(224 days)
Not Found
No
The device description and intended use describe a standard infusion set with mechanical components, and there are no mentions of AI, ML, or any computational processing.
No.
The device is an administration set for delivering IV fluids, which is a supportive rather than a therapeutic function.
No
The device is an administration set for delivering IV fluids and medications, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a bag spike, drip chamber, tubing, and clamps, indicating it is a hardware device.
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 "continuous or intermittent delivery of IV fluids, medications, including lipids, through intravascular routes of administration." This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details components like a bag spike, drip chamber, tubing, and connectors, all consistent with an infusion set for delivering fluids. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Language: The text does not use any language typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "analyte," "sample analysis," etc.
Therefore, the BD Secondary Set is an infusion set used for delivering fluids intravenously, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BD Secondary Set is indicated for continuous or intermittent delivery of IV fluids, medications, including lipids, through intravascular routes of administration. The BD Secondary Set may be used with any patient with consideration given to the procedure being performed and fluids being infused.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The BD Secondary Infusion Set is an administration set consisting primarily of a bag spike, drip chamber, tubing, roller clamp, micro luer lock connector, and a hanger. The drip chamber cap is located at the proximal end of the administration set, and the micro luer lock cap is located at the distal end of the administration set. The bag spike, located on the proximal end of the drip chamber is inserted into a prepared fluid container. The BD Secondary Infusion Set is supplied as fluid-path sterile using gamma irradiation in a perforated pouch, is non-pyrogenic, and is for single-use only. The BD Secondary Infusion Set is for gravity administration. The device is intended for prescription use (RX) only. DEHP or natural rubber latex are not part of the material formulation. The set can be used for up to 7 days (168 hours) provided the set is continuously attached to the primary administration set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel/vascular system (intravascular routes of administration)
Indicated Patient Age Range
any patient population
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)
Nonclinical Testing:
The BD Secondary Infusion Set was evaluated via non-clinical safety and performance testing to demonstrate that the subject device is substantially equivalent to the predicate device.
The bench and nonclinical testing on the BD Secondary Infusion Set was conducted according to the following FDA recognized consensus standards:
- 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
- ISO 8536-4:2019, Infusion equipment for medical use -Part 4: Infusion sets for single use, gravity feed
- ISO 8536-14:2016, Infusion equipment for medical use – Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- USP 41, National Formulary 36 (USP), General Chapter Particulate Matter In Injections
- ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
- ISO 11137-2:2013, Sterilization of health care . products - Radiation - Part 2: Establishing the sterilization dose
- ISO 11737-1:2018, Sterilization of health care . products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
- ISO 11607-1:2019. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Biocompatibility:
Tests were performed in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process. The BD Secondary Infusion Set is categorized as an externally communicating, indirect blood path, prolonged (> 24 hours to 30 days) device. The tests included:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation or Intracutaneous Activity (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Sub-acute/ Sub-chronic Toxicity (ISO 10993-11)
- Material Mediated Pyrogenicity (ISO 10993-11)
- Hemocompatibility (ASTM F756 and ISO 10993-4)
Key results: The subject device met the applicable test specifications and acceptance criteria. Biocompatibility and performance data demonstrated substantial equivalence. Functional testing on the subject device was conducted to demonstrate compatibility with fluid types. Verification testing was completed for the priming volume, and to confirm performance of drip rate, and to show performance of the subject device for the intended duration of 7 days (168 hours). Microbial barrier testing was conducted as part of shelf-life performance testing.
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.
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May 12, 2023
CareFusion Paulina Davis Staff Regulatory Affairs Specialist 10020 Pacific Mesa Blvd San Diego, California 92121
Re: K223101
Trade/Device Name: BD Secondary Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: April 12, 2023 Received: April 13, 2023
Dear Paulina Davis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Walloschek
David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223101
Device Name BD Secondary Infusion Set
Indications for Use (Describe)
The BD Secondary Set is indicated for continuous or intermittent delivery of IV fluids, medications, including lipids, through intravascular routes of administration. The BD Secondary Set may be used with any patient with consideration given to the procedure being performed and fluids being infused.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 8 |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K223101
| Submitter Name: | CareFusion | |
|---|---|---|
| Submitter Address: | 10020 Pacific Mesa Blvd | |
| San Diego, CA 92121, USA | ||
| Submitter | ||
| Information | Contact Person: | Paulina Davis |
| Staff Regulatory Affairs Specialist | ||
| Phone: 714-330-6037 | ||
| Email Address: Paulina.Davis@BD.com | ||
| Date of Preparation: | May 8, 2023 | |
| Trade Name: | BD Secondary Infusion Set | |
| Common Name: | Intravascular Administration Set and Extension Set | |
| Regulation Name: | Intravascular Administration Set | |
| Subject Device | Classification Panel: | General Hospital |
| Regulation Number: | 21 CFR 880.5440 | |
| Regulatory Class: | Class II | |
| Product Code: | FPA | |
| Trade Name: | Intravascular Administration Set and Extension Set | |
| Premarket Notification #: | K051499 | |
| Regulation Name: | Intravascular Administration Set | |
| Classification Panel: | General Hospital | |
| Predicate Device | Regulation Number: | 21 CFR 880.5440 |
| Regulatory Class: | Class II | |
| Product Code: | FPA | |
| Manufacturer: | Medegen Medical Manufacturing Services | |
| (Now owned by Becton, Dickinson and Company) |
| Reason for
Submission | CareFusion is submitting this traditional premarket notification for the BD
Secondary Infusion Set in support of a new 510(k) baseline for the
Secondary Infusion Set. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The BD Secondary Infusion Set is an administration set consisting
primarily of a bag spike, drip chamber, tubing, roller clamp, micro luer
lock connector, and a hanger. The drip chamber cap is located at the
proximal end of the administration set, and the micro luer lock cap is
located at the distal end of the administration set. The bag spike, located
on the proximal end of the drip chamber is inserted into a prepared fluid
container. The BD Secondary Infusion Set is supplied as fluid-path sterile
using gamma irradiation in a perforated pouch, is non-pyrogenic, and is for |
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| | single-use only. The BD Secondary Infusion Set is for gravity
administration. The device is intended for prescription use (RX) only.
DEHP or natural rubber latex are not part of the material formulation. The
set can be used for up to 7 days (168 hours) provided the set is
continuously attached to the primary administration set. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD Secondary Infusion Set is intended for the intravascular
administration of fluids from a container to a patient's vascular system. |
| Indications for Use | The BD Secondary Set is indicated for continuous or intermittent delivery of
IV fluids, medications, including lipids, through intravascular routes of
administration. The BD Secondary Set may be used with any patient
population with consideration given to the procedure being performed and
fluids being infused. |
| Technological
Characteristics | The BD Secondary Infusion Set was shown to be substantially equivalent to
the predicate device cleared per K051499. Any differences in technological
characteristics such as the material were addressed through
biocompatibility and performance testing. The biocompatibility and
performance data demonstrated substantial equivalence. There were no
new questions of safety or effectiveness. |
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The following table provides a comparison between the subject and the predicate device.
| Characteristic | Subject Device:
BD Secondary Infusion Sets | Predicate Device:
Intravascular Administration and
Extension Sets | Equivalence Discussion |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Status | Subject of 510(k) | K051499
Clearance date June 22, 2005 | N/A |
| Applicant | CareFusion (Now BD) | Medegen Medical Manufacturing
Services (Now BD) | N/A |
| Model Numbers | 72215N
10016073 | Various | N/A |
| Classification
Regulation | Same as predicate | 21 CFR 880.5440 | N/A |
| Regulation Name | Same as predicate | Intravascular Administration Set | N/A |
| Device Class | Same as predicate | ll | N/A |
| Product Code | Same as predicate | FPA | N/A |
| Review Branch | Same as predicate | General Hospital | N/A |
| Indications for Use | The BD Secondary Set is indicated
for continuous or intermittent
delivery of IV fluids, medications,
including lipids through intravascular
routes of administration. The BD
Secondary Set may be used with | The Intravascular Administration Set and
Extension Set is a device used to
administer fluids from a container to a
patient's vascular system through a
needle or catheter inserted into the
patient's artery or vein. The Intravascular | The indications are essentially the
same with the exception being the
subject device lists specific fluid
types and a general patient
population. The predicate device
does not specify fluid types or |
| Characteristic | Subject Device:
BD Secondary Infusion Sets | Predicate Device:
Intravascular Administration and
Extension Sets | Equivalence Discussion |
| | any patient population with
consideration given to the
procedure being performed and
fluids being infused. | Administration Set and Extension Set
may incorporate componentry that aid in
the prevention of accidental needle
sticks. | patient population. The subject
device fluids were assessed based
on clinical use. Functional testing
on the subject device was
conducted to demonstrate
compatibility with fluid types. |
| Intended Use | The BD Secondary Infusion Set is
intended for the intravascular
administration of fluids from a
container to a patient's vascular
system. | The Intravascular Administration Set and
Extension Set is a device used to
administer fluids from a container to a
patient's vascular system through a
needle or catheter inserted into the
patient's artery or vein. | The subject device intended use is
the same; intended for fluid
administration to the patient's
vascular system through a needle
or catheter. |
| Drip Chamber | PVC, Acrylonitrile
Butadiene Styrene (ABS),
Polyethylene | Butadiene Styrene (ABS),
Polypropylene, PTFE/PES, PVC | The safety of materials that
comprise the finished device was
demonstrated by the results of
biocompatibility. |
| Tubing (Non
DEHP) | Same as predicate | PVC | The safety of materials that
comprise the finished device was
demonstrated by the results of
biocompatibility. |
| Characteristic | Subject Device:
BD Secondary Infusion Sets | Predicate Device:
Intravascular Administration and
Extension Sets | Equivalence Discussion |
| Roller Clamp | Acrylonitrile
Butadiene Styrene (ABS) | Material type not listed in predicate
510(k) | Roller clamp is not patient
contacting. Verification testing was
completed to demonstrate the
performance of the roller clamp. |
| Male Luer Lock | Modified Acrylonitrile
Butadiene Styrene (MABS) | Acrylic | The safety of materials that
comprise the finished device was
demonstrated by the results of
biocompatibility. |
| Male Luer Lock
Cap | Polyethylene | Polypropylene | The safety of materials that
comprise the finished device was
demonstrated by the results of
biocompatibility. |
| Hanger | Same as predicate | HDPE | N/A |
| Set Length | 10016073: 31 inches
72215N: 40 inches | 40 inches | Substantially equivalent; the subject
and predicate devices have a
similar set length. |
| Priming Volume | 10016073: 11 mL
72215N: 13 mL | Not listed in predicate 510(k) | Verification testing was completed
for the priming volume. |
| Drip Rate | 10016073: 20/mL
72215N: 15/mL | 15/mL and 20/mL | Verification testing was conducted
to confirm performance of drip rate. |
| Characteristic | Subject Device:
BD Secondary Infusion Sets | Predicate Device:
Intravascular Administration and
Extension Sets | Equivalence Discussion |
| Packaging Type | Perforated Pouch | Peelable Tyvek/Film Pouch | The packaging is not the sterile
barrier. The sterile barrier consists
of the drip chamber cap and male
luer cap. Microbial barrier testing
was conducted as part of shelf-life
performance testing. |
| Sterilization
Method | Same as predicate | Irradiation | N/A |
| Sterility Assurance
Level | Same as predicate | 10-6 | N/A |
| Device Utility | Same as predicate | Disposable, Single use only, Fluid path
sterile | N/A |
| Shelf Life | Same as predicate | 3 years | N/A |
| Device Duration | Up to 7 days (168 hours) | Up to 96 hours | Verification testing was conducted
to show performance of the subject
device for the intended duration of 7
days (168 hours). |
| Mode of Fluid
Delivery | Same as predicate | Gravity | N/A |
| Biocompatibility | Same as predicate | Meets ISO 10993 | N/A |
3 | Раде
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Safety and Performance Testing
Nonclinical Testing
The BD Secondary Infusion Set was evaluated via non-clinical safety and performance testing to demonstrate that the subject device is substantially equivalent to the predicate device.
The bench and nonclinical testing on the BD Secondary Infusion Set was conducted according to the following FDA recognized consensus standards listed below. The subject device met the applicable test specifications and acceptance criteria as described in the submission.
- . FDA Recognition Number 6-11, ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
- . FDA Recognition Number 6-129, ISO 594-2:1998, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- . FDA Recognition Number 6-447, ISO 8536-4:2019, Infusion equipment for medical use -Part 4: Infusion sets for single use, gravity feed
- . ISO 8536-14:2016, Infusion equipment for medical use – Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- . USP 41, National Formulary 36 (USP), General Chapter Particulate Matter In Injections
- FDA Recognition Number 14-528, ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
- FDA Recognition Number 14-409, ISO 11137-2:2013, Sterilization of health care . products - Radiation - Part 2: Establishing the sterilization dose
- FDA Recognition Number 14- 514, ISO 11737-1:2018, Sterilization of health care . products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
- . FDA Recognition Number 14-530. ISO 11607-1:2019. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Biocompatibility
Biocompatibility tests for the subject device were performed in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk
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Management Process as recognized by the FDA. The BD Secondary Infusion Set is categorized as an externally communicating, indirect blood path, prolonged (> 24 hours to 30 days) device in accordance with ISO 10993-1 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." The battery of tests included the following:
- Cytotoxicity (ISO 10993-5, FDA recognition number 2-245) ●
- Sensitization (ISO 10993-10, FDA recognition number 2-296) .
- Irritation or Intracutaneous Activity (ISO 10993-10, FDA recognition number 2-296) ●
- Acute Systemic Toxicity (ISO 10993-11, FDA recognition number 2-255) ●
- Sub-acute/ Sub-chronic Toxicity (ISO 10993-11, FDA recognition number 2-255) ●
- Material Mediated Pyrogenicity (ISO 10993-11, FDA recognition number 2-255) ●
- Hemocompatibility (ASTM F756, FDA Recognition number 2-250 and ISO 10993-4, ● FDA recognition number 2-248)
Clinical Data
Not Applicable. There are no clinical data included in this submission.
Conclusion
The information provided in this 510(k) submission, including the non-clinical safety and performing testing, is sufficient to demonstrate substantial equivalence of the BD Secondary Infusion Set to the predicate device. The BD Secondary Infusion Set and its predicate have similar indications for use, the same intended use, and similar technological characteristics. Any differences between the subject and predicate devices are supported by performance data and do not raise new questions of safety and effectiveness.