(21 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device, a Peripherally Inserted Central Catheter, is used for venous access to the central circulation for intravenous therapy, which is a method of administering medication or fluids, not for treating a disease or condition itself.
No
This device is a catheter used for venous access and therapy, not for diagnosing conditions.
No
The device description clearly describes a physical catheter, which is a hardware component. The performance studies also focus on physical properties like tensile strength and burst pressure, further indicating it is a hardware 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 provide venous access to the central circulation through a peripheral vein for intravenous therapy. This is a therapeutic and access function, not a diagnostic one.
- Device Description: The description details a catheter for accessing the circulatory system, not for analyzing samples of bodily fluids or tissues.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties and functionality of the catheter (tensile strength, flex test, burst, fatigue, leakage), which are relevant to its use as a medical device for access, not for diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for therapeutic access.
N/A
Intended Use / Indications for Use
The Arrow International Peripherally Inserted Central Catheter is intended for short-term peripheral venous access to the central circulation. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
A Peripherally inserted Central Catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
Product codes
LJS
Device Description
The Arrow International Peripherally Inserted Central Catheters are similar to the currently marketed Arrow Trimmable and Blue FlexTip® single and double lumen catheters. The catheter juncture has been modified to improve overall catheter strength. The hub colors and catheter labeling have changed to distinguish the new Arrow catheters. The catheter is available in lengths of 40 cm - 60 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central circulation through a peripheral vein
Indicated Patient Age Range
adult and pediatric patients
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)
The following tests were performed to demonstrate substantial equivalence:
• Tensile Strength
• Flex Test
• Burst
• Fatigue
• Leakage
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
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
AUG 27 2004
ATTACHMENT 1: 510 (K) SUMMARY
| Submitter | ARROW International Inc
2400 Bernville Road
Reading, PA 19605-9607 USA |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Suzanne Schorle
Regulatory Affairs Associate
Phone: 610-378-0131, ext. 3443
Fax: 610-478-3167
Email: suzanne.schorle@arrowintl.com |
| Date summary prepared: | August 4, 2004 |
| Device trade name: | Peripherally Inserted Central Catheters |
| Device common name: | PICC |
| Device classification name: | Catheter, intravascular, therapeutic, long-term greater than
30 days |
| Legally marketed devices to
which the device is
substantially equivalent: | Arrow International's Peripherally Inserted Central
Catheter (K930129) and Two Lumen PICC with Blue
FlexTip® Catheter with Integral Needle Protection
(K003006) |
| Description of the device: | The Arrow International Peripherally Inserted Central
Catheters are similar to the currently marketed Arrow
Trimmable and Blue FlexTip® single and double lumen
catheters. The catheter juncture has been modified to
improve overall catheter strength. The hub colors and
catheter labeling have changed to distinguish the new
Arrow catheters. The catheter is available in lengths of 40
cm - 60 cm. |
| Intended use of the device: | The Arrow International Peripherally Inserted Central
Catheter is intended for short-term peripheral venous
access to the central circulation. It offers an alternative
method of intravenous therapy for select adult and
pediatric patients. |
| Technological
characteristics: | The proposed peripherally inserted central catheters have
the same technological design characteristics as the
predicate devices. |
| Performance tests: | The following tests were performed to demonstrate
substantial equivalence:
• Tensile Strength
• Flex Test
• Burst
• Fatigue
• Leakage |
| Assessment of non-clinical
performance data: | The results of the laboratory tests demonstrate that the
Arrow peripherally inserted central catheter are
substantially equivalent to the legally marketed predicate
devices. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2004
Ms. Suzanne Schorle Regulatory Affairs Associate Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605
Re: K042126
Trade/Device Name: Peripherally Inserted Central Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter. Regulatory Class: II Product Code: LJS Dated: August 5, 2004 Received: August 6, 2004
Dear Ms. Schorle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller by 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 Interstate conninetee prior to ria, 20, 1778, as a see and the provisions of Amendments, of to devices that ha 70 Act (Act). You may, therefore, market the device, the rederal rood, Drag, and Cosmonions of the Act and the limitations described below. subject to the general controls provisions of the Act include requirements for annual registration, I he general controls provisions turing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that The Office of Device Draiaator inded use not identified in your Indications For Use this device will be used for an menava sharm. Therefore, in accordance with Section Statement and that such as ecure can in the Warnings of device's labeling:
- The safety and effectiveness of this device for the use with power injection and high t power infusion systems has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the I icase not that the above laboring mirred before these limitations are modified in any way or removed from the device's labeling.
2
Page-2 Mr. Schorle
The FDA finding of substantial equivalence of your device to a legally marketed predicate I he FDA Inding of substantial equivalence or your device and permits your device to proceed to the device results in a classification for your de rice as described in your market. This letter will anow you to begin marteeining your marketing on and ed to vour labeling.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into cols. Existing major regulations affecting your (PMA), It may be subject to adultions, Title 21, Parts 800 to 898. In device can be louind in the Code of Peachards, rought in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 ISSuance of a bases on a base on plies with other requirements mean that IDA has made a decommanen in administered by other Federal agencies. of the Act of ally rederal statues and regaranents, including, but not limited to: registration You must continue with an the Free 5 rog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), idooling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to II you desire specific information as our art appear and compliance at (301) 594-4692. your device (21 CFR Part 607), presided, "Misbranding by reference to premarket Also, please note the regulation entitled, "You may obtain other general information on your notification (21 CFR Part 007.77): Touring Schall Manufacturers, International, and responsibilities under the Net Hom and Division of (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
[signature]
Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ATTACHMENT 2: INDICATIONS FOR USE STATEMENT
| 510(k) Number: | |
|---|---|
| Device Name: | Peripherally Inserted Central Catheter |
| Indications for Use: | A Peripherally inserted Central Catheter permits venous access to the |
| central circulation through a peripheral vein. It offers an alternative | |
| method of intravenous therapy for select adult and pediatric patients. |
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
- Use
(part C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Antin Dint
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________