The ER-REBOA™ 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™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a compliant occlusion balloon with an atraumatic distal tip (P-tip®), a dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. The catheter has a uni-body design and is designed to be used without a quidewire. 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. The device has an effective length of 72 cm and is compatible with 7 Fr or larger introducer sheaths. The device is a single use sterile device. The distal tip (P-tip®) eases advancement of the catheter in a blood vessel. The compliant occlusion balloon is capable of occluding vessels up to 32 mm in diameter. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate accurate balloon placement. A coaxial catheter shaft provides appropriate stiffness and a dedicated lumen for pressure monitoring distal to the balloon. Pad printed marks on the outer catheter shaft indicate distance to the center of the balloon to facilitate proper placement. The proximal end of the catheter has a hub and extension lines. The stopcocks provide control to each of the catheter's two lumens. The peelaway sheath can be separated from the catheter shaft after insertion if needed.

AI/ML Overview

This is an excellent question that breaks down the specifics needed to understand the validity and scope of a medical device's approval! Unfortunately, the provided text describes the regulatory clearance of a medical device (ER-REBOA™ Catheter) through the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial to establish new safety and effectiveness claims.

Therefore, the document does not contain the detailed information you're asking for regarding acceptance criteria, specific study design elements (like sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI performance). This type of information is typically found in full clinical study reports, scientific publications, or de novo submission summaries, which are not provided here for this 510(k) clearance.

Here's what can be extracted and what cannot:

What the document does provide:

Device Name: ER-REBOA™ Catheter
Purpose of Clinical Data: To demonstrate substantially equivalent safety and effectiveness compared to the predicate device when used as labeled, particularly regarding the added specific indication for "patients requiring emergency control of hemorrhage."
Type of Clinical Data:
1. Real-world clinical data from the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry (prospective).
2. A case series report of ER-REBOA™ Catheter use in an austere military environment.
Outcome Measured: Successful aortic occlusion.
Reported Performance:
- Successful aortic occlusion: 95.7% in the AORTA registry, 100% in the case series.
- No instances of extremity ischemia, distal embolism, or retroperitoneal hemorrhage as complications of the device.

What the document does not provide (and why):

Since this is a 510(k) submission and not a de novo or PMA application with a dedicated clinical trial to establish new performance metrics for a novel technology (like an AI algorithm), the detailed information about acceptance criteria for an AI device, sample sizes for training/test sets, ground truth methodology, expert qualifications, or MRMC studies is not applicable and therefore not present in this document.

The "acceptance criteria" discussed in the document relate to the shelf life extension and demonstrating that the device adheres to the same acceptance criteria used in the original 510(k) after aging equivalent to 3 years (non-clinical testing). For clinical performance, the criterion is essentially "substantial equivalence" to the predicate, supported by the observed success rates and lack of complications.

If this were an AI device, here's how the provided information would map (and what's missing):

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

Acceptance Criteria: Not explicitly stated as quantifiable thresholds for an AI device's specific performance metrics (e.g., "sensitivity ≥ 90%, specificity ≥ 80%"). Instead, the document frames "acceptance" around substantial equivalence and previous 510(k) criteria for device functionality and safety.
Reported Device Performance:
- Successful aortic occlusion: 95.7% (AORTA registry), 100% (case series).
- Complications (extremity ischemia, distal embolism, retroperitoneal hemorrhage): 0%
- This is performance for the catheter itself in its intended use, not an AI's diagnostic performance.

2. Sample sized used for the test set and the data provenance

Test Set Description:
- AORTA Registry: Prospectively identified trauma patients requiring aortic occlusion from eight ACS Level 1 centers.
- Case Series: ER-REBOA™ Catheter use in an austere military environment.
Sample Size (Number of Cases): Not explicitly stated, just that 27.7% of placements in the registry were without medical imaging and 68.1% with plain x-ray, and all case series placements were without medical imaging. This implies a number of patients, but the exact count isn't provided.
Data Provenance: USA (AORTA registry), unspecified "austere military environment."
Retrospective/Prospective: AORTA registry is prospective; case series is likely retrospective reporting, though it's not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. This information is for AI algorithm validation where expert consensus might define the "correct" diagnosis or finding. Here, the "ground truth" for the catheter's performance is whether it successfully occluded the aorta as determined by the treating clinicians in a real-world setting.

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

Not applicable/Not mentioned. This pertains to how disagreements among expert readers are resolved for AI ground truth.

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, not done/not mentioned. This is specific to AI-assisted reading.

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

Not applicable/Not mentioned. The device itself is a physical catheter, not a standalone AI algorithm.

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

Outcomes Data: The "successful aortic occlusion" and "no complications" are based on clinical outcomes observed by the treating medical staff.

8. The sample size for the training set

Not applicable/Not mentioned. There is no AI algorithm being trained.

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

Not applicable/Not mentioned. There is no AI algorithm being trained.

In summary, this document is for a medical device (catheter) clearance and therefore lacks the detailed AI-specific validation information you're seeking.

Summary

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Public Health Service

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April 4, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K170411

Trade/Device Name: ER-REBOA 110 Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN, DQY, DQO Dated: February 8, 2017 Received: February 10, 2017

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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando
Aguel-S

for 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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Indications for Use

510(k) Number (if known) K170411

Device Name ER-REBOA™ Catheter

Indications for Use (Describe)

The ER-REBOA™ 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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5. 510(k) Summary

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

5.1 Submitter Information

Company:
	Prytime Medical Devices, Inc.229 North Main StreetBoerne, Texas 78006 USATelephone: 210-340-0116Fax: 210-558-1860
Contact:	Brian YoungSVP, Quality and Regulatory
	229 North Main Street
	Boerne, Texas
	Telephone: 210-216-3020Fax: 210-558-1860
	byoung@prytimemedical.com
Date Summary Prepared:	March 28, 2017
5.2 Name of the Device
Trade Name:	ER-REBOA™ Catheter
Common Name:	Percutaneous balloon catheter
Classification Name:	Catheter, Percutaneous
Review Panel:	Cardiovascular (CV)
Regulation:	870.4450, 870.1250, 870.1200
Class:	Class II
Product Code:	MJN, DQY, DQO

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5.3 Equivalence Claimed to Predicate Device

The ER-REBOA™ Catheter is equivalent to the ER-REBOA™ Catheter (K151821), manufactured by Pryor Medical Devices, Inc. and the Equalizer Occlusion Balloon Catheter (K140273), manufactured by Boston Scientific Corp.

Device Description

The ER-REBOA™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring.

The device consists of a compliant occlusion balloon with an atraumatic distal tip (P-tip®), a dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. The catheter has a uni-body design and is designed to be used without a quidewire. 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. The device has an effective length of 72 cm and is compatible with 7 Fr or larger introducer sheaths. The device is a single use sterile device.

The distal tip (P-tip®) eases advancement of the catheter in a blood vessel. The compliant occlusion balloon is capable of occluding vessels up to 32 mm in diameter. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate accurate balloon placement. A coaxial catheter shaft provides appropriate stiffness and a dedicated lumen for pressure monitoring distal to the balloon. Pad printed marks on the outer catheter shaft indicate distance to the center of the balloon to facilitate proper placement. The proximal end of the catheter has a hub and extension lines. The stopcocks provide control to each of the catheter's two lumens. The peelaway sheath can be separated from the catheter shaft after insertion if needed.

Principle of Operation

The ER-REBOA™ Catheter is operated manually to occlude large vessels and monitor blood pressure.

Intended Use / Indications for Use

Indications for Use: The ER-REBOA™ Catheter is intended for temporary

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occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

Comparison of Technological Characteristics

The ER-REBOA™ Catheter is identical to the predicate device in terms of technological characteristics. The expiration date is being changed from 1 to 3 years. The labeling changes include minor administrative changes, updated sheath compatibility information, additional options for medical imaging, a clinical data summary, and an update to the indication for use.

The addition of "including patients requiring emergency control of hemorrhaqe" to the indication for use adds an additional specific indication to the existing general indications for use. The device was designed and intended for situations where emergency hemorrhage is ongoing or expected and this is the most common use of the predicate. Accordingly, the indication change does not alter the intended therapeutic, diagnostic, or surqical use of the device and clinical performance data has demonstrated substantially equivalent safety and effectiveness compared to the predicate device when used as labeled.

Performance Data

Nonclinical Testing

The shelf life extension is supported by test data demonstrating that the device and packaging adhere to the same acceptance criteria used in the original 510(k) after aqing equivalent to 3 years.

Clinical Data

Real world clinical data was available for the ER-REBOA™ Catheter and it was derived from: 1) the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry that prospectively identified trauma patients requiring aortic occlusion (AO) from eight ACS Level 1 centers; and 2) a case series report of ER-REBOA™ Catheter use in an austere military environment. All patients were critically injured and required emergency management of hemorrhaqe. 27.7% of the placements in the registry were without medical imaging and 68.1% of placements in the registry were with plain x-ray. All of the device placements in the case series were performed without medical imaging. Successful aortic occlusion with use of the device was achieved in 95.7% of cases in the registry and with all of the patients in the case series. There were

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no instances of extremity ischemia, distal embolism or retroperitoneal hemorrhage as complications of the device.

Conclusions

The ER-REBOA™ Catheter is substantially equivalent to the identified predicate devices.

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).