(35 days)
The CardioVations Optical Bipolar Device is intended to be used for endoscopic and open dissection, bipolar coagulation, and transection of vessels.
The CardioVations Optical Bipolar Device is indicated for endoscopic and open dissection, bipolar coagulation, and transection of vessels.
The CardioVations Optical Bipolar is a sterile, single patient use, bipolar electrosurgical instrument with features to dissect, coagulate, and transect tissue with a knife blade. The instrument will be indicated for endoscopic and open tissue dissection bipolar coagulation and transection of vessels. For example like the predicate device, the instrument will be used in vessel harvesting for side branch management (e.g., dissection, coagulation, cutting). The working end of the instrument is composed of the inline jaws for clamping tissue (vessels), the electrode surface for bipolar coagulation and the knife for vessel transection. A cannula port is included in the modified device design for endoscope insertion and a CO2 luer connection. The instrument is 50 cm (19.6 inches) in length, and utilizes bipolar energy from a standard bipolar electrosurgical generator (ESG).
This document describes the CardioVations Optical Bipolar Device, a surgical instrument for tissue dissection, coagulation, and transection.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states: "Results of verification testing indicates that the product meets the established performance requirements." However, it does not explicitly list specific numerical acceptance criteria or detailed performance metrics in a table format. The study primarily relies on demonstrating substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" or its sample size. The evaluation appears to be based on "verification testing" rather than a clinical trial with a defined test set of patients or cases. The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided. The study does not describe a process for establishing ground truth involving multiple experts for a test set.
4. Adjudication Method for the Test Set
No adjudication method is described, as the document does not detail a test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. This device is a surgical instrument, not an AI or imaging diagnostic tool where such studies are typically performed. The document focuses on performance requirements for the instrument itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The CardioVations Optical Bipolar Device is a physical surgical instrument, not an algorithm, and therefore does not have a "standalone" algorithmic performance. It is used with a human operator.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) does not directly apply to the evaluation of a surgical instrument for substantial equivalence in this context. The "ground truth" for the device's performance would be its ability to perform its intended functions (dissection, coagulation, transection) safely and effectively, as demonstrated through verification testing and comparison to a predicate device. The document states that the modified device has the same technological characteristics as the predicate device (Clearglide Precision Bipolar Device), implying that its performance is benchmarked against the known performance of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable. Surgical devices do not typically have "training sets" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons mentioned above.
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| JUL 2 1 2003ATTACHMENT V510(k) SUMMARYK031846 | ||
|---|---|---|
| Statement | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug, and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule ".... 510(k) Summariesand 510(k) Statements ...." (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requesting itfrom the Agency. | |
| MODIFIED DEVICE NAME: | CardioVations OpticalBipolar Device | |
| PREDICATE DEVICE NAME: | Clearglide Precision BipolarDevice | |
| Device Description | The CardioVations Optical Bipolar is a sterile, single patient use,bipolar electrosurgical instrument with features to dissect,coagulate, and transect tissue with a knife blade. The instrumentwill be indicated for endoscopic and open tissue dissection bipolarcoagulation and transection of vessels. For example like thepredicate device, the instrument will be used in vessel harvestingfor side branch management (e.g., dissection, coagulation, cutting).The working end of the instrument is composed of the inline jawsfor clamping tissue (vessels), the electrode surface for bipolarcoagulation and the knife for vessel transection. A cannula port isincluded in the modified device design for endoscope insertion anda CO2 luer connection. The instrument is 50 cm (19.6 inches) inlength, and utilizes bipolar energy from a standard bipolarelectrosurgical generator (ESG). | |
| Intended Use | The CardioVations Optical Bipolar Device is intended to be usedfor endoscopic and open dissection, bipolar coagulation, andtransection of vessels. | |
| Indications Statement | The CardioVations Optical Bipolar Device is indicated forendoscopic and open dissection, bipolar coagulation, andtransection of vessels. | |
| TechnologicalCharacteristics | The modified device has the same technological characteristics asthe predicate device. The form, fit, function and method ofoperation are similar. | |
| Performance Data | Results of verification testing indicates that the product meets theestablished performance requirements. | |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thesubject device is substantially equivalent to the predicate devicesunder the Federal Food, Drug and Cosmetic Act. | |
| Contact | Peter CecchiniManagerRegulatory AffairsETHICON, Inc.Rt. 22 WestSomerville, NJ 08876-0151 | |
| Date | June 13, 2003 |
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510(K) SUMMARY( continued)
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S." arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Mr. Peter Cecchini Manager, Regulatory Affairs Ethicon, Inc. Route 22 West Somerville, New Jersey 08876-0151
Re: K031846
Trade/Device Name: CardioVations Optical Bipolar Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 13, 2003 Received: June 26, 2003
Dear Mr. Cecchini:
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 - Mr. Peter Cecchini
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/cdrb/dsma/dsmamain.html
Sincerely yours,
Muriam 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): | K031846 |
|---|---|
| Device Name: | CardioVations Optical Bipolar Device |
| Indications for Use: | The CardioVations Optical Bipolar Device is indicated forendoscopic and open dissection, bipolar coagulation, andtransection of vessels. |
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INDICATIONS FOR USE
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-9G)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031846
CardioVations Optical Bipolar Device ETHICON, Inc.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.