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

Device Description

The ER-REBOA™ PLUS Catheter is a large vessel occlusion catheter. The device consists of an atraumatic distal tip (P-tip®), a compliant occlusion balloon and catheter shaft with a built-in central lumen for blood pressure monitoring. The catheter has a uni-body design and is intended to be placed and advanced without a guidewire. However, the catheter is compatible with straight tipped guidewires up to 0.025″ and may be used with a guidewire if desired to facilitate subsequent vascular procedures. The catheter contains two lumens which traverse the length of the catheter and connect to extension lines with stopcocks. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. Radiopaque marker bands are located on the catheter at the balloon to assist with positioning under fluoroscopy. A peel-away sheath is pre-loaded on the catheter shaft to ease insertion of the catheter's P-tip® into an introducer sheath hemostasis valve.

AI/ML Overview

This submission (K193440) describes the clearance of the ER-REBOA™ PLUS Catheter, which is an updated version of the predicate ER-REBOA™ Catheter (K172790). The primary change in the new device is the ability to be used with a 0.025" or smaller guidewire, which the predicate device could not accommodate.

The provided text discusses Performance Data but does not present a formal table of acceptance criteria and reported performance with quantitative values. However, it states that "Testing demonstrated that the changes had the desired effect, i.e., to allow passage of a 0.025″ or smaller straight-tip guidewire, but no unintended adverse effects." This implies that the device met the acceptance criteria for the tested performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or reported values. The information below is inferred from the description of the performance testing.

Acceptance Criterion	Reported Device Performance
Tensile Strength	(Implied: Met established requirements for tensile strength, confirming structural integrity after modifications)
Blood Pressure Monitoring Functionality	(Implied: Maintained accurate blood pressure monitoring functionality)
Guidewire Compatibility (0.025" or smaller)	Demonstrated successful passage of a 0.025" or smaller straight-tip guidewire without adverse effects.

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

Sample Size: The document does not specify the sample size used for the bench tests (tensile strength, blood pressure, guidewire compatibility).
Data Provenance: The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given that it's bench testing, it is likely laboratory-based and conducted by the manufacturer.

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

Not Applicable. The described performance testing (tensile strength, blood pressure, guidewire compatibility) are bench tests that do not typically require expert interpretation of results to establish ground truth in the same way clinical imaging studies do. The ground truth would be based on direct measurements and adherence to engineering specifications.

4. Adjudication Method for the Test Set

Not Applicable. Since the tests described are bench tests and not clinical studies requiring human interpretation of outputs, an adjudication method for a test set is not relevant here.

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

No. The document does not mention an MRMC comparative effectiveness study. The submission describes bench testing for a device modification, not AI performance.

6. Standalone (Algorithm only without human-in-the-loop) Performance

Not Applicable. This device is a physical medical catheter, not an algorithm or AI system, so standalone algorithm performance is not relevant.

7. Type of Ground Truth Used for Performance Testing

The ground truth for the performance testing (tensile strength, blood pressure, guidewire compatibility) would be based on engineering specifications, physical measurements, and functional verification according to predetermined test protocols. For example, guidewire compatibility would be demonstrated by the physical ability of the specified guidewire to pass through the catheter.

8. Sample Size for the Training Set

Not Applicable. This is a medical device, not an AI or machine learning model, so there is no "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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January 9, 2020

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

Re: K193440

Trade/Device Name: ER-REBOA PLUS Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: MJN, DQY, DQO Dated: December 5, 2019 Received: December 11, 2019

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

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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 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 Gacchina Johnson 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)

K193440

Device Name ER-REBOA™ PLUS Catheter

Indications for Use (Describe)

The ER-REBOA™ PLUS 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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K193440 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:	October 10, 2019
Name of the Device:
Trade Name:	ER-REBOA™ PLUS 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:	Special 510(k)
Predicate device:

The ER-REBOA™ PLUS Catheter claims substantial equivalence to the ER-REBOA™ Catheter (K172790), manufactured by Prytime Medical Devices, Inc.

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Device Description

Principle of Operation

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

Comparison of Technological Characteristics

Compared to the predicate ER-REBOA Catheter (K172790), the subject ER-REBOA PLUS Catheter is a modified device to enable the catheter to be used with a 0.025″ or smaller guidewire, whereas the predicate ER-REBOA Catheter is not guidewire compatible. This modification does not raise different questions of safety and effectiveness and can be evaluated with performance testing.

Performance Data

Risk assessment pursuant to ISO 14971 was performed to assess the impact of the change to enable guidewire compatibility and results of the analysis. The following bench testing was performed: tensile strength; blood pressure; and guidewire compatibility. Testing demonstrated that the changes had the desired effect, i.e., to allow passage of a 0.025″ or smaller straight-tip guidewire, but no unintended adverse effects. Accordingly, the results support substantial equivalence of the ER-REBOA™ PLUS Catheter to the 510(k) cleared predicate.

Conclusions

The ER-REBOA™ PLUS 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).