OCCLUSION BALLOON CATHETER

K070126 · Sentreheart, Inc. · DQY · Feb 8, 2008 · Cardiovascular

Device Facts

• Record ID: K070126
• Device Name: OCCLUSION BALLOON CATHETER
• Applicant: Sentreheart, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

Device Story

Occlusion Balloon Catheter; percutaneous catheter with two independent lumens and expandable balloon. Guide wire lumen facilitates placement and contrast injection; balloon lumen controls inflation/deflation. Radiopaque markers enable fluoroscopic visualization; hydrophilic coating on shaft reduces friction. Used by physicians in clinical settings for temporary vessel occlusion during arteriography, preoperative procedures, or emergency hemorrhage control. Device provides temporary flow cessation to assist in clinical interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing confirmed materials are safe for intended use.

Technological Characteristics

Catheter shaft with two lumens; expandable balloon; radiopaque markers for fluoroscopy; hydrophilic polymer coating. Materials are standard medical-grade. Mechanical device; no energy source or software.

Indications for Use

Indicated for temporary occlusion of large vessels in patients requiring arteriography, preoperative occlusion, or emergency controlled hemorrhage procedures.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• CODA Balloon Catheter (K032869)
• Equalizer Balloon Catheter (K021721)
• Sentry Balloon Catheter (993292)

Submission Summary (Full Text)

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# SECTION 4 - 510(K) SUMMARY

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) number: K070126

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Date Prepared: January 10, 2007 Revised February 5, 2008

Applicant Information: SentreHeart 2468 Embarcadero Way Palo Alto, CA 94303

Contact Person: Linda Guthrie, Manager Regulatory Affairs Phone Number: [phone] [phone] Fax Number:

#### Device Information:

| Trade Name: | Occlusion Balloon Catheter |
|----------------------|-----------------------------|
| Classification: | Class II per 21CFR 870.1250 |
| Classification Name: | Catheter, Percutaneous |
| Product Code: | DQY |

#### Physical Description:

The Occlusion Balloon Catheter consists of a catheter shaft with two independent lumens upon which an expandable balloon material is bonded. The "Guide Wire" lumen extends the length of the catheter and is used for placement of guide wires and injection of contrast for angiographic visualization. The "Balloon" lumen is used to inflate and deflate the balloon. Radiopaque markers at the location of the balloon provide fluoroscopic visualization of balloon placement. The outer diameter of the catheter shaft is coated with a hydrophilic polymer that reduces friction during manipulation in the vessel.

#### Intended Use:

The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

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## SECTION 4 - 510(K) SUMMARY

Predicate Devices: CODA Balloon Catheter, Cook Corp (K032869) Equalizer Balloon Catheter, Boston Scientific (K021721) Sentry Balloon Catheter, Boston Scientific (993292)

#### Safety and Performance:

Performance

Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the Occlusion Balloon Catheter is safe and effective for its intended use.

### Biocompatibility

The materials used in the Occlusion Balloon Catheter are commonly used materials in other medical devices. Results of testing demonstrate the Occlusion Balloon Catheter is biocompatible.

### Summary:

Based on the intended use, product testing, and information provided in this notification, the subject device has been shown to be safe and effective for its intended use and substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of an eagle or bird-like figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem. The emblem itself is composed of three curved lines that form the shape of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB -8 908

SentreHeart Inc. c/o Ms. Linda Guthrie Manager, Regulatory Affairs 2468 Embarcadero Way Palo Alto, CA 94303

Re: K070126

Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 1, 2008 Received: February 4, 2008

Dear Ms. Guthrie:

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.

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#### Page 2 - Ms. Linda Guthrie

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 begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Duna R. Vochner

A 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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and the state of the same of the same of the many of the same of the same of the same of

### SECTION 3 - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ______ K070126

Device Name: Occlusion Balloon Catheter

Indications for Use: The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. h. Lunes

ivision of Cardiovascular Devices

510(k) Number_k o

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