(266 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a catheter, with no mention of AI or ML technologies.
Yes
The device is indicated for "intravenous therapy," which is a form of medical treatment, and therefore qualifies it as a therapeutic device.
No
The device description and intended use indicate that it is a catheter for venous access, therapy, blood sampling, and contrast media injection. It is not described as analyzing or interpreting data to diagnose a condition.
No
The device description clearly outlines a physical catheter made of polyurethane with specific dimensions and features, indicating it is a hardware medical device.
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 "short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media." These are all procedures performed on the patient's body, not on samples outside the body.
- Device Description: The description details a catheter designed for insertion into the venous system. This is a medical device used for direct patient care.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed for testing samples in vitro. This device is designed for accessing the venous system in vivo (within the body).
N/A
Intended Use / Indications for Use
The Arrow(R) Pressure Injectable Midline Catheter 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).
0
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September 2, 2022
Arrow International LLC Subsidiary of Teleflex Incorporated Kim Pennington Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K213855
Trade/Device Name: Arrow® Pressure Injectable Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: August 2, 2022 Received: August 3, 2022
Dear Kim Pennington:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Wolloscheck, Ph.D. For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K213855
Device Name Arrow® Pressure Injectable Midline
Indications for Use (Describe)
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY - K213855
1. Submitter Information
| Name: | Arrow International LLC, Subsidiary of Teleflex Incorporated |
|---|---|
| Address: | 3015 Carrington Mill Blvd |
| Morrisville, NC 27560 | |
| Telephone Number: | (610) 451-3095 |
| Contact Peron: | Kim Pennington |
| Regulatory Affairs Specialist | |
| Email: | kim.pennington@teleflex.com |
| Date Prepared: | August 31, 2022 |
2. Device Name
| Device Trade Name: | Arrow® Pressure Injectable Midline Catheter |
|---|---|
| Common Name: | Midline Catheter |
| Classification Name: | Intravascular catheter |
| Regulation: | 21 CFR 880.5200 |
| Product Code: | PND |
| Class: | II |
3. Predicate Devices
K161313: Arrow Pressure Injectable Midline Catheter with ArrowG+ard Blue Advance Antimicrobial and Antithrombogenic Technology
4. Purpose
The purpose of this premarket notification is for the introduction to market of a sterile, single-use pressure injectable midline catheter without antimicrobial and antithrombogenic technology.
5. Device Description
The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4
4
Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec.
The catheters will be packaged sterile in kits that will include components to facilitate insertion.
6. Intended Use
The Pressure Injectable Midline Catheters are intended for short-term peripheral access to the venous system for intravenous therapy and blood sampling.
7. Indications for Use
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
8. Technological Characteristics and Substantial Equivalence
The subject device is substantially equivalent to the predicate device:
5
| Features | Subject Device:
Arrow Pressure
Injectable Midline
Catheter
K213855 | Arrow Pressure Injectable
Midline Catheter with
ArrowG+ard Blue Advance
Antimicrobial and
Antithrombogenic
Technology
(K161313) | Assessment of
Device
Differences |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Intravascular catheter | Intravascular catheter | Same |
| Product Code | PND | PND | Same |
| Regulation
Number | 880.5200 | 880.5200 | Same |
| Class | II | II | Same |
| Indications for
Use | The Arrow(R) Pressure
Injectable Midline Catheter is
indicated for short-term (≤
30 days) peripheral access to
the venous system for
intravenous therapy, blood
sampling, infusion, and
pressure injection of contrast
media. The maximum
pressure of pressure injector
equipment used with the
Arrow Pressure Injectable
Midline Catheter may not
exceed 300 psi (2068.4 kPa).
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
Midline Catheter with Chlorag+ard®
Antimicrobial and
Antithrombogenic Technology is
indicated for short-term (