(186 days)
No
The summary describes a physical medical device (microcatheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
The microcatheter is indicated to assist in the delivery of diagnostic agents and therapeutic agents, meaning it is a delivery device and not therapeutic itself.
No
Explanation: The device is a microcatheter intended to assist in the delivery of diagnostic and therapeutic agents, not to perform the diagnostic function itself. It's an interventional tool, not a diagnostic one.
No
The device description clearly states it is a "single lumen catheter" made of physical materials like PTFE and has a hydrophilic coating and a radiopaque tip, indicating it is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Soldier Microcatheter Function: The Soldier Microcatheter is a device used within the body (in vivo) to deliver diagnostic or therapeutic agents. It is a tool for accessing and treating the peripheral vasculature, not for analyzing samples taken from the body.
The description clearly states its purpose is to "assist in the delivery of diagnostic agents and therapeutic agents into the target treatment area" within the blood vessels. This is an interventional device, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
DQO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
blood vessels of the peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use Only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1. Results met defined acceptance criteria.
- Design Verification (Performance Bench-top Testing): Performed to ensure safety and effectiveness and demonstrate substantial equivalence to predicate device. Bench tests included Visual Inspection, Dimensional Verification, Hub Integrity, Catheter Burst & Leakage Pressure, Catheter Flow, Tensile Strength, Torsion, Bend & Buckle, Materials Test Report, Radiopacity, Particulate, Simulated Use in Peripheral Vasculature, Shipping and Packaging, Pouch Seal Strength, Pouch Seal Integrity, Corrosion Resistance.
- Sterilization: Performed using ethylene oxide in accordance with FDA guidance and ISO 10993-7:2008. All testing data met defined acceptance criteria.
- Shelf-Life: Validated for 12 months through accelerated aging in accordance with ASTM F1980:2016. All tests met pre-defined performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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"
1
(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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232536
Device Name Soldier Microcatheter
Indications for Use (Describe)
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.
| 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/4/Picture/0 description: The image shows the logo for EMBOLX. The logo consists of a spiral of black and red dots on the left, followed by the word "EMBOLX" in black, sans-serif font. The dots are arranged in a circular pattern, with the black dots on one side and the red dots on the other.
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
-
- 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
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.
7. INDICATION FOR USE STATEMENT
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.
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 | Differences
raise any
additional
safety issues? |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| General Information | | | | |
| Regulation # | 21 CFR 870.1200 | 21 CFR 870.1200 | Same | N/A |
| Regulation
Name | Diagnostic Intravascular
Catheter | Diagnostic Intravascular Catheter | Same | N/A |
| Regulatory
Class | Class II | Class II | Same | N/A |
| Product Code | DQO | DQO | Same | N/A |
| Indications
for Use | 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. | The Progreat 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 and all coronary
vessels. The Progreat is also
intended for drug infusion in intra-
arterial therapy and the infusion
of embolic materials for
hemostasis. The Progreat should
not be used in cerebral vessels. | Soldier
should not
be used in
coronary
vessels. It is
also not
intended for
use in
embolectomy
or
angioplasty
procedures. | No |
Table 2 – Comparison Table of Technological Characteristics: Subject Device to Predicate Device
| | Attributes | Soldier
(Subject Device) | Progreat Catheter
(Predicate Device)
(K033583) | Differences | Differences
raise any
additional
safety
issues? |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| | Device Specifications | | | | |
| Catheter | Catheter Size
Fr (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 OD
Distal End
Fr (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 | Differences
raise any
additional
safety
issues? | |
| Catheter OD
Proximal End
Fr (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 OD
Fr (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 | |
| Catheter
Effective
Lengths | 130 cm
155 cm | 100 cm
110 cm
130 cm
150 cm | Dimensions | None | |
| Tip Design | Atraumatic | Atraumatic | None | N/A | |
| Hub Design | Female Luer, Tapered
Funnel Access | Female Luer, Tapered
Funnel Access | None | N/A | |
| Hydrophilic
Coating Length
(Catheter
length/Coating
length, from the
distal tip) | 130 cm/ 70 cm
155 cm/ 70 cm | 100 cm/ 50 cm
110 cm/ 50 cm
130 cm/ 70 cm
150 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:
Guidewire
Guidewire Inserter
Catheter Mandrel (stylet)
2.5mL Syringe with Lock
Wire Stopper
Catheter Stopper XS
Hemostatic Valve | Soldier
packaged
without
Accessories | None |
| General Information | | | | | |
| Design/Construction | Single lumen catheter
consisting of metal coil
reinforced multi-layer
polymer tubing with
hydrophilic coating. | Single lumen catheter
consisting of metal coil
reinforced multi-layer
polymer tubing with
hydrophilic coating. | None | N/A | |
| Pouch | Polyester/Polyethylene/
Tyvek* | Unknown | N/A | N/A | |
| Attributes | Soldier
(Subject Device) | Progreat Catheter
(Predicate Device)
(K033583) | Differences | Differences
raise any
additional
safety
issues? | |
| 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 | Soldier
Shelf Life
Validated to
12 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.