(232 days)
Not Found
No
The device description details a software-controlled system that regulates power delivery based on temperature feedback and operator settings. There is no mention of AI/ML algorithms for decision-making, pattern recognition, or learning from data. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described with an "Intended Use / Indications for Use" section that clearly states its purpose is for "coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery" and "to coagulate blood and soft tissue to produce hemostasis." These actions are directly involved in treating or managing a medical condition (bleeding, tissue removal/modification), classifying it as a therapeutic device.
No
Explanation: The device, the Cobra® Cardiac Surgical Probe, is described as being "intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery" and for "coagulat[ing] soft tissues" and "blood and soft tissue to produce hemostasis." These are therapeutic actions, not diagnostic ones. The ESU measures temperature to regulate power delivery, which is part of its therapeutic function, not for diagnosing a condition.
No
The device description clearly outlines hardware components including a Surgical Probe, Electrosurgical Unit (ESU), and Instrument Cable, which are integral to the device's function. While the ESU is software-controlled, the device as a whole is not software-only.
Based on the provided information, the Cobra® Cardiac Surgical Probe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the coagulation of cardiac and soft tissues using radiofrequency energy during surgery. This is a therapeutic and surgical intervention performed directly on the patient's body.
- Device Description: The device is a surgical probe that delivers energy to tissue. It measures temperature to regulate this energy delivery. This is consistent with a surgical tool, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or examine specimens (like blood, tissue samples, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens and provide diagnostic information. The Cobra® Cardiac Surgical Probe is clearly designed for in vivo (within the living body) surgical procedures.
N/A
Intended Use / Indications for Use
The Cobra® Cardiac Surgical Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RE) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
Product codes
OCL, GEI
Device Description
The Boston Scientific Electrosurgical System is comprised of three components: the Surgical Probe, Electrosurgical Unit (ESU) and Instrument Cable. The Electrosurgical Unit measures temperatures from the thermocouples and uses the temperature measurements to regulate radiofrequency power delivery to the electrodes. The ESU is a software-controlled monopolar high frequency electronic instrument, provided with controls for set temperature, power limit, and number of active electrodes. The ESU has readouts for temperature, time of energy delivery, and delivered power. The ESU operates in a temperature controlled, power limited manner, based on operator settings and temperature feedback provided by thermocouples in the Surgical Probe. Front panel connectors include connections for the Instrument Cable, ESU Remote Cable, and DIP electrodes.
The Surgical Probe is provided in a variety of models, ranging from 2 electrodes to 7 electrodes, with either a malleable or flexible shaft that can be bent to the desired shape, providing improved tissue contact and maneuverability in hard-to-reach areas. The Instrument Cable connects the ESU to the Surgical Probe. Accessories included with the ESU include ESU Remote Cable, Footswitch, Instrument Cable, and mains power cord.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue, soft tissues, blood
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
This submission includes only an expanded indication for use, therefore there are no new issues of safety or efficacy, and the previously documented performance reports are still valid and applicable to the system. Specifically, previous non-clinical tests conducted for the Device showed the device met its design-input criteria, and support substantial equivalence. Additional testing showed the device to perform predictably (based on delivery temperature and time) when compared to an equivalent device in an animal model.
Key Metrics
Not Found
Predicate Device(s)
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 11 2002
: >
| Category: | Comments | ||
|---|---|---|---|
| Boston Scientific Corporation/EP Technologies, Inc. | |||
| 2710 Orchard Parkway | |||
| Sponsor: | San Jose, CA 95134 | ||
| Andrea L. Ruth | |||
| Senior Associate, Regulatory Affairs | |||
| 2710 Orchard Parkway | |||
| San Jose, CA 95134 | |||
| Correspondent: | e-mail: | rutha@bsci.com | |
| Phone: | 408.895.3625 | ||
| Contact Numbers: | Pager: | 888.509.6375 | |
| Fax: | 408.895.2202 | ||
| Device Common Name | Surgical Probe | ||
| Device Proprietary Name | Cobra® Cardiac Surgical Probe | ||
| Device Classification Name | Electrosurgical Unit and Accessories | ||
| Device Classification | Class II, 79 GEI, 21 CFR §878,4400 | ||
| Predicate Device | 1. | Medtronic Cardioblate RF Ablation System, | |
| K013392 | |||
| 2. | AFx Microwave Flex Ablation Wand System, | ||
| K003978 | |||
| 3. | Wedge Surgical System K870705 | ||
| Predicate Device | |||
| Manufacturer(s) | 1. | Medtronic | |
| 2. | AFx | ||
| 3. | Boston Scientific Inc./ Microvasive | ||
| Predicate Device Classification | |||
| Name(s) | Electrosurgical Units and Accessories | ||
| Predicate Device | |||
| Classification(s) | Class II, 79 GEI, 21 CFR §878,4400 |
Date Summary Was Prepared: July 3, 2002.
510(k) Summary
1
Description of the Device:
The Boston Scientific Electrosurgical System is comprised of three components: the Surgical Probe, Electrosurgical Unit (ESU) and Instrument Cable. The Electrosurgical Unit measures temperatures from the thermocouples and uses the temperature measurements to regulate radiofrequency power delivery to the electrodes. The ESU is a software-controlled monopolar high frequency electronic instrument, provided with controls for set temperature, power limit, and number of active electrodes. The ESU has readouts for temperature, time of energy delivery, and delivered power. The ESU operates in a temperature controlled, power limited manner, based on operator settings and temperature feedback provided by thermocouples in the Surgical Probe. Front panel connectors include connections for the Instrument Cable, ESU Remote Cable, and DIP electrodes.
The Surgical Probe is provided in a variety of models, ranging from 2 electrodes to 7 electrodes, with either a malleable or flexible shaft that can be bent to the desired shape, providing improved tissue contact and maneuverability in hard-to-reach areas. The Instrument Cable connects the ESU to the Surgical Probe. Accessories included with the ESU include ESU Remote Cable, Footswitch, Instrument Cable, and mains power cord.
Intended Use:
The Cobra® Cardiac Surgical Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RE) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
Non-clinical Data:
This submission includes only an expanded indication for use, therefore there are no new issues of safety or efficacy, and the previously documented performance reports are still valid and applicable to the system. Specifically, previous non-clinical tests conducted for the Device showed the device met its design-input criteria, and support substantial equivalence. Additional testing showed the device to perform predictably (based on delivery temperature and time) when compared to an equivalent device in an animal model.
Summary:
Based upon the design, materials, function, intended use, comparison with currently marketed devices, and the non-clinical testing performed by Boston Scientific, the Tissue Coagulation System ESU and Accessories has been shown to be substantially equivalent to currently marketed predicate devices
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. Andrea L. Ruth Senior Associate, Regulatory Affairs 2710 Orchard Parkway San Jose, CA 95134
Re: K013873 Trade Name: Cobra® Cardiac Electrosurgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, GEI Dated: May 15, 2002 Received: May 17, 2002
MAR 1 1 2008
Dear Ms. Ruth:
This letter corrects our substantially equivalent letter of July 11, 2002.
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 (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 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.
3
Page 2 - Ms. Andrea L. Ruth
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Q. Mall
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Intended Use Statement
510(k) Number (if known): __ K013873
. . . . .
Device Name:
Cobra® Cardiac Electrosurgical System
.
. .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indication for Use:
The Cobra® Cardiac Surgical Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K013873 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR Over-The-Counter Use |
|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |