(106 days)
No
The document describes a physical medical device (catheter) with antimicrobial and antithrombogenic coatings. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies listed are related to the physical properties and function of the catheter.
No.
The device is a peripheral access catheter used for administration and sampling, not for treating a disease or condition itself.
No
Explanation: The device is a catheter designed for short-term peripheral access for venous therapy, blood sampling, infusion, and contrast media injection. While blood sampling can be part of a diagnostic process, the device itself is not described as analyzing or interpreting data for diagnostic purposes. Its function is to facilitate the delivery or removal of substances from the body.
No
The device description clearly outlines a physical catheter made of polyurethane with a flexible tip, designed for insertion into the venous system. It also mentions packaging in kits with insertion components. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a catheter used for "short-term peripheral access to the venous therapy, blood sampling. infusion, and pressure injection of contrast media." This is a device used within the body for direct access and delivery/withdrawal of substances, not for testing samples outside the body.
- Lack of Diagnostic Purpose: The intended use and device description focus on providing venous access and facilitating procedures like infusion and injection. There is no mention of analyzing biological samples for diagnostic purposes.
Therefore, the Arrow Pressure Injectable Midline Catheter is a medical device used for therapeutic and procedural purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (
§ 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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2016
Arrow International, Inc. (subsidiary of Teleflex Inc.) Ms. Julie Lawson Regulatory Affairs Specialist 2400 Bernville Road Reading, Pennsylvania 19605
Re: K161313
Trade/Device Name: Arrow Pressure Injectable Midline Catheter with Chlorag+arde Antimicrobial and Antithrombogenic Technology Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: PND Dated: July 22, 2016 Received: July 25, 2016
Dear Ms. Lawson:
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 (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 yours,
Tina Kiang
Tina Kiang, Ph.D. Acting 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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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.
510(k) Number (if known) K161313
Device Name
- ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Indications for Use (Describe)
The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term ( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) SUMMARY
ARROW PRESSURE INJECTABLE MIDLINE CATHETER WITH CHLORAG ARD ANTIMICROBIAL AND ANTITHROMBOGENIC TECHNOLOGY
1. Submitter Information
| Name: | Arrow International, Inc. (subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 2400 Bernville Road |
| Reading, PA 19605-9607 | |
| Telephone Number: | (610) 378-0131 |
| Contact Person: | Julie Lawson |
| Regulatory Affairs Specialist | |
| Telephone Number: | (610) 378-0131 Extension 603256 |
| Fax Number: | (610) 478-3179 |
| Email: | julie.lawson@teleflex.com |
Date Prepared: May 9, 2016
2. Device Name
| Device Trade Name: | Arrow® Pressure Injectable Midline Catheter
with Chlorag+ard® Antimicrobial and Antithrombogenic
Technology |
|--------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name: | Midline Catheter |
| Regulation Number: | 21 CFR: 880.5200 |
| Regulation Name: | Intravascular Catheter |
| Product Code: | PND |
3. Predicate and Reference Devices
Arrow Peripherally Inserted Midline Catheter (K963257) - Predicate
ArrowEvolution™ Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896) - Reference
4. Device Description
The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term peripheral access to the venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue FlexTip (flexible distal tip). The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with a usable catheter length of 15 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with a Chlorhexidine-based solution
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technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.
The catheters will be packaged sterile in kits that will include components to facilitate insertion. The Chlorag+ard technology that is incorporated in the modified device's physical design is the same as the reference device.
5. Indications for Use
The Arrow Pressure Injectable Midline Catheter with Chlorag ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (in vitro and
in vivo test methods and no
correlation between these
testing methods and clinical
outcome has currently been
ascertained. It is not
intended to be used for the
treatment of existing
infections or vein
thrombosis. | Pressure Injectable
Midline Catheter may not
exceed 300 psi
(2068.4kPa). The
maximum pressure
injection flow rate for the
specific lumen being used
for pressure injection is
printed on the extension
line hub.
Chlorag+ard Technology
treatment on the external
surface of the catheter
body as well as the entire
fluid pathway of the
catheter has been shown
to be effective in
reducing microbial
colonization and
thrombus accumulation
on catheter surfaces.
Antimicrobial and
antithrombogenic
effectiveness were
evaluated using in vitro
and in vivo test methods
and no correlation
between these testing
methods and clinical
outcome has currently
been ascertained. It is not
intended to be used for
the treatment of existing
infections or vein
thrombosis. |
| Catheter OD | 3, 4 and 5 Fr | 4.5 Fr and 5.5 Fr | Same as reference device:
4.5 Fr and 5.5 Fr. |
| Catheter
Usable Length | 15 cm | 40, 50, and 55 cm | Same as predicate device:
15 cm. |
| Design
Characteristic | Predicate Device
Arrow Peripherally
Inserted Midline Catheter
(K963257) | Reference Device
AM/AT PICC (K112896) | Subject Pressure
Injectable CG+
MIDLINE |
| Number
of Lumens | 3, 4 and 5 Fr. - 1 lumen
4 and 5 Fr. - 2 lumens | 4.5 Fr. - 1 lumen
5.5 Fr. - 2 lumens | Same as reference device:
4.5 Fr. - 1 lumen
5.5 Fr. - 2 lumens |
| Internal
Lumen
Configuration | Round
Circle/crescent | 4.5 Fr. - Round
5.5 Fr. - Double D | Same as reference device:
4.5 Fr. - Round
5.5 Fr. - Double D |
| Catheter Tip
Configuration | Blunt Tip | Blue FlexTip | Same as reference device:
Blue FlexTip |
| Pressure
Injection
Capabilities | None | Distal lumen – 5 mL/sec,
Pressure Injectable
Proximal lumen – 5
mL/sec, Pressure Injectable | Distal lumen - 5 mL/sec,
Pressure Injectable
Proximal lumen- Not
labeled for Pressure
Injection |
| Chlorhexidine
-Based
Coating
Performance | None | Antimicrobial Efficacy
Effective in reducing
microbial colonization
Antithrombogenic Efficacy
Effective in reducing
thrombus accumulation | Same as reference device:
Antimicrobial Efficacy
Effective in reducing
microbial colonization
Antithrombogenic
Efficacy
Effective in reducing
thrombus accumulation |
| Catheter Body
Material | White Polyurethane with
20% Barium Sulfate | Blue Polyurethane
with 30% Bismuth
Oxychloride | Same as reference device:
Blue Polyurethane
with 30% Bismuth
Oxychloride |
| Catheter Tip
Material | White Polyurethane with
20% Barium Sulfate | Blue Polyurethane with
30% Bismuth Oxychloride | Same as reference device:
Blue Polyurethane with
30% Bismuth
Oxychloride |
| Juncture
Hub Material | White Polyurethane | Transparent Light Blue
Polyurethane | Same as reference device:
Transparent Light Blue
Polyurethane |
| Extension Line | Clear Polyurethane | Clear Polyurethane | Same as reference device: |
| Design
Characteristic | Predicate Device
Arrow Peripherally
Inserted Midline Catheter
(K963257) | Reference Device
AM/AT PICC (K112896) | Subject Pressure
Injectable CG+
MIDLINE |
| Material | | | Clear Polyurethane |
| Extension
Hub
Material | Natural Polyurethane | Distal - Pink Polyurethane
Proximal – White
Polyurethane | Same as reference device:
Distal – Pink
Polyurethane
Proximal – White
Polyurethane |
| Printing Ink | Printing Ink NT16 Black Ink
Black Hot Stamp Printing
Foil | Printing Ink 2405 Black Ink | Same as reference device:
Printing Ink 2405 Black
Ink |
| Safety and
Performance
Testing | Mechanical testing to:
• ISO 10555-1
• ISO 10555-3
Biocompatibility testing | Mechanical testing to:
• ISO 10555-1
• ISO 10555-3
Biocompatibility testing | Same as both predicate
and reference device:
Mechanical testing to:
• ISO 10555-1
• ISO 10555-3
Biocompatibility testing |
Predicate, Reference and Subject Device Comparison
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7. Nonclinical Testing
The following performance testing related to the device changes has been completed to support the substantial equivalence of the subject devices to the predicate and reference devices:
- O priming volume
- gravity flow rate O
- 10 psi pumped flow rate O
- O rate limited pressure injection
- pressure limited injection O
- static burst O
- mechanical hemolysis O
- tensile testing (extension line to luer hub) O
The following standards were used in the non-clinical testing listed above:
- o ASTM F756-08
- o ISO 10555-1
- ISO 10555-3 O
- o ISO 10993-7
- o ISO 11135
8. Conclusions
The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is the same device as the reference device, the ArrowEVOLUTION Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896) with the exception of usable catheter length, extension line hub design (on proximal lumen of 2 lumen midline catheter) and extension line text. The results of the testing performed have demonstrated that the devices are safe, effective, and perform as intended. The subject device and predicate and reference devices (K963257 and K112896 respectively) have the same insertion site and associated insertion procedure. The final indwelling tip position of the subject and predicate (K963257) device is the same because they are both midline catheters per the proposed indications for use.
In conclusion, the Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is substantially equivalent to the predicate Arrow Peripherally Inserted Midline Catheter (K963257) and the reference device, the ArrowEVOLUTION Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896).