The BD OneCath™ midline catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Device Description

The BD OneCath midline products are similar in design to other midline catheters. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer.

AI/ML Overview

The provided documentation (K042862) describes the BD OneCath™ Midline Catheter. However, it does not include detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device. This submission is for a traditional medical device (catheter) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, for aspects related to AI/ML device performance, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training, the information is not applicable or not provided in this document.

Here's the information that can be extracted or inferred from the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet regulatory standards for materials in contact with the human body.	Biocompatibility testing of the new polyurethane tubing was conducted. (Conclusion: Substantially equivalent to predicate, implying acceptable biocompatibility).
Physical Performance: Equivalent or superior to predicate in areas of potential failure (e.g., pull strength, junction security).	Physical testing on areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts) were conducted.
	The polyurethane used for the BD OneCath product has improved radiopacity, resistance to alcohol, and flex endurance than the polyurethane used for the current L-Cath midline catheter. (Implies performance meets or exceeds predicate).
Functional Equivalence: Perform intended functions (sample blood, monitor blood pressure, administer fluids) for short-term use.	The device is intended for peripheral use to sample blood, monitor blood pressure, or administer fluids, for short-term use (less than 30 days). The nonclinical tests concluded "The BD OneCath midline catheter is substantially equivalent to the BD L-Cath midline catheter" for these intended uses.
Material Properties: Improved radiopacity, alcohol resistance, and flex endurance.	The polyurethane used for the BD OneCath product has improved radiopacity, resistance to alcohol, and flex endurance than the polyurethane used for the current L-Cath midline catheter. (This describes the improved characteristics, implying these were target criteria and were met.)

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 for Test Set: Not specified. The document refers to "biocompatibility testing" and "physical testing" but does not detail the number of units or samples tested for each.
Data Provenance: Not specified. These are non-clinical (laboratory/bench) tests conducted by the manufacturer, Becton Dickinson.

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)

Not Applicable. This device is a physical medical device (catheter), not an AI/ML diagnostic or image analysis tool. Ground truth is established through laboratory measurements and established biocompatibility standards, not expert interpretation of outputs.

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

Not Applicable. Ground truth is based on objective laboratory measurements and standardized test results rather than expert adjudication.

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

No. This is not an AI/ML device, and no MRMC study was conducted or is relevant to this submission.

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

No. This is not an AI/ML device.

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

The ground truth for the non-clinical tests would be based on objective laboratory measurements (e.g., tensile strength, elongation, burst pressure, material composition analysis, radiopacity measurements) and established industry standards for biocompatibility (e.g., ISO 10993 series). Performance measurements would be compared against defined specifications or the performance of the predicate device.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device; there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Summary

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K042862
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Attachment D

Image /page/0/Picture/2 description: The image shows the BD logo, which consists of a stylized sun-like graphic to the left and the letters "BD" in bold, sans-serif font to the right. Below the letters, there is the text "Helping all people live healthy lives" in a smaller font size. The logo is simple and conveys a sense of health and well-being.

Premarket Notification [510(k)] Summary

Submitter:	Becton Dickinson Infusion Therapy Systems Inc
Address:	9450 South State StreetSandy, UT 84070
Contact Person:	Leslie WoodManager, Regulatory Affairs
Telephone Number:	(801) 565-2504
FAX Number:	(801) 565-2749
Date Summary Prepared:	October 4, 2004
Trade Name:	BD OneCath™
Common Name:	Midline Catheter
Classification Name:	Intravascular catheter
Classification:	Class II880.5200 FOZ
Predicate Device:	BD L-Cath Midline Catheter

Description of the BD OneCath Midline Catheter:

Desorrption of the Proponent of intravenous therapy. Some of the Device selection is an important confortient on the check (1) length and type of
patient considerations that are included in this decision and ectivity, and (5) setting in patient considerations that are included in this detivity, and (5) setting in
therapy, (3) adequacy of venous access, (4) lifestyle and (5) setting in therapy, (3) adequacy of venous access, (+) illestyn dina cathers are 20 cm long,
which therapy will be administered. BD OneCathers are 20 cm long, which therapy will be administered. DD One Outler blood pressure, or administer.
designed for peripheral use to sample blood prossure, The basili designed for peripheral tise to sample blood, montor brocher in the basilic, in the basilic,
fluids, and prescribed when IV therapy is expected to last for midline fluids, and prescribed when iv there is expected to factory.
cephalic and median cubital veins of the arm are the preferred locations for midline catheters are the cephalic and median cubital veins of the ann are the professor as a commended for midline catheters are the catheter insertion. The types of infaction peripheral IV catheters.

BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801 565.2300 fax: 801.565.2740 www.bd.com

DEC - 3 2004

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Intended Use of the BD OneCath Peripherally Inserted Central Catheter:

Technological Characteristics Comparison:

The polyurethane used for the BD OneCath product has improved radiopacity, resistance to alcohol, and flex endurance than the polyurethane used for the current L-Cath midline catheter. These improved characteristics will make the BD OneCath midline catheters more competitive in this market.

Nonclinical Tests Support Substantial Equivalence:

Biocompatibility testing of the new polyurethane tubing and physical testing on the areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts) were conducted.

Conclusions from Nonclinical Tests:

The BD OneCath midline catheter is substantially equivalent to the BD L-Cath midline catheter.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2004

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

Re: K042862

Trade/Device Name: BD OneCath™ Midline Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 13, 2004 Received: October 15, 2004

Dear Ms. Wood:

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.

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Page 2 - Ms. Wood

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. of the Fee of ally I vatinal the Act's requirements, including, but not limited to: registration r od inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 es revior the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet resir 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) rms retet 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), n you dontact 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/dsma/dsmamain.html

Sincerely yours,

Susan Burns
K. Chiu Lin, 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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K042862

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Indications For Use

K042862__ 510(k) Number (if known):

BD OneCath™ Midline Catheter Device Name:

Indications For Use:

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

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ank D. h.

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection of Anesthesiology, Gene

519(k) Number:_

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).