The Soldier Microcatheter is indicated for use in the blood vessels of the peripheral vasculature. It is intended to assist in the delivery of diagnostic agents and therapeutic agents into the target treatment area.

The Soldier Microcatheter is intended for Prescription Use Only.

Device Description

The Soldier is a single lumen catheter designed to access small, tortuous vasculature. It is available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal tip of the catheter is radiopaque to aid in visualization under fluoroscopy.

AI/ML Overview

This document is a 510(k) summary for the Embolx Soldier Microcatheter, seeking substantial equivalence to a predicate device (Progreat catheter). As such, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through non-clinical testing. It does not contain information about an AI/ML-driven device or a study involving human readers and AI assistance. Therefore, I am unable to provide information on acceptance criteria and study details for an AI/ML device from this document.

The document primarily details the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device through bench testing and biocompatibility assessments, rather than an AI/ML study.

Here's an analysis of the provided text, focusing on the available information regarding the "Soldier Microcatheter" as a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML context):

The document does not present a formal table of "acceptance criteria" versus "reported device performance" in the typical sense of numerical thresholds met by specific metrics from a study. Instead, it lists various non-clinical tests performed and states that "Results from each test met the defined acceptance criteria" for biocompatibility and "All tests met the pre-defined performance criteria" for shelf-life. For design verification, it states "Performance testing was conducted to ensure the safety and effectiveness of the Soldier Microcatheter and to demonstrate substantial equivalence to the predicate device: Progreat catheter."

Below is a summary of the types of tests conducted and the general performance statement, as the specific numerical acceptance criteria and results are not detailed in this public summary.

Acceptance Criteria Category/Test Type	Reported Device Performance (General Statement)
Biocompatibility Testing (ISO 10993-1 series):	"Results from each test met the defined acceptance criteria and support compliance to ISO 10993-1..."
- Cytotoxicity	Met defined acceptance criteria
- Sensitization	Met defined acceptance criteria
- Irritation	Met defined acceptance criteria
- Systemic Toxicity (Acute)	Met defined acceptance criteria
- Hemocompatibility	Met defined acceptance criteria
- Chemical/Material Review	Met defined acceptance criteria
Design Verification (Performance Bench-top Testing):	"Performance testing was conducted to ensure the safety and effectiveness... and to demonstrate substantial equivalence." (Implied all tests met internal criteria for equivalence)
- Visual Inspection	(Implied met criteria)
- Dimensional Verification	(Implied met criteria)
- Hub Integrity	(Implied met criteria)
- Catheter Burst & Leakage Pressure	(Implied met criteria)
- Catheter Flow	(Implied met criteria)
- Tensile Strength	(Implied met criteria)
- Torsion	(Implied met criteria)
- Bend & Buckle ("flexibility and kink test")	(Implied met criteria)
- Materials Test Report	(Implied met criteria)
- Radiopacity ("Radio-detectability")	(Implied met criteria)
- Particulate	(Implied met criteria)
- Simulated Use in Peripheral Vasculature	(Implied met criteria)
- Shipping and Packaging	(Implied met criteria)
- Pouch Seal Strength	(Implied met criteria)
- Pouch Seal Integrity	(Implied met criteria)
- Corrosion Resistance	(Implied met criteria)
Sterilization Validation (EtO, various ISO standards):	"All testing data met the defined acceptance criteria for sterility assurance level (SAL), EtO residuals, bacterial endotoxins and material mediated pyrogenicity..."
Shelf-Life (Accelerated Aging per ASTM F1980):	"All tests met the pre-defined performance criteria." (Validated to 12 months)

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

The document describes non-clinical bench testing. Therefore, the concept of "test set" in the context of data (images, records) for an AI/ML algorithm is not applicable. The sample sizes would refer to the number of physical devices tested for each bench-top, biocompatibility, and sterilization test. These specific numbers are not provided in this summary.

Data Provenance: Not applicable in the context of this non-AI/ML device. The "data" comes from laboratory bench testing of physical devices, not from patient-derived data (e.g., medical images). The testing was for a physical medical device (microcatheter).

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

This is not applicable for a physical medical device. Ground truth, in the context of AI/ML, refers to expert-labeled data for training and evaluating algorithms. For this microcatheter, performance is evaluated through objective physical and chemical tests, not human expert interpretation of data.

4. Adjudication Method for the Test Set:

This is not applicable as there is no human review of "data" from the test set for an AI/ML system. The tests are bench-top, objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This document pertains to a physical medical device (microcatheter), not an AI/ML-driven device or diagnostic tool that would involve human readers interpreting cases.

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

No, this is not applicable. The Soldier Microcatheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For this physical device, "ground truth" doesn't refer to clinical outcomes or expert consensus on patient data. Instead, it refers to:

Established laboratory standards and validated test methods (e.g., ISO 10993, ASTM F1980) for evaluating physical and chemical properties.
Engineering specifications and design requirements for the device, against which performance is measured (e.g., burst pressure, flow rate, dimensions).

8. The Sample Size for the Training Set:

This is not applicable. There is no software algorithm or "training set" for a physical microcatheter.

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

This is not applicable as there is no training set for a physical microcatheter.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

February 23, 2024

Embolx, Inc. Louise Musante Regulatory Compliance Consultant 530 Lakeside Dr. Suite 200 Sunnyvale, California 94085

Re: K232536

Trade/Device Name: Soldier Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: January 18, 2024 Received: January 25, 2024

Dear Louise Musante:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Lydia S.

Glaw -S

Digitally signed by Lydia S. Glaw -S Date: 2024.02.23 20:43:43 -05'00'

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices

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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) K232536

Device Name Soldier Microcatheter

Indications for Use (Describe)

The Soldier Microcatheter is intended for Prescription Use Only.

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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K232536

Section 5 - 510(k) Summary

510(k) Summary Embolx, Inc.'s Soldier

February 23, 2024 DATE PREPARED:

1. COMPANY NAME/CONTACT Embolx, Inc. 530 Lakeside Dr. #200 Sunnyvale, CA 94085

1. CONTACT: Louise Musante Regulatory Compliance Consultant Email: louisemusante@gmail.com Cell Phone: (650) 242-5563

3. DEVICE INFORMATION

Device Trade Name: Soldier Microcatheter Common Name: Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Product Code: DQO Device Class: Class II 510(k) Review Panel: Cardiovascular

4. PREDICATE DEVICE

Trade name: Progreat

510(k) submitter/holder: Terumo Medical Corporation

510(k) Numbers: K033583, K170223

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5. REFERENCE DEVICE USED IN NON-CLINICAL PERFORMANCE TESTING

Sniper Infusion Catheter with Balloon Occlusion (K180904)

6. DEVICE DESCRIPTION

7. INDICATION FOR USE STATEMENT

The Soldier Microcatheter is intended for Prescription Use Only.

8. INTENDED USE STATEMENTS:

The Soldier is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities. The Soldier is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis.

The Soldier is contraindicated for use in the cerebral and coronary vessels. It is not intended for use in embolectomy or angioplasty procedures.

9. SUBSTANTIAL EQUIVALENCE COMPARISON

The Soldier catheter is substantially equivalent to the claimed predicate device; the Progreat catheter (K033583), based on comparisons of the intended use and technological characteristics.

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Table 1 – Comparison Table of Subject Device to Predicate Device

Attributes	Soldier(Subject Device)	Progreat Catheter(Predicate Device)(K033583)	Differences	Differencesraise anyadditionalsafety issues?
General Information
Regulation #	21 CFR 870.1200	21 CFR 870.1200	Same	N/A
RegulationName	Diagnostic IntravascularCatheter	Diagnostic Intravascular Catheter	Same	N/A
RegulatoryClass	Class II	Class II	Same	N/A
Product Code	DQO	DQO	Same	N/A
Indicationsfor Use	The Soldier Microcatheter isindicated for use in the bloodvessels of the peripheralvasculature. It is intended toassist in the delivery ofdiagnostic agents andtherapeutic agents into thetarget treatment area.The Soldier Microcatheter isintended for Prescription UseOnly.	The Progreat is intended for theinfusion of contrast media into allperipheral vessels up to andincluding the cervical vessels, allvessels in the lower and upperextremities and all coronaryvessels. The Progreat is alsointended for drug infusion in intra-arterial therapy and the infusionof embolic materials forhemostasis. The Progreat shouldnot be used in cerebral vessels.	Soldiershould notbe used incoronaryvessels. It isalso notintended foruse inembolectomyorangioplastyprocedures.	No

Table 2 – Comparison Table of Technological Characteristics: Subject Device to Predicate Device

	Attributes	Soldier(Subject Device)	Progreat Catheter(Predicate Device)(K033583)	Differences	Differencesraise anyadditionalsafetyissues?
	Device Specifications
Catheter	Catheter SizeFr (mm)	2.0 Fr (0.67 mm)2.5 Fr (0.84 mm)	2.0 Fr (0.67 mm)2.4 Fr (0.80 mm)2.7 Fr (0.90 mm)2.8 Fr (0.93 mm)	Dimensions	None
	Catheter ODDistal EndFr (mm)	2.0 Fr (0.67 mm)2.5 Fr (0.84 mm)	2.0 Fr (0.67 mm)2.4 Fr (0.80 mm)2.7 Fr (0.90 mm)2.8 Fr (0.93 mm)	Dimensions	None
Attributes	Soldier(Subject Device)	Progreat Catheter(Predicate Device)(K033583)	Differences	Differencesraise anyadditionalsafetyissues?
Catheter ODProximal EndFr (mm)	2.0 Fr (0.67 mm)2.5 Fr (0.84 mm)	2.7 Fr (0.90 mm)2.9 Fr (0.97 mm)2.9 Fr (0.97 mm)3.0 Fr (1.00 mm)	Dimensions	None
Maximum ODFr (mm)	2.5 Fr (0.84 mm)2.9 Fr (0.97 mm)	2.7 Fr (0.90 mm)2.9 Fr (0.97 mm)2.9 Fr (0.97 mm)3.0 Fr (1.00 mm)	Dimensions	None
CatheterEffectiveLengths	130 cm155 cm	100 cm110 cm130 cm150 cm	Dimensions	None
Tip Design	Atraumatic	Atraumatic	None	N/A
Hub Design	Female Luer, TaperedFunnel Access	Female Luer, TaperedFunnel Access	None	N/A
HydrophilicCoating Length(Catheterlength/Coatinglength, from thedistal tip)	130 cm/ 70 cm155 cm/ 70 cm	100 cm/ 50 cm110 cm/ 50 cm130 cm/ 70 cm150 cm/ 90 cm	Dimensions	None
Coating	Hydrophilic Coating	Hydrophilic coating	None	N/A
Guidewire	Wire Diameter	Up to 0.018"	Up to 0.021"	Dimensions	None
Accessories		None	Packaged with:GuidewireGuidewire InserterCatheter Mandrel (stylet)2.5mL Syringe with LockWire StopperCatheter Stopper XSHemostatic Valve	SoldierpackagedwithoutAccessories	None
General Information
Design/Construction	Single lumen catheterconsisting of metal coilreinforced multi-layerpolymer tubing withhydrophilic coating.	Single lumen catheterconsisting of metal coilreinforced multi-layerpolymer tubing withhydrophilic coating.	None	N/A
Pouch	Polyester/Polyethylene/Tyvek*	Unknown	N/A	N/A
Attributes	Soldier(Subject Device)	Progreat Catheter(Predicate Device)(K033583)	Differences	Differencesraise anyadditionalsafetyissues?
Hoop	Polyethylene	Unknown	N/A	N/A
Display Carton	SBS Paperboard	Unknown	N/A	N/A
Configuration	Single Use/Disposable	Single Use/Disposable	None	N/A
Sterilization	EtO	EtO	None	N/A
Shelf-life	12 months	24 months	SoldierShelf LifeValidated to12 Months	No

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Section 5 – 510(k) Summary

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Section 5 - 510(k) Summary

10. SUMMARY OF TECHNOLOGICAL DIFFERENCES

Indications for Use:

The subject device: Soldier Microcatheter, has been validated for use in the blood vessels of the peripheral vasculature, with the exception of the coronary vessels. It is also not intended for use in embolectomy or angioplasty procedures. The limitations of use for the Soldier Microcatheter are clearly identified as contraindications in the product label. The predicate device: Progreat catheter, has been cleared for use in the peripheral vasculature, including the coronary vessels. It is also cleared for the infusion of embolic materials for hemostasis.

The differences described do not raise any additional safety or efficacy concerns for the subject device as the indications for use of the subject device, falls within the intended use of the cleared predicate device, therefore the two devices have the same intended use.

Dimensions:

The subject device: Soldier Microcatheter, offers fewer catheter configurations than the cleared predicate device: Progreat catheter. However, the catheter sizes, with the exception of the 155 cm length, fall within the largest and smallest catheter dimensions cleared to market for the predicate device. Performance data for the longer catheter length, in addition to the other sizes, support the substantial equivalency claim and therefore do not raise any additional safety or efficacy concerns for the subject device.

Accessories:

The subject device: Soldier Microcatheter, is packaged without accessories, unlike the predicate device: Progreat catheter, which is packaged with a guidewire, a guidewire

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inserter, a catheter mandrel (stylet), a 2.5mL syringe with lock, a wire stopper, a catheter stopper XS, and a hemostatic valve. Performance testing for the Soldier Microcatheter was performed using a third-party guidewire without incidence. Device compatibility specifications are outlined in the product labeling. Therefore, the absence of accessories packaged with the subject device, does not raise any additional safety or efficacy concerns for the subject device.

Shelf-life:

The subject device: Soldier Microcatheter, has been validated to a shelf-life of 12months (1 year) though accelerated aging, which will be included on the product label. The predicate device: Progreat catheter, has been validated to a shelf-life of 24-months (2 years). The difference in shelf-life does not raise any additional safety or efficacy concerns for the subject device.

11.SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990. A summary of any information regarding substantial equivalence of the device follows.

Included in this section are summary descriptions of the testing which substantiates the performance of the subject device: Śoldier Microcatheter as well as its substantial equivalence to the predicate device: Progreat;

Biocompatibility Testing ●
Design Verification (Performance Bench-Top Testing) ●
Sterilization Validation
Shelf-life
a) Biocompatibility Testing

Biocompatibility testing was conducted in accordance with the FDA recognized consensus standard; ISO 10993-1, Biological Evaluation of Medical Devices, Part 1 Evaluation and Testing within a risk management process (recognition #2-258), to ensure that patient contact materials are biocompatible for their intended use. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. Testing included the following:

Cytotoxicity: Cytotoxicity using the ISO L929 MEM Elution Test
Sensitization: ISO Kligman Maximum Sensitization Test A
Irritation: ISO Intracutaneous Injection Test
A Systemic Toxicity (Acute): ISO Systemic Injection Test, ISO Rabbit Pyrogen Test
Hemocompatibility: ASTM Partial Thromboplastin Time (PTT) Test; ISO C3a and SC5b-9 Complement Activation Test; ISO Dog Thrombogenicity Study in

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Dogs Test

Chemical/Material Review A
Results from each test met the defined acceptance criteria and support compliance to ISO 10993-1, Biological Evaluation of Medical Devices, Part 1 Evaluation and Testing within a risk management process (recognition #2-258).
b) Design Verification (Performance Bench-top Testing)
Performance testing was conducted to ensure the safety and effectiveness of the Soldier Microcatheter and to demonstrate substantial equivalence to the predicate device: Progreat catheter. The following bench tests were:
A Visual Inspection
Dimensional Verification A
Hub Integrity A
A Catheter Burst & Leakage Pressure
Catheter Flow A
Tensile Strength
Torsion
Bend & Buckle ("flexibility and kink test") A
Materials Test Report
Radiopacity ("Radio-detectability")
Particulate >
Simulated Use in Peripheral Vasculature
Shipping and Packaging >
Pouch Seal Strength A
Pouch Seal Integrity
Corrosion Resistance A
c) Sterilization

Sterilization of the subject device: Soldier catheter, is performed using ethylene oxide, an established sterilization method, as identified in the FDA guidance; Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, January 21, 2016. The predicate device: Progreat catheter, is also sterilized using ethylene oxide.

All testing data met the defined acceptance criteria for sterility assurance level (SAL), EtO residuals, bacterial endotoxins and material mediated pyrogenicity, in accordance with the FDA recognized consensus standard; ISO 10993-7:2008, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (recognition #2-275), in addition to other international sterility standards.

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d) Shelf-Life
A shelf-life of 12 months (1 year) has been validated though accelerated aging of the subject device: Soldier catheter. The predicate device: Progreat catheter, has been validated to 24 months (2 years). Testing was conducted on final device assemblies, packaged, and sterilized with ethylene oxide. Testing was performed in accordance with the FDA recognized consensus standard; ASTM F1980:2016: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (recognition # 14-497). All tests met the pre-defined performance criteria.

12. CONCLUSION

Embolx, Inc. believes that the Soldier Microcatheter is substantially equivalent in intended use and technological characteristics to the Progreat catheter (K033583). The Soldier catheter therefore meets the Federal Food, Drug and Cosmetic Act criteria for 510(k) clearance of this device.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).