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. The BD OneCath PICC is available in both single and dual lumens.

AI/ML Overview

I am sorry, but based on the provided document, I cannot fulfill your request for information on the acceptance criteria and a study proving the device meets them.

The document is a Premarket Notification [510(k)] Summary for the BD OneCath™ Peripherally Inserted Central Catheter. It primarily focuses on demonstrating "substantial equivalence" to a predicate device (BD L-Cath PICC), rather than presenting specific acceptance criteria and a detailed study proving the device meets those criteria for performance metrics like accuracy, sensitivity, or specificity.

Here's a breakdown of why the requested information is not available in the provided text:

Acceptance Criteria and Reported Device Performance: This document states that "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." It concludes from these nonclinical tests that the BD OneCath PICC and the predicate device are substantially equivalent. However, it does not provide specific numerical acceptance criteria for these tests (e.g., "pull strength must be X Newtons" or "biocompatibility results must meet ISO X standard with Y score") nor does it report the specific performance results against such criteria. The "Conclusion" is a qualitative statement of substantial equivalence.
Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Information: These are all concepts related to the evaluation of algorithms or diagnostic devices against a "ground truth" using a test set and a training set. The BD OneCath is a physical medical device (a catheter), not an algorithm or a diagnostic tool that produces a read-out to be compared with a ground truth. Therefore, these types of studies (MRMC, standalone, etc.) are not applicable in this context and are not mentioned in the document. The "tests" mentioned are physical and biocompatibility tests on the material and components, not clinical studies in the typical sense of evaluating diagnostic performance.

In summary, the provided document is a regulatory submission for a physical device, aiming to prove substantial equivalence through non-clinical testing of materials and physical components. It does not contain the specific information you are looking for regarding acceptance criteria, study methodologies for performance metrics (like sensitivity/specificity), or details about expert-reviewed ground truth, which are typically associated with diagnostic software or imaging devices.

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

JUL 2 5 2005

K051194
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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 figure with arms raised under a sunburst, all enclosed within a circle. 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:	April 13, 2005
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.

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K050194

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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 PICC dual lumen products 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 dual lumen product and the BD L-Cath PICC dual lumen product are substantially equivalent.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Druq, 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 and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the perimeter of the circle.

JUL 25 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051194

Trade/Device Name: BD OneCath™ Peripherally Inserted Central Catheter, Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: May 6, 2005 Received: May 10, 2005

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. 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,

Sylvia Y.M. Chain O MD

Chu 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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KOS1194

Attachment B

Indications For Use

510(k) Number (if known):

__BD OneCath™ Peripherally Inserted Central Catheter ... Device Name:

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Cem Vrtz

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

510(k) Number:_K4 S

Page 1 of __ 1__

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.”