The ARROWg+ard Blue® antimicrobial catheter is indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:

Lack of usable peripheral IV sites .
Central venous pressure monitoring .
Total parenteral nutrition (TPN) .
Infusions of fluids, medications, or chemotherapy .
Frequent blood sampling or receiving blood transfusions/blood products .
Iniection of contrast media .
When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi.

The ARROWq+ard Blue PLUS® antimicrobial multiple-lumen catheter is indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:

. Replacement of multiple peripheral sites for IV access
Lack of usable peripheral IV sites .
Central venous pressure monitoring .
Total parenteral nutrition (TPN)
Infusion of incompatible medications .
Multiple infusions of fluids, medications, or chemotherapy
Frequent blood sampling or receiving blood transfusions/blood products
Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
Injection of contrast media .
When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi.

The Arrow catheter is indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:

Replacement of multiple peripheral sites for IV access .
Lack of usable peripheral IV sites .
Central venous pressure monitoring
Total parenteral nutrition (TPN) .
Infusion of incompatible medications .
Multiple infusions of fluids, medications, or chemotherapy .
Frequent blood sampling or receiving blood transfusions/blood products .
Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
Injection of contrast media .
When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi.

Device Description

The Arrow CVC have the following characteristics:
Radiopaque polyurethane catheters
16Ga, 1 Lumen
7Fr through 8.5Fr, 2 through 4-Lumens
Usable lengths of 16 - 20cm
Catheters are provided sterile kit configurations.
The catheter is labeled with the maximum flow rating on the catheter distal hub to facilitate the proper use of the device.

AI/ML Overview

The provided document describes a 510(k) summary for Arrow Central Venous Catheters. The focus of the submission is to expand the Indications for Use to include the "injection of contrast media" with power injectors. The document details non-clinical performance tests to demonstrate substantial equivalence for this expanded use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Non-clinical Performance
- Flow rate Qualification Test: Ensure catheter can achieve specified flow rates.	"The Arrow Pressure Injectable CVC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of the bench tests demonstrate that Arrow's central venous catheters are as safe and effective as compared to the currently marketed predicate catheters." (Implied successful completion for the specified flow rates, though specific rates are not listed here beyond the instruction "do not exceed the maximum labeled flow rate.")
- Repeat Injection Test: Demonstrate durability and integrity under repeated pressure injections.	"The Arrow Pressure Injectable CVC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of the bench tests demonstrate that Arrow's central venous catheters are as safe and effective as compared to the currently marketed predicate catheters." (Implied successful completion, though specific number of injections or integrity metrics are not detailed.)
- Catheter Burst Pressure Test: Verify the catheter's ability to withstand pressure without bursting.	"The Arrow Pressure Injectable CVC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of the bench tests demonstrate that Arrow's central venous catheters are as safe and effective as compared to the currently marketed predicate catheters." (Implied successful completion, though the specific burst pressure achieved is not detailed, only the instruction that "maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi." suggests the catheters are designed to withstand this or higher pressures.)
Clinical Performance (Feasibility, Safety, Efficacy for Power Injection)	"Two studies evaluated the feasibility, safety and efficacy of the use of the Arrow International's central venous catheters for the purpose of power injection of contrast media during diagnostic imaging procedures. Arrow International's Pressure Injectable CVC devices have been demonstrated to be safe and effective for the high pressure administration of contrast media when hospital guidelines and injection protocol are followed." (High-level statement of success. Specific metrics, patient outcomes, or detailed findings from these studies are not provided in this summary.)
Substantial Equivalence to Predicate Devices	"Arrow International's central venous catheter has the same intended use as the predicate devices. Based on the assessment of non-clinical and clinical performance data to verify this new intended use, and the technological characteristic comparison, Arrow's central venous catheter is substantially equivalent to the legally marketed predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the non-clinical or clinical tests.
Data Provenance: Not specified. It only states "Two studies evaluated" for the clinical performance. The non-clinical tests are bench tests, so provenance is less relevant beyond being conducted by the manufacturer.

3. 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)

This information is not provided as the device is a physical medical device (catheter) and the studies described are performance tests and clinical feasibility/safety/efficacy studies, not diagnostic imaging studies requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. The studies mentioned are performance tests and clinical observations, not image interpretation requiring adjudication of ground truth.

5. 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

This information is not applicable/provided. This document describes a physical medical device (catheter), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests (Flow Rate, Repeat Injection, Catheter Burst Pressure): The "ground truth" would be the engineering specifications and recognized standards for catheter performance and safety. The tests directly measured physical properties against these predefined criteria.
For the clinical performance data: The "ground truth" would be patient safety, efficacy in delivering contrast media, and observation of adverse events or complications, as assessed in the "two studies." Specific outcomes data are not detailed in this summary.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

This information is not applicable/provided. There is no "training set" for this device.

Summary

{0}------------------------------------------------

K071538
Traditional

Traditional 510(k)

SECTION 4 – 510k Summary:

AUG 3 0 2007

In accordance with 21 CFR 807.87(h), the following 510(k) summary has been presared per 21 CFR 807.92.

Pressure Injectable Central Venous Catheter 510(k) Summary
Submitter:	ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA
Contact person:	Kirsten StowellRegulatory Affairs SpecialistPhone:610-378-0131, ext. 3514Fax: 610-478-3128Email: kirsten.stowell@arrowintl.com
Date summary prepared:	June 1, 2007
Device trade name:	Arrow Central Venous CatheterARROWg+ard Blue® Central Venous CatheterARROWg+ard Blue PLUS® Central Venous Catheter
Device common name:	Central Venous Catheter (CVC)
Device classification:	Catheter, intravascular, therapeutic, short-term less than30 days; Product Code FOZ;21 CFR 880.5200, Class II
Legally marketed devices towhich the device issubstantially equivalent:	Arrow Standard Multiple Lumen CVC with Blue FlexTip®(K862056, SE date 8/25/1986)ARROWg+ard Blue® CVC(K900263, SE date 7/24/1990 and K962577, SE date8/27/1997)ARROWg+ard Blue PLUS® CVC(K993691, SE date 3/8/2000)Bard Access System, Inc PowerHickman(K061179, SE date 8/9/2006)Arrow Berman Angiographic Catheter devices(K892530, SE date 9/26/1989)
Description of the device:	The Arrow CVC have the following characteristics:Radiopaque polyurethane catheters16Ga, 1 Lumen7Fr through 8.5Fr, 2 through 4-LumensUsable lengths of 16 - 20cmCatheters are provided sterile kit configurations.The catheter is labeled with the maximum flow rating on the catheter distal hub to facilitate the proper use of the device.

Intended use of the device:	The intended use is the same as the predicate devices.
Indications for use:	The Indications for Use were expanded to include:
	"The injection of contrast media. When used for the pressure injection of contrast media, do not exceed the maximum labeled flow rate. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi."
Technological characteristics:	The proposed central venous catheters have the same technological design characteristics as the predicate CVC devices.
Performance tests:	The following tests were performed to demonstrate substantial equivalence:Flow rate Qualification Test Repeat Injection Test Catheter Burst Pressure Test
Assessment of non-clinical performance data:	The Arrow Pressure Injectable CVC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of the bench tests demonstrate that Arrow's central venous catheters are as safe and effective as compared to the currently marketed predicate catheters.
Assessment of clinical performance data:	Two studies evaluated the feasibility, safety and efficacy of the use of the Arrow International's central venous catheters for the purpose of power injection of contrast media during diagnostic imaging procedures. Arrow International's Pressure Injectable CVC devices have been demonstrated to be safe and effective for the high pressure administration of contrast media when hospital guidelines and injection protocol are followed.
Summary	Arrow International's central venous catheter has the same intended use as the predicate devices. Based on the assessment of non-clinical and clinical performance data to verify this new intended use, and the technological characteristic comparison, Arrow's central venous catheter is substantially equivalent to the legally marketed predicate devices.

{1}------------------------------------------------

K07-1538
Traditional 510(k)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kirsten Stowell Regulatory Affairs Specialist Arrow International, Incorporated 2400 Bernville Road, PO Box 12888 Reading, Pennsylvania 19605

AUG 3 0 2007

Re: K071538

Trade/Device Name: ARROWg+ard Blue® Central Venous Catheter ARROWg+ard Blue PLUS® Central Venous Catheter Arrow Central Venous Catheter Regulation Number: 880.5200

Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 4, 2007 Received: June 5, 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 (301) 443-6597 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

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Traditional 510(k)

Indications for Use Statement

510(k) Number (if known): K07/538

Device Name: ARROWg+ard Blue® Central Venous Catheter

Lack of usable peripheral IV sites .
Central venous pressure monitoring .
Total parenteral nutrition (TPN) .
Infusions of fluids, medications, or chemotherapy .
Frequent blood sampling or receiving blood transfusions/blood products .
Iniection of contrast media .

When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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)

Charles B

(Division Sign-Off) 4 (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K071538

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):{

K07/538

Device Name: ARROWq+ard Blue PLUS® Central Venous Catheter

. Replacement of multiple peripheral sites for IV access
Lack of usable peripheral IV sites .
Central venous pressure monitoring .
Total parenteral nutrition (TPN)
Infusion of incompatible medications .
Multiple infusions of fluids, medications, or chemotherapy
Frequent blood sampling or receiving blood transfusions/blood products
Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
Injection of contrast media .

Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)

OR Over-The
(2

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)

Clark Buckner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K021538

{6}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): KOアノ538

Device Name: Arrow Central Venous Catheter

Replacement of multiple peripheral sites for IV access .
Lack of usable peripheral IV sites .
Central venous pressure monitoring
Total parenteral nutrition (TPN) .
Infusion of incompatible medications .
Multiple infusions of fluids, medications, or chemotherapy .
Frequent blood sampling or receiving blood transfusions/blood products .
Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
Injection of contrast media .

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR

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)

Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071538

Regulation Number and Section

§ 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).