COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0

K040104 · Boston Scientific Corp · GEI · Feb 18, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040104
• Device Name: COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
• Applicant: Boston Scientific Corp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 18, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Cobra Adhere Surgical System is an electrosurgical probe with a malleable or flexible shaft; used with Cobra Electrosurgical Unit (ESU). Device delivers radiofrequency (RF) energy to cardiac and soft tissues to achieve coagulation and hemostasis. Used in open surgical procedures by surgeons. Device functions as a conduit for RF energy; output is thermal coagulation of tissue. Benefits include effective hemostasis and tissue coagulation during surgery.

Clinical Evidence

No clinical data. Non-clinical bench testing conducted in accordance with 21 CFR Part 58 (GLP) confirmed the device met design-input criteria.

Technological Characteristics

Electrosurgical probe; RF energy source; polycarbonate tip material; 9F shaft size; 15-37 cm length; 2-7 electrodes (6-12.5 mm). EO sterilized; single-use. Operates with Cobra ESU.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring cardiac tissue coagulation and patients undergoing general surgery requiring soft tissue coagulation or 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 Cooled Surgical Probe (K032207)

Submission Summary (Full Text)

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# 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<br>2710 Orchard Parkway<br>San Jose, Ca 95134 |
| Correspondent: | | April I. Malmborg<br>Senior Specialist, Regulatory Affairs<br>Boston Scientific Corporation<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 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

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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<br>Probe | Cobra Adhere<br>Surgical Probe |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Device Manufacturer<br>& 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<br>during Cardiac surgery and<br>Soft Tissue during General<br>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

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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.

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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 [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 vours.

Elmelli

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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# 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