(82 days)
No
The summary focuses on the physical characteristics, intended use for imaging and sterilization, and performance testing related to mechanical, functional, and reliability aspects of the endoscope and its accessories. There is no mention of AI, ML, or any related computational analysis of the images or data.
No
This device is an endoscope and its accessories intended to provide real-time, 3D, high-definition imaging for surgeons performing minimally invasive surgery. It is a diagnostic and visualization tool, not one that directly provides therapy or treatment.
No
Explanation: The 12 mm Endoscope is described as providing "real-time, 3D, high-definition imaging enabling surgeons to perform minimally invasive surgery." This indicates its primary function is for visualization during surgical procedures, not for diagnosing medical conditions. The text focuses on its use in surgery and sterilization of its accessories, rather than diagnostic purposes.
No
The device description clearly states it is a rigid endoscope, cannulae, obturators, and a sterilization tray, all of which are physical hardware components. While it uses an existing imaging system, the subject device itself is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing real-time, 3D, high-definition imaging to enable surgeons to perform minimally invasive surgery. This is a surgical imaging device, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description details an endoscope, cannulae, obturators, and a sterilization tray. These are all components used in surgical procedures.
- Performance Studies: The performance studies focus on design verification, reliability, and animal testing related to the surgical imaging and mechanical aspects of the device. There are no studies related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), reagents, or providing diagnostic information based on the analysis of such samples.
The device is a surgical tool used for visualization during minimally invasive procedures.
N/A
Intended Use / Indications for Use
The 12 mm Endoscope is intended to provide real-time, 3D, high-definition imaging enabling surgeons to perform minimally invasive surgery.
The intended use for the 12 mm & Stapler Accessories is unchanged from what was cleared in K140553 (EndoWrist Stapler 45, Stapler 45 Reloads). They are being submitted again in this 510(k) to clear them for use with the subject device, da Vinci® Xi (IS4000) 12 mm Endoscope.
The indications for use for the 12 mm Endoscope Sterilization Tray is a modification of the indication statement for the Endoscope Sterilization Tray (K133942). The model numbers for the 12 mm Endoscope have been added. Steris V-Pro was also validated and therefore added to the indication statement. Finally, the maximum weight of the tray and endoscope has been adjusted to reflect the weight of the modified subject devices. The resulting indications for use for the 12 mm Endoscope Sterilization Tray are as follows:
The Intuitive Surgical 12 mm Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 951246 and 951247) for sterilization in any of the following sterilization machines/cycles:
- STERRAD 100NX sterilization system using the Express cycle
- STERRAD 100S sterilization system using the Standard cycle
- Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
- Steris V-PRO 1 using the V-PRO cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The maximum weight of tray and endoscope is 11.0 lbs. The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
Product codes
NAY, KCT
Device Description
The Intuitive Surgical da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories use the existing endoscopic imaging system submitted in K131861 (cleared March 28, 2014). The 12 mm rigid endoscopes come in both 0° and 30° angles for use through 12 mm ports.
Entry to the body cavity and maintenance of pneumoperitoneum are facilitated through the use of a12 mm & Stapler cannulae (both standard and long lengths), blunt obturators (also in standard and long lengths) and the 12 mm & Stapler Cannula Seal.
The Endoscope Sterilization Tray (an accessory to the 12 mm endoscope) is a thermoformed plastic tray with silicone inserts, a plastic lid, and a stainless steel cover. The tray, lid, and cover contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci 12 mm endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100S. STERRAD 100NX Express and Steris V-Pro sterilization systems.
Mentions image processing
Endoscopic imaging system, real-time, 3D, high-definition imaging.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons and operating room staff (implied from Human Factors and Usability Testing)
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 Data: Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements for the da Vinci® Xi (IS4000) 12 mm Endoscopes. The testing conducted consisted of design verification, reliability and animal testing.
Design Verification:
-
Test: Design Verification, 12 mm Endoscope – All final tests PASSED
-
Summary: The purpose of this test was to verify that the endoscopes met the dimensional, mechanical, functional, and electrical requirements and specifications. Test methods were based on pre-defined test procedures, and objective pass/fail criteria were defined in the protocol and used. Sample sizes up to six units were used. The following design verification tests were performed: Illumination, Mechanical, Electrical, Equipment Interface, Cleaning and Sterilization, Labeling.
-
Test: Design Verification, 12 mm Endoscope Sterilization Tray – All final tests PASSED
-
Summary: The purpose of this test was to verify that the 12 mm Endoscope Sterilization Tray met the dimensional, functional, and labeling requirements. Test methods were based on pre-defined test procedures, and objective pass/fail criteria were defined in the protocol and used. Sample sizes up to four units were used.
Reliability:
-
Test: Design Verification, Life, 12 mm Endoscope - All final tests PASSED
-
Summary: The purpose of this test was to verify that the endoscopes were robust when exposed to a typical use environment. A sample size of nine was used. Test articles were cycled through Simulated clinical use including the following: Visual Inspection, Mechanical Stressing, RFID Functional Test, Stereo Vision Test, Simulated Use, Clean, Sterilize.
-
Test: Design Verification, 12 mm Endoscope STERRAD 100S Compatibility-All final tests PASSED
-
Summary: The purpose of this test was to compare the material effects of STERRAD 100NX Express Cycle to the material effects of the STERRAD 100S Cycle on the 12 mm endoscope. A visual inspection of certain sites on the endoscope (different materials) was performed before and after sterilization cycling. Functional testing was also performed to confirm that the test article successfully survived sterilization cycling.
-
Test: Design Verification, 12 mm Endoscope Steris V-Pro maX Compatibility-All final tests PASSED
-
Summary: The purpose of this test was to compare the material effects of STERRAD 100NX Express Cycle to the material effects of the Steris V-Pro maX on the 12 mm endoscope. A visual inspection of certain sites on the endoscope (different materials) was performed before and after sterilization cycling. Functional testing was also performed to confirm that the test article successfully survived sterilization cycling.
Animal Testing:
-
Test: Design Validation – All final tests PASSED
-
Summary: The purpose of this testing was to confirm that the da Vinci Xi (IS4000) 12 mm Endoscope meets the user needs and intended use as documented in the Product Requirements document. Testing was completed across three labs conducted with three porcine. A variety of surgical tasks were completed to evaluate the 12 mm Endoscope's vision characteristics. Test methods were based on pre-defined test procedures and objective pass/fail criteria were defined in the protocol and used.
-
Test: Device Comparison – All final tests PASSED
-
Summary: This testing compared the basic clinical function of the da Vinci Xi (IS4000) 12 mm Endoscope with respect to the predicate device (IS4000 8 mm Endoscope). The study was a side-by-side comparison of the da Vinci Xi (IS4000) 12 mm Endoscope to the predicate device (IS4000 8 mm Endoscope). Two porcine were used in a pelvic, an upper GI, and a kidney setup to complete various visualization tasks for each device.
-
Test: Surgeon Evaluation – All final tests PASSED
-
Summary: The purpose of this testing was to confirm that the da Vinci Xi (IS4000) 12 mm Endoscope has clinically acceptable performance and allows for safe and effective surgical use as assessed by independent, external surgeon evaluators. Testing was completed across three labs, utilizing canines or porcine. Six independent, external surgeons served as evaluators to complete the vision assessments. All evaluators found each vision criteria clinically acceptable and safe for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
da Vinci® Xi Surgical System device, K131861, EndoWrist® Stapler 45, Stapler 45 Reloads, K140553, Intuitive Surgical Endoscope Sterilization Tray, K133942
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked one behind the other, with a wing-like shape extending from the back of the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2014
Intuitive Surgical Incorporated Ms. Crystal Ong Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K142683
Trade/Device Name: 12mm Endoscope and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, KCT Dated: September 18, 2014 Received: September 19, 2014
Dear Ms. Ong:
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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/Resourcesfor You/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.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 | |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--|
| | Indications for Use | See PRA Statement below. | |
| 510(k) Number (if known) | | | |
| K142683 | | | |
| Device Name
12 mm Endoscope and Accessories | | | |
| Indications for Use (Describe)
minimally invasive surgery. | The 12 mm Endoscope is intended to provide real-time, 3D, high-definition imaging enabling surgeons to perform | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| 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) | |
| | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |
| | | | |
| | FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | |
| | | | |
| | This section applies only to requirements of the Paperwork Reduction Act of 1995. | | |
| | 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 | | |
| | "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." | | |
| FORM FDA 3881 (1/14) | Page 1 of 1 | Publishing Services (301) 443-674 | |
Image /page/2/Picture/3 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in gray, all-caps letters, with a yellow dot above the "I". Below "INTUITIVE" is the word "SURGICAL" in smaller, gray, all-caps letters, followed by a registered trademark symbol.
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-012
Expiration Date: January 31, 2017
See PRA Statement below. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K142683 | |
| Device Name
12 mm Endoscope Sterilization Tray | |
| Indications for Use (Describe)
The Intuitive Surgical 12 mm Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi
endoscopes (Model #'s 951246 and 951247) for sterilization in any of the following sterilization machines/
cycles: | |
| • STERRAD 100NX sterilization system using the Express cycle | |
- · STERRAD 100S sterilization system using the Standard cycle
- · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- · Steris V-PRO 1 Plus using the Non Lumen or Lumen cvcles
- · Steris V-PRO 1 using the V-PRO cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The maximum weight of tray and endoscope is 11.0 lbs. The Intuitive Survical Endoscope Sterilization Tray is intended to be used with legally marketed. FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
Image /page/3/Picture/8 description: This image shows the first page of the FORM FDA 3881 (8/14). It includes information about the type of use, indicating that either prescription use or over-the-counter use can be selected. The form also includes a statement about the Paperwork Reduction Act of 1995 and provides contact information for the Department of Health and Human Services, Food and Drug Administration, and Paperwork Reduction Act (PRA) Staff. The burden time for this collection of information is estimated to average 79 hours per response.
Image /page/3/Picture/9 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a small yellow dot above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font. The overall design is simple and modern.
4
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Crystal Ong
Regulatory Affairs
Phone Number: 408-523-8636
Fax Number: 408-523-8907
Email: crystal.ong@intusurg.com | |
| Date Summary Prepared: | September 18, 2014 | |
| Trade Name: | da Vinci® Xi (IS4000) 12 mm Endoscope 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)
KCT (Sterilization Wrap) | |
| Classification Advisory Committee: | General and Plastic Surgery | |
| Predicate Device: | da Vinci® Xi Surgical System device, K131861
EndoWrist® Stapler 45, Stapler 45 Reloads,K140553
Intuitive Surgical Endoscope Sterilization Tray, K133942 | |
Device Description
The Intuitive Surgical da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories use the existing endoscopic imaging system submitted in K131861 (cleared March 28, 2014). The 12 mm rigid endoscopes come in both 0° and 30° angles for use through 12 mm ports.
Entry to the body cavity and maintenance of pneumoperitoneum are facilitated through the use of a12 mm & Stapler cannulae (both standard and long lengths), blunt obturators (also in standard and long lengths) and the 12 mm & Stapler Cannula Seal.
The Endoscope Sterilization Tray (an accessory to the 12 mm endoscope) is a thermoformed plastic tray with silicone inserts, a plastic lid, and a stainless steel cover. The tray, lid, and cover contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci 12 mm endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100S. STERRAD 100NX Express and Steris V-Pro sterilization systems.
5
Intended Use/Indications for Use:
The 12 mm Endoscope is intended to provide real-time, 3D, high-definition imaging enabling surgeons to perform minimally invasive surgery.
The intended use for the 12 mm & Stapler Accessories is unchanged from what was cleared in K140553 (EndoWrist Stapler 45, Stapler 45 Reloads). They are being submitted again in this 510(k) to clear them for use with the subject device, da Vinci® Xi (IS4000) 12 mm Endoscope.
The indications for use for the 12 mm Endoscope Sterilization Tray is a modification of the indication statement for the Endoscope Sterilization Tray (K133942). The model numbers for the 12 mm Endoscope have been added. Steris V-Pro was also validated and therefore added to the indication statement. Finally, the maximum weight of the tray and endoscope has been adjusted to reflect the weight of the modified subject devices. The resulting indications for use for the 12 mm Endoscope Sterilization Tray are as follows:
The Intuitive Surgical 12 mm Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 951246 and 951247) for sterilization in any of the following sterilization machines/cycles:
- · STERRAD 100NX sterilization system using the Express cycle
- · STERRAD 100S sterilization system using the Standard cycle
- Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
- · Steris V-PRO 1 using the V-PRO cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The maximum weight of tray and endoscope is 11.0 lbs. The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
Technological Characteristics:
In terms of intended use, indications for use, and technological characteristics, the da Vinci Xi (IS4000) 12 mm Endoscope and Accessories are substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861, EndoWrist" Stapler 45, Stapler 45 Reloads cleared under K140553, and the Intuitive Surgical Endoscope Sterilization Tray, cleared under K133942.
Performance Data:
Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input
6
requirements for the da Vinci® Xi (IS4000) 12 mm Endoscopes. The testing conducted consisted of design verification, reliability and animal testing.
Design Verification:
The testing provided in this submission consisted of dimensional measurements, mechanical, and functional verification.
| Test | Summary |
|---|---|
| Design Verification, 12 mm Endoscope – All | |
| final tests PASSED | The purpose of this test was to verify that the |
| endoscopes met the dimensional, mechanical, | |
| functional, and electrical requirements and | |
| specifications. Test methods were based on | |
| pre-defined test procedures, and objective | |
| pass/fail criteria were defined in the protocol | |
| and used. Sample sizes up to six units were | |
| used. The following design verification tests | |
| were performed: |
- Illumination
- Mechanical
- Electrical
- Equipment Interface
- Cleaning and Sterilization
- Labeling |
| Design Verification, 12 mm Endoscope
Sterilization Tray – All final tests PASSED | The purpose of this test was to verify that the
12 mm Endoscope Sterilization Tray met the
dimensional, functional, and labeling
requirements. Test methods were based on
pre-defined test procedures, and objective
pass/fail criteria were defined in the protocol
and used. Sample sizes up to four units were
used. |
Reliability:
The testing provided in this submission consisted of simulated use cycling test articles through their typical use environment, including sterilization. The evaluation method included visual inspections as well as functional testing.
Image /page/6/Picture/8 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, also in light gray.
7
| Test | Summary |
|---|---|
| Design Verification, Life, 12 mm Endoscope - | The purpose of this test was to verify that the |
| All final tests PASSED | endoscopes were robust when exposed to a |
| typical use environment. A sample size of nine | |
| was used. Test articles were cycled through | |
| Simulated clinical use including the following: | |
| Visual Inspection |
-
|
| | Mechanical Stressing
-
|
| | RFID Functional Test
-
|
| | Stereo Vision Test
-
|
| | Simulated Use
-
|
| | Clean
-
|
| | Sterilize
-
|
| Design Verification, 12 mm Endoscope | The purpose of this test was to compare the |
| STERRAD 100S Compatibility-All final | material effects of STERRAD 100NX Express |
| tests PASSED | Cycle to the material effects of the STERRAD |
| | 100S Cycle on the 12 mm endoscope. A visual |
| | inspection of certain sites on the endoscope |
| | (different materials) was performed before and |
| | after sterilization cycling. Functional testing |
| | was also performed to confirm that the test |
| | article successfully survived sterilization |
| | cycling. |
| Design Verification, 12 mm Endoscope Steris | The purpose of this test was to compare the |
| V-Pro maX Compatibility-All final tests | material effects of STERRAD 100NX Express |
| PASSED | Cycle to the material effects of the Steris V-Pro |
| | maX on the 12 mm endoscope. A visual |
| | inspection of certain sites on the endoscope
(different materials) was performed before and |
| | |
| | after sterilization cycling. Functional testing
was also performed to confirm that the test |
| | article successfully survived sterilization |
| | cycling. |
| | |
Animal Testing:
The testing provided in this submission was performed using simulated clinical models (animal) to evaluate the performance of the da Vinci Xi (IS4000) 12 mm Endoscope. This included design validation to confirm that the device meets the user needs and intended use, comparison testing against the predicate device (IS4000 8 mm Endoscope), and surgeon evaluations.
Image /page/7/Picture/5 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in gray, all-caps letters. Below that, the word "SURGICAL" is in smaller, gray, all-caps letters, with a registered trademark symbol to the right of the word.
8
| Test | Summary |
|---|---|
| Design Validation – All final tests PASSED | The purpose of this testing was to confirm that |
| the da Vinci Xi (IS4000) 12 mm Endoscope | |
| meets the user needs and intended use as | |
| documented in the Product Requirements | |
| document. Testing was completed across three | |
| labs conducted with three porcine. A variety | |
| of surgical tasks were completed to evaluate | |
| the 12 mm Endoscope's vision characteristics. | |
| Test methods were based on pre-defined test | |
| procedures and objective pass/fail criteria were | |
| defined in the protocol and used. | |
| Device Comparison – All final tests PASSED | This testing compared the basic clinical |
| function of the da Vinci Xi (IS4000) 12 mm | |
| Endoscope with respect to the predicate device | |
| (IS4000 8 mm Endoscope). The study was a | |
| side-by-side comparison of the da Vinci Xi | |
| (IS4000) 12 mm Endoscope to the predicate | |
| device (IS4000 8 mm Endoscope). Two | |
| porcine were used in a pelvic, an upper GI, and | |
| a kidney setup to complete various | |
| visualization tasks for each device. | |
| Surgeon Evaluation – All final tests PASSED | The purpose of this testing was to confirm that |
| the da Vinci Xi (IS4000) 12 mm Endoscope | |
| has clinically acceptable performance and | |
| allows for safe and effective surgical use as | |
| assessed by independent, external surgeon | |
| evaluators. Testing was completed across | |
| three labs, utilizing canines or porcine. Six | |
| independent, external surgeons served as | |
| evaluators to complete the vision assessments. | |
| All evaluators found each vision criteria | |
| clinically acceptable and safe for the subject | |
| device. |
Human Factors and Usability Testing:
Summative usability validation studies were conducted with users (surgeons and operating room staff) for the da Vinci® Xi Surgical System (K131861). These studies were conducted with the predicate endoscopes in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. With the exception of a separable light guide, the work-flow with the subject device is unchanged from the previously evaluated predicate device.
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Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories are substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861, EndoWrist® Stapler 45, Stapler 45 Reloads cleared under K140553, and the Intuitive Surgical Endoscope Sterilization Tray, cleared under K133942.
Image /page/9/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with the registered trademark symbol next to it. There is also a yellow dot above the word "INTUITIVE".