(136 days)
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is indicated for short-term (up to 30-days) access to the central venous system for intravenous therapy, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the Arrow Pressure Injectable JACC with Sustain Technology may not exceed 300 PSI. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is a single-use catheter intended for percutaneous insertion over a guidewire to facilitate access to the central venous system. The device is intended for short term use (up to 30 days) and is provided sterile in a convenience kit configuration which includes single-use accessories to facilitate the insertion procedure. These accessories may include, but are not limited to; introducer needles, guidewires, tissue dilators, and catheter securement devices. The Arrow Pressure Injectable JACC with Sustain Technology features a radiopaque polyurethane catheter body with a soft, tapered distal tip. The device design is summarized as follows: Catheter Body OD: 6 French, Lumens: 3, Catheter Body Length: 20 cm. The proximal end of the catheter includes extension lines with integral Luer hubs to facilitate access to the catheter body lumens for infusion and aspiration. The distal lumen of the Arrow Pressure Injectable JACC with Sustain Technology is compatible with power injection flow rates up to 6 ml /sec and pressures up to 300 PSI. The full-length of the outer surface (and partial length of the internal lumen surface) of the Arrow Pressure Injectable JACC with Sustain Technology is modified with a biomimetic polymer technology. The "Sustain" polymer surface modification technology is intended to reduce platelet adhesion and thrombus accumulation.
This document describes the regulatory submission for the Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology (K150109). The information provided focuses on non-clinical performance data to support substantial equivalence, rather than a clinical study with detailed acceptance criteria for an AI device. As such, several requested items regarding AI device performance (effect size of human readers with/without AI, standalone AI performance, sample sizes for training/test sets, ground truth establishment for training set, adjudication methods, and expert qualifications for ground truth) cannot be directly extracted from this document, as it pertains to a medical device approval that does not involve an AI component.
However, I can provide the available information regarding the device's performance, acceptance criteria (as performance verification tests), and the study conducted.
1. A table of acceptance criteria and the reported device performance:
Since this is a medical device, the "acceptance criteria" are the performance requirements met through various bench and in vitro tests, as well as an in vivo animal study. The reported performance is the successful completion of these tests, demonstrating the device's functionality and safety. The document states that the results "support substantial equivalence."
| Acceptance Criteria (Performance Requirements) | Reported Device Performance |
|---|---|
| Mechanical & Physical Properties (Bench Testing): | All tests successfully completed. |
| - Force at Break | Verified to meet standards (BS EN ISO 10555-1 & 10555-3) |
| - Elongation | Verified to meet standards (BS EN ISO 10555-1 & 10555-3) |
| - Flow Rate | Verified to meet standards (BS EN ISO 10555-1 & 10555-3) |
| - Liquid Leakage | Verified to meet standards (BS EN ISO 10555-1 & 10555-3), (BS EN 20594-1 & 1707) |
| - Air Leakage | Verified to meet standards (BS EN ISO 10555-1 & 10555-3), (BS EN 20594-1 & 1707) |
| - Gauging | Verified to meet standards (BS EN 20594-1 & 1707) |
| - Separation Force | Verified to meet standards (BS EN 20594-1 & 1707) |
| - Stress Cracking | Verified to meet standards (BS EN 20594-1 & 1707) |
| - Unscrewing Torque | Verified to meet standards (BS EN 20594-1 & 1707) |
| - Ease of Assembly | Verified to meet standards (BS EN 20594-1 & 1707) |
| - Resistance to Overriding | Verified to meet standards (BS EN 20594-1 & 1707) |
| - Repeat Pressure Injection | Successfully verified |
| - Static Burst | Successfully verified |
| - Flow Rate Under Pressure Injection | Successfully verified (distal lumen up to 6 ml/sec and 300 PSI) |
| - Flex Cycling | Successfully verified |
| - Compression Stiffness | Successfully verified |
| - Collapse Resistance | Successfully verified |
| - Kink Resistance | Successfully verified |
| - Pressure Monitoring | Successfully verified |
| - Site Care Chemical Exposure | Successfully verified |
| - Mechanical Hemolysis | Successfully verified |
| - Extension Line Clamp Functionality | Successfully verified |
| - Radiodetectability | Successfully verified |
| Biocompatibility (ISO 10993-1): | All tests successfully completed. |
| - Cytotoxicity | Successfully passed |
| - Irritation | Successfully passed |
| - Sensitization | Successfully passed |
| - Acute Systemic Toxicity | Successfully passed |
| - Subacute Toxicity | Successfully passed |
| - Genotoxicity | Successfully passed |
| - Implantation (4-week) | Successfully passed |
| - Hemocompatibility | Successfully passed |
| - Leachable and Extractable Chemical Components | Characterized |
| Thromboresistant Properties ( In vitro ): | Demonstrated significant reduction in platelet adhesion. |
| - Platelet adhesion on external catheter surface | Average reduction of 87% compared to an untreated polyurethane catheter. |
| Thromboresistant Properties ( In vivo ): | Demonstrated statistically equivalent performance to control and predicate devices. |
| - In-life catheter patency | Statistically equivalent to control and predicate devices. |
| - Post-mortem catheter and vessel patency | Statistically equivalent to control and predicate devices. |
| - Post-mortem device thrombus | Statistically equivalent to control and predicate devices. |
| - Post-mortem thrombus weight | Statistically equivalent to control and predicate devices. |
| - Safety (adverse events, gross pathology, histopathology) | No significant safety concerns. |
2. Sample size used for the test set and the data provenance:
- Test set for in vitro Platelet Adhesion: The document does not specify a numerical sample size (e.g., number of catheters tested). It mentions a "paired analysis of in vitro measurements" and implies a comparison between the Sustain JACC and an untreated polyurethane catheter.
- Data provenance: In vitro testing. "In vitro testing was conducted in a 1-2 hour flow loop utilizing bovine blood."
- Test set for in vivo Animal Testing: The document does not specify a numerical sample size but mentions "an ovine model" and "a randomized, controlled study." This refers to sheep as the animal model.
- Data provenance: In vivo animal study in an ovine (sheep) model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies described are non-clinical (bench and animal studies) for a medical device, not a human clinical study or an AI diagnostic study that would involve expert interpretation to establish ground truth.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations involving human readers. The documented studies are lab-based performance tests and an animal study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This was not an MRMC comparative effectiveness study, nor did it involve AI. The device is a physical catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This question pertains to AI algorithm performance, which is not relevant to this medical device submission.
7. The type of ground truth used:
- For in vitro Platelet Adhesion: The "ground truth" was the direct measurement of radio-labeled platelet adhesion on the catheter surface compared to an untreated control. This is a direct physical/biological measurement.
- For in vivo Animal Testing: The "ground truth" was established by direct observation and measurement in the ovine model, including:
- In-life catheter patency (observed function)
- Post-mortem vessel patency scores (direct examination)
- Post-mortem device thrombus scores (direct examination)
- Post-mortem thrombus weight (direct measurement)
- Safety endpoints (adverse events, gross pathology, and histopathology, assessed by veterinary pathologists/researchers).
8. The sample size for the training set:
This information is not applicable. There is no AI component, and thus no training set in the context of machine learning.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing connection and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
Arrow International (a Subsdiary of Teleflex, Inc.) Mr. Karl Nittinger Senior Regulatory Affairs Specialist 2400 Bernville Rd. Reading, Pennsylvania 19605
Re: K150109
Trade/Device Name: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 1, 2015 Received: May 4, 2015
Dear Mr. Nittinger:
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.
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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 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 yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 5. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
Indications for Use:
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is indicated for short-term (up to 30-days) access to the central venous system for intravenous therapy, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the Arrow Pressure Injectable JACC with Sustain Technology may not exceed 300 PSI. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image features the logo for Arrow International. The word "ARROW" is written in large, white, sans-serif font. Below it, in a smaller font, is the word "INTERNATIONAL", also in white. The background is a solid blue color, providing a stark contrast to the white text.
SECTION 6. 510(k) SUMMARY
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology Submission Number: K150109
-
- Applicant Information: Arrow International (a subsidiary of Teleflex, Inc.) 2400 Bernville Rd. Reading, PA 19607
| Contact Person: | Karl J. Nittinger |
|---|---|
| Telephone Number: | (610) 378-0131, ext. 603384 |
| Fax Number: | (610) 478-3179 |
Date Prepared: 5-June-2015
2. Device Name:
.
- Arrow Pressure Injectable Jugular Axillo-subclavian Proprietary Name: . Central Catheter (JACC) with Sustain Technology
- Classification Name: Intravascular catheter .
- 21 CFR 880.5200
- . CFR Number:
- Device Class: ●
- II FOZ (Catheter, Intravascular, Short-Term Less Than 30 Product Code: Days).
3. Predicate and Reference Device(s):
| Predicate Device Name | 510(k) | Original ApplicantName |
|---|---|---|
| Pressure Injectable JACC with Chlorag+ardAntimicrobial and Antithrombogenic Technology. | K132133 | Arrow International |
| Arrow, Arrowg+ard and Arrowg+ard Blue PlusPressure-Injectable Central Venous Catheters | K071538 | Arrow International |
| NMI PICC IV (BioFlo PICC with Endexo Technology) | K140266 | Navilyst Medical |
| 6 Fr, 3-Lumen Pressure Injectable PICC | K080604 | Arrow International |
| Reference Device Name | 510(k) | Original ApplicantName |
|---|---|---|
| Nylus™ PICC | K113225 | Semprus Biosciences |
Traditional 510(k) - Pressure Injectable JACC with Sustain Technology
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4. Description of Device:
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is a single-use catheter intended for percutaneous insertion over a guidewire to facilitate access to the central venous system. The device is intended for short term use (up to 30 days) and is provided sterile in a convenience kit configuration which includes single-use accessories to facilitate the insertion procedure. These accessories may include, but are not limited to; introducer needles, guidewires, tissue dilators, and catheter securement devices.
The Arrow Pressure Injectable JACC with Sustain Technology features a radiopaque polyurethane catheter body with a soft, tapered distal tip. The device design is summarized as follows:
- Catheter Body OD: 6 French .
- · Lumens: 3
- · Catheter Body Length: 20 cm
The proximal end of the catheter includes extension lines with integral Luer hubs to facilitate access to the catheter body lumens for infusion and aspiration. The distal lumen of the Arrow Pressure Injectable JACC with Sustain Technology is compatible with power injection flow rates up to 6 ml /sec and pressures up to 300 PSI.
The full-length of the outer surface (and partial length of the internal lumen surface) of the Arrow Pressure Injectable JACC with Sustain Technology is modified with a biomimetic polymer technology. The "Sustain" polymer surface modification technology is intended to reduce platelet adhesion and thrombus accumulation.
- న. Indications for Use:
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is indicated for short-term (up to 30 days) access to the central venous system for intravenous therapy, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the Arrow Pressure Injectable JACC with Sustain Technology may not exceed 300 PSI. The maximum flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
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6. Substantial Equivalence
Intended Use / Indications for Use:
The subject Arrow Pressure-Injectable JACC with Sustain Technology has the same intended use as the predicate devices. The subject and predicate devices are intended to provide access to the central venous system.
The indications for use of the subject device are similar to those of the predicate devices in that all are indicated to provide intravenous therapy including: infusion, pressure injection of contrast media, and central venous pressure monitoring. While the subject device is intended for short-term (up to 30-days) use only, the predicate and reference devices also include indications for long-term use.
Technological Characteristics:
The subject Arrow Pressure-Injectable JACC with Sustain Technology (Arrow Sustain JACC) and the predicate devices are all catheters of radiopaque polyurethane construction. All of the devices include multi-lumen design configurations (the subject device features a 3-lumen design only) and all are offered in outer diameter range of 3 Fr - 6 Fr (the subject device is offered in 6 Fr only). Both the subject Arrow Sustain JACC and the predicate: Arrow Chlora+gard JACC (K132133), Pressure-Injectable PICC (K080604), and Pressure Injectable CVC (K071538) feature tapered, flexible distal tips and all of the devices are pressure injectable with pressure injection flow ratings within the range of 4 ml/sec to 6 ml/sec.
The subject Arrow Sustain JACC as well as the predicate Arrow Pressure-Injectable JACC with Chlorag+ard Technology (K132133). the predicate Nylus PICC (K113225), and the predicate BioFlo PICC (K140266) are offered with antithrombogenic design features. While the predicate Arrow Chlora+gard JACC (K132133) incorporates an antimicrobial / antithrombogenic chlorhexidine-based coating technology, the subject device and the reference Nylus™ PICC (K113225) device incorporate the same "Sustain" biomimetic polymer surface modification to facilitate thromboresistant properties. The predicate BioFlo PICC (K140266) incorporates the Endexo™ technology to achieve its antithrombogenic properties.
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| Proposed Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Reference Device |
|---|---|---|---|---|---|
| Arrow Pressure-InjectableJACC with SustainTechnology | Arrow Pressure-InjectableJACC with Chlorag+ardAntimicrobial andAntithrombogenicTechnology | Arrow, Arrowg+ard,Arrowg+ard Blue PlusPressure-Injectable CentralVenous Catheters | Arrow Pressure-Injectable PICC | NMI PICC IV(BioFlo PICC withEndexo Technology) | NylusTM PICC |
| (K132133) | (K071538) | (K080604) | (K140266) | (K113225) | |
| Indications for Use: | Indications for Use: | Indications for Use: | Indications for Use: | Indications for Use: | Indications for Use: |
| The Arrow PressureInjectable Jugular Axillo-subclavian Central Catheter(JACC) with SustainTechnology is indicated forshort-term (up to 30 days)access to the central venoussystem for intravenoustherapy, infusion, pressureinjection of contrast media,and allows for centralvenous pressure monitoring.The maximum pressure ofpower injector equipmentused with the ArrowPressure Injectable JACCwith Sustain Technologymay not exceed 300 PSI.The maximum flow rate forthe specific lumen beingused for pressure injectionis printed on the extensionline hub. | The Arrow PressureInjectable Jugular Axillo-subclavian Central Catheter(JACC) with Chlorag+ardAntimicrobial andAntithrombogenicTechnology is indicated forshort-term or long-termaccess to the central venoussystem for intravenoustherapy, blood sampling,infusion, pressure injectionof contrast media, and allowsfor central venous pressuremonitoring. The maximumpressure of power injectorequipment used with theArrow Pressure InjectableJACC with Chlorag+ardAntimicrobial andAntithrombogenicTechnology may not exceed300 PSI. The maximumflow rate for the specificlumen being used forpressure injection is printedon the extension line hub. | The Arrow, Arrowg+ard,and Arrowg+ard Blue Pluscatheters are indicated topermit short-term (< 30days) access for thetreatment of diseases orconditions requiring centralvenous access including;replacement of multipleperipheral sites for IVaccess; lack of peripheralIV sites; central venouspressure monitoring; TPN;infusion of incompatiblemedications; multipleinfusions of fluids,medications, orchemotherapy; frequentblood sampling orreceiving bloodtransfusions/bloodproducts; infusions that arehypertonic, hyperosmolar,or infusions that havedivergent pH; injection ofcontrast media. When usedfor pressure injection ofcontrast media, do notexceed the maximum | The Arrow 6 Fr. Triple-Lumen, Pressure-Injectable PeripherallyInserted Central Catheteris indicated for short-termor long-term peripheralaccess to the centralvenous system forintravenous therapy,blood sampling, infusion,power injection ofcontrast media, and allowsfor central venouspressure monitoring. Themaximum of powerinjector equipment usedwith the pressureinjectable PICC may notexceed 300 PSI. | The NMI PICC IV isindicated for short-or long-term peripheral access tothe central venous systemfor intravenous therapy,including, but not limitedto, the administration offluids, medications andnutrients, the sampling ofblood, for central venouspressure monitoring andfor power injection ofcontrast media. | The NylusTM PICC isintended to provideperipheral access to thecentral venous system forinfusion, intravenoustherapy, blood sampling,central venous pressuremonitoring, and powerinjection of contrast media.The Nylus PICC is indicatecfor dwell times shorter orgreater than 30days. Thedevice has a recommendedinfusion rating of 5ml/sec. |
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| Proposed Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Reference Device |
|---|---|---|---|---|---|
| Arrow Pressure-InjectableJACC with SustainTechnology | Arrow Pressure-InjectableJACC with Chlorag+ardAntimicrobial andAntithrombogenicTechnology(K132133) | Arrow, Arrowg+ard,Arrowg+ard Blue PlusPressure-InjectableCentral Venous Catheters(K071538) | Arrow Pressure-InjectablePICC(K080604) | NMI PICC IV(BioFlo PICC withEndexo Technology)(K140266) | NylusTM PICC(K113225) |
| Catheter Length | |||||
| 20 cm | 15 - 35 cm | 16 cm - 20 | 40 cm - 55 cm | 55 cm | 60 cm |
| Catheter Outer Diameter ( Ga. and French) | |||||
| 6 | 4.5, 5.5, and 6 | 16 Ga., 7 Fr – 8.5 Fr | 6 | 3, 4, 5, and 6 | 5 |
| Number of Lumens | |||||
| 3 | 1, 2, and 3 | 1, 2, 3, and 4 | 3 | 1, 2, and 3 | 2 |
| Pressure Injection Capability | |||||
| Distal lumen only (6 ml/sec) | 1-lumen catheter:Distal lumen only (5 ml/sec)2-lumen catheter:Distal lumen (5 ml/sec)Proximal lumen (4 ml/sec)3-lumen catheter:Distal lumen only (6ml/sec) | 5 ml/sec - 10 ml/sec max.flow rates for pressureinjectable lumens. | Distal-lumen only (6ml/sec) | 6 ml/sec max. flow rate. | Both lumens(5ml/sec) |
| Catheter Body Materials | |||||
| Radiopaque Polyurethane | Radiopaque Polyurethane | Radiopaquepolyurethane | Radiopaque Polyurethane | RadiopaquePolyurethane | Radiopaque Polyurethane |
| Distal Tip | |||||
| Tapered, flexible tip. | Tapered, flexible tip. | Tapered, flexible tip. | Tapered, flexible tip. | Straight, blunt tip. | Straight, blunt tip. |
| Catheter Surface Treatment | |||||
| "Sustain" biomimeticpolymer surfacemodification with plateletadhesion-resistant andthrombus accumulation-resistant properties. | Chlorhexidine-based coatingwith antimicrobial as well asplatelet adhesion andthrombus accumulationresistant properties. | Arrow CVC: NoneArrowg+ard andArrowg+ard Blue PlusCVC: Chlorhexidine-based antimicrobialcoating. | None | "Endexo" polymeradditive with plateletadhesion-resistant andthrombus accumulation-resistant properties. | "Sustain" biomimeticpolymer surfacemodification with plateletadhesion-resistant andthrombus accumulation-resistant properties. |
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-
- Non-Clinical Performance Data.
Bench testing verifying the performance requirements of the subject Arrow Pressure-Injectable JACC with Sustain Technology (Sustain JACC) was conducted and the results support substantial equivalence.
- Non-Clinical Performance Data.
Testing included:
- BS EN ISO 10555-1 and BS EN ISO 10555-3: Force at Break, Elongation, Flow . Rate, Liquid Leakage, Air Leakage
- BS EN 20594-1 and BS EN 1707: Gauging, Liquid Leakage, Air Leakage, . Separation Force, Stress Cracking, Unscrewing Torque, Ease of Assembly, Resistance to Overriding.
- Additional Performance Verification Testing: Repeat Pressure Injection, Static . Burst, Flow Rate Under Pressure Injection, Flex Cycling, Compression Stiffness, Collapse Resistance, Kink Resistance, Pressure Monitoring, Site Care Chemical Exposure, Mechanical Hemolysis, Extension Line Clamp Functionality, Radiodetectability
- . Biocompatibility: According to the requirements identified in ISO 10993-1 for externally communicating devices with circulating blood contact for up to a 30day duration, the following tests were performed: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subacute Toxicity, Genotoxicity, Implantation (4-week), Hemocompatibility. In addition, a study characterizing any leachable and extractable chemical components associated with the subject device was included.
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The Sustain JACC features a polymer surface modification which is designed to provide thromboresistant properties to the catheter surface. In vitro assessment has shown that the external Sustain JACC catheter surface was more resistant to platelet adhesion than the external surface of an untreated catheter. No correlation of in vitro results to clinical performance has been ascertained.
| in vitro Performance Characteristic | in vitro Performance Result |
|---|---|
| Platelet Adhesion on External Catheter Surface | A paired analysis of in vitro measurementsof adhesion of radio-labeled platelets to theexternal catheter surface of the SustainJACC demonstrated an average reduction of87% when compared to platelet adhesionmeasurements on the external surface of anuntreated polyurethane catheter.1 |
1 In vitro testing was conducted in a 1-2 hour flow loop utilizing bovine blood. No correlation of in vitro results to clinical performance has been ascertained. In vivo testing of the Sustain JACC in an ovine model demonstrated statistically equivalent performance with respect to in-life catheter patency, post-mortem catheter and vessel patency, post-mortem device thrombus, and post-mortem thrombus weight in comparison to an untreated control catheter and a control catheter featuring thromboresistant technology.
Animal Testing:
Data from an in vivo study assessing the performance of the subject device in a biological environment were additionally included to support substantial equivalence. The evaluation was a randomized, controlled study in an ovine model and was conducted in conformity with the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP ) regulations of 21 CFR Part 58.
The 28-day in vivo evaluation studied the comparative performance and safety of the subject device as well as the untreated and unmodified predicate device (K080604) and the predicate BioFlo PICC with Endexo Technology (K140266). Study performance endpoints were in-life catheter patency and post-mortem vessel patency scores, device thrombus scores, and accumulated device thrombus weight. Safety endpoints studied included adverse events, gross pathology, and histopathology.
8. Clinical Performance Data.
No human clinical data was provided to support substantial equivalence.
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Conclusion Regarding Substantial Equivalence 9.
The information included in this premarket notification support the substantial equivalence of the subject Arrow Pressure-Injectable JACC with Sustain Technology to the stated predicate devices. The subject device has the same intended use, similar indications for use, incorporates the same fundamental technology, is composed of similar materials, and features a similar geometric design to the legally marketed predicate and reference devices to which it was compared.
In vitro performance and biocompatibility data were included to confirm the performance of the subject device against its physical design and performance requirements. Data from an in vivo evaluation confirmed the substantially equivalent performance of the subject device compared to the predicate devices in a biological environment.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).