(24 days)
No
The summary describes a mechanical device with a safety feature and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device description and intended use indicate it is an access device for peripheral arterial circulation, not a device for treating a disease or condition.
No
The device is an arterial catheterization device for access to the peripheral arterial circulation, designed with a safety feature to minimize sharps injuries. It does not perform any diagnostic function.
No
The device description clearly states it is a "sharps-protected version of the Arrow Radial Artery Catheterization Set" and contains a "catheter-over-needle assembly with an integral, passive needle protection feature," indicating it is a physical medical device with hardware components.
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." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is a "radial artery catheter-over-needle assembly." This is a tool used for accessing blood vessels within the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information based on sample analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for accessing the circulatory system, not for analyzing a sample from it.
N/A
Intended Use / Indications for Use
The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
Product codes
74 DQY
Device Description
The proposed device is a sharps-protected version of the Arrow Radial Artery Catheterization Set. It contains a radial artery catheter-over-needle assembly with an integral, passive needle protection feature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial circulation
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: · Device reliability · Clinical simulation · Deactivation force of safety feature · Safeguard interference fit · Tensile · Corrosion
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
MAY 0 2 2002
ecial 510(k)
SECTION 3 -- 510K SUMMARY Arrow International, Inc. Submitter: 2400 Bemville Road Reading, PA 19605 Contact person: Debra A. Peacock Regulatory Associate Phone: (610) 378-0131, ext. 3368 Fax: (610) 374-5360 E-mail: debbie.peacock@arrowintl.com April 3, 2002 Date summary prepared: Device trade name: Radial Artery Catheterization Set with Integral Needle Protection. Device common name: Radial artery catheterization set. Device classification name: Percutaneous catheter Legally marketed devices to Arrow Radial Artery Catheterization Set (K810675), and the Arrow PICC Two-lumen which the device is substantially equivalent: Peripherally-inserted Central Catheter Kit with Blue Flex Tip® Catheter and Integral Needle Protection (K003006). Description of device: The proposed device is a sharps-protected version of the Arrow Radial Artery Catheterization Set. It contains a radial artery catheter-over-needle assembly with an integral, passive needle protection feature. Intended use of the device: The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device. Technological characteristics: The proposed needle-protected RA device has the same technological characteristics as the predicate devices including design, packaging, sterilization and labeling. Performance Tests The following tests were performed to demonstrate substantial equivalence: · Device reliability · Clinical simulation · Deactivation force of safety feature · Safeguard interference fit · Tensile · Corrosion
Arrow International, Inc., April 2002
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is simple, clean, and easily recognizable.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 2 2002
Ms. Debra A. Peacock Regulatory Associate Arrow International, Inc. 2400 Bernville Road Reading, PA 19605
K021120 Radial Artery Catheterization Set with Integral Needle Protection Regulation Number: 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: 74 DQY Dated: April 3, 2002 Received: April 8, 2002
Dear Ms. Peacock: .
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.
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.
2
Page 2 - Ms. Debra A. Peacock
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
V. Dale Tull
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Radial Artery Catheterization Set with Integral Needle Protection
Special 510(k)
SECTION 7 - INDICATIONS FOR USE STATEMENT
Page of
510(k) Number:
02/120
Device Name: Radial Artery Catheterization Set with integral needle protection
Indications for Use: The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K21120