(212 days)
No
The device description and performance studies focus on the physical and functional characteristics of a microcatheter, with no mention of AI or ML.
No.
The device is intended for the introduction of other interventional devices or agents, not to provide therapy itself.
No
Explanation: The "Intended Use / Indications for Use" states that the device is intended for the "introduction of interventional devices and infusion of diagnostic or therapeutic agents," but it does not perform a diagnostic function itself. It's a delivery tool, not a diagnostic one.
No
The device description clearly outlines a physical catheter with specific dimensions, materials, and features like a hydrophilic coating and radiopaque marker. The performance studies also focus on physical and material properties of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system." This describes a device used within the body for procedures, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate procedures within the body.
N/A
Intended Use / Indications for Use
The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The catheter is not intended for use in either the coronary or neuro vasculature.
Product codes
DQO, KRA
Device Description
The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter constructed with a flexible polymer shaft of varying stiffness to aide in accessing vasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire for accessing the vasculature. The proximal end of the catheter has a diameter of 3.4F, tapering to a distal OD of 3.2F, which can be inserted into a 5F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with a straight tip configuration which can be steam-shaped to the doctor's preferred shape. A steam shaping mandrel is included in the packaging. The microcatheter has hydrophilic coating on the outer distal shaft to reduce friction during manipulation in vessels and has one radiopaque tip marker to facilitate fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 testing included biocompatibility testing of the assembled device as defined in ISO 10993, functional testing as defined in ISO 10555-1:2013, the FDA guidance for Short-Term and Long-Term Intravascular Catheters, dated March 16, 1995 and the FDA Special Controls Document for PTCA Catheters (Part VIII, section 13), dated September 8, 2010. Functional testing performed on the proposed device included:
Cytotoxicity: MEM elution test per ISO 10993-5. Results: Non-cytotoxic. Test article scores were 0 at 48 hours.
Sensitization: Kligman Maximization per ISO 10993-10. Results: Negative for dermal sensitization. Test articles sensitization scores were all 0.
Irritation/Intracutaneous Reactivity: Irritation/Intracutaneous reactivity test per ISO 10993-10. Results: Non-irritating. Extracts of the test article did not show a significantly greater biological reaction than sites injected with control article.
Acute systemic toxicity: Acute systemic injection test in mice per ISO-10993-11. Results: Non-toxic. Test articles showed no toxicity or animal weight loss for both cottonseed oil and saline extracts for 72 hour test period.
Materials mediated pyrogenicity: Rabbit pyrogen test per ISI 10993-11. Results: Non-pyrogenic. No increases in Individual temperatures.
Hemocompatibility – hemolysis by direct contact and extract: Direct contact method and extract method per modified ASTM 758-08. Results: Non-hemolytic. Corrected hemolysis index was 0.15% by direct method, 0.23% by extract.
Partial Thromboplastin Time: Partial thromboplastin time per ASTM F2382. Results: Both test article and predicate were minimal activators. Difference in clotting times between test article and predicate was 3 seconds.
Complement activation of C3a and SC5b-9: C3a and SC5b-9 levels tested per ISO 10993-4. Results: Complement activation by the test article was less than that of the predicate device.
Thrombogenicity in Dogs: Thrombogenicity test in dogs per ISO 10993-4. Results: Thrombosis grade comparable to predicate. Weight changes of the implants comparable between test and control articles.
Visual/Dimensional Inspection: Visual inspection for extraneous matter, process and surface defects or defects that may cause trauma to vessels. Dimensional inspection per drawings. Results: No surface defects or visible droplets of coating on catheters. All catheters met dimensional specifications.
Air Ingress/Negative Collapse: Tests per ISO 10555. Results: Hub fittings do not allow air ingress and no evidence of lumen collapse.
Kink Resistance: Tests for kinks after distal tip of catheter is wrapped around a 0.25" diameter peg. Results: Device was resistant to kinking around small diameter turns per specification.
Tensile Strength/Elongation: Tensile testing performed per ISO 10555-1 on distal, mesial and proximal catheter sections after simulated use. Results: All catheters met minimum force breakage based on tube diameters specified in ISO 10555-1.
Liquid Leakage under Pressure/Leakage at Hub: Test for leakage at 300-320 kPa per ISO 10555-1. Results: No leakage from hub or catheter body.
Tip Stiffness: Test for stiffness per ASTM D747-10. Results: Tip stiffness was comparable that of the predicate devices.
Pressure vs. Flow Characterization: Flow rates measured at two typical pressures: 100 and 300 psi. Results: Flow rates reported in Instructions for Use at 1.00 and 300 psi.
Static Burst Pressure: Burst pressure tested per ISO 10555-1. Results: Maximum peak pressures all exceeded 300 psi.
Dynamic Flow: Product used with power injection to 750 psi. Results: No leaks, breaks or occluded lumens at 750 psi.
Flexibility Fatigue and Profile: Worst case bend of 90° with an 8-fold safety factor for repetitions. Results: All catheters showed no signs of cracks or breakage post worst case simulated use.
Shape Retention: Catheters must maintain a specified % of initial angle after water-bath conditioning and insertions and withdrawals of a guidewire. Tensile strength must meet original specs after shaping. Results: All catheters maintained specified tip angle after steam shaping, water bath conditioning and simulated use of guidewires. Tensile testing after tip shaping passed minimum tensile strength requirements.
Torque to Failure: Torque turns to failure in an anatomical model to provide a 4-fold safety factor. Results: All catheters showed no signs of breakage, twists or collapsed lumens after specified number of torque turns.
Coating Lubricity and Durability: Frictional force of uncoated and coated catheters determined. Results: All catheters met specified frictional forces.
Coating Integrity: Coating uniformity and integrity visually examined on dyed samples after simulated use in a tortuous path. Results: All samples showed acceptable coating coverage post simulated use.
Particulates: Particulates counted in sizes ≥10µm, 25 µm, 50 µm, 65 µm, 100 µm, 200 µm and 500 µm after inserting a guidewire and advancing the catheter through a guide catheter multiple times. Results: The test and predicate catheters had comparable numbers of particles in each size range.
Chemical compatibility: Catheters were exposed to saline and contrast agent/saline solutions and examined for degradation. Results: All catheters showed no signs of degradation, corrosion or physical decomposition.
Latex Content: Tested for trace latex proteins per ASTM D6499-07. Results: No detectable traces of latex found.
Corrosion Resistance: Test for corrosion resistance per ISO 10555-1. Results: No signs of corrosion on metallic components of catheters.
Radiopacity: Catheters and predicates evaluated by physicians under simulated use in human cadavers. Results: Both test and predicate catheters had acceptable radiopacity.
MRI Compatibility: Catheters contain conducting and magnetic materials and should not have exposure to MRI. Results: Catheters are labeled MRI Unsafe on IFU.
Simulated Use: Anatomical model designed for tortuous anatomy used for simulated use testing. Results: Catheters and predicate devices had comparable Likert scores in terms of Guidewire tracking and guide catheter movement. Interventional devices successfully deployed.
Cadaver Testing: Cadaver used to evaluate catheter and predicate devices by physicians for performance, access time, and ability to deploy and retrieve interventional devices. Results: Test and predicate devices both exhibited comparable performance with similar access time to the designated target.
Packaging Testing: Packaging evaluated for pouch seal strength per ASTM F 88-00 and leak tests (bubble test) per ASTM F 2096-04. Results: All sterile barrier pouches met minimum seal strength and showed no bubbles under leak test conditions.
Shelf Life Testing: Functions testing repeated post accelerated aging and room temperature confirmatory storage. Results: Shelf life testing in progress. Expiration date will be advanced as aging data are available to demonstrate package and product continues to meet specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2015
Scientia Vascular, LLC % Mr. Mark Job Third Party Reviewer Regulatory Technology Services, LLC 1394 25th St., NW Buffalo, MN 55313
Re: K143398
Trade/Device Name: Plato MICROCATH 27B Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, KRA Dated: June 5, 2015 Received: June 12, 2015
Dear Mr. Job,
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.
1
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 the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143398
Device Name
Plato MICROCATH® 27B Microcatheter
Indications for Use (Describe)
The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The cather is not intended for use in cither the coronary or neuro vasculature.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Bram D. Zuckerman -S 2015.06.26 11:47:00 -04'00'
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
Image /page/4/Picture/0 description: The image shows a logo with a stylized letter "S" above the word "SCIENTIA". The "S" is formed by two parallel lines connected by a curved line, creating a three-dimensional effect. The word "SCIENTIA" is written in a futuristic font with sharp angles and lines, placed directly below the symbol.
K143398 Page 1 of 6
510(K) SUMMARY (21 CFR 807.92)
SCIENTIA VASCULAR LLC PLATO MICROCATH® 27B MICROCATHETER
510(k) Owner: Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 Tel: (775) 657-6330 Fax: (888) 503-6529
- Contact Person: Sharon Rockwell Tel: (714) 695-9269 Fax: (714) 779-0406 E-mail: srockwell(@writeme.com
- Date Prepared: October, 2014
Plato MICROCATH® 27B Microcatheter Trade Name:
- Common Name: Microcatheter
- Classification Name: Diagnostic Intravascular Catheter per 21 CFR 870.1200, DQO Continuous Flush Catheter per 21 CFR 870.1210, KRA
- ev3 Marksman™ Catheter, K111490, K091559 Predicate Devices: Scientia Vascular, LLC Plato MICROCATH 27 Microcatheter. K121734
- The Plato MICROCATH® 27B Microcatheter is a single lumen Device Description: microcatheter constructed with a flexible polymer shaft of varying stiffness to aide in accessing vasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire for accessing the vasculature. The proximal end of the catheter has a diameter of 3.4F, tapering to a distal OD of 3.2F, which can be inserted into a 5F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with a straight tip configuration which can be steam-shaped to the doctor's preferred shape. A steam shaping mandrel is included in the packaging. The microcatheter has hydrophilic coating on the outer distal shaft to
5
reduce friction during manipulation in vessels and has one radiopaque tip marker to facilitate fluoroscopic visualization.
Indications for Use: The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The catheter is not intended for use in either the coronary or neuro vasculature.
The indications for use are identical to those of the ev3 Marksman Catheter, with the exception that the Marksman Catheter is also indicated for neurovascular and coronary use. The MICROCATH 27B has not been evaluated for these indications. This difference does not affect the safety and effectiveness of the device for its intended application in the peripheral vasculature.
Technological Characteristics:
The Plato MICROCATH 27B Microcatheter is a single lumen, variable stiffness microcatheter designed to provide increased flexibility for accessing the vasculature. The proximal end of the catheter incorporates a polycarbonate Luer adapter to facilitate the attachment of accessories. The distal end has a polymeric skeletal support for improved distal navigation. The device is compatible with 5 F or larger guiding catheters and can be advanced over guidewires up to 0.025" in diameter. The distal shaft has a hydrophilic coating for lubricity and is shapeable.
The technological characteristics are comparable to the predicate device, the ev3 Marksman Catheter. The Marksman Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The distal end has a coiled support structure and the device is compatible with 4 F or larger guiding catheters and can accommodate guidewires up to 0.021" in diameter. The Marksman catheter has an embedded braid to impart strength and stiffness to the proximal end and a coiled structure in the distal end. The Plato MICROCATH 27B Microcatheter uses and embedded stainless steel braid on the proximal end and uses a polymeric skeletal support in the distal end to support the lumen and prevent collapse in tortuous vessels. The outer surface of the distal end of the catheter is coated to increase lubricity, and the catheter is shapeable. The technological differences between the Plato MICROCATH 27B Microcatheter and the ev3 Marksman Catheter do not raise new questions of safety or efficacy.
2
6
The technological differences between the Plato MICROCATH 27B and the marketed Plato MICROCATH 27 models include 1) the rigid hypotube at the proximal end has been replace with a braided coil to increase flexibility, 2) the outer diameter has been reduced to allow the microcatheter to be advanced into small vasculature, 3) the distal end of the catheter has been modified with a replacement thermoplastic elastomer, a polymer microstructure and alternate lubricious coating to improved usability, 4) a polycarbonate hub replaces the polymethylpentene hub based on physician preferences and, 5) a platinum marker replaces the platinum marker coil. These technological differences do not raise new questions of safety or efficacy.
Non-Clinical
- Performance Data: Non-clinical testing included biocompatibility testing of the assembled device as defined in ISO 10993, functional testing as defined in ISO 10555-1:2013, the FDA guidance for Short-Term and Long-Term Intravascular Catheters, dated March 16, 1995 and the FDA Special Controls Document for PTCA Catheters (Part VIII, section 13), dated September 8, 2010. Functional testing performed on the proposed device included:
| Test | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity | MEM elution test per ISO | |
| 10993-5. | Non-cytotoxic. Test article | |
| scores were 0 at 48 hours. | ||
| Sensitization | Kligman Maximization per | |
| ISO 10993-10 | Negative for dermal | |
| sensitization. Test articles | ||
| sensitization scores were all 0. | ||
| Irritation/Intracutaneous | ||
| Reactivity | Irritatino/Intracutaneous | |
| reactivity test per ISO | ||
| 10993-10. | Non-irritating. Extracts of the | |
| test article did not show a | ||
| significantly greater biological | ||
| reaction than sites injected with | ||
| control article. | ||
| Acute systemic toxicity | Acute systemic injection | |
| test in mice per ISO- | ||
| 10993-11. | Non-toxic. Test articles showed | |
| no toxicity or animal weight | ||
| loss for both cottonseed oil and | ||
| saline extracts for 72 hour test | ||
| period. | ||
| Materials mediated | ||
| pyrogenicity | Rabbit pyrogen test per ISI | |
| 10993-11. | Non-pyrogenic. No increases in | |
| Individual temperatures. | ||
| Hemocompatibility – | ||
| hemolysis by direct | ||
| contact and extract | Direct contact method and | |
| extract method per | ||
| modified ASTM 758-08. | Non-hemolytic. Corrected | |
| hemolysis index was 0.15% by | ||
| direct method, 0.23% by extract. | ||
| Test | Test Method Summary | Results |
| Partial Thromboplastin | ||
| Time | Partial thromboplastin | |
| time per ASTM F2382. | Both test article and predicate | |
| were minimal activators. | ||
| Difference in clotting times | ||
| between test article and | ||
| predicate was 3 seconds. | ||
| Complement activation | ||
| of C3a and SC5b-9 | C3a and SC5b-9 levels | |
| tested per ISO 10993-4. | Complement activation by the | |
| test article was less than that of | ||
| the predicate device. | ||
| Thrombogenicity in | ||
| Dogs | Thrombogenicity test in | |
| dogs per ISO 10993-4. | Thrombosis grade comparable | |
| to predicate. Weight changes of | ||
| the implants comparable | ||
| between test and control | ||
| articles. | ||
| Visual/Dimensional | ||
| Inspection | Visual inspection for | |
| extraneous matter, process | ||
| and surface defects or | ||
| defects that may cause | ||
| trauma to vessels. | ||
| Dimensional inspection | ||
| per drawings. | No surface defects or visible | |
| droplets of coating on catheters. | ||
| All catheters met dimensional | ||
| specifications. | ||
| Air Ingress/Negative | ||
| Collapse | Tests per ISO 10555. | Hub fittings do not allow air |
| ingress and no evidence of | ||
| lumen collapse. | ||
| Kink Resistance | Tests for kinks after distal | |
| tip of catheter is wrapped | ||
| around a 0.25" diameter | ||
| peg. | Device was resistant to kinking | |
| around small diameter turns per | ||
| specification. | ||
| Tensile | ||
| Strength/Elongation | Tensile testing performed | |
| per ISO 10555-1 on distal, | ||
| mesial and proximal | ||
| catheter sections after | ||
| simulated use. | All catheters met minimum | |
| force breakage based on tube | ||
| diameters specified in ISO | ||
| 10555-1. | ||
| Liquid Leakage under | ||
| Pressure/Leakage at | ||
| Hub | Test for leakage at 300- | |
| 320 kPa per ISO 10555-1. | No leakage from hub or catheter | |
| body. | ||
| Tip Stiffness | Test for stiffness per | |
| ASTM D747-10. | Tip stiffness was comparable | |
| that of the predicate devices. | ||
| Pressure vs. Flow | ||
| Characterization | Flow rates measured at | |
| two typical pressures: 100 | ||
| and 300 psi. | Flow rates reported in | |
| Instructions for Use at 1.00 and | ||
| 300 psi. | ||
| Static Burst Pressure | Burst pressure tested per | |
| ISO 10555-1. | Maximum peak pressures all | |
| exceeded 300 psi. | ||
| Dynamic Flow | Product used with power | |
| injection to 750 psi. | No leaks, breaks or occluded | |
| lumens at 750 psi. | ||
| Test | Test Method Summary | Results |
| Flexibility Fatigue and | ||
| Profile | Worst case bend of 90° | |
| with an 8-fold safety factor | ||
| for repetitions. | All catheters showed no signs of | |
| cracks or breakage post worst | ||
| case simulated use. | ||
| Shape Retention | Catheters must maintain a | |
| specified % of initial angle | ||
| after water-bath | ||
| conditioning and insertions | ||
| and withdrawals of a | ||
| guidewire. Tensile strength | ||
| must meet original specs | ||
| after shaping. | All catheters maintained | |
| specified tip angle after steam | ||
| shaping, water bath | ||
| conditioning and simulated use | ||
| of guidewires. Tensile testing | ||
| after tip shaping passed | ||
| minimum tensile strength | ||
| requirements. | ||
| Torque to Failure | Torque turns to failure in | |
| an anatomical model to | ||
| provide a 4-fold safety | ||
| factor. | All catheters showed no signs of | |
| breakage, twists or collapsed | ||
| lumens after specified number | ||
| of torque turns. | ||
| Coating Lubricity and | ||
| Durability | Frictional force of | |
| uncoated and coated | ||
| catheters determined. | All catheters met specified | |
| frictional forces. | ||
| Coating Integrity | Coating uniformity and | |
| integrity visually | ||
| examined on dyed samples | ||
| after simulated use in a | ||
| tortuous path. | All samples showed acceptable | |
| coating coverage post simulated | ||
| use. | ||
| Particulates | Particulates counted in | |
| sizes ≥10µm, 25 µm, 50 | ||
| µm, 65 µm, 100 µm, 200 | ||
| µm and 500 µm after | ||
| inserting a guidewire and | ||
| advancing the catheter | ||
| through a guide catheter | ||
| multiple times. | The test and predicate catheters | |
| had comparable numbers of | ||
| particles in each size range. | ||
| Chemical compatibility | Catheters were exposed to | |
| saline and contrast | ||
| agent/saline solutions and | ||
| examined for degradation. | All catheters showed no signs of | |
| degradation, corrosion or | ||
| physical decomposition. | ||
| Latex Content | Tested for trace latex | |
| proteins per ASTM | ||
| D6499-07. | No detectable traces of latex | |
| found. | ||
| Corrosion Resistance | Test for corrosion | |
| resistance per ISO 10555- |
-
| No signs of corrosion on
metallic components of
catheters. |
| Radiopacity | Catheters and predicates
evaluated by physicians
under simulated use in
human cadavers. | Both test and predicate catheters
had acceptable radiopacity. |
| Test | Test Method Summary | Results |
| MRI Compatibility | Catheters contain
conducting and magnetic
materials and should not
have exposure to MRI. | Catheters are labeled MRI
Unsafe on IFU. |
| Simulated Use | Anatomical model
designed for tortuous
anatomy used for
simulated use testing. | Catheters and predicate devices
had comparable Likert scores in
terms of Guidewire tracking and
guide catheter movement.
Interventional devices
successfully deployed. |
| Cadaver Testing | Cadaver used to evaluate
catheter and predicate
devices by physicians for
performance, access time,
and ability to deploy and
retrieve interventional
devices. | Test and predicate devices both
exhibited comparable
performance with similar access
time to the designated target. |
| Packaging Testing | Packaging evaluated for
pouch seal strength per
ASTM F 88-00 and leak
tests (bubble test) per
ASTM F 2096-04. | All sterile barrier pouches met
minimum seal strength and
showed no bubbles under leak
test conditions. |
| Shelf Life Testing | Functions testing repeated
post accelerated aging and
room temperature
confirmatory storage. | Shelf life testing in progress.
Expiration date will be
advanced as aging data are
available to demonstrate
package and product continues
to meet specifications. |
7
:
8
9
- Conclusions: Scientia Vascular, LLC has demonstrated that the Plato MICROCATH 27B Microcatheter is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principles and the indications for use as the ev3 predicate device, and represents a modification in design and matcrials to the existing MICROCATH 27 family of products. The testing supports a determination of substantial equivalence to products previously cleared by FDA.