(120 days)
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.
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.
The provided document describes a 510(k) summary for Bipolar Grasper and Bipolar Scissors for the ZEUS® MicroWrist™ Surgical System. This submission focuses on establishing substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined performance metrics.
Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not applicable to this type of regulatory submission. The document reports on non-clinical tests to demonstrate substantial equivalence, not a clinical trial with specific performance endpoints.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable (N/A) in the context of specific performance metrics.
This 510(k) submission is for substantial equivalence. The "acceptance criteria" are implicitly met by demonstrating that the new devices are "substantially equivalent in terms of size, shape, function, activation, and intended use to the predicate devices cited." The "reported device performance" is that these characteristics are maintained, even when manipulated by the robotic system.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Primary difference from predicate devices is manipulation method (robotic vs. hand-held). | Confirmed: "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." |
| Maintained fundamental characteristics (size, shape, function, activation, intended use) compared to predicate devices. | Stated: "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." Also: "As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version." Conclusion: "Data provided in this submission indicate that the basic functional characteristics of these devices are substantially equivalent to the predicates." |
2. Sample Size Used for the Test Set and Data Provenance
Not directly applicable as a clinical "test set" demonstrating performance metrics.
The submission relies on non-clinical tests to establish substantial equivalence. The document does not specify a "sample size" for a test set in the way one would for a clinical performance study (e.g., number of patients or cases). The "data provenance" would be from internal engineering and bench testing, likely conducted by Computer Motion, Inc. There is no mention of country of origin for clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
N/A. Ground truth from clinical experts is not relevant here as it's not a clinical performance study. The "ground truth" for substantial equivalence is based on engineering specifications and physical characteristics compared to predicate devices.
4. Adjudication Method for the Test Set
N/A. No adjudication method is described as there isn't a clinical test set requiring expert review or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
N/A. This device is a surgical instrument (bipolar grasper and scissors), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a surgical instrument that is part of a surgical system controlled by a human surgeon (“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”). It is not an algorithm, and the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- Engineering specifications and design characteristics of the new devices (Bipolar Grasper and Bipolar Scissors).
- Comparison to the known specifications and performance of the predicate hand-held devices (Lyons™ Dissecting Forceps and Evershears®).
- The fact that "the distal end that is used to perform surgical tasks remains unchanged from the hand-held version" implies that the functional part of the device is identical to established predicate devices.
8. The Sample Size for the Training Set
N/A. As this is a 510(k) for surgical instruments demonstrating substantial equivalence through non-clinical testing, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
N/A. See point 8.
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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 Scissorsfor 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.
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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.
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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.
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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
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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)
§ 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.