The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures.

The LANDMARK REBOA Catheter consists of five elements:

. Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
Catheter Handle (PA 12)
Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
Occluder Balloon (polyurethane)
Guide J-tip (stainless steel, nitinol, acrylic) ●

AI/ML Overview

The provided text is a 510(k) summary for the LANDMARK REBOA Catheter. While it outlines non-clinical testing performed to establish substantial equivalence to a predicate device, it does not contain information about studies involving human readers, AI assistance, or the use of expert consensus for ground truth. This device, a physical medical catheter, is evaluated based on its physical performance characteristics and biocompatibility, not on diagnostic accuracy derived from image analysis or human interpretation.

Therefore, many of the requested points regarding acceptance criteria and studies would not be applicable in this context. The document focuses on demonstrating that the new device performs comparably to a legally marketed predicate device through bench testing and an animal model, rather than validating a diagnostic algorithm's performance.

Here's an attempt to answer the applicable points based on the provided text, with an explanation for the missing information:

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

The document doesn't present a specific table of "acceptance criteria" with quantitative performance metrics for each test in the way one might for a diagnostic AI. Instead, it states that "Performance bench testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system."

The tests performed and implicitly, the criteria for passing them, are:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Balloon Burst Testing: Withstand pressure without bursting.	Met applicable design and performance requirements.
Balloon Inflation/Deflation Testing: Inflate and deflate correctly.	Met applicable design and performance requirements.
Balloon Diameter to Inflation Volume Testing: Consistent diameter for given inflation volume.	Met applicable design and performance requirements.
Occlusion Time Testing: Achieve and maintain occlusion for specified time.	Met applicable design and performance requirements.
Torque Testing: Withstand torsional forces.	Met applicable design and performance requirements.
Kink Diameter Testing: Resist kinking at specific diameters.	Met applicable design and performance requirements.
Fatigue Testing: Withstand repeated stress cycles.	Met applicable design and performance requirements.
Freedom From Leakage Testing: No leaks.	Met applicable design and performance requirements.
Tensile Strength Testing: Withstand pulling forces.	Met applicable design and performance requirements.
Dimensional Testing: Adhere to specified dimensions.	Met applicable design and performance requirements.
Maximum Inflation Volume Testing: Achieve specified max inflation volume.	Met applicable design and performance requirements.
Shelf-Life Testing: Maintain performance over specified shelf life (12 months).	Demonstrated to meet requirements throughout its shelf life.
Simulated Use: Clinically safe for prescription use.	Supported conclusion of clinical safety through simulated use results and risk analysis (ISO 14971:2019).
Biocompatibility (ISO 10993): Safe for patient contact.	Fulfilled requirements for External Communicating Device, Circulating Blood, A-Limited (<24 hr) duration.
Sterilization (EO): Achieve SAL of 10^-6.	Assured using validated EO sterilization method.
Packaging: Maintain sterility and provide physical protection.	Demonstrated appropriate sterilization, stability, and integrity.
In Vivo Performance (Porcine Model): Meet design and performance requirements, substantial equivalence to predicate.	Demonstrated to meet requirements and is substantially equivalent to the predicate device.

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

Test Set Sample Size: Not explicitly stated for each bench test. The "In Vivo Testing" mentions an "acute Porcine model," implying a number of animals were used, but the specific count is not provided.
Data Provenance: The bench testing and simulated use are laboratory-based, not patient data. The In Vivo testing was conducted using a Porcine (pig) model. The country of origin for the data is not specified, but the company is based in Salt Lake City, Utah, USA. The studies are prospective in nature, as they involve testing the manufactured device.

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

Not applicable. This device is a physical medical instrument, and its performance is assessed through engineering and biological in-vivo tests, not through expert interpretation of images or other data for diagnostic accuracy. "Ground truth" for this type of device relates to its physical performance meeting specifications (e.g., does the balloon burst at X pressure, does it occlude the vessel completely).

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

Not applicable. As this isn't an algorithm or diagnostic study relying on human interpretation or consensus, there's no adjudication process as described (e.g., for reconciling differing expert opinions).

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

Not applicable. This device does not involve AI assistance for human readers or interpretation of medical images.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for the device's performance in engineering and biological tests is derived from:

Pre-defined engineering specifications and standards (e.g., pressure tolerances, material properties, dimensional accuracy).
Observed physical and physiological responses in the animal model (e.g., successful occlusion, lack of damage to vessel walls, device integrity after deployment).
Compliance with recognized standards like ISO 14971:2019 (risk analysis) and ISO 10993 (biocompatibility).

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

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

Not applicable. This device is not an AI model.

Summary

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September 19, 2022

Zien Medical Technologies, Inc. Tim Nieman CEO 2757 South 300 West Suite F Salt Lake City, Utah 84115

Re: K214060

Trade/Device Name: LANDMARK REBOA Catheter Regulation Number: 21 CFR 870.4450, 21 CFR 870.1250 Regulation Name: Vascular clamp, percutaneous catheter Regulatory Class: Class II Product Code: MJN, DQY Dated: August 8, 2022 Received: August 10, 2022

Dear Tim Nieman:

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

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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 (OS) 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,

Carmen Gacchina Johnson, PhD for 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) K214060

Device Name LANDMARK REBOA Catheter

Indications for Use (Describe)

The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K214060

Image /page/3/Picture/1 description: The image shows the logo for ZIEN Medical Technologies. The logo consists of an orange circle with a white "Z" inside, and the text "ZIEN Medical Technologies" to the right of the circle. The text is in a sans-serif font and is gray in color. The logo is simple and modern.

510(k) SUMMARY (21 CFR 807.92)

GENERAL INFORMATION

Submitted by:

Owner's Name:	ZIEN Medical Technologies, Inc.
Address:	2757 South 300 West Suite FSalt Lake City, UT 84115
Contact Person:
Name:	Tim Nieman
Title:	Chief Executive Officer
Tel:	+1 (801) 891-8610
Email:	tim.nieman@zienmedical.com
FDA Registration Number:	3009756153
Date Prepared:	September 15, 2022
Trade Name:	LANDMARK REBOA Catheter
Regulation Name:	Vascular Clamp and Percutaneous Catheter
Classification Name:	• 21 CFR §870.4450, Product Code: MJNCatheter, Intravascular Occluding, Temporary• 21 CFR §870.1250, Product Code: DQYPercutaneous Catheter
Classification Panel:	Cardiovascular
Regulatory Class	Class II
Predicate Device:	ER-REBOA™ Catheter (K172790), Manufactured byPrytime Medical Devices, Inc. (Boerne TX)

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DEVICE DESCRIPTION:

The LANDMARK REBOA Catheter consists of five elements:

. Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
Catheter Handle (PA 12)
Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
Occluder Balloon (polyurethane)
Guide J-tip (stainless steel, nitinol, acrylic) ●

INDICATIONS FOR USE:

The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

LABELING AND TECHNOLOGICAL CHARACTERISTICS COMPARISON:

As shown in Table 1, the proposed LANDMARK REBOA Catheter has equivalent intended use and similar technology characteristics to the currently marketed ER-REBOA (K172790). Technological and Intended use differences include the lack of a secondary lumen in the subject device to monitor the patient's blood pressure, which can be monitored through more common means.

	Table 1: Comparison Table
	SUBJECT DEVICE	PREDICATE DEVICE
1. LABELING
Intended use	The LANDMARK REBOACatheter is intended fortemporary occlusion of largevessels including patientsrequiring emergency control ofhemorrhage	The ER-REBOA Catheter isintended for temporary occlusion oflarge vessels and blood pressuremonitoring including patientsrequiring emergency control ofhemorrhage
Rx or OTC	Rx	Same
Target population	Adult patients in need of largevessel occlusion	Same
Contraindications	Known allergic reactions tocontrast media	Same
	Table 1: Comparison Table
	SUBJECT DEVICE	PREDICATE DEVICE
	Do not have a femoral accesssite that can accommodate a 7Fr(minimum) introducer sheathHave an aortic diameter largerthan 30mm	Similar
	Are minors (younger than 18years old)	Same
2. TECHNOLOGY
Use Environment(Where used)	Emergency settings, Pre-hospital, In hospital, Acute Care,Military	Same
Insertion site	Femoral Artery	Same
Insertion depthassessment	Radiographic location usingradio-opaque markers and/orradio-opaque inflation media	Similar; predicate permitsfluoroscopy as optional
Mode of action	The user inserts the catheterthrough femoral access usingdepth marks and/or radiologicalconfirmation of location whereinthe balloon can be inflated usingvolume as indicator to provideocclusion of the vessel.	Same
3. CHARACTERISTICS
Sterile single usecomponents andaccessories	A pre-loaded peel-away sheathis provided to aid introduction ofthe catheter tip into theintroducer sheath.	A peel-away sheath is preloaded onthe catheter shaft to ease insertionof the catheters P-tip into anintroducer sheath hemostasis valve
Lengths offered	59 cm working length	64 cm working length (Similar)
Depth indicatormarkings oncannula	White indicator lines are locatedat 1 cm increments from thecenter of the balloon forassessing insertion depth.	Same
Maximum BalloonDiameter	30mm	32mm (Similar)
Introducer SheathCompatibility	7Fr	Same
Shelf life	12 months (1 year)	3 years
Sterility	Ethylene Oxide (EO), SAL 10-6	Same
BiocompatibilityPer ISO 10993	• External Communicatingdevice• Contacting Circulating Blood• Limited Duration (≤ 24h)	Same

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NON-CLINICAL TESTING

Performance (Bench) and Comparative Testing: Performance bench testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system. The following performance testing listed below was performed or fulfilled with the LANDMARK REBOA Catheter:

. Balloon Burst Testing
Balloon Inflation/Deflation Testing ●
. Balloon Diameter to Inflation Volume Testing
Occlusion Time Testing
Torque Testina ●
Kink Diameter Testing
Fatigue Testing ●
Freedom From Leakage Testing
Tensile Strength Testing
Dimensional Testing
Maximum Inflation Volume Testing
Shelf-Life Testing

Simulated use: Simulated use results provided by ZIEN Medical Technologies, Inc. support the conclusion that the proposed device is clinically safe for prescription use. Furthermore, ZIEN Medical Technologies, Inc. conducted a risk analysis on the proposed system in accordance with ISO 14971:2019. All identified risks have been addressed through device design, verification/validation or through documentation (labeling and Instructions for Use) provided to the user.

Biocompatibility: The patient-contacting (directlindirect fluid path) components of the LANDMARK REBOA Catheter, fulfil the requirements as set forth in:

. ISO 10993: Biological evaluation of medical devices – Part 1: Guidance on selection of tests for and External Communicating Device, Circulating Blood, A-Limited (<24 hr) duration.
Sterilization: The LANDMARK REBOA Catheter is sterilized via ethylene oxide (EO) sterilization. The sterility to a Sterility Assurance Level (SAL) of 10° is assured using a validated EO sterilization method.

Packaging: The sterilization, stability (accelerated aging followed by seal integrity and seal strength testing and package (sealing process) validation results demonstrate that the proposed terminally sterilized packaging system allows sterilization, provides physical protection, maintains sterility up to the point of use and allows aseptic presentation of the LANDMARK REBOA Catheter.

In Vivo Testing: Performance evaluation of the LANDMARK REBOA Catheter was performed in the aorta of an acute Porcine model to demonstrate the catheter meets applicable design and performance requirements and is substantially equivalent to the predicate device.

CONCLUSION OF COMPARISON

Based on the performance testing conducted and provided in this submission, it was concluded that the LANDMARK REBOA Catheter is substantially equivalent to the ER-REBOA (K172790).

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).