COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X

K023291 · Boston Scientific Corp · GEI · Oct 17, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023291
• Device Name: COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
• Applicant: Boston Scientific Corp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Cobra® Cooled Surgical Probe is a sterile, single-use electrosurgical device; transmits radiofrequency (RF) energy to coagulate cardiac and soft tissues; produces hemostasis. Device connects to a non-sterile, reusable electrosurgical unit via a sterile, reusable instrument cable. Used by surgeons in clinical settings during cardiac or general surgical procedures. Provides thermal coagulation via RF energy delivery to target tissue.

Clinical Evidence

Non-clinical testing performed in accordance with 21 CFR Part 58 (GLP). Testing included fluid path integrity, bond joint tensile and torsional strength, distal section fatigue, shaft-to-handle tensile strength, biocompatibility, and both acute and chronic in vivo performance testing.

Technological Characteristics

Electrosurgical probe; radiofrequency energy source; sterile, single-use design; connects to external electrosurgical unit via reusable cable; EO sterilized.

Indications for Use

Indicated for patients undergoing cardiac or general surgery requiring coagulation of soft tissue or blood to produce hemostasis.

Regulatory Classification

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.

Predicate Devices

• Cobra® Surgical Probe (K981981, K010956)

Submission Summary (Full Text)

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| Category: | | Comments |
|----------------------------------------|--|-----------------------------------------------------------------------------------------------------------|
| Sponsor: | | Boston Scientific Corporation<br>2710 Orchard Parkway<br>San Jose, CA 95134 |
| Correspondent: | | Andrea L. Ruth, RAC<br>Senior Associate, Regulatory Affairs<br>2710 Orchard Parkway<br>San Jose, CA 95134 |
| Contact Information: | | E-mail: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| 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<br>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).

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## 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# 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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
|--|-----------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |

| 510(k) Number | K023291 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <img alt="Prescription Use Check" src="prescription_use_check.png"/> | OR | Over-the-Counter Use |
|------------------|----------------------------------------------------------------------|----|----------------------|
|------------------|----------------------------------------------------------------------|----|----------------------|

(Per 21 CFR §801.109)