(228 days)
Not Found
No
The description focuses on the mechanical and functional aspects of a catheter system for delivering solutions, with no mention of AI/ML terms or capabilities. The performance studies are bench and animal tests, not related to algorithmic performance.
No
The device is described as an "Infusion Catheter System" intended for delivering diagnostic or therapeutic solutions, but it does not directly perform or constitute a therapy itself. Its function is to facilitate the delivery of solutions that may be therapeutic.
No
This device is an infusion catheter system designed to deliver diagnostic or therapeutic solutions, not to diagnose a condition itself.
No
The device description clearly outlines physical components like an infusion needle, needle hub, radiopaque marker, outer protective sheath, and haemostatic valve, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of diagnostic or therapeutic solutions into the perivascular area or intraluminally. This is a delivery mechanism for substances, not a device that performs a diagnostic test on a sample taken from the body.
- Device Description: The description details a catheter system designed to penetrate tissue and deliver solutions. It does not describe a device that analyzes biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Testing: There is no mention of the device performing any kind of test or analysis on a biological sample. IVD devices are specifically designed to perform such tests.
In summary, the Extroducer Infusion Catheter System is a medical device used for delivering substances, not for performing in vitro diagnostic tests.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KRA
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
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
perivascular area of the peripheral vasculature, intraluminally
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
physicians trained in its use / hospital operating theaters and catheterization labs under normal clinical conditions
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)
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
- Sensitization
- Intracutaneous Reactivity
- Systemic Toxicity, including Acute Systemic Toxicity and Material Mediated Pyrogenicity
- Hemocompatibility, including direct and indirect hemolysis, Complement activation assay and In vivo thrombogenicity
- Sterilization validation
- Transport testing
- Package testing (sterile barrier)
- Stability studies (selected bench tests and package tests)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
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.
4
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.
5
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 Infusion
Catheter System | Predicate device -
Bullfrog® Micro-
Infusion Device
(K161402) | Comparison |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | In selective areas of
peripheral and coronary
vessels, the Bullfrog
Micro-Infusion Device is
intended for the infusion
of diagnostic and
therapeutic agents into the
vessel wall and
perivascular area, or
intraluminally. | Same for the peripheral
vasculature, although not
identically phrased;
coronary vessels excluded
for the subject device. |
| Design | Infusion needle with radio-
opaque markers and a luer
port, placed inside a
protective sheath. | Catheter with a
perpendicular
microneedle, which is
sheathed by and contained
within a balloon, which
upon inflation provide a
force opposite the needle
tip for proper seating of
the needle. | There are differences in the
designs of the subject and
predicate devices; however,
they do not raise different
questions of safety and
effectiveness (S&E.) |
| Needle deployment
method | Manual deployment by
physician. | Inflation of balloon
attached the needle. | There are differences in the
needle deployment of the
subject and predicate
devices; however, they do
not raise different questions
of S&E. |
| Catheter length | 179cm (from needle hub) | 145 cm (not including
handle) | The difference in length of
the catheters does not raise
different questions of S&E. |
| Needle length | 5-15 mm from radiopaque
marker/depth limiting collar
(Three models: 5, 10, 15 mm) | 0.9 mm | Possible to insert the
subject device needle
further into the tissue;
however, this does not raise
different questions of S&E. |
| Outer diameter | 0.5 mm (Sheath) | 1.65 – 1.75 mm (balloon
location) | The difference in diameter
of the catheters does not
raise different questions of
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
10993 | Tested according to ISO
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;
however, this does not raise
different questions of S&E. |
| Radio-opaque markers | Yes | Yes | Same |
Table 2 Comparison of Predicate device and Subject device
6
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
7
- -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.