RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP

• K Number: K021120
• Device Name: RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP
• Manufacturer: ARROW INTL., INC.
• Date Cleared: 2002-05-02 ( 24 days)
• Product Code: DQY
• Regulation Number: 870.1250
• Type: Special
• Panel: Cardiovascular
• Reference & Predicate Devices: K810675 , K003006
• Predicate For: K071998 , K111334 , K151513

Intended 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.

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.

AI/ML Overview

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Device reliability	Performed
Clinical simulation	Performed
Deactivation force of safety feature	Performed
Safeguard interference fit	Performed
Tensile	Performed
Corrosion	Performed

Note: The document states that these tests were "performed to demonstrate substantial equivalence," implying that the device met the requirements for each criterion to establish equivalence with predicate devices. However, specific quantitative acceptance thresholds or detailed performance results (e.g., exact deactivation force values, tensile strength measures) are not provided in the summary.

Study that proves the device meets the acceptance criteria:

The study refers to a set of "Performance Tests" conducted by Arrow International, Inc. These tests are listed as:

• Device reliability
• Clinical simulation
• Deactivation force of safety feature
• Safeguard interference fit
• Tensile
• Corrosion

The document does not provide the following information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not explicitly stated. The nature of the tests (e.g., "clinical simulation") suggests some form of testing, but details on the participants or data collection are absent.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this device is a medical instrument (catheterization set) and not an AI/diagnostic tool requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" here would pertain to the physical performance of the device against engineering and safety specifications.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of performance tests described. Adjudication methods are typically used in clinical trials involving subjective assessments or diagnostic interpretations.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a medical instrument, not an AI diagnostic or assistance tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device would be engineering specifications, safety standards, and functional requirements for a radial artery catheterization set, including regulatory safety features for needle protection.
7. The sample size for the training set: Not applicable. This device is a physical medical instrument and does not involve AI/machine learning models that require a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary

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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: [phone], ext. 3368 Fax: [phone] E-mail: [e-mail] 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

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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

Regulation Number and Section

§ 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).