(160 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheterization device, with no mention of AI or ML.
No
The device is described as an "arterial catheterization device" that "permits access to the peripheral arterial circulation or to other small vessels." It is a tool for accessing a vessel, not for treating a condition.
No
Explanation: The device description and intended use state that it "permits access" to vessels and is used for "catheter insertion," which are interventional procedures, not diagnostic ones. It allows for visualization of blood flashback, which is an aid to placement, not a diagnostic finding.
No
The device description clearly outlines a physical, sterile, single-use arterial catheterization device made of polyurethane with a needle, hub, and wire guide. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit access to the peripheral arterial circulation or to other small vessels." This describes a device used for a medical procedure (accessing blood vessels), not for testing samples in vitro (outside the body).
- Device Description: The description details a physical device (catheter-over-needle, wire guide) used for insertion into the body. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD. The performance studies focus on the physical properties and functionality of the device itself (biocompatibility, tensile strength, leakage, etc.), not on the accuracy of diagnostic results.
In summary, the Arrow Arterial Catheterization Device is a medical device used for accessing blood vessels, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
The catheter is intended for short-term use (less than 30 days) to permit access to peripheral vessels.
Product codes
DQX, DQY
Device Description
The primary purpose of this Traditional 510(k) submission is for labeling modification to the Arrow Radial Artery Catheterization Set (K810675). Specifically, clarifications to the contraindications and warnings sections of the device labeling have been introduced as well as modifications to the recommended procedural technique to facilitate efficiencies in verbiage and add clarity. The subject device, the Arrow® Quickflash Arterial Catheterization Device, which is a sterile, single use arterial catheterization device, is designed to permit access to the peripheral arterial circulation or to other small vessels. The Arrow® Quickflash Arterial Catheterization Device is an all-in-one design consisting of a translucent polyurethane, radiopaque single lumen arterial catheter-over-needle device that includes a clear chamber as part of the needle hub which allows visualization of blood flashback. The needle has openings to enhance flashback visibility and the hub is connected proximally to a slotted housing that contains the integral spring wire guide. A handle projects through the slotted housing to permit the advancement of the spring wire guide through the introducer needle into the vessel. This design allows for quick and simple catheter insertion since all of the devices required for insertion are provided together.
The Arrow Quickflash Arterial Catheterization Device is available with and without integrated molded suture wings in 20 gauge configurations with usable lengths of 3.81 cm (1 ½").
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial circulation or to other small vessels.
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)
Bench test results related to design verification associated with the current design of the Arrow Quickflash Arterial Catheterization Device are included in support of the substantial equivalence of the subject device. The following testing has been completed for the subject device:
- Biocompatibility in accordance with ISO 10993-1, 10999-3, 10993-4, 10993-O 10, and 10993-11
- Requirements from ISO 10555 and ISO 11070 including:
- Surface
- Corrosion Resistance
- Freedom from leakage (Air and Liquid)
- Tensile Testing
- Luer testing in accordance with ISO 594-1 & ISO 594-2
- Simulated Use testing
- Penetration/Insertion force
- Catheter Kink resistance in accordance with BS EN 13868
- Dimensional Verification
- Needle Flexing Durability
- Spring Wire Guide Flexing Durability
- Catheter Resistance to Collapse
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a flowing ribbon representing the snakes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2016
Arrow International, Inc. Ms. Christine Ford Sr. Regulatory Affairs Manager 2400 Bernville Rd Reading, PA 19605
Re: K160018
Trade/Device Name: Arrow Ouickflash Arterial Catheterization Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DQY Dated: May 11, 2016 Received: May 16, 2016
Dear Ms. Ford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
1
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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160018
Device Name
Arrow Quickflash Arterial Catheterization Device
Indications for Use (Describe)
The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
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)
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510(k) SUMMARY FOR THE ARROW QUICKFLASH ARTERIAL CATHETERIZATION DEVICE
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: | Christine Ford |
| Sr. Regulatory Affairs Manager | |
| Telephone Number: | (610) 378-0131 |
| Fax Number: | (610) 374-5360 |
| Email: | christine.ford@teleflex.com |
| Date Prepared: | 12-MAY-2016 |
2. Device Name
| Device Trade Name: | Arrow® Quickflash Arterial Catheterization Device |
|---|---|
| Common Name: | Peripheral Intravascular Catheter |
| Classification Name: | Catheter guide wire, (Class II, DQX, 21 CFR 870.1330) |
| Percutaneous catheter, (Class II, DQY, 21 CFR 870.1250) |
3. Predicate Devices
- K810675: Arrow® Radial Artery Catheterization Set ●
4. Device Description
The primary purpose of this Traditional 510(k) submission is for labeling modification to the Arrow Radial Artery Catheterization Set (K810675). Specifically, clarifications to the contraindications and warnings sections of the device labeling have been introduced as well as modifications to the recommended procedural technique to facilitate efficiencies in verbiage and add clarity. The subject device, the Arrow® Quickflash Arterial Catheterization Device, which is a sterile, single use arterial catheterization device, is designed to permit access to the peripheral arterial circulation or to other small vessels. The Arrow® Quickflash Arterial Catheterization Device is an all-in-one design consisting of a translucent polyurethane, radiopaque single lumen arterial catheter-over-needle device that includes a clear chamber as part of the needle hub which allows visualization of blood flashback. The needle has openings to enhance flashback visibility and the hub is connected proximally to a slotted housing that contains the integral spring wire guide. A handle projects through the slotted housing to permit the advancement of the spring wire guide through the introducer needle into the vessel. This design allows for quick and simple catheter insertion since all of the devices required for insertion are provided together.
The Arrow Quickflash Arterial Catheterization Device is available with and without integrated molded suture wings in 20 gauge configurations with usable lengths of 3.81 cm (1 ½").
5. Intended Use
The catheter is intended for short-term use (less than 30 days) to permit access to peripheral vessels.
4
6. Indications for Use
The indications for use for the subject device are identical to the predicate and are listed below:
The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
7. Technological Characteristics
Information related to cumulative design modifications which have been implemented in the subject device are included and are summarized below.
| Design Feature | Predicate device: | Subject device: |
|---|---|---|
| Arrow® Radial Artery | Arrow® Quickflash Arterial | |
| Catheterization Set (K810675) | Catheterization Device | |
| Catheter body OD | 18, 20 Ga | 20 Ga |
| Catheter length | 1 3/4 inches (4.45cm) | 1 ½ inches (3.81cm) |
| Catheter body material | Teflon | Polyurethane with20% Barium Sulfate |
| Blood Flashback | Clear introducer needle proximal hub. | Transparent Quickflash blood flashback |
| Visualization | visualization chamber. | |
| Integrated Guide wire | Yes | Yes |
| Guide wire material/size | Stainless Steel 0.018", Straight, soft tip | Stainless Steel 0.018", Straight, soft tip |
| Sterilization Method | EO | EO |
8. Nonclinical Testing
Bench test results related to design verification associated with the current design of the Arrow Quickflash Arterial Catheterization Device are included in support of the substantial equivalence of the subject device. The following testing has been completed for the subject device:
- Biocompatibility in accordance with ISO 10993-1, 10999-3, 10993-4, 10993-O 10, and 10993-11
- Requirements from ISO 10555 and ISO 11070 including: o
- Surface
- . Corrosion Resistance
- I Freedom from leakage (Air and Liquid)
- I Tensile Testing
- Luer testing in accordance with ISO 594-1 & ISO 594-2 o
- Simulated Use testing O
- Penetration/Insertion force O
- Catheter Kink resistance in accordance with BS EN 13868 O
- Dimensional Verification O
- Needle Flexing Durability O
- Spring Wire Guide Flexing Durability O
- Catheter Resistance to Collapse O
9. Conclusions
The labeling modifications proposed to the subject device do not alter the intended use, indications for use, fundamental technology, or fundamental method of operation of the subject device. Summary verification results support the substantial equivalence of the subject Arrow Quickflash Arterial Catheterization Device, to the legally marketed predicate device, Arrow® Radial Artery Catheterization Set (K810675).