da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments

K214095 · Intuitive Surgical, Inc. · NAY · Aug 15, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K214095
• Device Name: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Aug 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

da Vinci X/Xi 8mm Reusable Instruments are articulating surgical tools used with the da Vinci Surgical System. Instruments feature EndoWrist technology at distal tips, allowing precise control of end effectors (e.g., dissectors, scissors, needle holders) by surgeons seated at a console. Used in operating rooms by trained physicians to perform tissue manipulation, grasping, cutting, suturing, and electrocautery. Subject device represents an update to existing instruments, specifically increasing the validated number of uses and reprocessing cycles. Surgeons view the surgical site via the system console and manipulate instruments to perform complex minimally invasive procedures. Benefits include enhanced precision and control during surgery.

Clinical Evidence

Bench testing only. Testing included cleaning validation (per AAMI TIR 12:2020, AAMI TIR 30:2011/(R)2016, ANSI/AAMI ST15883-1:2009/(R)2014), reliability/life testing, electrical performance testing (per FDA guidance for Electrosurgical Devices), and thermal effects testing. Results confirmed the instruments meet all acceptance criteria after the increased number of reprocessing cycles.

Technological Characteristics

Reusable 8mm endoscopic instruments with articulating EndoWrist distal tips. Components include bipolar forceps, needle drivers, and dissectors. Connectivity is via the da Vinci Surgical System. Sterilization/reprocessing involves manual or automated cleaning processes. Technological update involves increased validated life cycles (uses/reprocessing) compared to predicate.

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• da Vinci X/Xi 8mm Reusable Instruments (K203632)

Submission Summary (Full Text)

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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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 ([e-mail]) or phone [phone] 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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# 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) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary (K214095)

| 510(k) Owner | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|-------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal<br>Sr. Regulatory Affairs Specialist<br>Phone Number: 408-523-8017<br>Email: [e-mail] |
| Date | 12th August 2022 |
| Trade Name | da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
| Common Name | Endoscope and accessories |
| Classification | Class II,<br>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.

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#### 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.

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# Intuitive Surgical, Inc.

Table 1 includes a comparison between the subject devices and predicate devices.

| Characteristic | Predicate Device<br>da Vinci X/Xi (IS4200/IS4000) EndoWrist (8mm) Instruments<br>(K203632) | | | Subject Device<br>da Vinci X/Xi (IS4200/IS4000) EndoWrist (8mm)<br>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<br>and<br>Reprocessing<br>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.

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## 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

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#### 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.