(104 days)
Not Found
No
The summary describes a mechanical suction and irrigation device controlled by a surgeon, with no mention of AI or ML capabilities.
No.
The device is used to deliver and evacuate fluids, and for retraction and blunt dissection of tissue during surgery, rather than directly treating a disease or condition.
No
The device is described as an instrument for delivering fluid to a surgical site, evacuating fluids, retraction, and blunt dissection of tissue during surgery. Its function is to assist in surgical procedures, not to diagnose conditions.
No
The device description explicitly states it is a "single-use, disposable instrument" and mentions "Mechanical Requirements" and "Electrical Requirements" in the performance studies, indicating it is a physical 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 for surgical applications, specifically delivering and evacuating fluids during endoscopic surgery. It also mentions retraction and blunt dissection of tissue. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description focuses on its mechanical function within the da Vinci Surgical System for manipulating fluids and tissue.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition. IVDs are designed to perform tests on samples (like blood, urine, tissue) to diagnose diseases or conditions.
- Performance Studies: The performance studies focus on mechanical and functional performance in simulated surgical settings (bench testing, animal/cadaver models), not on the accuracy or reliability of diagnostic results.
Therefore, the EndoWrist® Suction Irrigator is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoWrist® Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissue.
The EndoWrist® Suction Irrigator is intended for use in all endoscopic surgical applications where the compatible da Vinci Surgical System is indicated.
Product codes
NAY
Device Description
The EndoWrist® Suction Irrigator is a single-use, disposable instrument developed for use with the da Vinci Surgical System. The instrument provides the surgeon with the ability to activate suction and irrigation directly from the surgeon console or by depressing buttons on the instrument. Activation from the surgeon console will be controlled through the foot pedals on the surgeon console. The suction and irrigation sources are supplied by conventional devices (suction - canister, hospital line, etc.; and irrigation - closet, compressed air, gravity flow, etc.) that are available in an operating room setting.
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
Not Found
Intended User / Care Setting
Operating room setting
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)
The EndoWrist® Suction Irrigator was evaluated using bench testing and clinical models (animals/cadavers) to demonstrate that the design output meets the input requirements and the device performed as intended.
Design Verification (bench testing): The subject device, EndoWrist" Suction Irrigator, was subjected to series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a da Vinci Xi Surgical System (Model IS4000). The design verification testing included confirmation that the device meets the:
- Physical Specifications
- Mechanical Requirements
- Electrical Requirements
- User Interface Requirements
- Equipment Interface Requirements
Design Validation (animal/cadaver): The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine models (in vivo) and cadavers to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements. Design validation demonstrated that the design outputs fulfill the user needs and that the intended use has been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2017
Intuitive Surgical, Inc. Ms. Melissa Gonzalez Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K162973
Trade/Device Name: EndoWrist Suction Irrigator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: December 16, 2016 Received: December 19, 2016
Dear Ms. Gonzalez:
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 of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162973
Device Name EndoWrist® Suction Irrigator
Indications for Use (Describe)
The EndoWrist® Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissue.
| 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) |
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3
510(k) Summary
[As Required by 21 CFR 807.92(c)]
October 24, 2016
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|---------------------------------------------------------------------------------------------------|
| Official Contact: | Melissa S. Gonzalez
Sr. Regulatory Affairs Specialist
Ph: 408-523-8684
Fax: 408-523-1390 |
| Trade Name: | Intuitive Surgical EndoWrist® Suction Irrigator |
| Common Name: | System, surgical, computer controlled instrument |
| Classification: | Endoscope and accessories, 21 CFR 876.1500, NAY |
| Predicate Device: | Intuitive Surgical EndoWrist® One Suction/Irrigator (K110451) |
Device Description: The EndoWrist® Suction Irrigator is a single-use, disposable instrument developed for use with the da Vinci Surgical System. The instrument provides the surgeon with the ability to activate suction and irrigation directly from the surgeon console or by depressing buttons on the instrument. Activation from the surgeon console will be controlled through the foot pedals on the surgeon console. The suction and irrigation sources are supplied by conventional devices (suction - canister, hospital line, etc.; and irrigation - closet, compressed air, gravity flow, etc.) that are available in an operating room setting.
Intended Use:
The EndoWrist® Suction Irrigator is intended for use in all endoscopic surgical applications where the compatible da Vinci Surgical System is indicated.
Indications for Use:
The EndoWrist Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue.
4
Technological Characteristics: The EndoWrist® Suction Irrigator is equivalent to the predicate device in terms of its indications for use, design, technology, and performance specifications. An overview of the device characteristics for the Endo Wrist® Suction Irrigator is provided in Table 1.
| Subject & Predicate Device(s): | K162973 | K110451 |
|---|---|---|
| General Device Characteristics | ||
| Instrument Shaft OD | 0.33" | Same |
| Shaft Lumen ID | 0.17" | Same |
| Shaft Length | 22.2" | 17.1" |
| Tubing Length | 13' | Same |
| Tubing ID/OD | 0.25"/0.375" | Same |
| Irrigation Flow Rate | $\geq$ 1.75 L/min | Same |
| Valve Function | Sliding Cylinders | Same |
| Tip Articulation | Pitch/Yaw | Same |
| Provided Sterile/Single Use | Yes | Same |
| Sterilization Method | EtO | Same |
Table 1: General Device Characteristics
Performance Data: The EndoWrist® Suction Irrigator was evaluated using bench testing and clinical models (animals/cadavers) to demonstrate that the design output meets the input requirements and the device performed as intended.
Design Verification (bench testing): The subject device, EndoWrist" Suction Irrigator, was subjected to series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a da Vinci Xi Surgical System (Model IS4000). The design verification testing included confirmation that the device meets the:
- . Physical Specifications
- Mechanical Requirements ●
- Electrical Requirements ●
- User Interface Requirements ●
- Equipment Interface Requirements .
Design Validation (animal/cadaver): The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine models (in vivo) and cadavers to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements. Design validation demonstrated that the design outputs fulfill the user needs and that the intended use has been met.
5
Summary: Based on the intended use, technical characteristics, and performance data, the EndoWrist® Suction Irrigator is equivalent to the predicate device in terms of safety, effectiveness, and performance.