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

Device Description

The Boomerang™ Plus Wire System is an extension of the Boomerang Wire System family of devices. The Boomerang Plus Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Plus Wire System includes design modifications to enhance ease of device removal and to minimize ooze from the tissue tract. The Boomerang Plus Wire System maintains the same indication for use as the Boomerang Wire System family of devices.

The Boomerang Plus Wire System consists of a sterile disposable Boomerang Plus Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang PlusWire System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Plus Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Plus Wire is deployed, which opens the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Plus 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 Plus 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 Plus 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 Plus Wire System.

AI/ML Overview

The provided text describes the Cardiva Medical Boomerang™ Plus Wire System. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, expert qualifications, or ground truth establishment methods as typically required for medical device clearance based on AI/ML.

Here's an analysis of what is present and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated. The document focuses on demonstrating substantial equivalence to a predicate device.
Reported Device Performance: No specific quantitative performance metrics (e.g., success rates, complication rates, time to hemostasis) are provided in a table. The document states that "various testing which included bench, biocompatibility, animal and clinical testing was performed... 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 and effective for its intended use." However, the results of this testing are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not provided. While "clinical testing" is mentioned, no details about the size or characteristics of the patient cohort are given.
Data Provenance: Not provided. There's no information about the country of origin, whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable/Not provided. This device is a mechanical hemostasis system, not an AI/ML diagnostic tool requiring expert ground truth establishment for image or data interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. As above, this is not an AI/ML diagnostic device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI/ML device, and therefore, no MRMC study or AI assistance comparison would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not explicitly stated for the "clinical testing." For a device like this, ground truth would likely be based on clinical outcomes relevant to hemostasis (e.g., successful closure, absence of bleeding, time to hemostasis, complication rates) assessed by treating physicians and follow-up. The document does not elaborate on how these outcomes were measured or whether they were adjudicated against a specific "ground truth" standard.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established:

Not applicable.

Summary of Device and Approval Process based on the text:

Device Name: Cardiva Medical Boomerang™ Plus Wire System
Intended Use: To promote hemostasis at arteriotomy sites as an adjunct to manual compression in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F, or 7F introducer sheaths.
Predicate Device: Cardiva Medical Boomerang™ Wire System (K051817)
Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "The Boomerang PlusWire System is substantially equivalent to the predicate device with regard to function, intended use, physical characteristics and performance testing."
Testing Mentioned: Bench, biocompatibility, animal, and clinical testing were performed to ensure safety and effectiveness and that the product meets performance requirements. However, detailed results or specific acceptance criteria from these tests are not included in this summary.

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than providing a detailed technical report of all performance testing results and acceptance criteria. For detailed performance data, one would usually refer to the full 510(k) submission or associated clinical trial reports, which are not provided here. The questions posed are highly relevant to AI/ML device submissions, which this is not.

Summary

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MAR 2 2 2007

Section II. 510(k) Summary

K070485

GENERAL INFORMATION

Manufacturer: Cardiva Medical, Inc. 2585 Leghorn Street Mountain View, CA 94043 Phone: 650-964-8900 Facsimile: 650-964-8911 Establishment Registration Number: 3004182619 (Glenn Foy, President)
Contact Person: Michael J. Billig Regulatory Consultant Experien Group Phone: 408-400-0856 Facsimile: 408-400-0865
Date Prepared: February 16, 2007

DEVICE INFORMATION

Trade Name:	Cardiva Medical Boomerang™ Plus Wire System
Classification Names:	Vascular Clamp (21 CFR §870.4450)
Classification:	Class II

PREDICATE DEVICES

Cardiva Medical Boomerang™ Wire System (K051817)

INTENDED USE/INDICATIONS FOR USE

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DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Boomerang PlusWire 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, biocompatibility, animal and clinical testing was performed on the Boomerang Plus Wire 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 and effective for its intended use.

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CONCLUSION

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

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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAR 2 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michael J. Billig Regulatory Consultant for Cardiva Medical Experien Group, LLC 155-A Moffett Park Drive Suite A-101 Sunnyvale, CA 94098

Re: K070485

Trade/Device Name: Cardiva Medical Boomerang PlusWire System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: II (two) Product Code: DXC Dated: February 16, 2007 Received: February 20, 2007

Dear Mr. Billig:

This letter corrects our substantially equivalent letter of March 22, 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

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Page 2 - Mr. Billig

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.

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B. Bernimor for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section I. Statement of Indications for Use

Statement of Indications for Use

510(k) Number (if known):_ K 070年85

Device Name: Cardiva Medical Boomerang™ PlusWire System

Indications for Use:

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

Please Do Not Write Below This Line – Continue On Another Page If Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription Use	X	Division of Cardiovascular Devices	Over-the-counter Use
Confidential	510(k) Number	K070485

Danna R. Vachney

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).