(193 days)
The FluidiTube® 2.7F Infusion Micro Catheter is intended to facilitate infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels and all coronary vessels. It is also intended for drug infusion in intra-arterial therapy and embolic materials for hemostasis. The FluidiTube® 2.7F Infusion Micro Catheter is not to be used in cerebral blood vessels.
The FluidiTube® 2.7F Infusion Micro Catheter is a tapered 2.7F/2.9F single lumen catheter with a luer lock hub designed to facilitate the access of distal vasculature over a guidewire. The FluidiTube® has a semi-rigid proximal shaft that becomes progressively more flexible towards the distal end. The shaft is reinforced with braided stainless steel wire for kink resistance. The inner lumen is lined with a lubricious material to facilitate the movement of a guidewire. The outer surface of the catheter has a hydrophilic coating that becomes lubricious when wet with saline or blood. The FluidiTube® catheter is introduced to the target location through a guiding catheter 0.038" (0.97 mm) or larger and is compatible with 0.021" (0.53 mm) guidewires or smaller. Device configurations consist of one profile size (2.7F) with two different usable lengths (110cm, 130cm). The final device is packaged in a Tyvek pouch and sterilized by ethylene oxide (EO). The device is for single use only.
The document provided is a 510(k) premarket notification for the Callisyn FluidiTube® 2.7F Infusion Micro Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than full clinical trials for novel devices. Therefore, the "acceptance criteria" and "device performance" are typically framed in terms of equivalence to the predicate and meeting established engineering and biocompatibility standards, rather than specific performance metrics like sensitivity/specificity for diagnostic devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a medical device (infusion micro catheter), "acceptance criteria" and "device performance" are defined by the comprehensive non-clinical testing and a comparative animal study demonstrating equivalence to the predicate device. The performance is assessed against established engineering standards and functional requirements relevant to the device's intended use.
| Acceptance Criterion (Category) | Specific Test/Evaluation | Acceptance Standard/Methodology | Reported Device Performance (FluidiTube® 2.7F) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | Compliant |
| Irritation | ISO 10993-10:2010 | Compliant | |
| Sensitization | ISO 10993-10:2010 | Compliant | |
| Acute Systemic Injection | ISO 10993-11:2006 | Compliant | |
| Materials Mediated Rabbit Pyrogen | USP <151> | Compliant | |
| Thrombosis (in vivo) | ISO 10993-4:2002 | Compliant | |
| Hemolysis | ASTM F756-08 | Compliant | |
| Complement Activation - C3a and SC5b-9 Assay | ISO 10993-4:2002 | Compliant | |
| In vitro Mouse Lymphoma with Extended Treatment | ISO 10993-3:2003 | Compliant | |
| In vivo Mouse Micronucleus Assay | ISO 10993-3:2003 | Compliant | |
| ISO Bacterial Mutagenicity Test - Ames Assay | ISO 10993-3:2002 | Compliant | |
| Extractables | ISO 10993-18:2005 | Compliant | |
| Physical & Mechanical Properties | Kink Resistance | Not specified (standard engineering test) | Met specifications |
| Tensile (Catheter) | Not specified (standard engineering test) | Met specifications | |
| Tensile (Hub-catheter) | Not specified (standard engineering test) | Met specifications | |
| Reliability (Marker Band Durability) | Not specified (standard engineering test) | Met specifications | |
| Coating Lubricity | Not specified (standard engineering test) | Met specifications | |
| Corrosion Resistance | Not specified (standard engineering test) | Met specifications | |
| Torqueability Testing | Not specified (standard engineering test) | Met specifications | |
| Guidewire Compatibility | 0.021" (0.53mm) or smaller | Met specifications (compatible with 0.021" in RCA, 0.014" in hepatic artery, 0.018" in iliac artery during animal study) | |
| Static Pressure (Burst) | Not specified (standard engineering test) | Met specifications | |
| Trackability | Not specified (standard engineering test) | Met specifications (successfully tracked microcatheters in animal study) | |
| Flow Rate | Not specified (standard engineering test) | Met specifications | |
| Size, OD and ID | Defined dimensions: distal OD 2.7F (0.90mm), proximal OD 2.9F (0.97mm), ID 0.025in (0.65mm) | Met specifications | |
| Hydrophilic Coating Coverage | Not specified (standard engineering test) | Met specifications | |
| Particulate Testing | Not specified (standard engineering test) | Met specifications | |
| Liquid and Air Leakage Testing | Not specified (standard engineering test) | Met specifications | |
| Guide Catheter Compatibility | 0.038" (0.97mm) or bigger | Met specifications | |
| Sterilization & Packaging | Shelf-life Testing | Not specified (standard stability test) | Compliant |
| Packaging Validation | ISO 11607-1:2006 | Compliant | |
| Simulated Transport Testing | ISTA 2A:2011 | Compliant | |
| Functional Equivalence (Animal Model) | Ability to flush packaging hoop and remove without damage | Qualitative assessment by operators | Acceptable |
| Ability to track through vessels and visualize fluoroscopically | Qualitative assessment by operators | Acceptable | |
| Compatibility with specified guidewires | Qualitative assessment by operators | Acceptable (0.014 in RCA, 0.021 in hepatic artery, 0.018 in iliac artery) | |
| Ability to visualize device under fluoroscopy | Qualitative assessment by operators | Acceptable | |
| Compatibility with infusion of contrast media, therapeutic drugs, and embolic materials | Qualitative assessment by operators | Acceptable | |
| Integrity (no kinking or damage to tip) | Qualitative assessment by operators | Acceptable (no kinking/damage, no | |
| No vascular dissection/thrombus observed | Microscopic/visual inspection post-procedure | No vascular dissection, no thrombus observed |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the simulated use environment (animal study), the document states the study was conducted in "a healthy male Yorkshire swine." This indicates a sample size of one animal.
- Data Provenance: The animal study was prospective, conducted in a simulated use environment using an animal model (Yorkshire swine). The country of origin of the data is not explicitly stated, but it's part of a submission to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two operators (presumably veterinarians or interventional specialists/researchers experienced in animal models for medical device testing) participated in the animal study.
- Qualifications of Experts: Their specific qualifications (e.g., years of experience, specific board certifications) are not detailed in the document. They are referred to as "Operators."
4. Adjudication Method for the Test Set
The document states: "Both Operators rated all test and control microcatheters as acceptable for:" followed by a list of performance criteria. This implies that:
- There was no explicit adjudication method described beyond the consensus or agreement of the two operators on the "acceptable" rating for all performance features.
- It appears to be a 100% agreement or shared determination approach, as both operators individually rated them as acceptable, and the conclusion mentions "both Operators determined that all study protocol specified acute performance requirements...were successfully met."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is more common for diagnostic imaging devices where reader performance is a key metric. For an infusion microcatheter, the focus is on device function, safety, and equivalence to established products.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical instrument, an infusion microcatheter, not an algorithm or AI system. Therefore, a standalone performance study in the context of an algorithm is not relevant.
7. Type of Ground Truth Used (for the animal study / simulated use)
For the animal study, the "ground truth" was established by the direct observation and qualitative assessment by the two experienced operators during and after the procedure in the swine model. This included visual inspection for tracking success, fluoroscopic visualization, compatibility with other devices, functional performance (infusion), and post-procedure integrity assessment of the catheter and animal vasculature. This falls under expert observation/assessment in a simulated environment.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning. The non-clinical testing (biocompatibility, physical/mechanical) establishes the device's inherent properties and performance against specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no "training set" in the machine learning sense for this medical device. The "ground truth" for the non-clinical testing is based on established engineering standards, ISO standards, and other recognized methodologies (e.g., ASTM, USP).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Callisyn Biomedical, Inc. % Gordon MacFarlane Regulatory Project Manager Icon 62 Forest Street. Suite 300 Marlborough, Massachusetts 01752
Re: K161967
Trade/Device Name: FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: December 28, 2016 Received: December 29, 2016
Dear Gordon MacFarlane:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando Agnel
Fernando Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
See PRA Statement below.
| 510(k) Number (if known) | K161967 |
|---|---|
| Device Name | FluidiTube® 2.7F Infusion Micro Catheter |
Indications for Use (Describe)
The FluidiTube® 2.7F Infusion Micro Catheter is intended to facilitate infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels and all coronary vessels. It is also intended for drug infusion in intra-arterial therapy and embolic materials for hemostasis. The FluidiTube® 2.7F Infusion Micro Catheter is not to be used in cerebral blood vessels.
| 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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FOR FDA USE ONLY
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5. 510(K) SUMMARY
510(k) Summary for the Callisyn FluidiTube 2.7F Infusion Micro Catheter
(per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)
1. SUBMITTER/510(K) HOLDER
Callisyn Biomedical, Inc. 260 Candlestick Road North Andover, MA 01845
| Contact: | Shallwei Sun, General Manager |
|---|---|
| Contact's Phone: | +1 (978)-687-0596 |
| Contact's Email: | Shallwei0@yahoo.com |
| Date Prepared: | July 14, 2016 |
2. DEVICE NAME
| Trade Name: | Callisyn FluidiTube® 2.7F Infusion Micro Catheter |
|---|---|
| Classification Name: | Continuous flush catheter |
| Classification Panel: | Cardiovascular |
| Classification Regulation: | 21 CFR 870.1210 |
| Product Code: | KRA |
| Class: | II |
3. PREDICATE DEVICE
- Progreat®, manufactured by Terumo Medical Corporation, K033913 ●
4. DEVICE DESCRIPTION
The FluidiTube® 2.7F Infusion Micro Catheter is a tapered 2.7F/2.9F single lumen catheter with a luer lock hub designed to facilitate the access of distal vasculature over a guidewire. The FluidiTube® has a semi-rigid proximal shaft that becomes progressively more flexible towards the distal end. The shaft is reinforced with braided stainless steel wire for kink resistance. The inner lumen is lined with a lubricious material to facilitate the movement of a guidewire. The outer surface of the catheter has a hydrophilic coating that becomes lubricious when wet with saline or blood. The FluidiTube® catheter is introduced to the target location through a guiding catheter 0.038" (0.97 mm) or larger and is compatible with 0.021" (0.53 mm) guidewires or smaller.
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Device configurations consist of one profile size (2.7F) with two different usable lengths (110cm, 130cm). The final device is packaged in a Tyvek pouch and sterilized by ethylene oxide (EO). The device is for single use only.
5. INDICATION FOR USE/INTENDED USE
The FluidiTube® 2.7F Infusion Micro Catheter is intended to facilitate infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels and all coronary vessels. It is also intended for drug infusion in intra-arterial therapy and embolic materials for hemostasis.
The FluidiTube® 2.7F Infusion Micro Catheter is not to be used in cerebral blood vessels.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE
A summary comparison of technological characteristics, including design and materials is provided in the table below:
| Feature | FluidiTube® 2.7F Infusion Micro Catheter | Progreat® |
|---|---|---|
| (Callisyn Biomedical, Inc.) | (Terumo Medical Corporation) | |
| Regulatory Status | Subject Device | K033913 |
| Indications for Use | The FluidiTube® 2.7F Infusion Micro Catheter isintended to facilitate infusion of contrast mediainto all peripheral vessels up to and including thecervical vessels, all vessels in the lower and upperextremities, visceral vessels and all coronaryvessels. It is also intended for drug infusion inintra-arterial therapy and embolic materials forhemostasis.The FluidiTube® 2.7F Infusion Micro Catheter isnot to be used in cerebral blood vessels. | The Progreat® is intended for the infusion ofcontrast media into all peripheral vessels up to andincluding the cervical vessels, all vessels in thelower and upper extremities, visceral vessels, andall coronary vessels. The Progreat is also intendedfor drug infusion in intra-arterial therapy and theinfusion of embolic materials for hemostasis inprocedures including but not limited to UterineFibroid Embolization. The Progreat should not beused in cerebral vessels. |
| HydrophilicCoating | Yes | Yes |
| Working Length | 110cm and 130cm | 100 - 150cm |
| RadiopaqueMarker | Yes | Yes |
| Dimensions | Outer diameter distal: 2.7F, 0.90mmOuter diameter proximal: 2.9F, 0.97mmInner diameter: 0.025in, 0.65mm | Outer diameter distal: 2.7F, 0.90mmOuter diameter proximal: 2.9F, 0.97mmInner diameter: 0.025in, 0.65mm |
| Strain Relief andHub | Yes | Yes |
| GuidewireCompatibility | 0.021" (0.53mm) or smaller | 0.021" (0.53mm) or smaller |
| Guiding CatheterCompatibility | 0.038" (0.97mm) or bigger | 0.038" (0.97mm) or bigger |
| Sterile | Yes (Ethylene Oxide) | Yes (Ethylene Oxide) |
| Single Use | Yes | Yes |
Callisyn Biomedical, Inc., Traditional 510(k) July 14, 2016
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The FluidiTube® 2.7F Infusion Micro Catheter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the Progreat Catheter K033913. Differences between the devices do not raise any significant issues of safety or effectiveness.
7. SUMMARY OF NON-CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Non-clinical testing of the Callisyn FluidiTube® 2.7F Infusion Micro Catheter to demonstrate that the device met its specifications is summarized below.
Biocompatibility Evaluation
Biocompatibility testing is summarized in the table below. Testing was conducted according to the referenced methodology.
| Biocompatibility Evaluation and Extractables Testing | ||
|---|---|---|
| Test | Methodology | |
| Cytotoxicity | ISO 10993-5:2009 | |
| Irritation | ISO 10993-10:2010 | |
| Sensitization | ISO 10993-10:2010 | |
| Acute Systematic Injection | ISO 10993-11:2006 | |
| Materials Mediated Rabbit Pyrogen | USP <151> | |
| Thrombosis (in vivo) | ISO 10993-4:2002 | |
| Hemolysis | ASTM F756-08 | |
| Complement Activation - C3a and SC5b-9 Assay | ISO 10993-4:2002 | |
| In vitro Mouse Lymphoma with Extended Treatment | ISO 10993-3:2003 | |
| In vivo Mouse Micronucleus Assay | ISO 10993-3:2003 | |
| ISO Bacterial Mutagenicity Test - Ames Assay | ISO 10993-3:2002 | |
| Extractables | ISO 10993-18:2005 |
Physicial and Mechanical Testing
Physical and mechanical testing is summarized below.
| Physical and Mechanical Testing | |
|---|---|
| • Kink resistance | • Static Pressure (Burst) |
| • Tensile (Catheter) | • Trackability |
| • Tensile (Hub-catheter) | • Flow Rate |
| • Reliability (Marker Band Durability) | • Size, OD and ID |
| • Coating Lubricity | • Hydrophillic Coating Coverage |
| • Corrosion Resistance | • Paticulate Testing |
| • Torqueability Testing | • Liquid and Air Leakage Testing |
| • Guidewire Compatibility | • Guide Catheter Compatibility |
In addition to the testing described above, the Callisyn FluidiTube® 2.7F Infusion Micro Catheter was also subject to shelf-life testing, packaging validation as per ISO 11607-1:2006, and simulated transport testing as per ISTA 2A:2011.
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8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Clinical testing was not conducted to evaluate substantial equivalence. Usability testing was conducted in an animal model under a simulated use environment to validate the performance of the device. Callisyn FluidiTube® 2.7F Infusion Micro Catheters were compared to Progreat® 2.7 F Microcatheters in a healthy male Yorkshire swine. Operators successfully tracked the microcatheters into the right artery, the hepatic arteries, and the contralateral iliac artery, and injected the representative diagnostic (non-ionic contrast media Omnipaque 300), therapeutic (Heparin), and embolic material (embolic microspheres 500-700μm) through each microcatheter into the hepatic arteries as required by the protocol. Both Operators rated all test and control microcatheters as acceptable for:
- . Ability to flush the packaging hoop and remove the microcatheter from the hoop without damage
- Ability to track the microcatheter through all three vessels and visualize them ● fluoroscopically
- Compatibility with the guidewire (0.014 in the RCA, 0.021 in the hepatic . artery, and 0.018 in the iliac artery)
- . Ability to visualize the device under fluoroscopy
- Compatibility 1mL of heparin, 2mL of non-dilute contrast media, and 1mL of ● 500-700um embolic microspheres when injected into the hepatic artery
- Integrity, with no kinking or damage to the tip ●
There was no damage to the catheters noted, no vascular dissection was observed, and no thrombus was observed on any catheter when removed from the animal.
After a thorough assessment of all test article performance features, including use in conjunction with common ancillary diagnostic and therapeutic products, both Operators determined that all study protocol specified acute performance requirements of the FluidiTube® were successfully met for this study and it is comparable to the Terumo Progreat® 2.7Fr Microcatheters predicate device.
9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The Indications for Use, overall design, technological and performance characteristics of the FluidiTube® and Progreat® are substantially equivalent. Based on the data and evidence presented (e.g., performance testing, simulated use testing, etc.) for the FluidiTube®, Callisyn concludes that the device is substantially equivalent to the legally marketed micro catheter for its intended use. Differences between the proposed and predicate device do not raise any new issues of safety or effectiveness.
§ 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).