The BD Careflow™ Central Venous Catheter is an intravascular catheter that is introduced into a patient's vascular system for short-term use (less than 30 days) using an introducer and guidewire. The catheter is used to sample blood, monitor blood pressure, or administer fluids.

Device Description

The BD Careflow™ Central Venous Catheter (CVC) is a polyurethane, radiopaque catheter. It is identical to the BD Hydrocath™ CVC except that the BD Careflow product does not have a hydrophilic coating.

The BD Careflow product line includes the same range of product offerings as the BD Hydrocath product line: 60-300mm lengths, 2.5-9.5 French sizes, and 1 – 5 lumens.

BD Careflow catheters are sold in convenience kit form containing components to facilitate catheter placement, such as a guidewire, introducer needle, introducer catheter, vessel dilator, syringe, injection caps, slide clamps, and movable suture wing. The kit components are identical to those that were provided in the BD Hydrocath CVC convenience kits.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the BD Careflow™ Central Venous Catheter. Based on the document, it is not a study that proves a device meets acceptance criteria in the way you've described (i.e., performance metrics, sample sizes, expert consensus, etc., typically associated with AI/software device evaluation).

Instead, this document is a submission to the FDA to demonstrate substantial equivalence of a new medical device (BD Careflow™ CVC) to a previously cleared predicate device (BD Hydrocath™ CVC). The core of this submission focuses on showing that the new device is essentially the same as the predicate, with a minor modification (absence of a hydrophilic coating), and thus does not raise new questions of safety or effectiveness.

Here's a breakdown of why your requested information isn't fully applicable and what can be extracted:

This is not an AI/software device: The BD Careflow™ Central Venous Catheter is a physical medical device (an intravascular catheter), not a software or AI-powered system. Therefore, the concepts of "test set," "training set," "ground truth," "MRMC study," "standalone performance," or "human readers improve with AI" do not apply.
"Acceptance Criteria" here relates to Substantial Equivalence: For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the new device has "substantially equivalent" technological characteristics and performance to a legally marketed predicate device, and does not pose new safety or effectiveness concerns.

However, I can extract the relevant information regarding the comparison made between the new device and its predicate:

This document describes a submission for a physical medical device, not software or AI. Therefore, the concepts of "acceptance criteria" in terms of performance metrics like sensitivity/specificity, or studies involving "expert consensus" for "ground truth," "training sets," or "MRMC studies" are not applicable to this type of medical device submission.

The "study" described is a non-clinical side-by-side comparison of the modified device (BD Careflow) and its predicate (BD Hydrocath) to demonstrate substantial equivalence.

Here's a summary based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (physical CVC), "acceptance criteria" are met by demonstrating substantial equivalence to a predicate device through comparative testing of key physical and functional characteristics. The performance reported is that these characteristics are substantially equivalent between the new and predicate device.

Characteristic Tested	Reported Performance (BD Careflow vs. BD Hydrocath)
Tensile Strength	Substantially Equivalent
Potential for Leakage	Substantially Equivalent
Catheter Stiffness	Substantially Equivalent

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The text mentions "Side-by-side testing," implying that samples of both the BD Careflow and BD Hydrocath were used for the comparative tests.
Data Provenance: Not explicitly stated (e.g., country of origin). It's "nonclinical tests" meaning in-vitro or bench testing, not human patient data.
Retrospective or Prospective: Not applicable as these are non-clinical, bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable. This is a non-clinical, comparative test of physical device attributes. Ground truth would be established by the measurement instruments and protocols themselves, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, there's no expert adjudication involved in mechanical and leakage testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is not relevant for a physical catheter device.

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

Not Applicable. This is not a software or algorithm-based device.

7. The type of ground truth used

Direct Measurement/Engineering Specifications: The ground truth for tensile strength, leakage, and stiffness would be derived from direct measurements using calibrated equipment against established engineering specifications or material standards.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As per point 8, there's no training set.

In summary: The provided document is a 510(k) submission for a physical medical device. It demonstrates "substantial equivalence" of a new device to a predicate device through non-clinical, side-by-side engineering tests. It does not describe a study in the context of performance metrics, clinical trials, or AI/software validation as implied by your detailed questions.

Summary

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BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801 565.2300 fax: 801 565 2740 www.bd.com

JAN 2 9 2004

Image /page/0/Picture/3 description: The image shows the BD logo. The logo consists of a stylized eye with rays emanating from the top, followed by the letters "BD" in a bold, sans-serif font. Below the letters, there is some faint text that is difficult to read.

Premarket Notification [510(k)] Summary of Safety and Effectiveness for BD Careflow™ Central Venous Catheters

Submitter:	Becton Dickinson Infusion Therapy Systems Inc
Address:	9450 South State StreetSandy, UT 84070
Contact Person:	Leslie Wood, Manager, Regulatory Affairs
Telephone Number:	(801) 565-2504
FAX Number:	(801) 565-2749
Date Summary Prepared:	October 27, 2003
Trade Name:	BD CareflowTM Central Venous Catheter
Common Name:	Central Venous Catheter
Classification Name:	Intravascular Catheter
Predicate Device:	BD HydrocathTM Central Venous Catheter

Product Description:

The BD Careflow product line includes the same range of product offerings as the BD Hydrocath product line: 60-300mm lengths, 2.5-9.5 French sizes, and 1 – 5 lumens.

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Intended Use:

Technological Characteristics Comparison:

The design and technological characteristics are the same as those of the BD Hydrocath CVC product except that there is no hydrophilic coating on the BD Careflow CVC products.

Nonclinical Tests Support Substantial Equivalence:

Side-by-side testing of BD Careflow (modified) and BD Hydrocath (unmodified) devices was conducted to compare tensile strength, potential for leakage, and catheter stiffness.

Conclusions from Nonclinical Tests:

Data have been provided to demonstrate that product attributes are substantially equivalent between the modified and unmodified devices.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2004

Becton Dickinson & Corporation Ms Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems Incorporated 9450 South State Street Sandy, Utah 84070

Re: K033500

Trade/Device Name: BD Careflow™ Central Venous Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 4, 2003 Received: November 5, 2003

Dear Ms. Wood

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed yoursed the device is substantially equivalent (for the It it it do a ve 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to de rises 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 approvin uppression (1) the Act. The general controls provisions of the Act include controls provinces of an 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 If your device is classified (obs acc additional controls. Existing major regulations affecting (I Mry, it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear oe roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Wood

Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast to advised that I Dr. determination that your device complies with other requirements Incall that I DA mas made a aves and regulations administered by other Federal agencies. or the receded any I ederal time Act's requirements, including, but not limited to: registration 1 od linest compt 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadistion 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) This teter whilanon your be of a finding of substantial equivalence of your device to a premainer notification - I sults 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), If you desire specifice of Compliance at (301) 594-4618. 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 may obtain 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,

Chiu-Ling, Ph.D.

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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K03560

BD Careflow™ Central Venous Catheter DEVICE NAME

INDICATIONS FOR USE

Vile Hibbard, Interim Branch Chief

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

510(k) Number: Ko 33 500

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: × (per 21 CFR 801.109)

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Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________

510(k) Indications

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).