The pREBOA-PRO™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

Device Description

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The pREBOA-PRO™ Catheter balloon is designed with flow channels to enable the clinician precise, smooth control during inflation and deflation. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use. The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a quidewire. In addition, the catheter is compatible with guidewires up to 0.025" that can be used to facilitate subsequent vascular procedures affer a REBOA procedure. A peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line Pressure Relief (safety) Valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The peel-away sheath can be separated from the catheter shaft affer insertion if needed. The device is a single-use, sterile device.

AI/ML Overview

The pREBOA-PRO Catheter is a medical device intended for temporary occlusion of large vessels and blood pressure monitoring, particularly in patients requiring emergency control of hemorrhage. The provided document is a 510(k) summary, which indicates that the device is seeking substantial equivalence to a legally marketed predicate device (ER-REBOA™ Catheter, K172790).

The document details performance data including various bench and in vivo animal tests to demonstrate the safety and effectiveness of the modifications made to the pREBOA-PRO Catheter compared to its predicate. Additionally, a retrospective clinical study using the predicate device is summarized to support the concept of partial REBOA, which the pREBOA-PRO Catheter is designed to facilitate with improved control.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance values for the pREBOA-PRO Catheter in a pass/fail format. Instead, it lists various "in vitro bench tests" and "in vivo animal tests" that were performed to demonstrate that the device "meets applicable design and performance requirements."

However, based on the types of tests mentioned, we can infer some of the performance aspects that were evaluated. For a medical device submission seeking substantial equivalence, "acceptance criteria" are often implicitly linked to demonstrating performance comparable to the predicate device and meeting recognized standards.

Here's a generalized table reflecting the types of performance assessed, acknowledging that specific numerical criteria are not provided in this summary:

Performance Aspect	Reported Device Performance (Implied)
Mechanical Integrity & Durability
Balloon Burst / Freedom from fragmentation	Meets requirements
Fatigue (inflation/deflation cycle)	Meets requirements
Tensile Strength	Meets requirements
Kink Diameter	Meets requirements
Corrosion Resistance	Meets requirements
Functional Performance
Balloon Inflation/Deflation Time	Meets requirements
Occlusion Time	Meets requirements
Peel-away Sheath Peelability	Meets requirements
Compatibility (Guidewire, Sheath, Luer)	Compatible as specified
Torque	Meets requirements
Dimensional Accuracy	Meets requirements
Balloon Occlusion Volume to Inflation Dia.	Meets requirements
Freedom from Leakage	Meets requirements
Printed Mark Legibility	Meets requirements
Pressure Relief Valve (Max. pressure, Dislodgement)	Meets specifications and functions
Pressure Response	Accurate pressure monitoring
Simulated Use (ex-vivo porcine, over-inflation, burst)	Meets safety and performance requirements
Repeatability & Reliability of Flow Char.	Consistent and controlled flow
Balloon Working Length Characterization	Characterized as designed
Balloon Internal Pressure Analysis	Supports PRV specifications
Aortic Depth / Diameter Range Analysis	Supports zone depth markings and occlusion capabilities
Biocompatibility	Meets ISO 10993-1 and FDA Guidance
Sterilization	Achieves SAL of 1 x 10^-6
In Vivo Performance (Animal Studies)
Performance Evaluation (porcine aorta)	Safe and effective in animal model
Thrombogenicity Study (ovine aorta)	Safe (low thrombogenicity)

It's crucial to note that the specific numerical targets or thresholds for "meets requirements" are not detailed in this summary. These would typically be found in the full submission to the FDA.

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

The document describes two main categories of studies:

Bench and Animal Tests (for pREBOA-PRO Catheter itself):
- Sample Size: Not explicitly stated for individual bench tests (e.g., how many catheters were tested for burst strength, fatigue, etc.).
- Data Provenance: Not explicitly stated for the bench tests. For the in vivo animal tests, they were conducted using porcine and ovine models. These are prospective animal studies designed to evaluate the new device.
Clinical Study (Retrospective, using the predicate ER-REBOA™ Catheter):
- Sample Size: 46 patients were included in the retrospective clinical study.
- Provenance: This was a retrospective analysis of data collected from a local prospectively collected database at a major US trauma center. The data was collected between January 2016 and May 2019. The information indicates the data is from the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not provided in the document.

For the retrospective clinical study, the "ground truth" would generally be established by clinical outcomes and diagnoses within the patient medical records. The study refers to "electronic data and local REBOA registry", implying that medical professionals (e.g., trauma surgeons, intensivists) made the clinical decisions and recorded outcomes. However, the exact number and qualifications of experts involved in data abstraction, adjudication, or "ground truth" determination for the study are not specified.

For the animal studies, the "ground truth" is measured physiological responses and observations, typically assessed by veterinarians and research personnel. Their specific qualifications are not mentioned.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

For the retrospective clinical study, it's unclear if any formal adjudication process was used to resolve discrepancies in patient data or outcomes. For bench and animal studies, "adjudication" in the sense of expert consensus on outcomes is less common; results are typically based on objective measurements and observations by the study team.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device (pREBOA-PRO Catheter) is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human "readers" interpreting cases with or without AI assistance. Therefore, the concept of "effect size of how much human readers improve with AI" is not applicable here.

The document discusses the clinical effectiveness of a technique (REBOA, specifically partial REBOA) and the device's role in facilitating that technique, but not cognitive assistance.

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

No, this refers to a physical medical device, not a standalone algorithm. The "performance data" section details the device's mechanical, functional, and biological performance characteristics, evaluated through bench and animal testing. These are assessments of the device itself, akin to "standalone" performance for a physical product.

7. The Type of Ground Truth Used:

For Bench Tests: The "ground truth" for bench tests is based on engineering specifications, recognized standards, and objective measurements of the device's physical and functional properties. For example, "balloon burst" would have an objective standard for acceptable pressure.
For Animal Studies: The "ground truth" is based on physiological measurements (e.g., blood pressure, blood flow), observed performance (e.g., occlusion success, ease of deployment), and pathological findings from the animal models. This is considered outcomes data from an experimental setting.
For Retrospective Clinical Study (using predicate device): The "ground truth" was derived from patient medical records, clinical outcomes data (e.g., mortality, organ failure, ventilator days, dialysis, vasopressor requirements), and the local REBOA registry. This is essentially retrospective clinical outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable in the conventional sense for this type of device submission.

The pREBOA-PRO Catheter is a physical medical device. It does not employ machine learning algorithms that require a "training set" of data.
The "Performance Data" describes validation and verification testing, not a training process.
The "Real World Evidence" clinical study using the predicate device is an observational study of clinical outcomes, not a dataset used for "training" an algorithm.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no "training set" in the context of an AI algorithm described for this device. The "ground truth" for the device's design and testing (as described in point 7) was established through engineering principles, adherence to standards, and direct measurement in laboratory and animal settings, and for the retrospective study, through recorded clinical outcomes.

Summary

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June 3. 2020

Prytime Medical Devices, Inc. Brian Young SVP, Quality and Regulatory 229 North Main Street Boerne. Texas 78006

Re: K200459

Trade/Device Name: pREBOA-PRO Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN, DQY, DQO Dated: February 21, 2020 Received: February 25, 2020

Dear Brian Young:

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. 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.

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

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devices or post-marketing 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 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.

for Carmen Johnson, Ph.D. Assistant Director DHT2B: Division of Circulatory Support. Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200459

Device Name pREBOA-PRO Catheter

Indications for Use (Describe)

The pREBOA-PRO Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

Type of Use (Select one or both, as applicable)X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image contains the logo for Prytime Medical, which is a medical company. The logo consists of a red symbol that looks like a stylized person with arms raised, surrounded by a gray and blue swoosh. To the right of the symbol, the words "PRYTIME MEDICAL" are written in blue, with "PRYTIME" in a larger, bolder font than "MEDICAL". Below the logo is the text "The REBOA Company" in a smaller, bolder font.

510(k) Summary

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

Company:	Prytime Medical Devices, Inc.229 North Main StreetBoerne, TX 78006
Contact:	Brian YoungSVP, Quality and RegulatoryPrytime Medical Devices, Inc.Tel: (210) 340-0116FAX: (210) 558-1860Email: byoung@prytimemedical.com
Date Summary Prepared:	June 2, 2020
Name of the Device:
Trade Name:	pREBOA-PRO™ Catheter
Common Name:	Occlusion balloon catheter
Classification Name:	Vascular Clamp
Review Panel:	Cardiovascular (CV)
Regulation:	870.4450, 870.1250, 870.1200
Class:	II
Product Code:	MJN, DQY, DQO
Submission Type:	Traditional 510(k)

Predicate device:

The pREBOA-PRO™ Catheter claims substantial equivalence to the ER-REBOA™ Catheter, 510(k) number K172790, manufactured by Prytime Medical Devices, Inc.

Device Description

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief

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valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen.

The pREBOA-PRO™ Catheter balloon is designed with flow channels to enable the clinician precise, smooth control during inflation and deflation. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use.

The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a quidewire. In addition, the catheter is compatible with guidewires up to 0.025" that can be used to facilitate subsequent vascular procedures affer a REBOA procedure. A peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line Pressure Relief (safety) Valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The peel-away sheath can be separated from the catheter shaft affer insertion if needed. The device is a single-use, sterile device.

Principle of Operation

The pREBOA-PRO™ Catheter is operated manually to occlude large vessels and monitor blood pressure via an arterial fluid line connection to an external blood pressure monitor.

Indications for Use

The pREBOA-PRO™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

Comparison of Technological Characteristics with the Predicate Device

The pREBOA-PROT™ Catheter is identical to the predicate device in terms of intended use and basic technological characteristics. The pREBOA-PRO™ Catheter employs the same basic technologies as the identified predicate including:

Large Vessel Occlusion with inflatable / deflatable occlusion balloon .
. Fluid column pressure monitoring

The pREBOA-PRO™ Catheter has the following differences from the predicate device:

Guidewire compatibility, including a corresponding P-tip™ change •
Semi-compliant balloon with in-line Pressure Relief (safety) Valve
. Smaller maximum inflation diameter and larger maximum inflation volume
. Longer mounted balloon length

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Improved flow characteristics
Two-sided outer shaft markings with indication of average Aortic Zone depth

Performance bench and in vivo (animal) testing was performed to support the safety and effectiveness of these modifications. The results of these tests demonstrate that the pREBOA-PRO™ Catheter has been designed and tested to conform to its intended use and is comparable to the predicate device. The modifications do not raise different questions of safety and effectiveness, and can be evaluated with performance testing. As such, it claims substantial equivalence to the predicate device.

Performance Data

The following in vitro bench tests were performed to demonstrate that the pREBOA-PRO™ Catheter meets applicable design and performance requirements and is therefore equivalent to its predicate device:

. Balloon Burst / Freedom from fragmentation testing
. Balloon inflation / deflation time testing
. Occlusion time testing
. Peel-away sheath peelability testing
. Compatibility testing (Guidewire, Sheath, Catheter Tag, and Luer)
Torque testing
. Fatigue (inflation/deflation cycle testing)
. Tensile strength testing
. Dimensional testing
Balloon occlusion volume to inflation diameter testing
. Kink diameter testing
Freedom from leakage testing
. Printed mark legibility testing
Pressure relief valve testing (max. pressure and dislodgement)
. Corrosion resistance testing
Pressure response testing ●
Simulated use testing (ex-vivo porcine aorta over-inflation and burst testing)
. Repeatability and reliability testing of flow characteristics (flow loop, Smooth Control Testina)
. Balloon working length characterization testing
. Balloon internal pressure analysis to support Pressure Relief Valve specifications

The following engineering analyses were performed: aortic depth analysis in the target patient population to support zone depth markings on the catheter shaft; and aortic diameter range analysis in the target patient population to support the maximum occlusion capabilities of the pREBOA-PRO™ balloon.

The pREBOA-PRO™ Catheter is categorized as an externally communicating device of limited contact (≤24 hours) with circulating blood, according to ISO 10993-1:2018 and the 2016 FDA Biocompatibility Guidance. Acceptable biocompatibility test results were obtained in accordance with the ISO 10993-1 Standard and FDA Guidance.

The pREBOA-PRO™ Catheter is sterilized by Ethylene Oxide to an SAL of 1 X 10-6 Sterilization validation was performed in accordance with the recognized consensus standard ANSI AAMI ISO 11135:2014 Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices. 3 of 4

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The following in vivo animal tests were performed to demonstrate that the pREBOA-PRO™ Catheter meets applicable design and performance requirements and is therefore substantially equivalent to the predicate device:

GLP Performance Evaluation of the pREBOA-PRO™ Catheter in the Aorta . of an Acute Naïve Porcine.
. A GLP Thrombogenicity Study in the Ovine Aorta

Real World Evidence was obtained from a retrospective analysis of data collected from a local prospectively collected database which included consecutive patients who received REBOA for hemorrhagic shock at a major US trauma center between January 2016 and May 2019. Additional data was collected from the patient's medical records. The predicate ER- REBOA™ Catheter was used to perform the REBOA procedures in this study. This data was used to demonstrate feasibility, safety and effectiveness of partial occlusion compared to total occlusion. Corresponding bench and animal test data was used to demonstrate that the pREBOA-PRO Catheter™ is an improved tool allowing clinicians greater ability to control blood flow by the balloon. A brief summary of the study follows:

Initial Clinical Use of Partial Resuscitative Endovascular Balloon Occlusion of the Aorta in a High-Volume Trauma Center.

Clinical Study Summary

Introduction

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used to temporize patients with infradiaphragmatic hemorrhage. Current guidelines advise <30 minutes, to avoid ischemia/ reperfusion iniury. whenever possible. The technique of partial REBOA (P-REBOA) has been developed to minimize the effects of distal ischemia. This study presents clinical experience with P-REBOA, comparing outcomes to complete occlusion (C-REBOA).

Patients and Methods

Retrospective analysis of patients' electronic data and local REBOA registry between January 2016 and May 2019. The Prytime ER-REBOATM Catheter was used to perform REBOA. Inclusion criteria: adult trauma patients who received Zone I C-REBOA or P-REBOA for infradiaphragmatic hemorrhage, who underwent attempted exploration in the operating room. Comparison of outcomes Based on REBOA technique (P-REBOA vs C-REBOA) and occlusion time (>30 min. vs. ≤30 min.).

Results

46 patients were included, with 14 treated with P-REBOA. There were no demographic differences between P-REBOA or C-REBOA. Prolonged (>30 min) REBOA (regardless of tvpe of occlusion) was associated with increased mortality (32% vs 0%, p=0.044) and organ failure. When comparing prolonged P-REBOA with C-REBOA, there was a trend towards lower ventilator days- median (IQR) (19 (11) vs 6 (9): p=0.483) and dialysis (36.4% vs 16.7%; p=0.228) with significantly less vasopressor requirement (72.7% vs 33.3%; p=0.026).

Conclusion

This study demonstrates that REBOA > 30 min. in Zone 1 is associated with increased mortality and need for organ support, while prolonged P-REBOA is associated with less organ failure than C-REBOA might be a useful tool in safely prolonging REBOA, while avoiding the detrimental consequences of prolonged complete occlusion.

Conclusions

The pREBOA-PRO™ Catheter is substantially equivalent to the predicate device.

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).