(191 days)
Not Found
No
The description focuses on the mechanical function of suction and irrigation controlled by foot pedals and manual activation, with no mention of AI or ML.
No.
The device is described as a "general purpose suction and/or irrigation device" used during surgical procedures, which assists in the surgical process rather than directly treating a disease or condition.
No
Explanation: The device is described as a general purpose suction and/or irrigation device used during surgical procedures, not as a device for diagnosing conditions.
No
The device description explicitly states it is a "single-use, disposable instrument" and describes physical components like an "instrument" and "foot pedal," indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "general purpose suction and/or irrigation device used during surgical procedures." This describes a device used during a surgical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description reinforces its use in the operating room setting, connected to external suction/irrigation sources, and controlled by the surgeon or assistant during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD device.
Therefore, the EndoWrist® One Suction/Irrigator is a surgical instrument used for suction and irrigation during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoWrist® One Suction/Irrigator, when attached to an external suction/irrigation source(s), is intended for use with the da Vinci Si Surgical System as a general purpose suction and/or irrigation device used during surgical procedures.
Product codes
NAY
Device Description
The EndoWrist® One 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. Activation will be controlled through the foot pedal at the surgeon side console. An additional feature allows manual activation by the patient side assistant. 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 normally 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
Not Found
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 tests (bench and animal lab tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safely or effectiveness as compared to the predicate device for the same indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Surgiflex® WAVE™ Suction-Irrigation System (K992126)
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
//0457/
510(k) Summary [As Required by 21 CFR 807.92(c)]
AUG 2 6 2011
May 22, 2011
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Brandon Hansen
Sr. Manager, Regulatory Affairs
408-523-74858 (phone)
408-523-1390 (fax)
brandon.hansen@intusurg.com |
| Trade Name: | Intuitive Surgical EndoWrist® One Suction/Irrigator |
| Common Name: | system, surgical, computer controlled instrument |
| Classification: | endoscope and accessories, 21 CFR 876.1500, NAY |
Predicate Device: Surgiflex® WAVE™ Suction-Irrigation System (K992126)
Device Description: The EndoWrist® One 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. Activation will be controlled through the foot pedal at the surgeon side console. An additional feature allows manual activation by the patient side assistant. 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 normally available in an operating room setting.
Intended Use: The EndoWrist® One Suction/Irrigator, when attached to an external suction/irrigation source(s), is intended for use with the da Vinci Si Surgical System as a general purpose suction and/or irrigation device used during surgical procedures.
Technological Characteristics: The EndoWrist® One Suction/Irrigator is equivalent to the predicate device in terms of its indications for use, design, technology and performance specifications.
Performance Data: Performance tests (bench and animal lab tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safely or effectiveness as compared to the predicate device for the same indications for use.
1
KII 0457
:
Summary: Based on the intended use, technical characteristics and performance data, the EndoWrist® One Suction/Irrigator is equivalent to the predicate device in terms of safety, effectiveness, and performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 · Silver Spring, MD 20993-0002
Intuitive Surgical, Inc. % Mr. Brandon Hansen Sr. Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
AUG 2 6 2011
Re: K110451
Trade/Device Name: EndoWrist® One Suction/Irrigator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: August 02, 2011 Received: August 08, 2011
Dear Mr. Hansen:
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
3
Page 2 - Mr. Brandon Hansen
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Eriel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number if known: K1 10451 Device Name: EndoWrist® One Suction/Irrigator
INDICATION FOR USE:
The EndoWrist® One Suction/Irrigator, when attached to an external suction/irrigation source(s), is intended for use with the da Vinci Si Surgical System as a general purpose suction and/or irrigation device used during surgical procedures.
Prescription Use X (Per 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-the-Counter Use _ (Per 21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E. Keith
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110451
Intuitive Surgical, Inc.
Confidential