(155 days)
The ZEUS® Microwrist™ Robotic Surgical System is intended to assist in the accurate control of blunt dissectors, retractors, atraumatic graspers and stabilizers during laparoscopic and thoracoscopic surgery.
The users of the ZEUS® Microwrist™ Robotic Surgical System are surgeons trained in minimally invasive surgery. Assistant surgeons can also use this system while under the direction of the primary surgeon in accordance with hospital's customary practice.
Not Found
The provided text is a 510(k) summary for the ZEUS® MicroWrist™ Robotic Surgical System. It primarily focuses on the device's substantial equivalence to a previously cleared device (ZEUS® Robotic Surgical System K003431) and its compliance with various electrical and safety standards. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria related to its surgical assistance function.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that the device is "designed and tested to the following Computer Motion and voluntary standards," and then lists several electrical safety and EMC standards (EN60601-1, EN60601-1-1, EN60601-2-18, UL 2601-1, EN55011/A1, CISPR 11, EN61000-4-2, EN61000-4-3, EN50204, EN61000-4-4, EN61000-4-5, EN61000-4-6, CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92). These are safety and electromagnetic compatibility standards, not performance-based acceptance criteria for its surgical assistance capabilities.
The 510(k) process for this device relied on demonstrating substantial equivalence to a predicate device, which often means that extensive new clinical performance studies are not required if the new device does not raise new questions of safety and effectiveness. The summary primarily addresses safety and regulatory compliance rather than a detailed performance study against specific acceptance criteria for its intended use as a surgical assistant.
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01355/
Premarket Notification 510(k) Safety and Effectiveness Summary 11.
ZEUS® MicroWrist™ Robotic Surgical System 510(k) Summary
In accordance with 21 CFR section 807.92 Computer Motion is submitting the following safety and effectiveness summary.
- Submitter Information
Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117
Contact: David U. Thomas Prepared: October 23, 2001
- Name of Device:
Proprietary Name: ZEUS® MicroWrist™ Robotic Surgical System Common Name is ZEUS MicroWrist System Classification Name: Laparoscope for Use in General and Plastic Surgery, Regulation Number 876.1500, Class II.
- Substantially equivalent to ZEUS® Robotic Surgical System K003431
-
- The ZEUS® MicroWrist™ Robotic Surgical System is intended to assist in the accurate control of blunt dissectors, retractors, atraumatic graspers and stabilizers during laparoscopic and thoracoscopic surgery.
The users of the ZEUS® MicroWrist™ Robotic Surgical System are surgeons trained in minimally invasive surgery. Assistant surgeons can also use this system while under the direction of the primary surgeon in accordance with hospital's customary practice.
- The ZEUS® MicroWrist™ Robotic Surgical System is intended to assist in the accurate control of blunt dissectors, retractors, atraumatic graspers and stabilizers during laparoscopic and thoracoscopic surgery.
-
- The ZEUS MicroWrist System is designed and tested to the following Computer Motion and voluntary standards.
EN60601--1 Second Edition 1994 International Standard for Medical Electrical Equipment EN60601-1-1 1994 International Standard for Medical Electrical Equipment EN60601-2-18 First Edition 1997 International Standard for Medical Electrical Equipment UL 2601-1
- The ZEUS MicroWrist System is designed and tested to the following Computer Motion and voluntary standards.
Conducted & Radiated Emission EN55011/A1: 1998; CISPR 11:1997
Immunity Tests EN61000-4-2: 1995; EN61000-4-3: 1996; EN50204:1996; EN61000-4-4:1995; EN61000-4-5:1995; EN61000-4-6:1996.
CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2002
Computer Motion, Inc. Mr. Douglas Bueschel Director, Regulatory Affairs and Quality Assurance 130 B Cremona Drive, Suite B Goleta. California 93117
Re: K013551
Trade Name: Zeus Microwrist Robotic Surgical System Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 28, 2001 Received: January 3, 2002
Dear Mr. Bueschel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Douglas Bueschel
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally presidence modicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, «Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K013551
Device Name: Microwrist™ ZEUS® Robotic Surgical System
Indication For Use:
The ZEUS® Microwrist™ Robotic Surgical System is intended to assist in the accurate control of blunt dissectors, retractors, atraumatic graspers and stabilizers during laparoscopic and thoracoscopic surgery.
The users of the ZEUS® Microwrist™ Robotic Surgical System are surgeons trained in minimally invasive surgery. Assistant surgeons can also use this system while under the direction of the primary surgeon in accordance with hospital's customary practice.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013551
§ 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.