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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Cardiva Medical Boomerang™ Catalyst II System. A 510(k) summary is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish new performance criteria through clinical studies directly.

Based on the provided document, the device (Boomerang™ Catalyst II System) is being considered substantially equivalent to a predicate device (Cardiva Medical Boomerang™ Catalyst System, K070485) rather than being subject to a de novo approval pathway requiring specific acceptance criteria beyond demonstrating equivalence.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, clinical study results, sample sizes for test/training sets, expert qualifications, or ground truth establishment in the way one might expect for a primary clinical trial or AI/software validation.

However, I can extract the information that is present and explain why certain sections are not applicable or missing based on the nature of a 510(k) submission for substantial equivalence.

Here's a breakdown based on your request, explaining what is available and what is not:

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

Not Applicable/Not Provided Directly in this Document.
A 510(k) submission for substantial equivalence typically does not define new, quantitative clinical acceptance criteria in the same way as a de novo or PMA submission. Instead, the device is evaluated against the performance and safety profile of the predicate device.
The document states: "The Boomerang Catalyst II System is substantially equivalent to the predicate device with regard to function, intended use, physical characteristics and 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."
This indicates that performance testing was done, but specific quantitative acceptance criteria and their corresponding results are not detailed in this summary. The "performance requirements" would implicitly be those demonstrated by the predicate device.

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

Not Provided Directly.
The document mentions "various testing which included bench and biocompatibility," but it does not describe clinical test sets, patient sample sizes, or data provenance (e.g., country of origin, retrospective/prospective). This often means the substantial equivalence was based primarily on engineering design, material equivalence, and non-clinical testing rather than new clinical trials with patient cohorts.

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.
Since no clinical test set or ground truth establishment is described in this summary, information about experts and their qualifications is not present. This type of detail would be relevant for studies evaluating diagnostic accuracy or a new clinical endpoint, which is not the focus of this 510(k) summary.

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

Not Applicable/Not Provided.
Similar to point 3, without a described clinical test set requiring ground truth establishment, there is no mention of adjudication methods.

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

Not Applicable/Not Provided.
This type of study is relevant for AI or diagnostic imaging devices. The Boomerang Catalyst II System is a physical medical device (vascular clamp) intended to promote hemostasis. It does not involve AI, image reading, or human interpretative tasks.

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

Not Applicable/Not Provided.
As noted in point 5, this is a physical device, not an algorithm, so standalone algorithm performance is not relevant.

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

Not Applicable/Not Provided.
For a substantial equivalence claim based on bench and biocompatibility testing for a physical device, the "ground truth" refers to established engineering standards, material properties, and biological safety profiles, rather than clinical outcomes or expert consensus for diagnostic interpretation. These are implicitly compared to the predicate.

8. The sample size for the training set

Not Applicable/Not Provided.
The concept of a "training set" is relevant for machine learning algorithms. This is a physical medical device, not an AI/ML product.

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

Not Applicable/Not Provided.
As noted in point 8, this is not an AI/ML product.

Summary of what the document focuses on regarding device performance and substantial equivalence:

Device Description: The Boomerang™ Catalyst II System is described as a sterile, disposable wire and clip system that promotes hemostasis through temporary site-specific compression at a femoral access site.
Intended Use/Indications for Use: To promote hemostasis at arteriotomy sites as an adjunct to manual compression, for 5F, 6F, or 7F introducer sheaths in femoral artery catheterization.
Substantial Equivalence Claim: The Boomerang Catalyst II System is claimed to be substantially equivalent to the predicate device (Boomerang™ Catalyst System, K070485) "with regard to function, intended use, physical characteristics and performance testing."
Performance Testing Mentioned: "Various testing which included bench and biocompatibility 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 for the intended use of the device."

In conclusion, this 510(k) summary for the Cardiva Medical Boomerang™ Catalyst II System indicates that the device met acceptance criteria by demonstrating substantial equivalence to an existing predicate device (K070485) through bench and biocompatibility testing. The document does not provide details on specific quantitative performance criteria, clinical study designs, sample sizes, or expert involvement, as these types of detailed studies are generally not required for a 510(k) submission based on substantial equivalence of a physical device with a known mechanism of action.

Summary

{0}------------------------------------------------

K072297

SEP 1 2 2007 .

Section II. 510(k) Summary

GENERAL INFORMATION

Manufacturer:	Cardiva Medical, Inc.2585 Leghorn StreetMountain View, CA 94043Phone: 650-964-8900Facsimile: 650-964-8911Establishment Registration Number: 3004182619(Glenn Foy, President)
---------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Kit Cariquitan Contact Person: Regulatory Consultant Experien Group, LLC Phone: 408-400-0856 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

{1}------------------------------------------------

DEVICE DESCRIPTION

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.

{2}------------------------------------------------

CONCLUSION

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

Confidential

. . . .

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected.

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 (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 vour 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,

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:

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)

(Division Sign-Off)	Page 1 of 1
Division of Cardio...
510(k) Number	K022297

Confidential

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).