(230 days)
Not Found
No
The summary focuses on the mechanical and electrical performance of the surgical system and instruments, with no mention of AI or ML capabilities. The testing described relates to cleaning, reliability, electrical performance, and thermal effects, not algorithmic performance.
No.
The device is described as assisting in the control of surgical instruments for manipulation of tissue during surgical procedures, not for treating a condition itself.
No
Explanation: The Intended Use/Indications for Use section states that the device is "intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments" and describes various surgical tasks it can perform (e.g., grasping, cutting, suturing). There is no mention of the device being used for diagnosis or identifying disease.
No
The device description explicitly mentions "Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories" and describes "articulating design at their distal tips". The performance studies also include "Electrical Performance Testing" and "Thermal Effects testing", which are related to hardware components. This indicates the device is a physical system with instruments, not solely software.
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 designed to assist in the control of endoscopic instruments for various surgical procedures on the human body. This involves direct manipulation of tissue in vivo.
- Device Description: The description focuses on the mechanical aspects of the system and its instruments for performing surgical tasks.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens outside the body.
The device described is a surgical robot system used for minimally invasive surgery, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System, Model IS4000) and the Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model 154200) 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NAY, GCJ
Device Description
The da Vinci XXi (IS4200/IS4000) 8mm EndoWrist Instruments have a unique articulating design at their distal tips the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, or tissue manipulation.
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)
Performance test data demonstrates that the subject device is substantially equivalent to the predicate device. The testing conducted consisted of Cleaning Validation, Reliability/Life Testing, Electrical Performance Testing and Thermal Effects Testing.
- Cleaning Validation: Cleaning Validation was performed to validate the efficacy of the manual and automated cleaning process in accordance with the following standards and guidance documents:
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", document issued on: March 17, 2015 (Amended on June 9, 2017).
- AAM TIR 12:2020 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR 30: 2011/(R)2016, A compendium of processes, materials, and acceptance criteria for cleaning reusable medical devices
- ANSI/AAMI ST15883-1:2009/(R) 2014. Washer-disinfectors: General requirements, terms and definitions and tests
The da Vinci X/Xi 8mm Reusable Instruments successfully met the acceptance criteria for all markers. The test results demonstrate that the da Vinci X/Xi 8mm Reusable Instruments can be cleaned using the following cleaning methods:
- Automated cleaning process using a compatible automated washer/disinfector.
- Manual cleaning process using an ultrasonic bath. -
- Reliability/Life Testing: Reliability/Life Testing was performed to ensure that da Vinci X/Xi 8mm Reusable Instruments are not adversely affected by the increased number of lives (uses) and reprocessing cycles for these as listed in Table 1.
- Electrical Performance Testing: Electrical Performance Testing was performed after subjecting the representative subject devices/instruments (which have "active components/accessories") to multiple reuse and reprocessing cycles (including both manual and automated cleaning process). This testing was performed to ensure the da Vinci X/X 8mm Extended Lives Instruments family (subject devices as listed in Table 1) meet the requirements within the FDA guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, Document Issued on March 9, 2020.
- Thermal Effects testing: Thermal Effects testing was performed to confirm that thermal effects on tissue are comparable between the subject and predicate devices. The testing was performed in accordance with the FDA guidance, "Premarket Notification (510(k)) Submissions for Glectrosurgical Devices for General Surgery", Document Issued on March 9, 2020.
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.
K203632 (da Vinci X/Xi 8mm Reusable Instruments)
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/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 15, 2022
Intuitive Surgical, Inc. Kunal Gunjal Sr. Regulatory Affairs Specialist 1266 Kifer Road, Building 101 Sunnyvale, California 94086
Re: K214095
Trade/Device Name: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: July 21, 2022 Received: July 22, 2022
Dear Kunal Gunjal:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
Indications for Use
510(k) Number (if known) K214095
Device Name
da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System, Model IS4000) and the Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model 154200) 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 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.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary (K214095)
| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal
Sr. Regulatory Affairs Specialist
Phone Number: 408-523-8017
Email: Kunal.Gunjal@intusurg.com |
| Date | 12th August 2022 |
| Trade Name | da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
| Common Name | Endoscope and accessories |
| Classification | Class II,
21 CFR 876.1500 |
| Product Codes | NAY, GCJ |
| Review Panel | General and Plastic Surgery |
| Predicate Devices | K203632 (da Vinci X/Xi 8mm Reusable Instruments) |
Image /page/3/Picture/4 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the letter "U". The font is sans-serif and appears to be a company logo. The text is horizontally centered.
4
Intuitive Surgical, Inc.
Device Description:
The da Vinci XXi (IS4200/IS4000) 8mm EndoWrist Instruments have a unique articulating design at their distal tips the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, or tissue manipulation.
Indications for Use:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) and the Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) 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, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gyneologic 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.
Image /page/4/Picture/6 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and the letters are evenly spaced.
5
Intuitive Surgical, Inc.
Table 1 includes a comparison between the subject devices and predicate devices.
| Characteristic | Predicate Device
da Vinci X/Xi (IS4200/IS4000) EndoWrist (8mm) Instruments
(K203632) | | | Subject Device
da Vinci X/Xi (IS4200/IS4000) EndoWrist (8mm)
Instruments (K214095) | | | | | | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------|--------------|-----------------------------------------------|------------------------------------------------------------------------------------------|--------------|-----------------------------------------|--------|-----------------------------------------------|--|--|
| | da Vinci X/Xi 8mm Reusable Instruments | Model Number | Number of Lives and Reprocessing Cycles | da Vinci X/Xi 8mm Reusable Instruments | Model Number | Number of Lives and Reprocessing Cycles | | | | |
| | | | Number of Lives Number of Reprocessing Cycles | | | | | Number of Lives Number of Reprocessing Cycles | | |
| | | | | | | | | | | |
| Number of Lives
and
Reprocessing
Cycles | 8mm Maryland Bipolar Forceps | 470172 | 10 15 | | | 8mm Maryland Bipolar Forceps | 471172 | 14 19 | | |
| | 8mm Fenestrated Bipolar Forceps | 470205 | 10 15 | | | 8mm Fenestrated Bipolar Forceps | 471205 | 14 19 | | |
| | 8mm Force Bipolar | 470405 | 10 15 | | | 8mm Force Bipolar | 471405 | 12 17 | | |
| | 8mm Large Needle Driver | 470006 | 10 15 | | | 8mm Large Needle Driver | 471006 | 15 20 | | |
| | 8mm Mega SutureCut Needle Driver | 470309 | 10 15 | | | 8mm Mega SutureCut Needle Driver | 471309 | 15 20 | | |
| | 8mm Cadiere Forceps | 470049 | 10 15 | | | 8mm Cadiere Forceps | 471049 | 18 23 | | |
| | 8mm ProGrasp Forceps | 470093 | 10 15 | | | 8mm ProGrasp Forceps | 471093 | 18 23 | | |
| | 8mm Micro Bipolar Forceps | 470171 | 10 15 | | | 8mm Micro Bipolar Forceps | 471171 | 14 19 | | |
| | 8mm Curved Bipolar Dissector | 470344 | 10 15 | | | 8mm Curved Bipolar Dissector | 471344 | 14 19 | | |
| | 8mm Long Bipolar Grasper | 470400 | 10 15 | | | 8mm Long Bipolar Grasper | 471400 | 14 19 | | |
| | 8mm Large SutureCut Needle Driver | 470296 | 10 15 | | | 8mm Large SutureCut Needle Driver | 471296 | 15 20 | | |
| | 8mm Long Tip Forceps | 470048 | 10 15 | | | 8mm Long Tip Forceps | 471048 | 18 23 | | |
| | 8mm Cobra Graspers | 470190 | 10 15 | | | 8mm Cobra Graspers | 471190 | 18 23 | | |
| Table 1: Comparison of Predicate and Subject Devices (da Vinci X/Xi EndoWrist 8mm Instruments) | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | ------------------------------------------------------------------------------------------------ | -- | -- | -- | -- | -- |
Technological Characteristics:
There are changes to the do Vinci X/Xi 8mm Reusable Instruments labeling, with increased number of lives (uses) and reprocessing cycles. The impacted Product Part number of lives (uses) and reprocessing cycles for the subject devices are listed in Table 1.
6
Performance Data:
Performance test data demonstrates that the subject device is substantially equivalent to the predicate device. The testing conducted consisted of Cleaning Validation, Reliability/Life Testing, Electrical Performance Testing and Thermal Effects Testing.
- Cleaning Validation: Cleaning Validation was performed to validate the efficacy of the manual and automated cleaning process in accordance with the following standards and guidance documents:
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", document issued on: March 17, 2015 (Amended on June 9, 2017).
- AAM TIR 12:2020 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR 30: 2011/(R)2016, A compendium of processes, materials, and acceptance criteria for cleaning reusable medical devices
- ANSI/AAMI ST15883-1:2009/(R) 2014. Washer-disinfectors: General requirements, terms and definitions and tests
The da Vinci X/Xi 8mm Reusable Instruments successfully met the acceptance criteria for all markers. The test results demonstrate that the da Vinci X/Xi 8mm Reusable Instruments can be cleaned using the following cleaning methods:
- Automated cleaning process using a compatible automated washer/disinfector. ।
- Manual cleaning process using an ultrasonic bath. -
- o Reliability/Life Testing: Reliability/Life Testing was performed to ensure that da Vinci X/Xi 8mm Reusable Instruments are not adversely affected by the increased number of lives (uses) and reprocessing cycles for these as listed in Table 1.
- o Electrical Performance Testing: Electrical Performance Testing was performed after subjecting the representative subject devices/instruments (which have "active components/accessories") to multiple reuse and reprocessing cycles (including both manual and automated cleaning process). This testing was performed to ensure the da Vinci X/X 8mm Extended Lives Instruments family (subject devices as listed in Table 1) meet the requirements within the FDA guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, Document Issued on March 9, 2020.
O INTUITIVE
7
Intuitive Surgical, Inc.
- o Thermal Effects testing: Thermal Effects testing was performed to confirm that thermal effects on tissue are comparable between the subject and predicate devices. The testing was performed in accordance with the FDA guidance, "Premarket Notification (510(k)) Submissions for Glectrosurgical Devices for General Surgery", Document Issued on March 9, 2020.
Conclusion:
Based on the intended use, indications for use, technological characteristics and performance data, the subject device is substantially equivalent to the proposed predicate device.
Image /page/7/Picture/5 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the letter "U". The font is sans-serif and appears to be a corporate logo.