BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM

K072297 · Cardiva Medical, Inc. · DXC · Sep 12, 2007 · Cardiovascular

Device Facts

• Record ID: K072297
• Device Name: BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
• Applicant: Cardiva Medical, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Sep 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boomerang™ Catalyst/Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Catalyst/Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

Device Story

Boomerang Catalyst II System; temporary hemostasis device for femoral arteriotomy sites. Consists of sterile disposable wire and clip. Physician inserts wire through existing introducer sheath post-catheterization; deploys distal disc within femoral artery lumen. Sheath removed; disc conforms to vessel intima to seal arteriotomy. External clip maintains tension on wire, compressing tissue tract against disc. Allows distal perfusion during use. Facilitates natural vessel wall recoil and clotting. Device removed post-procedure; no components left in body. Adjunct to manual/mechanical compression. Benefits patient by promoting hemostasis while maintaining blood flow.

Clinical Evidence

Bench testing and biocompatibility testing performed. No clinical data provided.

Technological Characteristics

Vascular clamp; sterile disposable wire and clip. Mechanical deployment of disc within artery lumen. Tension-based compression mechanism. No software or electronic components.

Indications for Use

Indicated for patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F, or 7F introducer sheaths to promote hemostasis at arteriotomy sites as an adjunct to manual compression.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Cardiva Medical Boomerang™ Catalyst System (K070485)

Submission Summary (Full Text)

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K072297

SEP 1 2 2007 .

# Section II. 510(k) Summary

#### GENERAL INFORMATION

| Manufacturer: | Cardiva Medical, Inc.<br>2585 Leghorn Street<br>Mountain View, CA 94043<br>Phone: [phone]<br>Facsimile: 650-964-8911<br>Establishment Registration Number: 3004182619<br>(Glenn Foy, President) |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Kit Cariquitan Contact Person: Regulatory Consultant Experien Group, LLC Phone: [phone] Facsimile: 408-400-0865

#### Date Prepared: August 16, 2007

#### DEVICE INFORMATION

| Trade Name: | Cardiva Medical Boomerang™ Catalyst II System |
|----------------------|-----------------------------------------------|
| Classification Name: | Vascular Clamp (21 CFR §870.4450) |
| Classification: | Class II |

#### PREDICATE DEVICES

Cardiva Medical Boomerang™ Catalyst System (K070485), formerly referred to as the Cardiva Medical Boomerang™ PlusWire System.

Information regarding the predicate devices can be found in Appendix A.

#### INTENDED USE/INDICATIONS FOR USE

The Boomerang™ Catalyst/Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Catalyst/Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

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# DEVICE DESCRIPTION

The Boomerang™ Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang Catalyst II System includes design modifications to minimize ooze from the tissue tract and promote the hemostasis process. The Boomerang Catalyst II System maintains the same indication for use as the Boomerang Catalyst System family of devices, formerly referred to as the Boomerang PlusWire System.

The Boomerang Catalyst II System consists of a sterile disposable Boomerang Catalyst II wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Catalyst II System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Catalyst II wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Catalyst II wire is deployed, which opens the flat, lowprofile Boomerang Disc within the lumen of the femoral artery. The introducer sheath is then removed from the vessel over the Boomerang Catalyst II wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Catalyst II wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Catalyst II wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Catalyst II System.

#### SUBSTANTIAL EQUIVALENCE

The Boomerang Catalyst II System is substantially equivalent to the predicate device with regard to function, intended use, physical characteristics and performance testing.

#### PERFORMANCE TESTING

Various testing which included bench and biocompatibility was performed on the Boomerang Catalyst II System to insure the product and the product materials were adequately tested and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe for the intended use of the device.

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# CONCLUSION

The Boomerang Catalyst II System was properly designed, tested and shown to be substantially equivalent to the identified predicate device.

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Confidential

. . . .

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NOV 2 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Experien Group LLC c/o Mr. Kit Cariquitan Regulatory Consultant for Cardiva Medical 155 Moffett Park Drive, Suite A-210 Sunnyvale, CA 94089

Re: K072297

Boomerang™ Catalyst II System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 16, 2007 Received: August 17, 2007

Dear Mr. Cariquitan:

This letter corrects our substantially equivalent letter of September 12, 2007.

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 - Mr. Kit Cariquitan

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 vour 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,

R. bochner

n 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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### Statement of Indications for Use

#### 510(k) Number (if known): K072297

# Device Name: Cardiva Medical Boomerang™ Catalyst II System

Indications for Use:

The Boomerang™ Catalyst/Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Catalyst/Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

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

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | Page 1 of 1 |
| Division of Cardio... | |
| 510(k) Number | K022297 |

Confidential