The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medication, fluids, nutrients, blood and blood products.

Device Description

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

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the BD OneCath™ Peripherally Inserted Central Catheter (PICC). This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics like sensitivity, specificity, etc.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance measurements, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's why the requested information is absent and what the document does provide:

A table of acceptance criteria and the reported device performance: This is not available because 510(k) submissions for devices like PICCs typically do not involve establishing specific performance criteria like accuracy, sensitivity, or specificity as one would for an AI/CAD diagnostic device. The "performance" demonstrated here is primarily through non-clinical testing to show the new device characteristics are comparable to the predicate.
- Acceptance Criteria (Implied): The implied acceptance criteria for a 510(k) for this type of device are met if the device can demonstrate "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
- Reported Device Performance:
  - Nonclinical Tests conducted: Biocompatibility testing of the new polyurethane tubing.
  - Nonclinical Tests conducted: Physical testing on areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts).
  - Key Technological Improvement: The new polyurethane tubing has "improved radiopacity and resistance to alcohol" compared to the predicate device (BD L-Cath PICC).
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned because there wasn't a clinical performance study in the way requested for an AI/CAD diagnostic device. The evaluation was primarily through non-clinical laboratory testing of materials and device integrity.
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. There was no "ground truth" derived from expert consensus on patient data described in the document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
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 physical medical device (PICC), not an AI/CAD diagnostic software, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this type of submission is typically based on established engineering standards, material science testing results, and comparison to the predicate device's known performance for safety and efficacy.
The sample size for the training set: Not applicable. There is no "training set" in the context of developing an AI model for this physical medical device.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is for a traditional medical device (Catheter) seeking 510(k) clearance, which focuses on demonstrating "substantial equivalence" through non-clinical testing and comparison to a predicate device. It does not involve the types of studies, metrics, or data sets that would be associated with AI/CAD diagnostic devices referenced in your prompt.

Summary

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

K\u03b142491 left 2

BD Medical Systems 9450 South State Street andv Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com

NOV 2 2 2004

Attachment D

Image /page/0/Picture/4 description: The image shows the BD logo. The logo consists of a circular emblem on the left and the letters "BD" on the right. The emblem features a stylized image of a person with arms raised, with rays emanating from above. The letters "BD" are in a bold, sans-serif font.

Helping all people live healthy lives

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:	August 30, 2004
Trade Name:	BD OneCath™™
Common Name:	Peripherally Inserted Central Catheter or PICC
Classification Name:	Intravascular, therapeutic, long-term catheter
Classification:	Class II880.5970 - LJS
Predicate Device:	BD L-Cath PICC

Description of the BD OneCath Peripherally Inserted Central Catheter:

Device selection is an important component of intravenous therapy. Some of the patient considerations that are included in this decision are the: (1) length and type of therapy, (3) adequacy of venous access, (4) lifestyle and activity, and (5) setting in which therapy will be administered. Peripherally inserted central catheters (PICC) are selected for intermediate length therapy, while tunneled percutaneous catheters and subcutaneous ports are selected for long-term central venous access.

A PICC is a central venous catheter that is inserted into a peripheral vein and advanced to the superior vena cava. The basilic, cephalic and median cubital veins of the arm are the preferred locations for PICC insertion in adults; scalp veins such as the posterior auricular and temporal veins may be used for neonatal patients. For pediatric patients, the saphenous, popliteal, and femoral veins of the leg may be used, with the tip location in the inferior vena cava. The PICC is generally selected for IV therapy that is prescribed for less than 6 to 8 weeks. Although a PICC may indwell for a shorter period, the average indwelling time for a PICC is 2-6 months.

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

7.47

Intended Use of the BD OneCath Peripherally Inserted Central Catheter:

The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medications, fluids, nutrients, blood and blood products.

Technological Characteristics Comparison:

The polyurethane used for the BD OneCath product has improved radiopacity and resistance to alcohol than the polyurethane used for the current L-Cath product. These improved characteristics will make the BD OneCath PICC 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 PICC is substantially equivalent to the BD L-Cath PICC.

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.

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

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

NOV 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042491

Trade/Device Name: BD OneCath™ Peripherally Inserted Central Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 13, 2004 Received: September 14, 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.

{3}------------------------------------------------

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. 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 (OS) 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/dsma/dsmamain.html

Sincerely yours,

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

{4}------------------------------------------------

Indications For Use

510(k) Number (if known): K042491

BD OneCath™ Peripherally Inserted Central 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)

1 of 1

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tuan Dima

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

510(k) Number: _ K P Y 2 40)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”