(136 days)
No
The summary describes a physical catheter with a biomimetic polymer surface modification. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Sustain Technology" refers to the polymer coating, not an intelligent system.
No.
The device is indicated for short-term access to the central venous system for intravenous therapy, infusion, pressure injection of contrast media, and central venous pressure monitoring, rather than directly treating a disease or condition.
No.
The device is a central venous catheter for intravenous therapy, infusion, and pressure injection of contrast media. While it allows for central venous pressure monitoring, which is a diagnostic measurement, the primary purpose of the device itself (the catheter) is not to diagnose but to provide access and facilitate these therapies and procedures. Diagnostic devices are primarily used to identify or characterize a disease or condition.
No
The device description clearly describes a physical catheter and associated accessories, not a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "access to the central venous system for intravenous therapy, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring." These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description details a catheter for percutaneous insertion into the central venous system. This is an invasive medical device used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide diagnostic information based on those samples. IVDs are typically used in a laboratory setting or at the point of care to analyze biological specimens.
The device described is a medical device used for therapeutic and monitoring purposes within the patient's circulatory system.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central venous system, Jugular, Axillo-subclavian
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 Performance Data: Bench testing was conducted to verify performance requirements.
- 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: Tests performed according to ISO 10993-1 for externally communicating devices with circulating blood contact for up to a 30-day duration: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subacute Toxicity, Genotoxicity, Implantation (4-week), Hemocompatibility. A study characterizing leachable and extractable chemical components was also included.
- Platelet Adhesion In Vitro: A paired analysis of in vitro measurements of adhesion of radio-labeled platelets to the external catheter surface of the Sustain JACC demonstrated an average reduction of 87% when compared to platelet adhesion measurements on the external surface of an untreated polyurethane catheter. (In vitro testing conducted in a 1-2 hour flow loop utilizing bovine blood. No correlation of in vitro results to clinical performance has been ascertained.)
- Animal Testing: An in vivo study assessed the performance of the device in a biological environment.
- Study Type: Randomized, controlled study in an ovine model, conducted in conformity with GLP (21 CFR Part 58).
- Sample Size: Not explicitly stated, but includes the subject device, an untreated and unmodified predicate device (K080604), and the predicate BioFlo PICC with Endexo Technology (K140266).
- Key Results:
- Performance Endpoints: In-life catheter patency and post-mortem vessel patency scores, device thrombus scores, and accumulated device thrombus weight.
- Safety Endpoints: Adverse events, gross pathology, and histopathology.
- The in vivo 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.
- Clinical Performance Data: No human clinical data was provided to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- In vitro platelet adhesion reduction: 87% (average reduction compared to untreated polyurethane catheter).
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.
K132133, K071538, K140266, K080604
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.
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
§ 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).
0
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.
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 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
2
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 Applicant
Name |
|---------------------------------------------------------------------------------------------|---------|----------------------------|
| Pressure Injectable JACC with Chlorag+ard
Antimicrobial and Antithrombogenic Technology. | K132133 | Arrow International |
| Arrow, Arrowg+ard and Arrowg+ard Blue Plus
Pressure-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 Applicant
Name |
|-----------------------|---------|----------------------------|
| Nylus™ PICC | K113225 | Semprus Biosciences |
Traditional 510(k) - Pressure Injectable JACC with Sustain Technology
4
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-Injectable | |||||
| JACC with Sustain | |||||
| Technology | Arrow Pressure-Injectable | ||||
| JACC with Chlorag+ard | |||||
| Antimicrobial and | |||||
| Antithrombogenic | |||||
| Technology | Arrow, Arrowg+ard, | ||||
| Arrowg+ard Blue Plus | |||||
| Pressure-Injectable Central | |||||
| Venous Catheters | Arrow Pressure- | ||||
| Injectable PICC | NMI PICC IV | ||||
| (BioFlo PICC with | |||||
| Endexo 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 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. | The Arrow Pressure | ||||
| Injectable Jugular Axillo- | |||||
| subclavian Central Catheter | |||||
| (JACC) with Chlorag+ard | |||||
| Antimicrobial and | |||||
| Antithrombogenic | |||||
| Technology is indicated for | |||||
| short-term or long-term | |||||
| access to the central venous | |||||
| system for intravenous | |||||
| therapy, blood sampling, | |||||
| 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 Chlorag+ard | |||||
| Antimicrobial and | |||||
| Antithrombogenic | |||||
| 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. | The Arrow, Arrowg+ard, | ||||
| and Arrowg+ard Blue Plus | |||||
| catheters are indicated to | |||||
| permit short-term (in vitro Performance Characteristic | in vitro Performance Result | ||||
| ------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ||||
| Platelet Adhesion on External Catheter Surface | A paired analysis of in vitro measurements | ||||
| of adhesion of radio-labeled platelets to the | |||||
| external catheter surface of the Sustain | |||||
| JACC demonstrated an average reduction of | |||||
| 87% when compared to platelet adhesion | |||||
| measurements on the external surface of an | |||||
| untreated 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.