(441 days)
Not Found
No
The device description focuses on the physical components of an infusion set and its compatibility with a pump, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an administration set designed to deliver medications, not to treat a condition itself. It is an accessory to a pump and an epidural catheter for medication delivery.
No
The device is an administration set designed to deliver medications, not to diagnose a condition.
No
The device description clearly outlines physical components like bag spike, tubing, connectors, and a drip chamber, indicating it is a hardware device.
Based on the provided text, the BD Alaris™ Pump Epidural Infusion Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for delivering medications through the epidural route to patients (adults, pediatrics, and neonates). This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a system for administering fluids into the body, including components like a bag spike, tubing, and connectors for patient attachment.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples taken from the body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or monitoring.
- Using reagents or assays to detect specific substances.
In summary, the BD Alaris™ Pump Epidural Infusion Set is a medical device used for administering substances into the body, not for analyzing samples from the body. This aligns with the definition of a therapeutic or delivery device, not an IVD.
N/A
Intended Use / Indications for Use
The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.
Product codes (comma separated list FDA assigned to the subject device)
PWH
Device Description
The BD Alaris™ Pump Epidural Infusion Set is an administration set consisting primarily of bag spike, vent cap, drip chamber, tubing (including pump segment), safety clamp, roller clamp, male NRFit™ connector, and male NRFit™ cap. The drip chamber cap located at the proximal end of the administration set, and the male NRFit™ cap, located at the distal end of the administration set, maintain sterility of the fluid path prior to usage. The spike located on the proximal end of the drip chamber is inserted into a prepared fluid container. The male NRFit™ connector enables connection of the administration set to a compatible female NRFit™ connector on the patient's epidural catheter. The BD Alaris™ Pump Epidural Infusion Set is intended to interface with the BD Alaris™ Pump Module. The device is supplied fluid-path sterile using gamma irradiation, in a perforated pouch, is non-pyrogenic, and is for single-use only. The device tubing is color-coded with a yellow stripe to signify administration of medication intended for an epidural route of administration. The BD Alaris™ Pump Epidural Infusion Set is not intended for gravity administration. The device is intended for prescription use only. DEHP or natural rubber latex are not part of the material formulation.
The BD Alaris™ Pump Epidural Infusion Set is designed to deliver medications intended for the epidural route of administration. The NRFit™ connector conforms to ISO 80369-6, Smallbore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The NRFit™ connector is not compatible with the standard luer connector commonly used for intravenous infusion. The addition of the NRFit™ connector eliminates the risk of misconnection that may result in infusion of medications not intended for an epidural route of administration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural route
Indicated Patient Age Range
adults, pediatrics and neonates
Intended User / Care Setting
trained healthcare professionals within healthcare facilities
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 BD Alaris™ Pump Epidural Infusion Set was evaluated via non-clinical safety and performance testing to demonstrate that the device met pre-established acceptance criteria and is substantially equivalent to the predicate device.
The safety and performance testing on the BD Alaris™ Pump Epidural Infusion Set was conducted according to the following FDA recognized and internally recognized consensus standards listed below:
Human Factors
- FDA Recognition Number 5-57, ANSI/AAMI HE75: 2009 (R2013), Human factors engineering- Design of medical devices
- FDA Recognition Number 5-114, IEC 62366-1: Edition 1.0 2015, Medical devices -Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
The following functional, bench and system testing have been performed: - FDA Recognition Number 6-318. ISO 8536-4: 2010/Amd1: 2013(E), Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)]
- FDA Recognition Number 6-358, ISO 8536-8: 2015, Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
- FDA Recognition Number 5-121. ISO 80369-1: 2018. Small-bore connectors for liquids . and gases in healthcare applications - Part 1: General requirements
- FDA Recognition Number 5-108, ISO 80369-6: 2016, Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
- FDA Recognition Number 5-97, ISO 80369-20: 2015, Small-bore connectors for liquids • and gases in healthcare applications - Part 20: Common test methods
- Flow Rate Accuracy
- AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
- FDA guidance document, Infusion Pumps Total Product Life Cycle
- Bolus Accuracy
- AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
- FDA guidance document, Infusion Pumps Total Product Life Cycle
- Air-in-Line
- Upstream Occlusion Time-to-Alarm
- Post Occlusion Bolus & Downstream Occlusion Time to Alarm
- EN ISO 14971: 2012, Medical devices - Application of risk management to medical devices
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 Management Process as recognized by the FDA. Per ISO 10993-1: 2018 the device is categorized as:
- externally communicating, blood path indirect, and prolonged exposure (>24 hours to 30 days).
- externally communicating, tissue contact (indirect), and prolonged exposure; and,
- surface contacting, intact skin, and limited duration (E 24 hours).
A biological and Chemical Risk Assessment for BD Alaris™ Pump Epidural Infusion Sets was conducted, and the following tests were addressed: - Cytotoxicity: FDA Recognition Number 2-245, ISO 10994-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
- Sensitization: FDA Recognition Number 2-174, ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- Irritation or Intracutaneous Activity: FDA Recognition Number 2-291, ISO 10993-23:2021, Biological evaluation of medical devices – Part 23: Tests for irritation
- Acute Systemic Toxicity: FDA Recognition Number 2-255, ISO 10993-11: 2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Hemocompatibility: FDA Recognition Number 2-250, ASTM F756-2017, Standard Practice for Assessment of Hemolytic Properties of Materials
- Hemolysis: FDA Recognition Number 2-248, ISO 10993-4: 2017, Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
- USP 41, National Formulary 36 (USP), General Chapter Particulate Matter In Injections
- Genotoxicity per ISO 10993-3:2014. Biological evaluation of medical devices -Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- FDA Recognition Number 2-289, ISO 10993-12: 2021, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO 10993-17: 2002/(R)2008, Biological evaluation of medical devices -Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18: 2020, Biological evaluation of medical devices Part 18: Chemical characterization of materials
- FDA Recognition Number 2-258, ISO 10993-1: 2018, Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process
- FDA Recognition Number 2-222. ISO 10993-2: 2006, Biological Evaluation of medical devices - Part 2: Animal welfare requirements
- USP 41, National Formulary 36 (USP), General Chapter : 2018, Pyrogen Test (USP Rabbit Test)
Sterilization and Shelf Life/Packaging
- 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 product
- FDA Recognition Number 14-541, ANSI/AAMI ST72: 2019, Bacterial endotoxins -Test methods, routine monitoring, and alternatives to batch testing
- ASTM D4728-17, Random vibration testing of shipping containers
- FDA Recognition Number 14-499, ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D5276-19, Standard Test Method for Drop Test of Loaded Containers by Free Fall
- FDA Recognition Number 14-497, ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- USP 41, National Formulary 36 (USP), General Chapter : 2018, Medical Devices- Bacterial Endotoxin and Pyrogen Tests
- USP 41, National Formulary 36 (USP), General Chapter :2018, Bacterial Endotoxins Test
- FDA Recognition Number 5-117, ISO 15223-1: 2016, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
All testing met pre-established acceptance criteria and successfully demonstrated that the device, the BD Alaris™ Pump Epidural Infusion Set, is safe for its intended use and performs as intended.
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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July 21, 2023
CareFusion Paulina Davis Staff Regulatory Affairs Specialist 10020 Pacific Mesa Blvd San Diego, California 92121
Re: K221319
Trade/Device Name: BD Alaris™ Pump Epidural Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: PWH Dated: June 21, 2023 Received: June 21, 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
Page 2
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. 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) K221319
Device Name BD Alaris™ Pump Epidural Infusion Set
Indications for Use (Describe)
The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K221319 - 510(K) SUMMARY
Submitter Information
510(k) Submitter:
CareFusion 10020 Pacific Mesa Blvd San Diego, CA 92121, USA
Contact Person:
Paulina Davis Staff Regulatory Affairs Specialist Phone: 714-330-6037 Email Address: Paulina.Davis(@BD.com
Date of Summary Preparation:
July 21, 2023
Subject Device Identification
Trade Name: Common Name:
Regulation Name: Classification Panel: Regulation Number: Regulatory Class: Product Code:
Predicate Device Identification
Trade Name:
510(k) Number: 510(k) Clearance Date: Regulation Name: Classification Panel: Regulation Number: Regulatory Class: Product Code: Manufacturer:
BD Alaris™ Pump Epidural Infusion Set Intravascular Administration Set with Neuraxial Connector Intravascular Administration Set General Hospital 21 CFR 880.5440 Class II PWH
CADD® Yellow High Volume Administration Set with NRFit™ Connector K172592 May 17, 2018 Intravascular Administration Set General Hospital 21 CFR 880.5440 Class II PWH Smiths Medical ASD, Inc.
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Reason for Submission
The purpose of this Traditional 510(k) is to obtain clearance to market the BD Alaris™ Pump Epidural Infusion Set which contains an NRFit™ connector. The NRFit™ connector conforms to ISO 80369-6, Smallbore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The NRFit™ connector is not compatible with the standard luer connector commonly used for intravenous infusion. The addition of the NRFit™ connector eliminates the risk of misconnection that may result in infusion of medications not intended for an epidural route of administration.
Device Description
The BD Alaris™ Pump Epidural Infusion Set is an administration set consisting primarily of bag spike, vent cap, drip chamber, tubing (including pump segment), safety clamp, roller clamp, male NRFit™ connector, and male NRFit™ cap. The drip chamber cap located at the proximal end of the administration set, and the male NRFit™ cap, located at the distal end of the administration set, maintain sterility of the fluid path prior to usage. The spike located on the proximal end of the drip chamber is inserted into a prepared fluid container. The male NRFit™ connector enables connection of the administration set to a compatible female NRFit™ connector on the patient's epidural catheter. The BD Alaris™ Pump Epidural Infusion Set is intended to interface with the BD Alaris™ Pump Module. The device is supplied fluid-path sterile using gamma irradiation, in a perforated pouch, is non-pyrogenic, and is for single-use only. The device tubing is color-coded with a yellow stripe to signify administration of medication intended for an epidural route of administration. The BD Alaris™ Pump Epidural Infusion Set is not intended for gravity administration. The device is intended for prescription use only. DEHP or natural rubber latex are not part of the material formulation.
The BD Alaris™ Pump Epidural Infusion Set is designed to deliver medications intended for the epidural route of administration. The NRFit™ connector conforms to ISO 80369-6, Smallbore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The NRFit™ connector is not compatible with the standard luer connector commonly used for intravenous infusion. The addition of the NRFit™ connector eliminates the risk of misconnection that may result in infusion of medications not intended for an epidural route of administration.
Indication for Use
The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.
Comparison of Technological Characteristics with Predicate Device
Table 5 - 1 compares the BD Alaris™ Pump Epidural Infusion Set to the predicate device, CADD® Yellow High Volume Administration Set with NRFit™ Connector, including the technological characteristics. The results of this comparison demonstrate that the design,
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technology, materials and composition of the BD Alaris™ Pump Epidural Infusion Set are substantially equivalent to the predicate CADD® Yellow High Volume Administration Set with NRFit™ Connector.
Table 5 - 1. Comparison of BD Alaris™ Pump Epidural Infusion Set with Predicate CADD® Yellow High Volume Administration Set with NRFit™ Connector
| Characteristic | New Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(K) | K221319 | K172592 | N/A |
| Applicant | CareFusion | Smiths Medical ASD, Inc. | N/A |
| Trade Name | BD Alaris™ Pump Epidural | ||
| Infusion Set | CADD® Yellow High | ||
| Volume | |||
| Administration Set | |||
| with NRFit™ | |||
| Connector | N/A | ||
| Model Numbers | NRF2208-0007 | ||
| NRF2206-0007 | 21-7684-24 | N/A | |
| Classification | |||
| Regulation | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Regulation Name | Intravascular Administration | ||
| Set | Intravascular Administration | ||
| Set | Same | ||
| Device Class | II | II | Same |
| Product Code | PWH | PWH | Same |
| Indications for Use | The BD Alaris™ Pump | ||
| Epidural Infusion Set is | |||
| indicated for use by trained | |||
| healthcare professionals | |||
| within healthcare facilities | |||
| through the epidural route | |||
| for adults, pediatrics and | |||
| neonates. | CADD® Yellow High | ||
| Volume | |||
| Administration Set | |||
| with NRFit™ | |||
| connectors are | |||
| intended for use only | |||
| with NRFit™ | |||
| components for | |||
| delivery of regional | |||
| anesthetics or | |||
| narcotics, excluding | |||
| subarachnoid / spinal block, | |||
| and are | |||
| designed for use with | |||
| CADD® pumps (see | |||
| CADD® pump | Epidural administration | ||
| (the administration route | |||
| for subject device) is a | |||
| type of regional | |||
| administration. The | |||
| subject device has the | |||
| same intended use as the | |||
| predicate device. Both | |||
| the subject device and | |||
| predicate device are | |||
| intended to be used with | |||
| infusion pumps and in | |||
| the same patient | |||
| populations (adults and | |||
| pediatrics (also includes | |||
| neonates). | |||
| Characteristic | New Device | Predicate Device | Comparison |
| Operator's Manual for | |||
| compatibility). | |||
| The intended population is | |||
| pediatrics and adults. | |||
| Rx or OTC? | Rx | Rx | Same |
| Utility | Disposable, for Single Use | ||
| Only | Disposable, Single Use Only | Same | |
| Connection | ISO 80369-6 compliant male | ||
| connector | ISO 80369-6 compliant male | ||
| connector | Same | ||
| Bag Spike | Acrylonitrile | ||
| Butadiene Styrene (ABS) | Acrylonitrile | ||
| butadiene styrene | |||
| (ABS) - ABS - HI | |||
| 121H-Natural | |||
| Granule 9700640000 | |||
| Colorant: Yellow | Different; safety of | ||
| materials that comprise | |||
| the finished device was | |||
| demonstrated by the | |||
| passing results of ISO | |||
| 10993 biocompatibility | |||
| testing. | |||
| Tubing | PVC, silicone | PVC | Different; safety of |
| materials that comprise | |||
| the finished device was | |||
| demonstrated by the | |||
| passing results of ISO | |||
| 10993 biocompatibility | |||
| testing. | |||
| Male NRFit™ | |||
| connector | ABS | Polycarbonate - Makrolon | |
| RX-1805- | |||
| 013771 | |||
| Colorant: White | Different; safety of | ||
| materials that comprise | |||
| the finished device was | |||
| demonstrated by the | |||
| passing results of ISO | |||
| 10993 biocompatibility | |||
| testing. | |||
| Check valve | No | Yes (part of male NRFit™ | |
| connector) | Different; subject device | ||
| does not have a check- | |||
| valve as part of the male | |||
| NRFit™ connector. | |||
| Check valve is not | |||
| required because no | |||
| additional infusion line | |||
| Characteristic | New Device | Predicate Device | Comparison |
| will be connected for | |||
| epidural infusions. | |||
| Flowstop | Yes (safety clamp) | Yes | Different; Verification |
| testing was completed to | |||
| demonstrate that the | |||
| safety clamp performs as | |||
| intended | |||
| Set Length | NRF2208-0007: 117 inches | ||
| NRF2206-0007: 96 inches | 130 inches | Different; system-level | |
| performance testing (flow | |||
| rate and occlusion time- | |||
| to-alarm) demonstrates | |||
| the subject device | |||
| performs as intended. | |||
| Priming Volume | NRF2208-0007: 14.4 mL | ||
| NRF2206-0007: 13 mL | 16-23 mL | Different; priming | |
| volume of subject devices | |||
| is calculated based on | |||
| tubing length and subject | |||
| device components, and | |||
| verified through | |||
| performance testing. | |||
| Flow Type | Pump Operated | Pump Operated | Same |
| Packaging Type | Perforated Pouch | Tyvek Pouch | Different; microbial |
| barrier testing was | |||
| conducted as part of | |||
| shelf-life performance to | |||
| demonstrate the subject | |||
| device performs as | |||
| intended | |||
| Sterilization | Provided fluid path sterile by | ||
| gamma irradiation | Provided sterile by ethylene | ||
| oxide | Different; both Category | ||
| A sterilization methods. | |||
| CareFusion has validated | |||
| that the sterilization | |||
| method and parameters | |||
| are adequate to ensure a | |||
| Sterility Assurance Level | |||
| (SAL) of 10-6. | |||
| Shelf Life | 3 years | Unknown | Different; performance |
| testing on accelerated- | |||
| aged devices | |||
| demonstrates the subject | |||
| device performs as | |||
| Characteristic | New Device | Predicate Device | Comparison |
| intended through its | |||
| labeled shelf life. |
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Safety and Performance Testing
The BD Alaris™ Pump Epidural Infusion Set was evaluated via non-clinical safety and performance testing to demonstrate that the device met pre-established acceptance criteria and is substantially equivalent to the predicate device.
The safety and performance testing on the BD Alaris™ Pump Epidural Infusion Set was conducted according to the following FDA recognized and internally recognized consensus standards listed below:
Human Factors
- FDA Recognition Number 5-57, ANSI/AAMI HE75: 2009 (R2013), Human ● factors engineering- Design of medical devices
- FDA Recognition Number 5-114, IEC 62366-1: Edition 1.0 2015, Medical devices -Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
The following functional, bench and system testing have been performed:
- . FDA Recognition Number 6-318. ISO 8536-4: 2010/Amd1: 2013(E), Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)]
- FDA Recognition Number 6-358, ISO 8536-8: 2015, Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
- FDA Recognition Number 5-121. ISO 80369-1: 2018. Small-bore connectors for liquids . and gases in healthcare applications - Part 1: General requirements
- FDA Recognition Number 5-108, ISO 80369-6: 2016, Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
- FDA Recognition Number 5-97, ISO 80369-20: 2015, Small-bore connectors for liquids ● and gases in healthcare applications - Part 20: Common test methods
- Flow Rate Accuracy
- AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
- FDA guidance document, Infusion Pumps Total Product Life Cycle •
- Bolus Accuracy
- AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps •
- FDA guidance document, Infusion Pumps Total Product Life Cycle
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- Air-in-Line ●
- Upstream Occlusion Time-to-Alarm ●
- Post Occlusion Bolus & Downstream Occlusion Time to Alarm ●
- EN ISO 14971: 2012, Medical devices - Application of risk management to medical devices
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 Management Process as recognized by the FDA. Per ISO 10993-1: 2018 the device is categorized as:
- externally communicating, blood path indirect, and prolonged exposure (>24 hours . to 30 days).
- externally communicating, tissue contact (indirect), and prolonged exposure; and, .
- surface contacting, intact skin, and limited duration (≤ 24 hours). .
A biological and Chemical Risk Assessment for BD Alaris™ Pump Epidural Infusion Sets was conducted, and the following tests were addressed:
- Cytotoxicity: FDA Recognition Number 2-245, ISO 10994-5: 2009, Biological ● evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
- Sensitization: FDA Recognition Number 2-174, ISO 10993-10: 2010, Biological ● evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- Irritation or Intracutaneous Activity: FDA Recognition Number 2-291, ISO 10993-23:2021, Biological evaluation of medical devices – Part 23: Tests for irritation
- Acute Systemic Toxicity: FDA Recognition Number 2-255, ISO 10993-11: 2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Hemocompatibility: FDA Recognition Number 2-250, ASTM F756-2017, Standard ● Practice for Assessment of Hemolytic Properties of Materials
- Hemolysis: FDA Recognition Number 2-248, ISO 10993-4: 2017, Biological ● evaluation of medical devices--Part 4: Selection of tests for interactions with blood
- USP 41, National Formulary 36 (USP), General Chapter Particulate Matter In Injections
- Genotoxicity per ISO 10993-3:2014. Biological evaluation of medical devices -● Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- FDA Recognition Number 2-289, ISO 10993-12: 2021, Biological evaluation of ● medical devices - Part 12: Sample preparation and reference materials
- ISO 10993-17: 2002/(R)2008, Biological evaluation of medical devices -● Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18: 2020, Biological evaluation of medical devices Part 18: ●
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Chemical characterization of materials
- FDA Recognition Number 2-258, ISO 10993-1: 2018, Biological evaluation of ● medical devices - part 1: Evaluation and testing within a risk management process
- FDA Recognition Number 2-222. ISO 10993-2: 2006, Biological Evaluation of ● medical devices - Part 2: Animal welfare requirements
- USP 41, National Formulary 36 (USP), General Chapter : 2018, Pyrogen Test (USP Rabbit Test)
Sterilization and Shelf Life/Packaging
- . 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 product
- FDA Recognition Number 14-541, ANSI/AAMI ST72: 2019, Bacterial endotoxins -● Test methods, routine monitoring, and alternatives to batch testing
- ASTM D4728-17, Random vibration testing of shipping containers ●
- FDA Recognition Number 14-499, ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D5276-19, Standard Test Method for Drop Test of Loaded Containers by Free Fall
- FDA Recognition Number 14-497, ASTM F1980-16, Standard Guide for Accelerated ● Aging of Sterile Barrier Systems for Medical Devices
- USP 41, National Formulary 36 (USP), General Chapter : 2018, Medical ● Devices- Bacterial Endotoxin and Pyrogen Tests
- USP 41, National Formulary 36 (USP), General Chapter :2018, Bacterial ● Endotoxins Test
- . FDA Recognition Number 5-117, ISO 15223-1: 2016, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
All testing met pre-established acceptance criteria and successfully demonstrated that the device, the BD Alaris™ Pump Epidural Infusion Set, is safe for its intended use and performs as intended. Additionally, the BD Alaris™ Pump Epidural Infusion Set and the predicate CADD® Yellow High Volume Administration Set with NRFit™ Connector were tested to similar standards, including ISO 80369-6, and thus the subject device is considered substantially equivalent to the predicate device.
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Clinical Data
There are no clinical data included in this submission.
Conclusion
The information provided in this 510(k) submission, including the non-clinical safety and performance testing, is sufficient to demonstrate substantial equivalence of the BD Alaris™ Pump Epidural Infusion Set to the predicate device. The results of non-clinical safety and performance testing met the pre-established acceptance criteria. The BD Alaris™ Pump Epidural Infusion Set and its predicate have similar indications for use, the same intended use, and similar technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise new or different questions of safety and effectiveness. Additionally, the information provided demonstrates the subject device is as safe and effective as the predicate device.