The Extroducer Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature. The Extroducer Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally.

Device Description

The Extroducer™ Infusion Catheter System is a minimally invasive device for administering diagnostic or therapeutic solutions through the vascular wall directly to perivascular tissue of adult patients. At the selected site, the device is used to penetrate through the vascular wall into the tissue requiring treatment. The diagnostic or therapeutic solution is then delivered through the device. The device is sterile and designed for single patient use only. The device is to be used in hospital operating theaters and catheterization labs under normal clinical conditions, only by physicians trained in its use. The duration of use is no more than 60 minutes. The Extroducer™ Infusion catheter system consists of two main parts: An infusion needle with a needle hub and radiopaque marker and An outer protective sheath to protect the needle during positioning of the device, with a haemostatic valve to secure the infusion needle during use.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Extroducer Infusion Catheter System." It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data and an animal study.

The request asks for information regarding acceptance criteria, study details, and ground truth establishment, which are typical for an AI/ML-based device submission, especially those involving diagnostic image analysis. However, the provided text describes a physical medical device (an infusion catheter system) and its non-clinical and animal testing. It does not involve any AI/ML components, image analysis, or human reader studies.

Therefore, many of the requested details, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone (algorithm only) performance," are not applicable to this type of device and submission.

The document focuses on demonstrating that the new device has similar technological characteristics, indications for use, and performance to a legally marketed predicate device, thereby proving "substantial equivalence."

Based on the provided text, here is the information that is available or can be inferred, and an explanation of why other requested information is not present:

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

The provided text does not contain a formal table of acceptance criteria with specific quantitative thresholds. Instead, it lists the types of non-clinical tests performed to demonstrate functionality and safety, implying that the device met the expected performance for each test to claim substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Non-clinical Performance:
Dimensional verification (e.g., Catheter length, Needle length, Outer diameter, Needle diameter)	Catheter length: 179cm (from needle hub) Needle length: 5-15 mm from radiopaque marker/depth limiting collar (Three models: 5, 10, 15 mm) Outer diameter: 0.5 mm (Sheath) Needle diameter (OD): 0.19 mm
Simulated use (including trackability)	Successfully navigated to all intended target arteries (Animal Study). Tested for functionality and safety.
Catheter bond strength	Tested
Flexibility and kinking	Tested
Torque strength	Tested
Radiopacity	Yes, radiopaque marker band included. Tested.
Particulate evaluation	Tested
Catheter body burst pressure	Tested
Infusion flow rate	Tested
Visual inspection	Tested
Needle characteristics (tensile strength, tip strength etc.)	Tested
Functional testing of Thumb wheel/haemostatic valve	Tested
Leakage testing	Tested
Infusion force	Tested
Biocompatibility (ISO 10993)	Successfully tested for: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity (Acute Systemic Toxicity, Material Mediated Pyrogenicity), Hemocompatibility (direct and indirect hemolysis, Complement activation assay, In vivo thrombogenicity).
Sterilization validation	Validated. Provided sterile.
Transport testing	Tested
Package testing (sterile barrier)	Tested
Stability studies (selected bench tests and package tests)	Tested. Shelf Life: 1 year.
Animal Study:
Evaluation of device safety and performance compared to predicate	Concluded that the Extroducer™ Infusion Catheter System was able to be navigated to all intended target arteries. Results from treatment procedures, performance assessments, thrombosis evaluation, gross pathology, histopathology, and clinical pathology assessments support the conclusions of safety for intended clinical use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify exact sample sizes for the individual non-clinical (bench) tests. For the animal study, a specific sample size is not mentioned, but it is implied to be a prospective study conducted for the purpose of this submission.
Data Provenance: The Smartwise Sweden AB is based in Tullinge, Sweden. The non-clinical tests would have been performed in a laboratory setting, likely in Sweden or a contracted test facility. The animal study would have been performed as part of the pre-clinical development process. The exact country of origin for the data is not specified beyond the applicant's location. The studies are prospective as they were conducted specifically for this application.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable. This is a physical medical device. Ground truth as typically understood for AI/ML diagnostic devices (e.g., based on expert image review) is not relevant here. The "ground truth" for the performance of this device is established through the physical and biological testing conducted (e.g., measured dimensions, observed mechanical performance, histological findings from animal studies).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) provide independent assessments that need to be reconciled for ground truth establishment. This is not a human reader study. The "adjudication" for the non-clinical tests would be adherence to pre-defined test protocols and pass/fail criteria. For the animal study, it would involve standard veterinary and pathology assessments.

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

This question is not applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. This device is a physical infusion catheter; it does not involve AI assistance for human readers.

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

This question is not applicable. This device does not have an algorithm component for diagnostic performance. Its "standalone" performance is measured by its physical, mechanical, and biological properties through non-clinical and animal testing.

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

The "ground truth" for this device's performance is established through:

Engineering/Bench Test Measurements: Direct physical measurements (e.g., dimensions, flow rates, strengths).
Observed Performance in Bench Tests: Qualitative and quantitative observations of mechanical function (e.g., trackability, leakage, kinking).
Pathology and Clinical Pathology from Animal Models: Histological analysis, gross pathology findings, and blood work from the animal study to confirm safety (e.g., absence of thrombosis, tissue damage).

8. The sample size for the training set

This question is not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

This question is not applicable as there is no AI/ML training set for this device.

Summary

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June 10, 2022

Smartwise Sweden AB Maria Nordlinder QA/RA Manager Alfred Nobels allé 150 Tullinge, SE-146 48 Sweden

Re: K213442/S001

Trade/Device Name: Extroducer Infusion Catheter System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: May 2, 2022 Received: May 5, 2022

Dear Maria Nordlinder:

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

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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 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

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention 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) K213442

Device Name Extroducer Infusion Catheter System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Extroducer Infusion Catheter System

510(k) Summary K213442

Date prepared: June 07, 2022

Applicant:

Jonathan Clarke, MD CEO Smartwise Sweden AB Alfred Nobels Allé 150 SE-146 48 Tullinge SWEDEN Phone: +46 (0)73 963 53 68 Email: jonathan.clarke@smartwise.se

Maria Nordlinder Contact Person: Regulatory Affairs Manager Phone: +46 (0)79 006 53 81 Email: maria.nordlinder@smartwise.se

1 Device Information

Trade Name: Extroducer™ Infusion Catheter System Regulation number: 21 CFR 870.1210 Regulation name: Continuous flush catheter Product code: KRA Class: II

Predicate Device: 1.1

Bullfrog® Micro-Infusion Device, manufactured by Mercator MedSystems, Inc. (K161402)

2 Device description

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The device is sterile and designed for single patient use only. The device is to be used in hospital operating theaters and catheterization labs under normal clinical conditions, only by physicians trained in its use. The duration of use is no more than 60 minutes.

The Extroducer™ Infusion catheter system consists of two main parts:

An infusion needle with a needle hub and radiopaque marker -
An outer protective sheath to protect the needle during positioning of the device, with a haemostatic valve to secure the infusion needle during use

The package also includes the following accessories, which are optional to use:

A 0.25 mL syringe with a male Luer lock -
A dispensing tip to aid in the flush of the outer protective sheath -

Additional accessories, not covered by this submission, includes:

Guide catheters with a minimum ID of 0.021" -
Additional syringes 0.25-1.0 mL, male Luer lock (one syringe included in package) -

During the procedure, the needle is inserted into the outer protective sheath, secured in place with the haemostatic valve, then the device is fed through a guide catheter, prepositioned inside the vessel, to the selected site of treatment. Once in place the needle is released and manually moved forward out of the outer protective sheath through the vessel wall, and into the perivascular tissue. The radiopaque marker band near the distal tip of the needle provides for visualization of the needle under fluoroscopy and also functions as a depth limiting collar.

2.1 Models

The Extroducer™ Infusion Catheter system is available in three models, see Table 1, each with the radiopaque marker band/depth limiting collar positioned at different lengths from the infusion needle distal tip: 5mm, 10mm and 15mm, enabling penetration of tissue at different depths. Aside from the position of the radiopaque marker band/depth limiting collar, the models are identical.

Name	Article number	Penetration depth (mm)
Extroducer™ infusion catheter system	200101-5	5
Extroducer™ infusion catheter system	200101-10	10
Extroducer™ infusion catheter system	200101-15	15

Table 1 Available models of the Extroducer™ infusion catheter system

2.2 Indications for Use

The Extroducer™ Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature. The Extroducer™ Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally.

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Technological characteristics 2.3

The Extroducer™ Infusion Catheter System has a manual deployment method and compared to the predicate device do not use a balloon or hydraulic system. The subject device has been tested to verify functionality and safety and is therefore considered substantially equivalent to the predicate device. See Table 2 for details.

Item	Subject device -Extroducer InfusionCatheter System	Predicate device -Bullfrog® Micro-Infusion Device(K161402)	Comparison
Indications for use	The Extroducer InfusionCatheter System is intendedfor infusion of diagnostic ortherapeutic solutions into theperivascular area of theperipheral vasculature. TheExtroducer Infusion CatheterSystem is also intended forthe infusion of diagnostic andtherapeutic solutionsintraluminally.	In selective areas ofperipheral and coronaryvessels, the BullfrogMicro-Infusion Device isintended for the infusionof diagnostic andtherapeutic agents into thevessel wall andperivascular area, orintraluminally.	Same for the peripheralvasculature, although notidentically phrased;coronary vessels excludedfor the subject device.
Design	Infusion needle with radio-opaque markers and a luerport, placed inside aprotective sheath.	Catheter with aperpendicularmicroneedle, which issheathed by and containedwithin a balloon, whichupon inflation provide aforce opposite the needletip for proper seating ofthe needle.	There are differences in thedesigns of the subject andpredicate devices; however,they do not raise differentquestions of safety andeffectiveness (S&E.)
Needle deploymentmethod	Manual deployment byphysician.	Inflation of balloonattached the needle.	There are differences in theneedle deployment of thesubject and predicatedevices; however, they donot raise different questionsof S&E.
Catheter length	179cm (from needle hub)	145 cm (not includinghandle)	The difference in length ofthe catheters does not raisedifferent questions of S&E.
Needle length	5-15 mm from radiopaquemarker/depth limiting collar(Three models: 5, 10, 15 mm)	0.9 mm	Possible to insert thesubject device needlefurther into the tissue;however, this does not raisedifferent questions of S&E.
Outer diameter	0.5 mm (Sheath)	1.65 – 1.75 mm (balloonlocation)	The difference in diameterof the catheters does notraise different questions ofS&E.

Needle diameter (OD)	0.19 mm	34 G (0.18 mm)	Same
Target vessel diameter	2-8 mm	2-8 mm	Same
Biocompatibility	Tested according to ISO10993	Tested according to ISO10993	Same
Number of uses	Single patient use	Single patient use	Same
Sterility	Provided sterile	Provided Sterile	Same
Shelf Life	1 year	Not available	Possibly different shelf life;however, this does not raisedifferent questions of S&E.
Radio-opaque markers	Yes	Yes	Same

Table 2 Comparison of Predicate device and Subject device

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Extroducer Infusion Catheter System

Traditional 510(k) Premarket submission

3 Performance Data

The following performance data were provided in support of the substantial equivalence determination.

3.1 Non-clinical performance data

The following tests have been conducted:

Dimensional verification of catheter -
Simulated use (including trackability) -
Catheter bond strength -
Flexibility and kinking -
Torque strength -
Radiopacity -
Particulate evaluation -
Catheter body burst pressure -
Infusion flow rate -
Visual inspection -
-Needle characteristics (tensile strength, tip strength etc.)
Functional testing of Thumb wheel/haemostatic valve -
Leakage testing -
Infusion force -
Biocompatibility (according to ISO 10993): -
- Cytotoxicity O
- Sensitization O
- O Intracutaneous Reactivity
- Systemic Toxicity, including Acute Systemic Toxicity and Material Mediated o Pyrogenicity
- Hemocompatibility, including direct and indirect hemolysis, Complement o activation assay and In vivo thrombogenicity
Sterilization validation -
-Transport testing

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-Package testing (sterile barrier)
Stability studies (selected bench tests and package tests) -

3.2 Animal testing

An animal study has been performed in order to evaluate the safety of the subject device compared to the predicate device. It was concluded that the Extroducer™ Infusion Catheter System was able to be navigated to all intended target arteries. The results from the treatment procedures, performance assessments, thrombosis evaluation of the device, gross pathology, histopathology, and clinical pathology assessments support the conclusions of safety of the intended clinical use of the Extroducer™ Infusion Catheter System.

3.3 Clinical data

No clinical studies have been performed. Available non-clinical bench performance testing data, animal and biocompatibility studies are considered sufficient to support a substantial equivalence determination.

4 Conclusions

The results of the non-clinical tests described above demonstrate that the Extroducer™ Infusion Catheter System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).