(99 days)
Not Found
No
The summary describes a robotic surgical system and its instruments, focusing on mechanical control and manipulation. There is no mention of AI, ML, or image processing that would suggest the incorporation of such technologies for tasks like image analysis, decision support, or autonomous control. The performance studies focus on mechanical and functional validation.
Yes
The device is described as assisting in the accurate control of surgical instruments for various procedures, indicating its direct involvement in treating or mitigating a disease or condition.
No
The document describes the use of the device in surgical procedures to manipulate tissue with instruments. It does not mention a diagnostic purpose or process.
No
The device description explicitly details physical components like housing, shaft, wrist, and tip, indicating it is a hardware device with software control, not a software-only device.
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 performed on samples like blood, urine, or tissue biopsies.
- Device Description: The description details surgical instruments designed for interacting directly with patient tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze biological samples, or provide information about a patient's health status based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model 154000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and shap 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, grnecologic 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 trained physicians in an operating room enviroument in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Product codes (comma separated list FDA assigned to the subject device)
NAY, GCJ
Device Description
The subject IS4000 da Vinci EndoWrist Instruments are to be used with the IS4000 da Vinci Surgical System. The EndoWrist Instruments consist of the housing, shaft, wrist, and tip. The housing contains the connection mechanism to the IS4000 da Vinci Surgical System arm. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. These instruments are reusable and provided non-sterile. The six subject IS4000 EndoWrist Instruments are:
| Name | Part No. |
|---|---|
| Needle Drivers | |
| 8 mm Mega Needle Driver | 470194 |
| 8 mm Large SutureCut Needle Driver | 470296 |
| Graspers | |
| 8 mm Cadiere Forceps | 470049 |
| 8 mm Cobra Grasper | 470190 |
| 8 mm DeBakey Forceps | 470036 |
| Scissors | |
| 8mm Round Tip Scissors | 470007 |
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 pediatic use
Intended User / Care Setting
trained physicians in an operating room enviroument
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 on the subject instruments.
Design Verification: Bench testing performed on an IS4000 da Vinci Surgical System to verify mechanical and labeling requirements (instrument reliability and durability, leakage, roll, pitch, and yaw range of motion, jaw close and open positions, friction, torque, instrument insertion, adequacy of labeling). Software compatibility testing and instrument data verification testing were also performed.
Design Validation: Validated general, functional, and interaction (compatibility) requirements. Safety and efficacy assessed in representative simulated clinical settings using porcine (in vivo) and cadaveric tissue models.
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.
K131861 – IS4000 da Vinci Surgical System
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.
Not Found
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/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines that resemble a bird or a wing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Intuitive Surgical Incorporated Ms. Sarah Rizk Senior Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, Califiornia 94086
Re: K150284
Trade/Device Name: IS4000 da Vinci EndoWrist® Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: April 14, 2015 Received: April 15, 2015
Dear Ms. Rizk:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
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
Form Annroved: OMB No 0910-0120
Expiration Date: January 31, 2017
e PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
IS4000 da Vinci EndoWrist® Instruments
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model 154000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and shap 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, grnecologic 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 trained physicians in an operating room enviroument 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."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publiching Survious (301) 443-6740
Image /page/2/Picture/22 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font above the word "SURGICAL" which is in a smaller font. There is a yellow dot above the "I" in Intuitive.
Prairie Partie
3
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Rizk
Regulatory Affairs
Phone Number: 408-523-6906
Fax Number: 408-523-8907
Email: sarah.rizk@intusurg.com |
| Date Summary Prepared: | Feb 4, 2015 |
| Trade Name: | IS4000 da Vinci EndoWrist® Instruments |
| Common Name: | Endoscope and accessories |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY, GCJ |
| Classification Advisory Committee: | General and Plastic Surgery |
| Predicate Device: | K131861 – IS4000 da Vinci Surgical System |
Device Description
The subject IS4000 da Vinci EndoWrist Instruments are to be used with the IS4000 da Vinci Surgical System. The EndoWrist Instruments consist of the housing, shaft, wrist, and tip. The housing contains the connection mechanism to the IS4000 da Vinci Surgical System arm. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. These instruments are reusable and provided non-sterile. The six subject IS4000 EndoWrist Instruments are:
| Name | Part No. |
|---|---|
| Needle Drivers | |
| 8 mm Mega Needle Driver | 470194 |
| 8 mm Large SutureCut Needle Driver | 470296 |
| Graspers | |
| 8 mm Cadiere Forceps | 470049 |
4
| Name | Part No. | |
|---|---|---|
| 8 mm Cobra Grasper | 470190 | |
| 8 mm DeBakey Forceps | 470036 | |
| Scissors | ||
| 8mm Round Tip Scissors | 470007 |
Intended Use/Indications for Use:
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 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.
Substantial Equivalence:
The subject IS4000 da Vinci EndoWrist Instruments are very similar to the predicate devices (IS4000 da Vinci EndoWrist Instruments in K131861). They have the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device. Modifications consist of geometrical changes to instrument tips to provide an assortment of distal tips and offer more options for grasping, dissecting, manipulating, and transecting tissue for surgeon preference.
Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of modifications to the predicate instruments. Design verification and design validation testing were conducted on the subject instruments to confirm that the design outputs meet design input requirements and that each instrument is safe and effective for its intended use.
Image /page/4/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Above the "U" in Intuitive is a yellow dot. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font and also in light gray. To the right of the word "SURGICAL" is a registered trademark symbol.
5
Design Verification:
The bench testing with the subject EndoWrist Instruments was performed on an IS4000 da Vinci Surgical System. The general and instrument-specific design verification summarized in this submission verifies mechanical and labeling requirements for the subject instruments, such as:
- instrument reliability and durability,
- leakage,
- roll, pitch, and yaw range of motion, ●
- jaw close and open positions,
- friction,
- torque,
- instrument insertion ●
- adequacy of labeling. ●
Other verification performed includes software compatibility testing and instrument data verification testing to confirm the subject EndoWrist instruments function as intended with the current production IS4000 System software.
Design Validation:
The design validation summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject EndoWrist Instruments. Design validations for each subject EndoWrist Instrument address how the features of the instrument meet the user needs and intended use as documented in the product requirements documents. The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine (in vivo) and cadaveric tissue models to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the subject IS4000 da Vinci EndoWrist Instruments are substantially equivalent to the predicate IS4000 da Vinci EndoWrist Instruments cleared in K131861.
Image /page/5/Picture/17 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Above the "I" in Intuitive is a yellow dot. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font and also in light gray.