Extroducer Infusion Catheter System

K213442 · SmartWise Sweden AB · KRA · Jun 10, 2022 · Cardiovascular

Device Facts

• Record ID: K213442
• Device Name: Extroducer Infusion Catheter System
• Applicant: SmartWise Sweden AB
• Product Code: KRA · Cardiovascular
• Decision Date: Jun 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Minimally invasive infusion catheter system for delivering diagnostic or therapeutic solutions to perivascular tissue or intraluminally in peripheral vasculature. Device consists of infusion needle with radiopaque marker/depth-limiting collar and outer protective sheath with haemostatic valve. Used in hospital operating theaters or catheterization labs by trained physicians. Procedure involves navigating device through guide catheter to treatment site; manual deployment of needle through vessel wall into perivascular tissue. Radiopaque marker provides fluoroscopic visualization and depth control. Enables targeted drug delivery; benefits include precise administration of therapeutic agents to peripheral tissue. Single-patient use; duration ≤60 minutes.

Clinical Evidence

No clinical studies performed. Evidence consists of non-clinical bench performance testing (dimensional verification, trackability, bond strength, burst pressure, infusion flow, leakage, etc.), biocompatibility testing per ISO 10993, and an animal study evaluating safety, navigation, and histopathology compared to the predicate device.

Technological Characteristics

Manual deployment infusion catheter. Components: infusion needle with radiopaque marker/depth-limiting collar, outer protective sheath, haemostatic valve. Dimensions: 179cm length, 0.5mm sheath OD, 0.19mm needle OD. Target vessel diameter: 2-8mm. Materials tested per ISO 10993. Sterile, single-use. No balloon or hydraulic system.

Indications for Use

Indicated for adult patients requiring infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature or intraluminally.

Regulatory Classification

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.

Predicate Devices

• Bullfrog® Micro-Infusion Device (K161402)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="line-height: normal;"> <span style="orphans: auto;"> <span style="text-align: start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: auto;"> <span style="word-spacing: 0px;"> <span style="-webkit-text-stroke-width: 0px;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="line-height: normal;"> <span style="orphans: auto;"> <span style="text-align: start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: auto;"> <span style="word-spacing: 0px;"> <span style="-webkit-text-stroke-width: 0px;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> |

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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: [phone] Email: [e-mail]

Maria Nordlinder Contact Person: Regulatory Affairs Manager Phone: [phone] Email: [e-mail]

#### 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

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.

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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 -<br>Extroducer Infusion<br>Catheter System | Predicate device -<br>Bullfrog® Micro-<br>Infusion Device<br>(K161402) | Comparison |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Extroducer Infusion<br>Catheter System is intended<br>for infusion of diagnostic or<br>therapeutic solutions into the<br>perivascular area of the<br>peripheral vasculature. The<br>Extroducer Infusion Catheter<br>System is also intended for<br>the infusion of diagnostic and<br>therapeutic solutions<br>intraluminally. | In selective areas of<br>peripheral and coronary<br>vessels, the Bullfrog<br>Micro-Infusion Device is<br>intended for the infusion<br>of diagnostic and<br>therapeutic agents into the<br>vessel wall and<br>perivascular area, or<br>intraluminally. | Same for the peripheral<br>vasculature, although not<br>identically phrased;<br>coronary vessels excluded<br>for the subject device. |
| Design | Infusion needle with radio-<br>opaque markers and a luer<br>port, placed inside a<br>protective sheath. | Catheter with a<br>perpendicular<br>microneedle, which is<br>sheathed by and contained<br>within a balloon, which<br>upon inflation provide a<br>force opposite the needle<br>tip for proper seating of<br>the needle. | There are differences in the<br>designs of the subject and<br>predicate devices; however,<br>they do not raise different<br>questions of safety and<br>effectiveness (S&E.) |
| Needle deployment<br>method | Manual deployment by<br>physician. | Inflation of balloon<br>attached the needle. | There are differences in the<br>needle deployment of the<br>subject and predicate<br>devices; however, they do<br>not raise different questions<br>of S&E. |
| Catheter length | 179cm (from needle hub) | 145 cm (not including<br>handle) | The difference in length of<br>the catheters does not raise<br>different questions of S&E. |
| Needle length | 5-15 mm from radiopaque<br>marker/depth limiting collar<br>(Three models: 5, 10, 15 mm) | 0.9 mm | Possible to insert the<br>subject device needle<br>further into the tissue;<br>however, this does not raise<br>different questions of S&E. |
| Outer diameter | 0.5 mm (Sheath) | 1.65 – 1.75 mm (balloon<br>location) | The difference in diameter<br>of the catheters does not<br>raise different questions of<br>S&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 ISO<br>10993 | Tested according to ISO<br>10993 | 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;<br>however, this does not raise<br>different 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.