Thoracic Grasper is re-usable, provided non-sterile, and must be cleaned and sterilized using prevacuum autoclave before use. The instrument is programmed for a limited number of uses to ensure reliability and consistent performance. The sterilized instrument is connected to the manipulator arm of the da Vinci Surgical System and the distal tip and shaft of the instrument are inserted through a cannula placed through the body wall of the patient.
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
The EndoWrist 5mm Thoracic Grasper was evaluated using bench testing and animal/cadaver testing to demonstrate that the design output meets the input requirements and the device performed as intended.
Design Verification (bench testing): The subject device, EndoWrist 5mm Thoracic Grasper, was subjected to a series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. The design verification testing included confirmation that the device meets the:
- Physical Specifications including:
- Physical measurements
- Compatibility with accessories
- Performance Requirements including:
- Range of motion
- Friction
- Grip offset
The device main shaft PEEK coating was also tested for verification/reliability to evaluate its ability to meet the requirements/specifications throughout the intended life of the device.
- Reprocessing and abrasion testing were performed to ensure the main tube is able to function adequately for the expected life of the instrument.
- Testing was performed per IEC60601-2-2:2009-02, 5th edition, to ensure the PEEK coating retained its insulative properties throughout life.
Design Validation (animal/cadaver): The safety and efficacy of the instrument was assessed in a canine model (in vivo) and cadavers to evaluate applicable requirements through normal and expected worst case use. Representative tissue types were used, as appropriate, for evaluating applicable requirements. Design validation demonstrated that the design outputs fulfill the user needs and that the intended use has been met.
Testing included:
- Compatibility with accessories and system
- Range of motion, intuitive motion, lack of friction
- CO2 insufflation maintained
- Tissue manipulation and atraumatic blunt dissection of tissue
- Instrument retains performance throughout intended life
Reprocessing: The Intuitive Surgical EndoWrist 5mm Thoracic Grasper is a reusable instrument that is cleaned and sterilized using pre-vacuum autoclave by the sterile reprocessing department of a hospital prior to use according to the instructions provided by Intuitive Surgical.
- The cleaning validation was performed to demonstrate the cleaning efficacy of the cleaning process with ultrasonic bath using pH neutral enzymatic detergent.
- Thermal disinfection validation was performed to demonstrate the efficacy of low level thermal disinfection based on temperature and time parameters in a washerdisinfector.
- Steam sterilization validation was performed to demonstrate a sterility assurance level of at least 10-6.
Key Metrics
Not Found
Predicate Device(s)
Intuitive Surgical EndoWrist 8mm Thoracic Grasper (K123329)
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 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.
May 31, 2018
Intuitive Surgical, Inc. Gayle Perry Sr. Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K173415
Trade/Device Name: EndoWrist 5mm Thoracic Grasper Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: October 31, 2017 Received: November 1, 2017
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | ||
|---|---|---|
| Food and Drug Administration | ||
| Indications for Use | Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | ||
| See PRA Statement below. | ||
| 510(k) Number (if known) | K173415 | |
| Device Name | EndoWrist 5mm Thoracic Grasper | |
| Indications for Use (Describe) | The Intuitive Surgical 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 laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI 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 trained 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/2/Picture/3 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a small yellow circle above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font, with the registered trademark symbol to the right.
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510(k) Summary
[As Required by 21 CFR 807.92(c)]
May 30, 2018
| Submitter: | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Official Contact: | Gayle Perry |
| Sr. Regulatory Affairs Engineer | |
| Ph: 408-523-7252 | |
| Fax: 408-523-1390 | |
| Trade Name: | EndoWrist® 5mm Thoracic Grasper |
| Common Name: | Endoscope and accessories |
| Classification: | Endoscope and accessories, 21 CFR 876.1500, NAY |
| Predicate Device: | Intuitive Surgical EndoWrist® 8mm Thoracic Grasper (K123329) |
Device Description: The EndoWrist 5mm Thoracic Grasper is an endoscopic instrument for use with the Intuitive Surgical da Vinci S Surgical System (K050369) or da Vinci Si Surgical System (K081137). The instrument is designed for atraumatic grasping, manipulation and blunt dissection of tissue while fitting through a 5mm instrument cannula. The EndoWrist 5mm Thoracic Grasper is re-usable, provided non-sterile, and must be cleaned and sterilized using prevacuum autoclave before use. The instrument is programmed for a limited number of uses to ensure reliability and consistent performance. The sterilized instrument is connected to the manipulator arm of the da Vinci Surgical System and the distal tip and shaft of the instrument are inserted through a cannula placed through the body wall of the patient.
Intended Use:
Intended use of the IS2000/IS3000 EndoWrist instruments:
EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
Image /page/3/Picture/10 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, also in light gray, with a registered trademark symbol to the right.
4
Each individual instrument is intended to be used for a subset of uses listed in the overall intended use. The subset of the intended uses that applies to the EndoWrist 5mm Thoracic Grasper includes only those that are applicable to this instrument.
Intended use of the EndoWrist 5mm Thoracic Grasper:
The EndoWrist 5mm Thoracic Grasper is intended for endoscopic manipulation of tissue, including grasping, retraction, blunt dissection and approximation.
Indications for Use:
The Intuitive Surgical 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/pickups, 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 laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI 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 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 EndoWrist 5mm Thoracic Grasper is equivalent to the predicate device in terms of its indications for use, design, technology, and performance specifications.
The patient contacting materials used in the EndoWrist 5mm Thoracic Grasper are used in other instruments cleared under predicate K123329 except for the main shaft material. The main shaft consists of a stainless steel tube with a PEEK coating.
The shaft diameter and wrist architecture of the EndoWrist 5mm Thoracic Grasper are identical to other EndoWrist 5mm instruments. The instrument employs a "snake wrist" architecture to provide 4 degrees of freedom (wrist pitch, wrist yaw, roll and grip).
The grip design was modified from previously cleared instruments to optimize the instrument's performance in atraumatic grasping and manipulation of soft tissues such as or comparable to pulmonary tissue and atraumatic blunt dissection around vessels and pulmonary structures.
5
Performance Data: The EndoWrist 5mm Thoracic Grasper was evaluated using bench testing and animal/cadaver testing to demonstrate that the design output meets the input requirements and the device performed as intended.
Design Verification (bench testing): The subject device, EndoWrist 5mm Thoracic Grasper, was subjected to a series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. The design verification testing included confirmation that the device meets the:
- . Physical Specifications including:
- o Physical measurements
- Compatibility with accessories o
- Performance Requirements including: ●
- Range of motion o
- 0 Friction
- Grip offset o
The device main shaft PEEK coating was also tested for verification/reliability to evaluate its ability to meet the requirements/specifications throughout the intended life of the device.
- Reprocessing and abrasion testing were performed to ensure the main tube is able to function adequately for the expected life of the instrument.
- Testing was performed per IEC60601-2-2:2009-02, 5th edition, to ensure the PEEK . coating retained its insulative properties throughout life.
Design Validation (animal/cadaver): The safety and efficacy of the instrument was assessed in a canine model (in vivo) and cadavers to evaluate applicable requirements through normal and expected worst case use. Representative tissue types were used, as appropriate, for evaluating applicable requirements. Design validation demonstrated that the design outputs fulfill the user needs and that the intended use has been met.
Testing included:
- . Compatibility with accessories and system
- Range of motion, intuitive motion, lack of friction
- CO2 insufflation maintained ●
- Tissue manipulation and atraumatic blunt dissection of tissue ●
- Instrument retains performance throughout intended life
Reprocessing: The Intuitive Surgical EndoWrist 5mm Thoracic Grasper is a reusable instrument that is cleaned and sterilized using pre-vacuum autoclave by the sterile reprocessing department of a hospital prior to use according to the instructions provided by Intuitive Surgical.
Image /page/5/Picture/22 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in light gray, with a registered trademark symbol next to it. There is a yellow dot above the word "INTUITIVE".
6
Cleaning, low level thermal disinfection and sterilizations were performed in accordance with FDA guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff. Document Issued on March 17, 2015.
- The cleaning validation was performed to demonstrate the cleaning efficacy of the ● cleaning process with ultrasonic bath using pH neutral enzymatic detergent.
- . Thermal disinfection validation was performed to demonstrate the efficacy of low level thermal disinfection based on temperature and time parameters in a washerdisinfector.
- . Steam sterilization validation was performed to demonstrate a sterility assurance level of at least 10-6.
Summary: Based on the intended use, technical characteristics, and performance data, the EndoWrist 5mm Thoracic Grasper is equivalent to the predicate device in terms of safety, effectiveness, and performance.
Image /page/6/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with a registered trademark symbol to the right of it.