(100 days)
No
The summary describes a surgical access port kit, a mechanical accessory to a robotic surgical system. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical and usability aspects.
No.
The device is described as an accessory to a surgical system, intended to provide access for instruments and an endoscope during endoscopic surgery, not to treat a condition itself.
No
The device is described as an "Access Port Kit" used in endoscopic surgery to provide access for instruments. Its function is to facilitate surgical procedures by creating an entry point, not to diagnose conditions.
No
The device description clearly states it is a "sterile, single-use, disposable accessory" and describes physical components like ports and compatibility with instruments, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access for surgical instruments and an endoscope during endoscopic surgery. This is a surgical access device, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The description clearly states it's a sterile, single-use, disposable accessory to a surgical system, providing surgical access.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is a surgical accessory used during a surgical procedure, not a diagnostic tool used on samples outside the body.
N/A
Intended Use / Indications for Use
The SP Advanced Access Port Kit is intended to be used in endoscopic surgery to provide access for da Vinci SP instruments, a da Vinci SP Endoscope, and assist instruments through a single port.
Product codes
NAY, GCJ
Device Description
The subject da Vinci SP Advanced Access Port Kit, Large Incision is a sterile, single-use, disposable accessory to the da Vinci SP Surgical System, Model SP1098, the predicate device is the cleared da Vinci SP Access Port Kit 510(k) #K202571). It provides surgical access for the SP1098 system during minimally invasive robotic surgery. The da Vinci SP Advanced Access Port Kit is compatible with the existing EndoWrist SP Instruments, SP Endoscope, and manual laparoscopic instruments (referred to as "assist instruments") and other compatible laparoscopic devices through a single incision while maintaining insufflation, which is identical to the predicate device. It is also compatible with Intuitive da Vinci SP 12mm Instruments, unlike the predicate device. The subject device enables superficial instrument articulation, like the predicate device.
The subject device comprises of an Advanced Access Port, a removable 12-6mm Reducer, and a Large Wound Retractor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2.
Indicated Patient Age Range
adult use.
Intended User / Care Setting
trained physicians in an operating room environment; Hospital
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 (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements.
Bench Verifications: Testing was performed on the subject device, da Vinci SP Advanced Access Port Kit to verify that the design meets physical, mechanical, user interface, and equipment interface requirements. Testing categories included Physical specifications, Mechanical requirements, User Interface and Patient Safety, Reliability, Environmental requirements, Shelf-life and Sterilization, and Shipping and Storage, Package and Labeling.
Cadaver and Animal Validations: Cadaver models were used to demonstrate clinical performance for anatomical access and reach for SP Instruments using da Vinci SP Advanced Access Port Kit. Live animal models were used to assess safety and performance for da Vinci SP Advanced Access Port Kit in cases where a live tissue model was required. These models replicate factors experienced during clinical use, including working with perfused organs, bleeding, normal tissue handling, and ensuring that appropriate hemostasis is achieved and maintained. Procedures were chosen on the basis of the types of surgical tasks that are performed, and which da Vinci SP Advanced Access Port Kit is needed for the tasks.
Human Factors:
- Known use-related issues for predicate devices and devices similar to the subject devices were analyzed using post-market data and the MAUDE database. All identified use-related issues that are relevant to the use of the subject devices were documented in the risk analysis.
- A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user-device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
- A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for each user task identified as New or Modified from the predicate in the CTA.
- Formative usability evaluations were conducted during the development process to inform the device user interface design and confirm assessment of use-related risks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
February 28, 2025
Intuitive Surgical, Inc. Manjunath Ramappa Bisalehalli Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K243582
Trade/Device Name: da Vinci SP Advanced Access Port Kit (432701) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: January 29, 2025 Received: January 29, 2025
Dear Manjunath Ramappa Bisalehalli:
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 (the 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 available 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.
1
K243582 - Manjunath Ramappa Bisalehalli
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-comprehensive-regulatory
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assistance/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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S - Date: 2025.02.28 14:52:36
-05'00' Mark Trumbore, Ph.D. 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
da Vinci SP Advanced Access Port Kit (432701)
Indications for Use (Describe)
The SP Advanced Access Port Kit is intended to be used in endoscopic surgery to provide access for da Vinci SP instruments, a da Vinci SP Endoscope, and assist instruments through a single port.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| 510(k) Owner | Intuitive Surgical, Inc. | |
|---|---|---|
| 1266 Kifer Road | ||
| Sunnyvale, CA 94086 | ||
| Contact | Manjunath Bisalehalli | |
| Sr. Regulatory Affairs Specialist | ||
| Cell Phone Number: 412-298-4604 | ||
| Email: Manjun.RamappaBisalehalli(@intusurg.com | ||
| Date Summary | November 19, 2024 | |
| Prepared | ||
| Trade Name | da Vinci SP Surgical System, Model SP1098, EndoWrist SP | |
| Instruments, and Accessories | ||
| Common Name | Endoscope and accessories | |
| Classification | Class II, | |
| 21 CFR 876.1500, Endoscope and Accessories | ||
| Product Codes | NAY (System, Surgical, Computer Controlled Instrument) | |
| Review Panel | General and Plastic Surgery | |
| Predicate Device(s) | da Vinci SP Access Port (K202571) | |
510(k) Summary
Device Description
The subject da Vinci SP Advanced Access Port Kit, Large Incision is a sterile, single-use, disposable accessory to the da Vinci SP Surgical System, Model SP1098, the predicate device is the cleared da Vinci SP Access Port Kit 510(k) #K202571). It provides surgical access for the SP1098 system during minimally invasive robotic surgery. The da Vinci SP Advanced Access Port Kit is compatible with the existing EndoWrist SP Instruments, SP Endoscope, and manual laparoscopic instruments (referred to as "assist instruments") and other compatible laparoscopic devices through a single incision while maintaining insufflation, which is identical to the predicate device. It is also compatible with Intuitive da Vinci SP 12mm Instruments, unlike the predicate device. The subject device enables superficial instrument articulation, like the predicate device. Figure 1 provides an image of the da Vinci SP Advanced Access Port and its components.
5
Image /page/5/Picture/2 description: The image shows a medical device with a white and transparent body. The device has several components, including a handle, a transparent container, and a tube. The handle is located at the top of the device and is used to control the device. The transparent container is located in the middle of the device and is used to collect fluids. The tube is located at the bottom of the device and is used to drain fluids. There are also blue knobs on the side of the device.
Figure 1: da Vinci SP Advanced Access Port Kit
Indications for Use:
da Vinci SP Advanced Access Port Kit
The SP Advanced Access Port Kit is intended to be used in endoscopic surgery to provide access for da Vinci SP instruments, a da Vinci SP Endoscope, and assist instruments through a single port.
Image /page/5/Picture/7 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the "I" in the word. The font is a simple sans-serif font. The background is white.
6
Comparison of Technological Characteristics with the Predicate Device(s)
The subject device comprises of an Advanced Access Port, a removable 12-6mm Reducer, and a Large Wound Retractor. In addition to all the existing compatibilities with the predicate device, the subject device adds new compatibility with Intuitive da Vinci SP 12 mm instruments.
The key differences between the subject device and predicate device, da Vinci SP Access Port Kit (510(k) # K202571) are:
- New Entry Guide lumen configuration (with an increased diameter from 25mm . (predicate) to 32mm) to support Intuitive's 12mm instrument
- Non-removable Integrated Entry Guide with new seals ●
- . Introduction of a Reducer (12-6mm) to support use of a third 6mm instrument through the 12mm lumen
- New magnet configuration for system identification .
- . Two additional chamber seals
- . Reduced number of insufflation tubes and shortened tube length
Both the subject and predicate devices are single use, Ethylene Oxide (EO) sterilized devices.
Table 1: Subject Devices and Predicate Device, da Vinci SP Accessories
| Subject Device SP Accessory | | Previously cleared SP Accessory
(Predicate device submission, K202571) | |
|---------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------|---------------------------------------|
| da Vinci SP Accessory | da Vinci SP Accessory
Model Number | da Vinci SP Accessory | da Vinci SP Accessory
Model Number |
| da Vinci SP Advanced Access Port Kit,
Large Incision | 432701 | da Vinci SP Access Port Kit, Large
Incision | 430075 |
Image /page/6/Picture/14 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the "U" in the word. The font is sans-serif and the letters are evenly spaced.
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For reference, Table 2 includes a comparison of the indications for use of the SP1098 System with the Subject Device (do Vinci SP Advanced Access Port Kit) and the previously cleared SP1098 System (K242318). The are no changes being made to the da Vinci SP® Surgical System, Model SP1098 as part of this 510(k) submission.
| Characteristic | SP1098 System | SP1098 System |
|---|---|---|
| (with subject device, da Vinci SP Advanced Access Port Kit) | (K242318) | |
| Indications for Use | da Vinci SP® Surgical System, Model SP1098 |
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical
System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical
EndoWrist SP Instruments during urologic, colorectal, and general thoracoscopic surgical
procedures that are appropriate for a single port approach; and transoral otolaryngology
surgical procedures in the oropharynx restricted to benign tumors and malignant tumors
classified as T1 and T2. The system is indicated for adult use. It is intended for use by
trained physicians in an operating room environment in accordance with the
representative, specific procedures set forth in the Professional Instructions for Use.
EndoWrist SP Instruments
Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical
System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic
dissectors, scissors, 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, and suturing through a single
port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical
procedures that are appropriate for a single port approach; and transoral otolaryngology
surgical procedures in the oropharynx restricted to benign tumors and malignant tumors
classified as T1 and T2. The system is indicated for adult use. It is intended for use by
trained physicians in an operating room environment in accordance with the
representative, specific procedures set forth in the Professional. | IDENTICAL to the
subject device |
Table 2. SP1098 System's Indications for Use Comparison
8
Table 3 includes a comparison of the Subject Device (da Vinci SP Advanced Access Port Kit) and the Predicate device (Predicate Device, da Vinci SP Access Port Kit cleared via K202571).
| Characteristic | Subject Device | Predicate Device | |
|---|---|---|---|
| da Vinci SP Advanced Access Port Kit | da Vinci SP Access Port Kit (K202571) | ||
| General Information | |||
| Manufacturer | Intuitive Surgical, Inc. | IDENTICAL to the subject device | |
| Trade Name | da Vinci SP Advanced Access Port | da Vinci SP Access Port | |
| Model # | da Vinci SP Advanced Access Port Kit, Large | ||
| Incision (432701) | da Vinci SP Access Port Kit, Large Incision | ||
| (430075) | |||
| Common Name | Endoscope and accessories | IDENTICAL to the subject device | |
| Regulation Number | 21 CFR 876.1500 | IDENTICAL to the subject device | |
| Product Code | NAY, GCJ | IDENTICAL to the subject device | |
| Device Classification | Class II | ||
| IDENTICAL to the subject device | |||
| Classification Advisory | |||
| Committee | General and Plastic Surgery | IDENTICAL to the subject device | |
| System Compatibility | Compatible with the SP1098 system | IDENTICAL to the subject device | |
| Principles of Operation | Facilitates accurate movement of surgical instruments and IDENTICAL to the subject device | ||
| an endoscope through a single surgical port by using a | |||
| Characteristic | Subject Device | Predicate Device | |
| da Vinci SP Advanced Access Port Kit | da Vinci SP Access Port Kit (K202571) | ||
| master/slave servomechanism that incorporates servo | |||
| drive and system-level motor control. | |||
| Indications for Use | da Vinci SP® Advanced Access Port Kit | da Vinci SP® Access Port Kit | |
| The SP Advanced Access Port Kit is intended to be used | |||
| in endoscopic surgery to provide access for da Vinci SP | |||
| instruments, a da Vinci SP Endoscope, and assist | |||
| instruments through a single port. | The SP Access Port Kit is intended to be used in | ||
| endoscopic surgery to provide access for da Vinci SP | |||
| instruments, a da Vinci SP Endoscope, and assist | |||
| instruments through a single port. | |||
| Intended Use | To assist in the accurate control of endoscopic | ||
| instruments in minimally invasive surgery. | IDENTICAL to the subject device | ||
| Prescription use | Prescription/Physician use only | IDENTICAL to the subject device | |
| Where used (hospital, home, | |||
| ambulance, etc.) | Hospital | IDENTICAL to the subject device | |
| Design | |||
| Components | Advanced Access Port, Large Incision (with | ||
| ● | |||
| integrated Entry Guide) | |||
| Wound Retractor | |||
| ● | |||
| 12-6mm Reducer | |||
| ● | Access Port (small and large) | ||
| ● | |||
| SP Short Entry Guide | |||
| ● | |||
| Wound Retractor (small and large) | |||
| ● | |||
| No Reducer Component | |||
| Access Port | Flexible | ||
| Transparent | IDENTICAL to the subject device | ||
| Spherical | |||
| Characteristic | Subject Device | Predicate Device | |
| da Vinci SP Advanced Access Port Kit | da Vinci SP Access Port Kit (K202571) | ||
| SP Entry Guide | Two 6 mm lumens One 12 mm lumen One endoscope lumen | Three 6 mm instrument lumens One endoscope lumen | |
| Incision Retraction | Wound Retractor | IDENTICAL to the subject device | |
| Ability to Use Instruments | |||
| Immediately Inside Incision | Yes | IDENTICAL to the subject device | |
| Size Accepted for Laparoscopic | |||
| Assist Instruments | Chamber Seal: 5 mm to 10 mm Rotating Access Port Seal: 5 mm to 12 mm | IDENTICAL to the subject device | |
| Number of Chamber Seals | Three (3) | One (1) | |
| Rotational Range of | |||
| Laparoscopic Assist Instrument | |||
| Insertion Around SP | |||
| Instrument Cluster | 270° | IDENTICAL to the subject device | |
| Incision Size Range | 2.9 cm - 7 cm (SP Advanced Access Port Kit, Large Incision, when not using SP 12mm Instrument. 3.5 cm - 7 cm (SP Advanced Access Port Kit, Large Incision, when using SP 12mm Instrument | Small Access Port Kit: 2.7 cm to 4 cm Large Access Port Kit: 2.7 cm to 7 cm | |
| Sterilization Method | Ethylene Oxide | IDENTICAL to the subject device | |
| Disposable or Reusable | Disposable | IDENTICAL to the subject device | |
| Biocompatibility | All patient-contacting materials are biocompatible per ISO 10993-1. For a comparison of the patient contacting | IDENTICAL to the subject device | |
| Characteristic | Subject Device | Predicate Device | |
| da Vinci SP Advanced Access Port Kit | da Vinci SP Access Port Kit (K202571) | ||
| materials for the subject vs. the predicate, and a summary | |||
| of the biocompatibility testing, refer to Section 6. | |||
| Cleaning and Disinfection | Single Use Device - Not Applicable | IDENTICAL to the subject device | |
| Method | |||
| Packaging | lid. The packaging configuration consists of six (6) da | ||
| Vinci SP Advanced Access Port Kits, packaged in | |||
| individual cartons, and sealed in a corrugate shipper box. | Thermoformed PETG tray, PETG retainer lid, and Tyvek Thermoformed PETG tray, PETG retainer lid, and Tyvek | ||
| lid. The packaging configuration consists of six (6) da | |||
| Vinci SP Access Port Kits, packaged in individual cartons, | |||
| and sealed in a corrugate shipper box. A layer of | |||
| polyurethane foam that is placed at two (2) opposite ends | |||
| of the shipper box. |
Table 3 Comparison – Subject Device and Predicate Device
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Performance Data:
Performance test data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements.
Bench Verifications
Testing was performed on the subject device, da Vinci SP Advanced Access Port Kit to verify that the design meets physical, mechanical, user interface, and equipment interface requirements. A summary of the bench verification testing for the subject device is described in Table 4.
Table 4: Summary of the bench verification testing for the da Vinci SP Advanced Access Port Kit
| Subject Device | Testing |
|---|---|
| da Vinci SP Advanced Access | |
| Port Kit | 1. Physical specifications |
| 2. Mechanical requirements | |
| 3. User Interface and Patient Safety | |
| 4. Reliability | |
| 5. Environmental requirements | |
| 6. Shelf-life and Sterilization | |
| 7. Shipping and Storage | |
| 8. Package and Labeling |
Cadaver and Animal Validations
Cadaver models were used to demonstrate clinical performance for anatomical access and reach for SP Instruments using da Vinci SP Advanced Access Port Kit. Live animal models were used to assess safety and performance for da Vinci SP Advanced Access Port Kit in cases where a live tissue model was required. These models replicate factors experienced during clinical use, including working with perfused organs, bleeding, normal tissue handling, and ensuring that appropriate hemostasis is achieved and maintained. Procedures were chosen on the basis of the types of surgical tasks that are performed, and which da Vinci SP Advanced Access Port Kit is needed for the tasks.
Human Factors
Human Factors process conducted for the subject devices included the following activities:
- Known use-related issues for predicate devices and devices similar to the subject devices O were analyzed using post-market data and the MAUDE database. All identified userelated issues that are relevant to the use of the subject devices were documented in the risk analvsis.
13
- A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user- O device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
- A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for O each user task identified as New or Modified from the predicate in the CTA.
- Formative usability evaluations were conducted during the development process to O inform the device user interface design and confirm assessment of use-related risks.
Summary:
Based on the intended use, indications for use, technological characteristics and performance data, the subject device, da Vinci SP Advanced Access Port is substantially equivalent to its predicate device, da Vinci SP Access Port Kit (K202571).
Image /page/13/Picture/7 description: The image shows the word "INTUITIVE" in blue font with a small circle above the letter "U". Below the word, the number "10" is written in bold font. The text is centered and the background is white.