(15 days)
Not Found
No
The description focuses on the device's function using radiofrequency energy for coagulation and hemostasis, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The device is used for coagulation of cardiac and soft tissues and to produce hemostasis, which are therapeutic actions.
No
The device description and intended use clearly state that the Cobra® Cardiac Surgical Probe is for coagulation of tissue and to produce hemostasis, which are therapeutic functions, not diagnostic ones. It transmits radiofrequency energy rather than receiving or processing signals for diagnosis.
No
The device description explicitly states it is a "sterile, single use electrosurgical device" and describes physical components like electrodes, an instrument cable, and a connection to an electrosurgical unit. The performance studies also focus on physical characteristics and in vivo performance, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
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, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an electrosurgical device that transmits RF energy. This aligns with surgical tools, not diagnostic instruments that analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The purpose is to physically alter tissue through coagulation.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes
GEI, OCL
Device Description
The Boston Scientific Corporation Surgical Probe is a sterile, single use electrosurgical device intended to be used to coagulate soft tissues. The surgical probe transmits radiofrequency energy from electrodes which are connected to an Electrosurgical unit (non-sterile; re-useable) through an Instrument Cable (sterile; re-useable).
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
Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device included Fluid Path Integrity, Bond Joint Tensile Strength, Bond Joint Torsional Strength, Distal Section Fatigue, Shaft to Handle Tensile Strength, Biocompatibility and, both acute and chronic, In vivo performance.
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.
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| Category: | Comments | |
|---|---|---|
| Sponsor: | Boston Scientific Corporation | |
| 2710 Orchard Parkway | ||
| San Jose, CA 95134 | ||
| Correspondent: | Andrea L. Ruth, RAC | |
| Senior Associate, Regulatory Affairs | ||
| 2710 Orchard Parkway | ||
| San Jose, CA 95134 | ||
| Contact Information: | E-mail: rutha@bsci.com | |
| Phone: 408.895.3625 | ||
| Fax: 408.895.2202 | ||
| Device Common Name | Electrosurgical Probe | |
| Device Proprietary Name | Cobra® Cooled Surgical Probe | |
| Device Classification | 21 CFR § 878.4400, class II, product code GEI | |
| Predicate Device | Electrosurgical Probe | |
| Predicate Device Manufacturer(s) | Boston Scientific Corporation/EP | |
| Technologies, Inc. | ||
| Predicate Device Proprietary Name(s) | Cobra® Surgical Probe | |
| Predicate Device Classification Number | Class II |
Date Summary Was Prepared:
September 20, 2002
Description of the Device:
The Boston Scientific Corporation Surgical Probe is a sterile, single use electrosurgical device intended to be used to coagulate soft tissues. The surgical probe transmits radiofrequency energy from electrodes which are connected to an Electrosurgical unit (non-sterile; re-useable) through an Instrument Cable (sterile; re-useable).
1
Intended 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.
Comparison to Predicate Device:
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) Reference | K981981; K010956 | Current Submission |
| Intended Use | Coagulation of tissue | Same |
| Device Description | Electrosurgical Probe | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | Boston Scientific Corporation/EP Technologies, Inc. | Same |
| Device Classification | Class II, 21 CFR §878.4400, code GEI | Same |
Summary of the Non-clinical Data:
Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device included Fluid Path Integrity, Bond Joint Tensile Strength, Bond Joint Torsional Strength, Distal Section Fatigue, Shaft to Handle Tensile Strength, Biocompatibility and, both acute and chronic, In vivo performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a protective shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 2 1 2008
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: K023291
Trade/Device Name: Cobra® Cooled Cardiac Surgical Probe, Model 1596X Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical probe Regulatory Class: Class II (two) Product Code: OCL, GEI Dated: October 1, 2002 Received: October 2, 2002
Dear Ms. Ruth:
This letter corrects our substantially equivalent letter of October 17, 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 (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.
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
Attachment 2 Intended Use Statement
510(k) Number (if known):_
Cobra® Cooled Surgical Probe Device Name:
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.
(023291
(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 | K023291 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-the-Counter Use | |
|---|---|---|---|
| ------------------ | ---------------------------------------------------------------------- | ---- | ---------------------- |
(Per 21 CFR §801.109)