COBRA COOLED SURGICAL PROBE, MODEL 1596X

K021046 · Boston Scientific Corp · GEI · Apr 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021046
• Device Name: COBRA COOLED SURGICAL PROBE, MODEL 1596X
• Applicant: Boston Scientific Corp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 16, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Probe is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissues to produce hemostasis.

Device Story

Cobra® Cooled Surgical Probe is a sterile, single-use electrosurgical device. It functions by transmitting radiofrequency (RF) energy from electrodes to soft tissue to achieve coagulation and hemostasis. The probe connects to an external, reusable electrosurgical unit via a reusable instrument cable. Used in open, general surgical procedures; operated by a physician under direct visual control. The device benefits patients by providing controlled thermal coagulation of soft tissues and blood during surgery.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing, including fluid path integrity, bond joint tensile and torsional strength, distal section fatigue, shaft-to-handle tensile strength, and biocompatibility testing. Acute and chronic in vivo performance testing was also conducted in accordance with GLP requirements.

Technological Characteristics

Electrosurgical probe for RF energy delivery. Single-use, sterile. Connects to external electrosurgical unit via reusable cable. Materials and design validated through mechanical testing (tensile/torsional strength, fatigue). EO sterilized.

Indications for Use

Indicated for use in patients undergoing open, general surgical procedures requiring soft tissue coagulation and hemostasis. Contraindicated for use without direct visual control by a physician.

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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APR 1 6 2002

| Attachment 4<br>510(k) Summary | K021046 1/2 | |
|----------------------------------------|--------------------------------------------------------------------------------------------|--|
| Category: | Comments | |
| Sponsor: | Boston Scientific Corporation<br>2710 Orchard Parkway<br>San Jose, CA 95134 | |
| Correspondent: | Susan R. Pool<br>Manager, 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 | |
| Predicate Device Classification(s) | 21 CFR § 878.4400, product code GEI | |

## Date Summary Was Prepared:

March 28, 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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K021046 2/2

#### Intended Use:

The Probe is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissues 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<br>Description | Electrosurgical Probe | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | Boston Scientific Corporation/EP<br>Technologies, Inc. | Same |
| Device<br>Classification | Class II, 21 CFR §878.4400, code<br>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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized representation of a human figure, with three abstract shapes forming the body and head, symbolizing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 6 2002

Ms. Susan Pool Regulatory Manager Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134

Re: K021046

Trade/Device Name: Cobra Cooled Surgical Probe, Model 1596X Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 28, 2002 Received: April 1, 2002

Dear Ms. Pool:

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 application (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 such 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.

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.

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## Page 2 - Ms. Susan Pool

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse of substantial equivalence of your device to a legally promatics notification: "The Pressification 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 and If you desire specific ad roo for your witten diagnostic devices), please contact the Office of additionally 21 OF IC For 659. Additionally, for questions on the promotion and advertising of Compliance at [phone] - 1007 - 1001) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I cither general information on your responsibilities under the Act may be obtained from the Other general mionmator thernational 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,

Miriam C. Provost

Cor Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment 2 Intended Use Statement

KO21046 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Cobra® Cooled Surgical Probe Device Name:

Indication for Use:

The Probe is intended for use only under direct visual control of the physician The I robe is incended for ass base of a coagulate soft tissues. The Probe during open, general bargical produce blood and soft tissues to produce hemostasis.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR §801.109)

Over-

Over-the-Counter Use_

Muriam C. Provost

ion of General, Restorative Neurological Device

510(k) Number K021046

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