(65 days)
No
The summary describes a physical needle with an echogenic surface treatment and provides results from bench tests related to its physical properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is an introducer needle used for access to the vascular system, not for treating a disease or condition.
No
The device is an introducer needle designed to facilitate the placement of catheters by allowing access to the vascular system for a guidewire. Its function is interventional (enabling a procedure), not diagnostic (identifying or characterizing a condition).
No
The device description clearly outlines physical characteristics (diameter, length, surface treatment) and performance studies (penetration, bond strength) related to a physical needle, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Arrow Echogenic Introducer Needle is used to access the vascular system in a living patient to facilitate the placement of a catheter. It is a tool used directly on the patient's body, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states it's for "access to the vascular system for the introduction of a guidewire to facilitate catheter placement." This is an in-vivo procedure.
The device's function and intended use are entirely focused on a procedure performed directly on a patient, not on analyzing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
The intended use is the same as the predicate devices.
The Indication for Use is the same as the predicate device.
The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.
Product codes
FMI
Device Description
The Arrow Echogenic Introducer Needle has the following characteristics:
- Outside Diameter = 18Ga - 21Ga
- Inside Diameter = 0.0240 - 0.042 in.
- Usable lengths of 1 ½ - 2 ¾ in. (3.81 - 7cm)
- Grit-blast echogenic surface treatment
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following tests were performed to demonstrate substantial equivalence:
- Needle penetration test
- Hub bond tensile strength test
The results of the bench tests demonstrate that Arrow's echogenic introducer needle is as safe and effective as compared to the currently marketed predicate introducer needle.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040100, K924338, K021120, K003006
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
SEP 26 0007
510(k) Summary – K071998
In accordance with 21 CFR 807.87(h), the following 510(k) summary has been prepared per 21 CFR 807.92.
Echogenic Introducer Needle 510(k) Summary
| Submitter: | ARROW International, Inc.
2400 Bernville Road
Reading, PA 19605-9607 USA |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Kirsten Stowell
Regulatory Affairs Specialist
Phone: 610-378-0131, ext. 3514
Fax: 610-478-3128
Email: kirsten.stowell@arrowintl.com |
| Date summary prepared: | August 30, 2007 |
| Device trade name: | Arrow Echogenic Introducer Needle |
| Device common name: | Introducer Needle |
| Device classification: | Hypodermic single lumen needle; Product Code FMI;
21 CFR 880.5570, Class II |
| Legally marketed devices to
which the device is
substantially equivalent: | Arrow Echogenic Needle (K040100, SE date 3/1/2004)
Arrow Extended Vascular Access Needle (K924338, SE
date 3/18/1993)
Radial Artery Catheterization Set with integral needle
protection (K021120, SE date: 5/2/2002)
PICC Two-Lumen Peripherally Inserted Central Catheter
Kit with Blue FlexTip® Catheter and Integral Needle
Protection (K003006, SE date: 10/27/2000) |
| Description of the device: | The Arrow Echogenic Introducer Needle has the following
characteristics:
Outside Diameter = 18Ga - 21GaInside Diameter = 0.0240 - 0.042 in.Usable lengths of 1 ½ - 2 ¾ in. (3.81 - 7cm)Grit-blast echogenic surface treatment |
| Intended use of the device: | The intended use is the same as the predicate devices. |
| Indications for use: | The Indication for Use is the same as the predicate device. |
1
| Technological
characteristics: | The proposed echogenic introducer needle has the same
technological design characteristics as the predicate
echogenic introducer needle devices. This design
includes the same needle lubricant as the predicate
introducer needles with integral needle protection. |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance tests: | The following tests were performed to demonstrate
substantial equivalence:
• Needle penetration test
• Hub bond tensile strength test |
| Assessment of non-clinical
performance data: | The results of the bench tests demonstrate that Arrow's
echogenic introducer needle is as safe and effective as
compared to the currently marketed predicate introducer
needle. |
| Summary | Arrow International's echogenic introducer needle has the
same intended use as the predicate devices. Based on the
assessment of non-clinical performance data to verify the
intended use, and the technological characteristic
comparison, Arrow's echogenic introducer needle is
substantially equivalent to the legally marketed predicate
device. |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract representation of a human form or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kirsten Stowell Regulatory Affairs Specialist ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607
SFP 26 2007
Re: K071998
Trade/Device Name: Arrow Echogenic Introducer Needle Component Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 28, 2007 Received: August 29, 2007
Dear Ms. Stowell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Stowell
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Arrow Echogenic Introducer Needle Component
The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
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)
Intre 20m
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Arrow International, Inc.