(120 days)
Not Found
No
The document describes surgical instruments (grasper and scissors) and a robotic surgical system. While the system includes voice recognition (HERMES®), which can be considered a form of AI, the core function of the submitted devices (the bipolar grasper and scissors) and the overall description of the system's operation do not indicate the use of AI/ML for tasks like image analysis, decision support, or automated control beyond basic voice commands. The focus is on mechanical manipulation and electrosurgical function.
No.
The devices are surgical instruments designed to grasp, dissect, cut, and coagulate tissue during electrosurgical procedures, which are actions performed during a therapeutic procedure but the devices themselves are not the therapeutic agent.
No.
The devices are described as surgical instruments (bipolar grasper and bipolar scissors) used for grasping, dissecting, cutting, and coagulating tissue during electrosurgical procedures. Their function is therapeutic/interventional, not diagnostic.
No
The device description clearly states that the devices are physical surgical instruments (bipolar grasper and bipolar scissors) used with a surgical system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instruments are used for grasping, dissecting, cutting, and coagulating tissue during surgical procedures. This is an in-vivo (within a living organism) application, not an in-vitro (outside a living organism) diagnostic test.
- Device Description: The description details surgical instruments used with a robotic surgical system to perform tasks on tissue. It doesn't mention any analysis of biological samples or diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Measuring specific analytes
The device is a surgical instrument designed to assist surgeons in performing procedures directly on a patient's body.
N/A
Intended Use / Indications for Use
The Bipolar Grasper and Bipolar Scissors are instruments used with the ZEUS® MicroWrist™ Surgical System. The Bipolar Grasper is intended to grasp, dissect, and coagulate tissue. The Bipolar Scissors provide mechanical cutting and bipolar coagulation. These bipolar instruments augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System.
Product codes
NAY
Device Description
This premarket notification adds a bipolar grasper and bipolar scissors to the ZEUS® MicroWrist™ Surgical System. These surgical instruments are used in conjunction with an electrosurgical generator unit (ESU), and they augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System. These devices are additions to the MicroAssist 100 line of ZEUS surgical instruments. MicroAssist instruments consist of commercially available hand-held devices that have been modified in order to be attached to the ZEUS arm. As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version.
The ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments in order to perform selected surgical tasks. One arm of the ZEUS System incorporates the AESOP® endoscope positioner which provides the surgeon with a steady view of the internal operating field. The HERMES® O.R. Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS System.
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
Data provided in this submission indicate that the basic functional characteristics of these devices are substantially equivalent to the predicates.
Key Metrics
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.
0
JUN 2 4 2003
510(k) Summary
Bipolar Grasper and Bipolar Scissors for the ZEUS® MicroWrist™ Surgical System
In accordance with 21 CFR section 807.92 Computer Motion is submitting the following 510(k) summary:
1) Submitter Information
Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117
Contact: Cathy Stupak, Ph.D. Regulatory Specialist
2) Name of Device:
| Proprietary Name: | Bipolar Grasper and Bipolar Scissors
for the ZEUS® MicroWrist™ Surgical System | |
|----------------------|-----------------------------------------------------------------------------------|--|
| Common Name: | Bipolar Grasper and Bipolar Scissors | |
| Classification Name: | System, Surgical, Computer Controlled Instrument | |
| Regulation Number: | 876.1500 | |
| Product Code: | NAY | |
| Class: | Class II. | |
3) Substantial Equivalence:
This submission establishes the substantial equivalence of the ZEUS Bipolar Grasper and ZEUS Bipolar Scissors to the hand-held versions of these instruments:
- The Lyons™ Dissecting Forceps manufactured by Gyrus Medical, . (K904993)
- The Evershears®, manufactured by Gyrus Medical, (K904993) ●
4) Description of the Device:
This premarket notification adds a bipolar grasper and bipolar scissors to the ZEUS® MicroWrist™ Surgical System. These surgical instruments are used in conjunction with an electrosurgical generator unit (ESU), and they augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System. These devices are additions to the MicroAssist 100 line of ZEUS surgical instruments. MicroAssist instruments consist of commercially available hand-held devices that have been modified in order to be attached to the ZEUS arm. As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version.
1
The ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments in order to perform selected surgical tasks. One arm of the ZEUS System incorporates the AESOP® endoscope positioner which provides the surgeon with a steady view of the internal operating field. The HERMES® O.R. Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS System.
5) Intended Use
The Bipolar Grasper and Bipolar Scissors are surgical instruments used with the ZEUS® MicroWrist 110 Surgical System. The Bipolar Grasper is intended to grasp, dissect, and coagulate tissue. The Bipolar Scissors provide mechanical cutting and bipolar coagulation. These bipolar instruments augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System.
6) Technological Characteristics in Comparison to the Predicates
The Bipolar Grasper and Bipolar Scissors, instruments for the ZEUS® MicroWrist™ Surgical System, are essentially identical in terms of size, shape, function, activation, and intended use to the predicate devices cited. The primary difference between the subject devices and the predicate devices is that the predicates are hand-held instruments while the subject devices are positioned and manipulated by the ZEUS® MicroWrist™ Surgical System.
7) Conclusion drawn from the Non-Clinical Tests
Data provided in this submission indicate that the basic functional characteristics of these devices are substantially equivalent to the predicates.
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
JUN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Munjal, Ph.D. Vice President, RA/QA/CA Computer Motion, Inc. 130-B Cremona Drive Santa Barbara, California 93117
Re: K030578
Trade/Device Name: Bipolar Grasper and Bipolar Scissors for the ZEUS® Microwrist™ Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Computer controlled instrument surgical system Regulatory Class: II Product Code: NAY Dated: May 28, 2003 Received: May 29, 2003
Dear Dr. Munjal:
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. Iisting 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.
3
Page 2 - David Munjal, Ph.D.
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 marketed predicate 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), 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) you may obtain. 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,
Miriam C. Provost
(WCelia 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
4
INDICATION FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Bipolar Grasper and Bipolar Scissors Device Name: for the ZEUS® MicroWrist™ Surgical System
The Bipolar Grasper and Bipolar Scissors are instruments used with the ZEUS® MicroWrist™ Surgical System. The Bipolar Grasper is intended to grasp, dissect, and coagulate tissue. The Bipolar Scissors provide mechanical cutting and bipolar coagulation. These bipolar instruments augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System.
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
| Miriam C. Provost | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K030578 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-the-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
Concurrence of CRDH, Office of Device Evaluation (ODE)