(331 days)
Not Found
No
The summary describes a simple mechanical extension set for fluid delivery and monitoring, with no mention of AI or ML capabilities.
No
The device is an extension set for an intravascular administration set, used for fluid delivery and central venous pressure monitoring/blood sampling. It does not directly treat or diagnose a disease or condition.
No
This device is an extension set for administering fluids and monitoring central venous pressure, not for diagnosing conditions.
No
The device description clearly indicates a physical extension set designed to connect to a catheter for fluid delivery, blood sampling, and pressure monitoring. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for extending an intravascular administration set for fluid delivery and facilitating central venous pressure monitoring and/or blood sampling. This is a direct interaction with the patient's circulatory system for therapeutic and monitoring purposes.
- Device Description: The description reinforces its use in connecting to a catheter for fluid administration and accessing the bloodstream for monitoring and sampling.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing. The blood sampling mentioned is for obtaining a sample, not for performing a diagnostic test on the sample using this device.
Therefore, this device falls under the category of a medical device used for fluid administration and access to the circulatory system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard® proximally valved catheters. The extension set will connect the IV administration set to the catheter.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Extension Set is designed for Bard proximally valved catheters and attaches to the end of the catheter hub for use in the administration of fluids. The Extension Set opens the valve to facilitate central venous pressure monitoring and/or blood sampling. Extension Sets are packaged individually for single use for a period no longer than 96 hours.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Bard Extension Set met the bench performance testing requirements of the following standards where applicable in conjunction with in-house protocols which were used to determine appropriate methods for evaluating the performance of the device: ISO 8536-4:2007 :- Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed ISO 594-1:1986 :- Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements ISO 594-2:1998 :- Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)], dated April 15, 2005.
Summary Results of Verification Testing:
- Evaluation: Assembly Leak. Predetermined Acceptance Criteria: No leaks at 43.5 psi minimum (air method used).
- Evaluation: Gravity Flow. Predetermined Acceptance Criteria: 750 ml/hr minimum.
- Evaluation: Priming Volume. Predetermined Acceptance Criteria: NA, test and report results.
- Evaluation: Assembly Tensile. Predetermined Acceptance Criteria: Must withstand an axial, static tensile force of 15 N (3.37 lbs) for 15 seconds.
- Evaluation: ISO 594 - 1 & 2 Luer Testing. Predetermined Acceptance Criteria: Must pass acceptance criteria outlined in ISO 594-1 and -2.
- Evaluation: Aspiration Flow. Predetermined Acceptance Criteria: NA, test and report results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
K 102405
Image /page/0/Picture/1 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with a unique design where the letters are connected and have a slightly angled appearance. Below the word "BARD", the words "ACCESS SYSTEMS" are printed in a smaller, sans-serif font.
:
510(k) Summary
21 CFR 807.92(a)
JUL 2 1 2011
Extension Set for Bard® Proximally Valved Catheters
| General
Provisions | Submitter Name:
Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:
Telephone Number:
Fax Number:
Date of Preparation: | Lynn Kirchoff
Regulatory Affairs Manager
(801) 522-5636
(801) 522-5425
March 9, 2011 |
| Subject
Device | Trade Name:
Classification Name: | Extension Set for Bard Proximally Valved Catheters
Set, Administration, Intravascular
FPA, 21 CFR § 880.5440 Class II |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | IV Extension Set with Needleless Access Device
Set, Administration, Intravascular
FPA, 21 CFR § 880.5440 Class II
K980992
Venetec Intl., Inc. now owned by Bard Medical
Division |
| Device
Description | The Extension Set is designed for Bard proximally valved catheters and
attaches to the end of the catheter hub for use in the administration of fluids.
The Extension Set opens the valve to facilitate central venous pressure
monitoring and/or blood sampling. Extension Sets are packaged individually
for single use for a period no longer than 96 hours. | |
| Intended Use | An extension set to be used as an extension to the intravascular
administration set used for fluid delivery through Bard proximally valved
catheters. The extension set will connect the IV administration set to the
catheter. | |
| Indications For
Use | An extension set to be used as an extension to the intravascular
administration set used for fluid delivery through Bard proximally valved
catheters. The extension set will connect the IV administration set to the
catheter. | |
| Technological
Characteristics | Technological characteristics of the subject Bard Extension Set are equivalent
with respect to the basic design and function to those of the predicate IV
Extension Set with Needleless Access Device. Both the subject and predicate
device have infusion tubing with ISO compatible luers connections with the
exception that the subject device has a cannula on the distal end of the
device. Differences do not raise any new questions regarding safety and
effectiveness. Accepted scientific methods such as, performance (bench)
testing do exist for assessing the effect of the differences in characteristics. | |
| | The Bard Extension Set met the bench performance testing requirements of
the following standards where applicable in conjunction with in-house
protocols which were used to determine appropriate methods for evaluating
the performance of the device:
ISO 8536-4:2007 :- Infusion equipment for medical use - Part 4:
Infusion sets for single use, gravity feed ISO 594-1:1986 :- Conical Fittings with a 6 % (Luer) Taper for
Syringes, Needles and Certain Other Medical Equipment - Part 1:
General Requirements ISO 594-2:1998 :- Conical Fittings with a 6 % (Luer) Taper for
Syringes, Needles and Certain Other Medical Equipment - Part 2:
Lock Fittings Guidance for Industry and FDA Review Staff - Intravascular
Administration Sets Premarket Notification Submissions [510(k)],
dated April 15, 2005 | |
| Summary of
Nonclincal
Testing | Risk management, including a failure modes and effects analysis (FMEA), of
the subject device was conducted in accordance with ISO 14971:2009,
Medical Devices - Risk Management for Medical Devices. No new types of
safety or efficacy questions were identified for the subject Bard Extension Set.
Biocompatibility assessment was conducted on the Bard Extension Set based
on the guidelines presented in blue book memorandum #G95-1 entitled "Use
of International Standard ISO-10993, "Biological Evaluation of Medical
Devices Part-1: Evaluation and Testing and ISO 10993-1:2009 - Biological
Evaluation of Medical Devices Part-1: Evaluation and Testing.
The sterility of the Bard Extension Set is assured by using a validated
sterilization method qualified in accordance with ISO 11135-1:2007 :-
Sterilization of Healthcare products - Ethylene Oxide- Part 1: Requirements
for Development, Validation and Routine Control of a Sterilization Process for
Medical Devices to a sterility assurance level (SAL) of 10-6. Ethylene Oxide
residual levels resulting from EtO Sterilization are in compliance with ISO
10993-7:2008 - Biological Evaluation of Medical Devices- Part 7: Ethylene
Oxide Sterilization Residuals. The Bard Extension is also tested for
pyrogenicity. | |
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Summary of Verification Activities
Summary Results of Verification Testing | |
---|---|
Evaluation | Predetermined Acceptance Criteria |
Assembly Leak | No leaks at 43.5 psi minimum (air method |
used) | |
Gravity Flow | 750 ml/hr minimum |
Priming Volume | NA, test and report results |
Assembly Tensile | Must withstand an axial, static tensile force |
of 15 N (3.37 lbs) for 15 seconds | |
ISO 594 - 1 & 2 Luer | |
Testing | Must pass acceptance criteria outlined in |
ISO 594-1 and -2. | |
Aspiration Flow | NA, test and report results |
Summary of Substantial Equivalence
. :
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.. . .
Based on the indications for use, technological characteristics, and safety and performance testing, the subject Bard Extension Set met the requirements for its intended use/indications for use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available predicate infusion set.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Lynn M. Kirchoff Regulatory Affairs Manager C.R. Bard, Incorporated 605 North 5600 West Salt Lake City, Utah 84116
JUL 21 2011
Re: K102405
Trade/Device Name: Extension Set for Bard Proximally Valved Catheters Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 27, 2011 Received: June 29, 2011
Dear Ms. Kirchoff:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
Page 2 - Ms. Kirchoff
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/CDR H/CDRHOffices/ucm1 1.5809.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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Antmony D. Orona
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Extension Set for Bard® Proximally Valved Catheters
Indications for Use:
An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard® proximally valved catheters. The extension set will connect the IV administration set to the catheter.
Prescription Use (Part 21 CFR §801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR §801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard C. Chayen 7/21/11
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102405
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