(33 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not mention any AI/ML functionalities.
Yes
The device is used for the coagulation of cardiac and soft tissues and to produce hemostasis, which are therapeutic actions aimed at treating or alleviating a condition.
No
The device is described as an electrosurgical probe intended for coagulation of cardiac and soft tissues and for hemostasis. Its function is therapeutic (coagulation), not diagnostic (identifying or characterizing disease).
No
The device description explicitly states it is an "Electrosurgical Probe" with a "malleable or flexible shaft," indicating it is a physical hardware device.
Based on the provided information, the Cobra Cooled Surgical Probe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery" and "to coagulate soft tissues" and "to coagulate blood and soft tissue to produce hemostasis." These are all in vivo procedures, meaning they are performed directly on living tissue within the body.
- Device Description: The description reinforces this by stating it's an "Electrosurgical Probe" used in conjunction with an "Electrosurgical Unit (ESU)" for use by "surgeons for the coagulation of cardiac and soft tissues during open surgical procedure." This further confirms its use in surgical procedures on living patients.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. The provided information does not mention any analysis of specimens or diagnostic purposes.
Therefore, the Cobra Cooled Surgical Probe is a surgical device used for therapeutic purposes (coagulation and hemostasis) directly on the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use for Cobra Cooled Surgical Probe is as follows:
The Cobra Cooled Surgical 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 (comma separated list FDA assigned to the subject device)
OCL, GEI
Device Description
The Cobra Cooled Surgical Probe is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The system is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue, soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, cardiac surgery, general surgery
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)
non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary of Safety and Effectiveness 3.
General Information a.
Modified Device Information
| Category: | Comments: |
|---|---|
| Sponsor: | Boston Scientific Corporation |
| 2710 Orchard Parkway | |
| San Jose, Ca 95134 | |
| Correspondent: | April I. Malmborg |
| Regulatory Affairs Specialist II | |
| Boston Scientific Corporation | |
| 2710 Orchard Parkway | |
| San Jose, Ca 95134 | |
| Contact Information: | E-mail: malmbora@bsci.com |
| Phone: (408) 895-3637 | |
| Fax: (408) 895-2202 | |
| Device Common Name: | Electrosurgical Probe |
| Device Proprietary Name: | Cobra Cooled Surgical Probe (K032207) |
| Device Classification: | 21 CFR §878.4400 |
Predicate Device Information
| Predicate Device: | Cobra Cooled Surgical Probe (K023291) |
|---|---|
| Predicate Device Manufacturer: | Boston Scientific Corporation |
| Predicate Device Common Name | Electrosurgical Probe |
| Predicate Device Classification: | 21 CFR §878.4400 |
| Predicate Device Classification Number: | Class II |
Boston Scientific Corporation Special 510(k) Submission
1
K032207
Page ② z Pac
SPECIAL 510(K) SUBMISSION Cobra Cooled Surgical Probe
b. Date Summary Prepared
August 18, 2003
Description of Device C.
The Cobra Cooled Surgical Probe is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The system is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedure.
d. Intended Use
The intended use for the Cobra Cooled Surgical Probes is as follows:
The Cobra Cooled 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 e.
See Table I- Comparison of Device Characteristics to Predicate on the following page.
000006
2
| Device Manufacturer
| & Name | Cobra® Cooled Surgical Probe | |
|---|---|---|
| Boston Scientific Corporation | Same | |
| Device Description | Electrosurgical Probe | Same |
| 510(k) Number | K023291 | K032207 |
| Regulatory Class | II | Same |
| Device Classification | 21 CFR §878.4400 | Same |
| Intended Use | Coagulation of Cardiac Tissue | |
| during Cardiac surgery and Soft | ||
| Tissue during General Open | ||
| Surgical Procedures | Same | |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Shaft Size | 9F | Same |
| Tip Material | Polycarbonate | Same |
| Length (cm) | 15-35 | Same |
| Electrode Size (mm) | 6 to 12.5 mm | Same |
| Electrode Number | 2 to 7 | Same |
Table 1 - Comparison of Device Characteristics to Predicate
f. 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 showed the device met its design-input criteria, and was safe and effective for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and body.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. April I. Malmborg Regulatory Affairs Specialist II 2710 Orchard Parkway San Jose, CA 95134
Re: K032207
Trade/Device Name: Cobra Cooled Surgical Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, GEI Dated: July 17, 2003 Received: July 22, 2003
Dear Ms. Malmborg:
This letter corrects our substantially equivalent letter of August 20, 2003.
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.
4
Page 2 - Ms. April I. Malmborg
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,
el. Mall
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SPECIAL 510(K) SUBMISSION Cobra Cooled Surgical Probe
K032207
4. Premarket Notification -Indication for Use Statement
Device Name: Cobra Cooled Surgical Probe
Indication for Use:
The intended use for Cobra Cooled Surgical Probe is as follows:
The Cobra Cooled Surgical 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 IS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR (Per 21 CFR §801.109) Over-the-Counter Use_
Mark N. Mellema
f General, Restorative and Neurological Devic
510(k) Number.
Boston Scientific Corporation Special 510(k) Submission