The BD L-Cath™ single and dual lumen peripherally inserted central catheters intended use shall be for the administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.

The BD L-Cath™ Midline™ Catheter intended use shall be for the administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.

Device Description

Becton Dickinson obtained the L-Cath™ catheter product lines through the purchase of Luther Medical Inc, a California based company, in January 1999. Luther Medical obtained market clearance from the US Food and Drug Administration (FDA) during 1993 for the L-Cath™ peripherally inserted central catheters through the premarket notification [510(k)] process. Becton Dickinson currently markets the L-Cath single lumen, dual lumen, and midline catheters. These catheters have a plastic bushing material that is used for the purpose of catheter assembly and/or extension tubing with a female luer lock adapter.

The primary modification addressed in this 510(k) submission relates to a material modification in the bushing component. The modifications to the devices pertain to a modified bushing material that is known as PC Makrolon RX2530-1118, which has been tested by Becton Dickinson's supplier and meets FDA & ISO standards. The bushing material is used in all three types of catheters to join the tubing to the female luer lock adapter. The material modification affects only the bushing that is seated within the luer adapters of the BD L-Cath™ PICC and BD L-Cath™ Midline products. The formulation modification is a linear polycarbonate with the same end groups, formulation, additives, and colorants. The only difference being a higher molecular weight for the modified material.

AI/ML Overview

This document is a 510(k) premarket notification for a material modification to the BD L-Cath™ family of catheters. It is not a study that proves a device meets acceptance criteria through performance data. Instead, it argues for "substantial equivalence" to a previously cleared device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in this document because a clinical performance study was not conducted or required for this type of submission.

Here's what can be extracted based on the provided text, and where gaps exist:

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

This information is not provided in the document. The submission focuses on demonstrating "substantial equivalence" based on material modification rather than performance criteria.

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

This information is not provided in the document. No "test set" in the context of a clinical performance study is mentioned. The submission describes a material modification.

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 in the document. No "ground truth" establishment by experts for a test set is mentioned.

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

This information is not provided in the document. No "adjudication method" for a test set is mentioned.

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 provided in the document. This is not an AI/software device, and no MRMC study was conducted.

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

This information is not provided in the document. This refers to a physical medical device, not an algorithm.

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

This information is not provided in the document. No "ground truth" in the context of a clinical performance study is mentioned.

8. The sample size for the training set

This information is not provided in the document. No "training set" in the context of machine learning is relevant here.

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

This information is not provided in the document. No "training set" or "ground truth" for a training set is relevant here.

Summary of what the document does state:

The core of this submission is to demonstrate that a material modification to the bushing component of the BD L-Cath™ catheters does not alter the safety or effectiveness of the device, making it substantially equivalent to the previously cleared devices.

Device: BD L-Cath™ Single Lumen, BD L-Cath™ Dual Lumen, and BD L-Cath™ Midline Intravascular Catheters.
Modification: Change in the bushing material from an unspecified polycarbonate to PC Makrolon RX2530-1118. The only difference noted is a "higher molecular weight for the modified material."
Support for Substantial Equivalence:
- The modified material has been tested by the supplier and "meets FDA & ISO standards." (Details of these tests and specific results are not included in this summary).
- "The L-Cath products have the same technological characteristics with no changes in part geometry or performance, and have the same formulation, additives, and colorants as the current device material."
- "The following qualities of the three devices are the same and support substantial equivalence: Indications for use, fundamental scientific technology, gauge sizes of the devices, visualization of blood return and potential for blood exposure during use."
- The "intended use and technological characteristics... have not been altered."

Conclusion: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed under the general controls provisions of the Act. This determination is based on the argument that the material modification does not introduce new questions of safety or effectiveness.

Summary

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BD Seament Name

K091670

1 of 2

JUL - 1 2009

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Helping all people live healthy lives

SPECIAL PREMARKET NOTIFICATION [510(K)] Summary- (Bundled Submission)

Submitter:

Becton Dickinson Infusion Therapy Systems, Inc.

Specialist, Regulatory Affairs

9450 South State Street

Sandy, UT 84070

Justice Alder

801-565-2662

801-565-2749

June 2, 2009

Address:

Contact Person:

Telephone Number: Fax Number:

Date Summary Prepared:

Trade Names:

BD L-Cath™ Single Lumen BD L-Cath™ Dual Lumen BD L-Cath™ Midline

Intravascular Catheter (IV Catheter)

Common Name:

Classification Name:

Catheter, Intravascular, Therapeutic, Long- Term Greater Than 30 Days (LJS/FOZ)

Peripherally Inserted Central Catheter (PICC);

Unmodified/Predicate Device: (K925979) Dual lumen L-Cath® Catheter System (K920755) L-Cath Peel Away Systems Catheter

Description of the device:

The primary modification addressed in this 510(k) submission relates to a material modification in the bushing component. The modifications to the devices pertain to a

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modified bushing material that is known as PC Makrolon RX2530-1118, which has been tested by Becton Dickinson's supplier and meets FDA & ISO standards. The bushing material is used in all three types of catheters to join the tubing to the female luer lock adapter. The material modification affects only the bushing that is seated within the luer adapters of the BD L-Cath™ PICC and BD L-Cath™ Midline products. The formulation modification is a linear polycarbonate with the same end groups, formulation, additives, and colorants. The only difference being a higher molecular weight for the modified material.

Intended Use of the L-Cath™ single lumen, and BD L-Cath™ dual lumen catheter devices: [21 CFR Part 880---- GENERAL HOSPITAL AND PERSONAL USE DEVICES: General Hospital and Personal Use Therapeutic Devices Sec. 880.59701

Intended Use of the BD L-Cath™ Midline catheter devices:

Technological Characteristics Comparison:

The L-Cath products have the same technological characteristics with no changes in part geometry or performance, and have the same formulation, additives, and colorants as the current device material. The only difference being a higher molecular weight in the formulation change which is not evident to the end user.

Nonclinical Tests Support Substantial Equivalence:

The following qualities of the three devices are the same and support substantial equivalence: Indications for use, fundamental scientific technology, gauge sizes of the devices, visualization of blood return and potential for blood exposure during use.

Conclusions from Nonclinical Tests:

The intended use and technological characteristics of the BD L-Cath™ products described in this submission have not been altered and therefore have remained the same since receiving their original 510(k) approval from the FDA.

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

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Becton Dickinson and Company C/O Ms. Justice Alder Regulatory Affairs Specialist Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070

Re: K091670

Trade/Device Name: BD L-Cath™ Midline™ Catheter BD L-Cath™ Single Lumen BD L-Cath™ Dual Lumen

Peripherally Inserted Central Catheters (PICC)

Regulation Number: 21 CFR 880.5970

Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II

Product Code: LJS, FOZ

Dated: June 2, 2009

Received: June 9, 2009

Dear Ms. Alder:

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 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. Alder

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Wathenfer

Susan Runner, D.D.S., M. Acting 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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KO91670 1 of 1

Indications for Use

510(k) Number (if known): K091670

Device name: BD L-Cath™ Midline™ Catheter

Indications for Use: The intended use shall be for the administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.

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

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles R. Hoppe

Page 1 of

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

510(k) Number. K091670

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K091670

, of /

Indications for Use

510(k) Number (if known): K091670 K091670

Device name: BD L-Cath™ Single Lumen/ BD L-Cath™ Dual Lumen Peripherally Inserted Central Catheters (PICC)

Indications for Use: The intended use shall be for the administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.

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

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles R

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

Page 1 of

510(k) Number: K091670

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.”