(29 days)
Not Found
No
The 510(k) summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard electrosurgical technology.
Yes
This device is identified as an "Electrosurgical Probe" intended for “coagulation” during surgery, which directly implies a therapeutic function by altering tissue to treat a medical condition.
No
The device is described as a surgical system for coagulation of tissue and blood; its function is therapeutic, not diagnostic.
No
The device description explicitly states it is an "Electrosurgical Probe" with a "malleable or flexible shaft," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
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 procedures performed on the patient's body during surgery.
- Device Description: The device is described as an "Electrosurgical Probe" used in conjunction with an "Electrosurgical Unit (ESU)." This is a surgical tool used directly on tissue.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health.
This device is a surgical tool used in vivo (within the living body) for therapeutic purposes (coagulation and hemostasis), not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The intended use for the Cobra Adhere Surgical System is as follows: The Cobra Adhere Surgical System (System) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System 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 Adhere Surgical System 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 procedures.
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, during open surgical procedures
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)
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.
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
SPECIAL 510(K) SUBMISSION Cobra Adhere Surgical System
Page ① of ②
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 | |
| Senior Specialist, Regulatory Affairs | ||
| 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 Adhere Surgical System | |
| Device Classification: | 21 CFR §878.4400 |
Predicate Device Information
| Predicate Device: | Cobra Cooled Surgical Probe (K032207) | |
|---|---|---|
| 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 |
Confidential
1
Page ② of ③
b. Date Summary Prepared
January 16, 2004
Description of Device c.
The Cobra Adhere Surgical System 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 procedures.
d. Intended Use
The intended use for the Cobra Adhere Surgical System is as follows:
The Cobra Adhere Surgical System (System) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
e. Comparison to Predicate Device
See Table I- Comparison of Device Characteristics to Predicate on the following page.
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Page ③ 8 ③
| | Cobra® Cooled Surgical
Probe | Cobra Adhere
Surgical Probe |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Device Manufacturer
& Name | Boston Scientific Corporation | Same |
| Device Description | Electrosurgical Probe | Same |
| 510(k) Number | K032207 | Same |
| 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 |
| Mandrel-Length and | 6.5 inches | 11.73 inches; |
| Distal tip OD | 0.036 inches | 0.035 inches |
| Tip Material | Polycarbonate | Same |
| Length | 15-35 cm | 15-37 cm |
| Electrode Size | 6 to 12.5 mm | Same |
| 9F Hypotube Length | 12 inches | 8 inches |
| Electrode Number | 2 to 7 | Same |
Table 1 - Comparison of Device Characteristics to Predicate
Summary of the Non-clinical Data f.
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.
CONFIDENTIAL
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. April I. Malmborg Senior Specialist, Regulatory Affairs 2710 Orchard Parkway San Jose, CA 95134
Re: K040104
Trade/Device Name: Cobra Adhere Surgical 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: January 16, 2004 Received: January 20, 2004
FEB 2 1 2008
Dear Ms. Malmborg:
This letter corrects our substantially equivalent letter of February 18, 2004.
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 (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 vours.
Elmelli
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K040104
4. Premarket Notification -Indication for Use Statement
Cobra Adhere Surgical System Device Name:
Indication for Use:
The intended use for Cobra Adhere Surgical System is as follows:
The Cobra Adhere Surgical System (System) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System 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) Overathe-Counter Use
(Division Sign-Off)
Division of General, Restora...
and Neurological Devices
510(k) Number K040104
Boston Scientific Corporation Special 510(k) Submission
Confidential