The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.

Device Description

The preCARDIA System is for use in selectively stopping or controlling blood flow of the inferior and superior vena cava, in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring. The System includes a Balloon Occlusion Catheter (Catheter), Controller and Console. The Catheter has an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.

AI/ML Overview

The provided text is a 510(k) summary for the preCARDIA Occlusion System. It details the device, its intended use, and a comparison with predicate devices. While it lists various performance tests conducted, it does not contain specific acceptance criteria or the reported device performance for an AI/ML-based device.

The document outlines bench testing and an animal study to evaluate the performance of the preCARDIA Catheter. However, it does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes for a test set or data provenance for an AI/ML context.
Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
Details on MRMC studies or a standalone algorithm performance.
The type of ground truth used relevant to AI/ML (e.g., pathology, outcomes data).
Sample size for a training set or how ground truth was established for AI/ML training data.

The text is for a physical medical device (vascular clamp/occlusion system), not an AI/ML algorithm. Therefore, the concepts requested in the prompt, such as "acceptance criteria for an AI/ML model," "training set," "test set," "ground truth," "expert consensus," and "MRMC study," are not applicable to the content provided.

Based on the provided document, I cannot fulfill the request as it pertains to AI/ML device validation. The document describes the regulatory submission for a physical medical device and its associated non-AI/ML performance testing.

Summary

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June 30, 2023

Abiomed Inc. Ken Ryder Sr. Director, Regulatory Affairs 22 Cherry Hill Drive Danvers, Massachusetts 01923

Re: K221294

Trade/Device Name: preCARDIA Occlusion System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: MJN, DQY, DQO Dated: May 31, 2023 Received: May 31, 2023

Dear Ken Ryder:

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 and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

The OHT2: Office of Cardiovascular Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings and Precautions section of the device's labeling:

1. The safety and effectiveness of this device for use in the treatment of heart failure have not been established.

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Furthermore, the indication for use "The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring" must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

	Sincerely,
	William C.
for	Macfarland -S
	Bram Zuckerman, M.D.
	Director
	OHT2: Office of Cardiovascular Devices
	Office of Product Evaluation and Quality
	Center for Devices and Radiological Health

	Digitally signed by William C. Macfarland -S
	Date: 2023.06.30 10:50:45 -04'00'

Enclosure

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Indications for Use

510(k) Number (if known) K221294

Device Name preCARDIA Occlusion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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preCARDIA Occlusion System 510(k) Summary

This summary is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807.92.

A. Application Information

Date Prepared:	June 27, 2023
Submitters Name & Address:	ABIOMED, Inc.22 Cherry Hill DriveDanvers, MA 01923
Contact Person:	J. Kenneth RyderSenior Director, Global Regulatory AffairsPh: 978-646-1707E-mail: kryder@abiomed.com

B. Device Information

Trade or Proprietary Name:	preCARDIA Occlusion System
Regulation Number:	21 CFR 870.4450
FDA Classification:	Class II
Product Code:	MJN, DQY, DQO
Regulation Description:	Vascular Clamp

C. Predicate Device

The predicate device is the NEURESCUE Device (K210358) manufactured by Neurescue Aps. The QXMedical Occlusion Balloon Catheter (K183679) and the CoAxia FloControl Catheter (K090970) serve as reference devices.

The predicate and reference devices have not been subjected to any design-related recall.

D. Device Description:

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an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.

E. Intended Use/Indications for Use:

F. Technological Characteristics Comparison of Subject and Predicate Devices

Feature	Subject Device:preCARDIA Device	Predicate:NeurescueDevice	ReferenceDevice: CoAxiaFloControlCatheter	Reference Device:QX MedicalOcclusion BalloonCatheter
Intended Use	The preCARDIA device isintended for use inselectively stopping orcontrolling blood flow ofthe inferior and superiorvena cava in applicationsincluding perioperativeprocedures in patientsrequiring emergencycontrol of hemorrhage, andfor blood pressuremonitoring.	The Neurescuedevice isintended fortemporaryocclusion of largevessels andblood pressuremonitoringincluding patientsrequiringemergencycontrol ofhemorrhaging.	The CoAxiaFloControlCatheter isintended for usein selectivelystopping orcontrolling flowin the peripheralvasculature,which includesthe descendingaorta.	The OcclusionBalloon Catheter isindicated fortemporary occlusionof large vessels,including the superiorvena cava, inapplications includingperioperativeocclusion andemergency control ofhemorrhage.
GeneralSystemComponents	Occlusion BalloonCatheter	OcclusionBalloon Catheter	OcclusionBalloonCatheter	Occlusion BalloonCatheter
CatheterLumen	10 Fr	7 Fr	7 Fr	8 and 10 Fr
Length	63 and 65 cm workinglengths	72 cm	62 cm workinglength	90 cm shaft length
OcclusionBalloon	32 mm in diameter	30 mm indiameter	32 mm indiameter	36 mm in diameter

A technological characteristics comparison table is provided below.

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Feature	Subject Device:preCARDIA Device	Predicate:NeurescueDevice	Reference Device: CoAxiaFloControlCatheter	Reference Device:QX MedicalOcclusion BalloonCatheter
Balloon	Expandable Polyurethaneocclusion balloon andexpandable Polyurethanedistal floatation balloon	2 expandablePolyurethaneballoonsseparated by 8cm	SingleexpandablePolyurethaneBalloon	Single expandablePolyurethane Balloon
Controller	Control unit that enablesmechanical inflation anddeflation of the occlusionballoon as directed by theuser	Control unit thatenablesmechanicalinflation anddeflation of theocclusion balloonas directed bythe user	Manifold hubthat enablesmanual inflationand deflation ofthe occlusionballoon	Manifold hub thatenables manualinflation and deflationof the occlusionballoon
Mechanism ofAction, General	Inserted manually usingstandard techniques.Indwelling (in vessel) afterinsertion. Occlusion ofvessel occurs onceinitiated by the physician.	Insertedmanually usingstandardtechniques.Indwelling (invessel) afterinsertion.Occlusion ofvessel occursonce initiated bythe physician.	Insertedmanually usingstandardtechniques.Indwelling (invessel) afterinsertion.Occlusion ofvessel occursonce initiated bythe physician.	Inserted manuallyusing standardtechniques.Indwelling (in vessel)after insertion.Occlusion of vesseloccurs once initiatedby the physician.
InflationCyclingCapabilities	Manual and Automatic	Manual	Manual	Manual
Marker Bands	2 platinum-iridium markerbands	3 marker bands	3 platinum-iridium markers	1 marker band

The differences between the subject and the predicate devices in terms of technological characteristics do not raise new questions of safety or effectiveness.

G. Performance Testing

The following performance testing was conducted on the preCARDIA Occlusion System.

Bench Testing:

Visual Inspection and Dimensional Verification ●
System Verification
System Interaction Testing ●
User Validation Testing
Air Leakage Testing
. Liquid Leakage Testing
Leakage - Tubing Set Testing
Static Leakage of Occlusion Balloon with Tubing
Thermistor Testing
Thermodilution Impact Testing

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Occlusion Balloon Diameter to Filling Volume Test ●
Robustness Test of Occlusion Balloon
Torque and Kink Testing
. Burst Pressure Testing
Tensile and Peak Tensile Testing
Crack Pressure Testing ●
. Pressure Transducer Testing
Luer-Compliance Testing
Tensile Strength Testing
. Connector Testing
Inflation and Deflation Time Testing ●
Bend/Kink Resistance Testing
Radiopacity Testing
. 1-hour Occlusion Testing
. Guidewire Tracking Testing
Packaging Validation
Sterilization Validation ●
Shelf Life
Biocompatibility
. Electrical Safety and EMC
Software Verification and Validation ●

An animal study to evaluate the performance of the preCARDIA Catheter in the intended anatomy was performed to demonstrate that the device meets applicable design and performance requirements and is therefore substantially equivalent to the predicate device.

H. Conclusions

Performance testing was completed and showed that the subject device, preCARDIA Occlusion System, met the acceptance criteria and demonstrated substantial equivalence.

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).