(22 days)
Not Found
No
The 510(k) summary describes a material modification to a catheter bushing and does not mention any AI or ML components or functionalities.
No
The device is described as a catheter for administering fluids, medications, and nutrients, sampling blood, and monitoring physiological parameters (blood pressure and temperature) intravenously. These functions are supportive or diagnostic in nature but do not directly treat a disease or condition.
No
Explanation: The device is intended for administering fluids, medications, and nutrients, sampling blood, and monitoring blood pressure and temperature. While it involves monitoring, it is a tool for delivering care and obtaining data, not for making a diagnosis based on the data.
No
The device description explicitly states it is a catheter, which is a physical medical device, and the modification is to a material component (bushing). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the administration of fluids, medications, and nutrients, blood sampling, and monitoring blood pressure and temperature intravenously. These are all procedures performed directly on or within the patient's body.
- Device Description: The description details a catheter and its components used for insertion into a vein.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens outside the body.
The device is a medical device used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
LJS, FOZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
BD Seament Name
1 of 2
JUL - 1 2009
Image /page/0/Picture/3 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 sun with rays emanating from the top half and a stylized figure below. The letters "BD" are in a bold, sans-serif font.
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:
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
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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
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.
Intended Use of the BD L-Cath™ Midline catheter devices:
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.
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.
3
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
5
, 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