(35 days)
Clearglide Precision Bipolar Device
Not Found
No
The device description focuses on mechanical and electrical functions (dissection, coagulation, transection, bipolar energy) and does not mention any AI/ML components or capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an electrosurgical instrument for dissection, coagulation, and transection of vessels. It is used in procedures like vessel harvesting, which are surgical interventions, not therapeutic treatments in themselves, but rather part of a broader therapeutic process (e.g., bypass surgery). The device functions to manipulate tissue, not to treat a disease or restore health directly.
No
The device is described as an electrosurgical instrument for dissection, coagulation, and transection of vessels. It is used for therapeutic procedures (cutting and coagulating tissue), not for diagnosing conditions or diseases.
No
The device description clearly outlines a physical, sterile, single-patient-use electrosurgical instrument with features like jaws, electrodes, a knife blade, a cannula port, and a CO2 luer connection. It also mentions utilizing bipolar energy from a standard bipolar electrosurgical generator. These are all hardware components, not software.
Based on the provided information, the CardioVations Optical Bipolar Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for "endoscopic and open dissection, bipolar coagulation, and transection of vessels." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical instrument used for manipulating and cutting tissue (vessels) with electrosurgical energy and a knife blade. It's designed for direct interaction with the patient's anatomy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. The description of the CardioVations device does not mention any such use or interaction with patient specimens.
Therefore, the CardioVations Optical Bipolar Device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
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)
Results of verification testing indicates that the product meets the established performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Clearglide Precision Bipolar Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| JUL 2 1 2003
ATTACHMENT V
510(k) SUMMARY
| K031846 | ||
|---|---|---|
| Statement | Information supporting claims of substantial equivalence, as | |
| defined under the Federal Food, Drug, and Cosmetic Act, | ||
| respecting safety and effectiveness is summarized below. For the | ||
| convenience of the Reviewer, this summary is formatted in | ||
| accordance with the Agency's final rule ".... 510(k) Summaries | ||
| and 510(k) Statements ...." (21 CFR 807) and can be used to | ||
| provide a substantial equivalence summary to anyone requesting it | ||
| from the Agency. | ||
| MODIFIED DEVICE NAME: | CardioVations Optical | |
| Bipolar Device | ||
| PREDICATE DEVICE NAME: | Clearglide Precision Bipolar | |
| Device | ||
| 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 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). | ||
| Intended Use | The CardioVations Optical Bipolar Device is intended to be used | |
| for endoscopic and open dissection, bipolar coagulation, and | ||
| transection of vessels. | ||
| Indications Statement | The CardioVations Optical Bipolar Device is indicated for | |
| endoscopic and open dissection, bipolar coagulation, and | ||
| transection of vessels. | ||
| Technological | ||
| Characteristics | The modified device has the same technological characteristics as | |
| the predicate device. The form, fit, function and method of | ||
| operation are similar. | ||
| Performance Data | Results of verification testing indicates that the product meets the | |
| established performance requirements. | ||
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR |
- and the information provided herein, we conclude that the
subject device is substantially equivalent to the predicate devices
under the Federal Food, Drug and Cosmetic Act. | |
| Contact | Peter Cecchini
Manager
Regulatory Affairs
ETHICON, Inc.
Rt. 22 West
Somerville, NJ 08876-0151 | |
| Date | June 13, 2003 | |
1
510(K) SUMMARY( continued)
2
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.
3
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
4
| 510(k) Number (if known): | K031846 |
|---|---|
| Device Name: | CardioVations Optical Bipolar Device |
| Indications for Use: | The CardioVations Optical Bipolar Device is indicated for |
| endoscopic and open dissection, bipolar coagulation, and | |
| transection of vessels. |
.
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.