The Cardiva Medical VasoStasis™ Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

Device Description

The VasoStasis Vascular Closure System consists of the following components: (1) a sterile. disposable catheter (VasoStasis™ VCS Catheter), and (2) a sterile, disposable tensioning device (VasoStasis™ VCS Tensioner). The VasoStasis Vascular Closure System, in conjunction with manual compression, provides hemostasis at femoral access sites after femoral arterial catheterization while allowing continued perfusion of the lower extremities. The VasoStasis VCS Catheter is a single lumen, low profile catheter with an elastomeric membrane at the distal tip. The membrane is covered by a tip guide, which protects the membrane as the cledeployed catheter is inserted into the artery through a previously placed introducer sheath. A small loon handle is at the proximal end of the device and moves axially to deploy or de-deploy a Nitinol coil within the membrane. Once the catheter is introduced into the vessel, the membrane is positioned distal to the introducer sheath and deployed by pushing the loop handle forward. In its fully deployed state, the membrane nominally achieves 13 F in diameter. The Cardiva VasoStasis VCS Tensioner clips on the VasoStasis VCS Catheter shaft on the surface of the skin at the entrance to the arteriotomy and holds the catheter secure while the membrane is deployed in the vessel.

AI/ML Overview

Acceptance Criteria and Study for Cardiva Medical VasoStasis™ Vascular Closure System

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Cardiva Medical VasoStasis™ Vascular Closure System does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for success rates or complication rates against which the observed performance was directly measured. Instead, it refers to "performance requirements" that the system met or exceeded, and then presents the clinical study results as evidence of safety and effectiveness, implying these results are within acceptable ranges.

However, based on the narrative, the implicit acceptance criteria can be inferred from the positive statements made about the study outcomes.

Acceptance Criteria (Inferred from Narrative)	Reported Device Performance (Clinical Study Results)
Device Success Rate (>70%)	Observed device success rates: >70% in US II, US I, and Canadian clinical evaluations.
Major Complication Rate (<5%)	Observed low major complication rates: <5% in US II, US I, and Canadian clinical evaluations.
Reduction in Direct Manual Compression Time	Average direct manual compression time using VasoStasis VCS was significantly less compared to literature control.
Reduction in Time to Ambulation	Average time to ambulation using VasoStasis VCS was significantly less compared to literature control.
Overall Hemostasis (Not Decreased)	Overall time to hemostasis (tension time + direct manual compression time) was not decreased. (This indicates non-inferiority in overall time, although individual components were improved).
Safety and Effectiveness for Intended Use	Studies "support the safe and effective use of the current VasoStasis VCS for its intended use."
Biocompatibility	Demonstrated to be biocompatible based on ISO 10993-1 and ISO 10993-4 testing.
Performance Requirements	System meets or exceeds performance requirements for intended clinical use (bench testing).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Test Set: A total of 441 patients were included across four clinical studies (one enrolled but not treated).
- German clinical evaluation: 144 patients (post-market study).
- US II, US I, and Canadian Clinical Studies: 278 consecutive phase patients (prospective studies).
Data Provenance:
- Initial clinical evaluations: Conducted in Germany and Canada.
- Followed by two Non-Significant Risk (NSR) studies: US I (sponsored by BioInterventional) and US II (sponsored by Cardiva Medical), conducted in the United States.
Study Design:
- German clinical evaluation: Post-market study.
- US II, US I, and Canadian Clinical Studies: Prospective studies.
- The data from the prospective Canadian Clinical Study was retrospectively analyzed using the same outcome definitions as the US I Studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided document does not specify the number of experts used to establish ground truth for the clinical test set, nor does it detail their qualifications (e.g., radiologist with X years of experience). The clinical studies evaluated "safety and effectiveness" based on device success rates, complication rates, and time metrics, which would typically be assessed by treating physicians and study investigators rather than independent experts establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set outcomes. Given the nature of a vascular closure device study evaluating success/complication rates and time metrics, these are often directly observed and recorded by the clinical staff involved in the procedure and patient follow-up, rather than requiring a separate adjudication panel for "ground truth" per se.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the context of human readers improving with AI vs. without AI assistance. This device is a mechanical vascular closure system, not an AI-powered diagnostic tool. The comparison made was between the VasoStasis VCS (as an adjunct to manual compression) and manual compression alone (based on literature control), evaluating device performance and patient outcomes.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

Yes, a form of standalone performance was assessed through bench performance testing and animal studies.

Bench performance testing: Demonstrated that the "System meets or exceeds the performance requirements for the intended clinical use of the device" and "satisfies all of its performance requirements."
Animal studies: Included acute animal studies, chronic animal studies, and device performance verification studies. These evaluated aspects like control of bleeding, promotion of hemostasis, prolonged placement and tension, and specific performance characteristics such as positioning techniques and membrane pull-through force. These studies assess the device's inherent mechanical performance.

7. Type of Ground Truth Used

The "ground truth" for evaluating the clinical performance of the VasoStasis VCS was based on:

Clinical Outcomes Data: Observed device success rates, major complication rates, direct manual compression time, and time to ambulation, as determined by the clinical investigators and recorded during the patient follow-up.
Biocompatibility Testing: Adherence to established ISO standards (ISO 10993-1, ISO 10993-4) for biological evaluation.
Bench Testing: Engineering performance requirements for the device's mechanical function.
Animal Models: In-vivo observations of hemostasis, tissue response, and specific device characteristics.

8. Sample Size for the Training Set

The document does not mention or imply the use of a "training set" in the context of machine learning or AI. This device is a mechanical medical device, and its development and evaluation followed traditional engineering and clinical study methodologies, not machine learning paradigms requiring training sets for algorithm development.

9. How the Ground Truth for the Training Set Was Established

Since there was no "training set" in the machine learning sense, this question is not applicable. The device's design and mechanism are based on mechanical principles and physiological understanding of hemostasis, not on learning from a dataset.

Summary

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OCT 2 2 2004

510(k) SUMMARY Cardiva Medical, Inc. VasoStasis™ Vascular Closure System 510(k) Notification K041486

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

Augustine Lien Contact Person: Founder, Chairman and CEO

Date Prepared: October 15, 2004

DEVICE INFORMATION

Trade name:	VasoStasis™ Vascular Closure System
Classification Names:	Vascular Clamp (21 C.F.R. § 870.4450);Catheter, Intravascular, Diagnostic (21 C.F.R. § 870.1200);Surgical Vessel Dilator (21 C.F.R. § 870.4475);Blood Access Device and Accessories (21 C.F.R. § 870.5540)

Class II Classification:

PREDICATE DEVICES

Radi Medical Systems AB, FemoStop™ System 1.
Instromedix, Inc., COMPRESSAR® Universal System 2.
1. CardioThoracic Systems, Inc., CTS FloCoil™ Shunt
Bio-Vascular, Inc., Flo-Rester® Internal Vessel Occluder 4.

INTENDED USE/INDICATIONS FOR USE

The Cardiva Medical VasoStasis Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

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K041456 3306.

Cardiva Medical, Inc.

VasoStasis™ Vascular Closure System 510(k) Notification

DEVICE DESCRIPTION

The VasoStasis VCS Catheter is a single lumen, low profile catheter with an elastomeric membrane at the distal tip. The membrane is covered by a tip guide, which protects the membrane as the cledeployed catheter is inserted into the artery through a previously placed introducer sheath. A small loon handle is at the proximal end of the device and moves axially to deploy or de-deploy a Nitinol coil within the membrane. Once the catheter is introduced into the vessel, the membrane is positioned distal to the introducer sheath and deployed by pushing the loop handle forward. In its fully deployed state, the membrane nominally achieves 13 F in diameter. The Cardiva VasoStasis VCS Tensioner clips on the VasoStasis VCS Catheter shaft on the surface of the skin at the entrance to the arteriotomy and holds the catheter secure while the membrane is deployed in the vessel.

METHOD OF USE

The VasoStasis VCS Catheter is inserted through a previously placed catheter introducer sheath in its de-deployed state. Once positioned, the VasoStasis VCS Catheter membrane is deployed in the inner lumen of the femoral artery and is physically seated against the arterial wall at the arteriotomy site by the user. The VasoStasis VCS Tensioner is applied to the VasoStasis VCS Catheter on the surface of the skin at the entrance to the arteriotomy to control movement of the membrane and to provide a slight upward tension on the system to ensure that the membrane remains seated against the arteriotomy and hemostasis is maintained. This membrane provides temporary occlusion of the arteriotomy while the natural mechanisms of hemostasis are enacted. Closure of the arteriotomy occurs when the smooth muscle wall of the artery and the fascial tract contract, and the blood remaining in the tract coagulates. The VasoStasis VCS does not have any mechanism to alter or manipulate the natural response of the body, and no part of the device remains in the patient after it is removed.

DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE

Bench performance testing of the VasoStasis Vascular Closure System demonstrated that the System meets or exceeds the performance requirements for the intended clinical use of the device. The results demonstrated that the VasoStasis Vascular Closure System satisfies all of its performance requirements, which are designed to ensure that the System is safe and effective for its intended use.

Biocompatibility testing of all device components and materials was conducted pursuant to FDA's Guidance Document (#G95-1), Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995), which specifically outlines the types of biocompatibility tests that are required based on the nature of the device and the extent and duration of its contact with blood or tissues. Additional tests have also been conducted according to ISO 10993-4, "Biological Evaluation of Medical Devices, Part 4, Selection of Tests for Interaction with Blood." Based on the test results the VasoStasis Vascular Closure System has been demonstrated to be biocompatible.

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VasoStasis™ Vascular Closure System 510(k) Notification

The performance and safety of the VasoStasis Vascular Closure System were evaluated in vivo in The performance and salery of the Passimal studies have been conducted: acute animal studies, a several animal study, as well as device performance verification studies. The acute animal study chionic allinial sudy, as wer as device person to control bleeding and promote evaluations support the sale and effectre ig femoral artery catheterization procedures. The chronic nemostasis at the arteriormy site tonewing thirty to place the device in the femoral artery through an annial study was ochadeted to Nature the device, place it in tension and achieve hemostasis. Three anteral access muroducer sheath aspied of three weeks after which tissue harvests were obtained to allimals were then survived for a person or a virus of healing responses after treatment. Several animal studies were also conducted to evaluate certain performance characteristics of the VCS, including positioning techniques and membrane pull-through force. The animal studies v Co, monamig positioning wonnee and safety of the VasoStasis Vascular Closure System.

Four Cardiva Medical and BioInterventional (former Company) sponsored clinical studies were r our Cardival with the VasoStasis VCS and prior versions of the technology comprising an evaluation of a total of 441 patients (one enrolled but not treated). The four separate clinical studies evaluated the a tour of 11 f ectiveness of the system. Initial clinical evaluations, sponsored by BioInterventional were conducted in Germany and in Canada. These studies were followed by two Non-Significant were conductions in Cormairy and in Callauates, one sponsored by BioInterventional (US I) and one sponsored by Cardiva Medical (US II).

Summaries of the clinical evaluations were provided and the results support the safe and effective use of the current VasoStasis VCS for its intended use. The German clinical evaluation was a postor the carrent & abouting a total of 144 patients. The US II, US I, and Canadian Clinical multies comprised an evaluation of a total of 278 consecutive phase patients. The data obtained from the prospective Canadian Clinical Study was retrospectively analyzed using the same outcome definitions as the US I Studies. The clinical results obtained from the US II, US I and Canadian clinical evaluations demonstrate the safety and effectiveness of the VasoStasis Vascular Closure System as an adjunct to manual compression for providing hemostasis at arteriotomy sites in Cloud of demonstic femoral artery catheterization procedures. This was demonstrated by the observed device success rates (>70%) and low major complication rates (<5%). The average direct manual compression time and the average time to ambulation using the VasoStasis VCS were significantly less as compared to the literature control. The overall time to hemostasis, defined as the tension time plus direct manual compression time, was not decreased. Thus, the VasoStasis Vascular Closure System as an adjunct to manual compression is safe and effective in managing vascular access sites in patients who have had a percutaneous access procedure with a 5 or 6 French introducer sheath.

CONCLUSION

Performance, Biocompatibility, Animal Testing and Clinical Studies conducted demonstrate that the Cardiva Medical VasoStasis Vascular Closure System is safe and effective for its intended use and is substantially equivalent to the predicate devices.

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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 stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

Cardiva Medical, Inc. c/o Mr. Augustine Lien Chairman and CEO 2585 Leghorn Street Mountain View, CA 94043

K041486 Re:

K041460
Cardiva Medical VasoStasis™ Vascular Closure System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: October 6, 2004 Received: October 7, 2004

Dear Mr. Lien:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(ts) premained in the mailer (for the indications
referenced above and have determined the device is substantial in interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device. Amendments for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1976, the chaculeur with the provisions of the Federal Food. Drug, devices that have been recults approval of a proval as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assemble approviaions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the uctives, subject to the genires for annual registration, listing of
general controls provisions of the Act include required withings are inchea general controls provisions of the Act mendo requirements.
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 If your device is classified (see above) mo existing major regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additional controlist Existing includes In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Pederal Regarities in the Federal Register.

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Page 2 - Mr. Augustine Lien

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a subscunnts of the requirements of the Act
that FDA has made a determination that your device with other requirements of the Act that FDA nas made a determination and your and read by other Federal agencies. You must or any Federal statures and regulations administered of registration and listing (21 l
comply with all the Act's requirements, including, but not no registration and isting ( comply with all the Act s requirements, mendants, one tice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR 1 at 607); good manant 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 200); and 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Action S product faction control provisions (occtions (occtions of evice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your douice t I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale and thus, n premarket notheadon. The PDA miding of backand virus, permits 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 If you desire specific advice for your 3010 594-4646. Additionally, for questions on the contact the Office of Complanee at (301) 51 - 11 - 11 - 11 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (301) 394-4639. "Also, picase note the regation management information on your premarket nouthcation (21GF N Far obtained from the Division of Small Manufacturers,
responsibilities under the Act may be obtained from the Division of Small Manufacturers, responsibilities under the Acchiner at its toll-free number (800) 638-2041 or (301) 443-6597 niceriational and Oonbailers://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Vecner

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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KOHILJB6

Cardiva Medical, Inc.

VasoStasis™ Vascular Closure System 510(k) Notification

Indications for Use

510(k) Number (if known): __K041486

Device Name: Cardiva Medical VasoStasis™ Vascular Closure System

Indications For Use:

The Cardiva Medical VasoStasis™ Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis nemosusio at arcertoring brooms tad for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

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

Diana R. Va. Jones

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko4148(e

Page 1 of 1

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).