(441 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of an infusion set, with no mention of AI or ML technologies.
Yes
The device is used for the administration of fluids via intravenous, intra-arterial, and subcutaneous routes, which are therapeutic interventions.
No
The device is an infusion set designed to deliver fluids, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like fluid container spike, drip chamber, pump segment assembly, etc., indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for administering fluids intravenously, intra-arterially, subcutaneously, or for irrigation. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is an infusion set designed to deliver fluids. It does not perform any tests on biological samples to diagnose a condition.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for the delivery of substances into the body, which falls under the category of medical devices used for treatment or procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The BD Alaris™ Pump Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through intravenous, intra-arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The BD Alaris™ Pump Infusion Set is designed to interface with the BD Alaris™ Pump Module or to be used for gravity infusion. The BD Alaris™ Pump Infusion Set is a single-use infusion set that is available in various configurations of the following components: fluid container spike, vent cap, drip chamber, pump segment assembly, roller clamp and/or pinch clamp, SmartSite™ Y-sites, check valve and male luer lock connector. The drip chamber cap located at the proximal end of the infusion set and the male luer lock cap located at the distal end of the infusion set maintain sterility of the fluid path prior to use. The spike located on the proximal end of the drip chamber is inserted into a fluid container. The infusion set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic.
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
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)
Design verification testing was performed to demonstrate that the subject devices are equivalent to the predicate device. All test results met their acceptance criteria and support that the BD Alaris™ Pump Infusion Sets are as safe and effective as the predicate device and are appropriately designed for their intended use.
Performance testing completed on the subject device were limited to those tests required to support a substantial equivalence determination between the subject and predicate devices.
Human factors testing was performed in according to the following FDA recognized performance standards and guidelines:
- IEC 62366-1:2015, Medical devices-Part 1: Application of usability engineering ● to medical devices.
- IEC 62366-2:2016, Medical devices-Part 2: Guidance on the application of ● usability engineering to medical devices
- . ANSI/AAMI HE75:2009/ (R 2018), Human factors engineering Design of medical devices.
- AAMI TIR 101:2021 Fluid Delivery Performance Testing for Infusion Pumps. ●
- AAMI TIR17:2008 Compatibility of materials subject to sterilization. ●
- IEC 60601-1-6: 2013 Third Edition, Medical Electrical Equipment General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
- Guidance for Industry and FDA staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008
- Guidance for Industry and Food and Drug Administration Staff; Applying Human ● Factors and Usability Engineering to Medical Devices, February 3, 2016
- Guidance for Industry and FDA staff; Infusion Pumps Total Product Life Cycle, December 2, 2014
The following functional, bench and system testing have been performed:
- . Gravity Flow Rate utilizing ISO 8536-4 Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed
- . Microbial Ingress per FDA guidance document, Intravascular Administration Sets Premarket Notification Submissions [510(k)] Aerosol Challenge per internal protocol.
- Human Factors/Usability Engineering per standards listed above ●
- 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 ●
A biocompatibility evaluation was conducted in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Biological evaluation and testing within a risk management process, FDA's guidance document, Use of ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Biological evaluation and testing within a risk management process'' (September 4, 2020), and FDA guidance document, Premarket Assessment of Pediatric Medical Devices (March 24, 2014). Contact classification per ISO 10993-1 is as follows:
- . Externally communicating, blood path indirect, and prolonged exposure (>24 hours to 30 days):
- Externally communicating, tissue contact (indirect), and prolonged exposure (>24 hours to ● 30 days); and
- Surface contacting, intact skin (gloved user), and limited duration (≤ 24 hours). ●
A Biological and Chemical Risk Assessment for BD Alaris™ Pump Infusion Sets was conducted, and the following tests were addressed:
- Cytotoxicity per ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests . for in vitro cytotoxicity
- . Irritation per ISO 10993-23:2021, Biological evaluation of medical devices – Part 23: Tests for irritation
- Sensitization per ISO 10993-10:2021 Biological evaluation of medical devices Part 10: ● Tests for skin sensitization
- Material Mediated Pyrogenicity per ISO 10993-11:2017, Biological evaluation of medical ● devices - Part 11: Tests for systemic toxicity
- System Toxicity per ISO 10993-11:2017, Biological evaluation of medical devices Part ● 11: Tests for systemic toxicity
- Hemolysis per ISO 10993-4:2017, Biological evaluation of medical devices Part 4: . Interactions with blood
- Genotoxicity per ISO 10993-3:2014, Biological evaluation of medical devices Part 3: . Tests for genotoxicity, carcinogenicity and reproductive toxicity
- Particulates per USP Particulate matter in injections ●
The subject BD Alaris™ Pump Infusion Sets met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility, and other performance criteria, including the essential system performance, which verify the sets to be substantially equivalent to the predicate devices. Results of the testing demonstrate that there are no new issues of safety and efficacy that are raised with the BD Alaris™ Pump Infusion Sets. A risk assessment was completed, and no new or additional risks were identified.
The subject device is radiation sterilized and data supports a shelf-life claim of 3 years. Sterilization and shelf-life testing were completed in accordance with the following FDA recognized guidelines:
Sterilization:
- ISO 11137-1:2006/AMD 1:2013 "Sterilization of health care products -. Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1"
- ISO 11137-2:2013 "Sterilization of health care products Radiation Part 2: ● Establishing the sterilization dose"
- United States Pharmacopeia, National Formulary (USP), General Chapter ● , Bacterial Endotoxins Test
- United States Pharmacopeia, National Formulary (USP), General Chapter , ● Medical Devices - Bacterial Endotoxin and Pyrogen Tests (2015)
- ANSI/AAMI ST72:2011 R:2016 Bacterial endotoxins Test methods, routine ● monitoring and alternatives to batch testing.
Shelf-Life:
- . ASTM D642-15 Standard Test Method for Determining Compressive RESISTANCE OF Shipping Containers, Components, and Unit Loads
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping . Containers and Systems
- ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or . Packaging Components for Testing
- ASTM D4728-06 Standard Test Method for Random Vibration Testing of . Shipping Containers
- . ISO 11607-1 First Edition 2006-04-15 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]; and
- ISO 11607-2 First Edition 2006-04-15 Packaging for Terminally Sterilized ● Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes [Including: Amendment 1 (2014)].
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 Roya Borazjani VP Regulatory Affairs, WWIPD 10020 Pacific Mesa Blvd San Diego, California 92121
Re: K221327
Trade/Device Name: BD Alaris™ Pump Infusion Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: June 21, 2023 Received: June 21, 2023
Dear Roya Borazjani:
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. 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) K221327
Device Name BD Alaris™ Pump Infusion Sets
Indications for Use (Describe)
The BD Alaris™ Pump Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through intravenous, intra-arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K221327 - 510(k) Summary
Submitter Information
| Company Name: | CareFusion |
|---|---|
| Company Address: | 10020 Pacific Mesa Blvd. |
| San Diego, CA 92121, USA | |
| Name of Contact: | Roya Borazjani, Ph.D. |
| Company Phone: | 1-(801)-231-0002 |
| Email: | roya.borazjani@bd.com |
| Date Prepared: | July 21, 2023 |
Device Identification
| Trade Name: | BD Alaris™ Pump Infusion Sets |
|---|---|
| Common Name: | Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set |
| Classification Panel: | General Hospital |
| Regulation Number: | 21 CFR 880.5440 |
| Regulatory Class: | Class II |
| Product Code: | FPA |
Predicate Device Identification
The BD Alaris™ Pump Infusion Sets are substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer | 510(k) # | Date Cleared |
|---|---|---|---|
| ALARIS Medical | |||
| Infusion System | |||
| Administration Sets | ALARIS Medical Systems, | ||
| Incorporated (now owned by Becton | |||
| Dickinson) | K022209 | August 6, 2002 |
Reason for Submission
The reason for this submission is to update the BD Alaris™ Pump Infusion Sets Indications for Use to include applicable routes of administration and patient populations.
Device Description
The BD Alaris™ Pump Infusion Set is designed to interface with the BD Alaris™ Pump Module or to be used for gravity infusion. The BD Alaris™ Pump Infusion Set is a single-use infusion
4
set that is available in various configurations of the following components: fluid container spike, vent cap, drip chamber, pump segment assembly, roller clamp and/or pinch clamp, SmartSite™ Y-sites, check valve and male luer lock connector. The drip chamber cap located at the proximal end of the infusion set and the male luer lock cap located at the distal end of the infusion set maintain sterility of the fluid path prior to use. The spike located on the proximal end of the drip chamber is inserted into a fluid container. The infusion set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic.
Intended Use
The BD Alaris™ Pump Infusion Set is for use with the BD Alaris™ Pump Module or gravity flow and is intended for continuous or intermittent delivery of fluids and medications through clinically acceptable routes of administration.
Indication for Use
The BD Alaris™ Pump Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through intravenous, intra-arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults.
Technological Characteristics
Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject BD Alaris™ Pump Infusion Sets achieve their intended use based on the same technology and principles of operation as the predicate ALARIS Medical Infusion System Administration Sets. A comparison of the subject and predicate device technological characteristics is provided in the Table 5-1.
5
Substantial Equivalence Table and Discussion
The BD Alaris™ Pump Infusion Sets are substantially equivalent to the predicate device in terms of intended use and technological characteristics. Table 5-1 below provides a comparison of the intended use and key technological features.
| Parameters | SUBJECT DEVICE
BD Alaris™ Pump Infusion Sets
(K221327) | PREDICATE DEVICE
ALARIS Medical Infusion System Administration
Sets
(K022209) | Comparison |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CareFusion | CareFusion
(formerly ALARIS Medical Systems) | Same |
| Indications for
Use | The BD Alaris™ Pump Infusion Set is
indicated for use by trained healthcare
professionals within healthcare facilities
through intravenous, intra-arterial and
subcutaneous routes for adults, pediatrics and
neonates or irrigation of fluid spaces for
adults. | The following ALARIS Medical Infusion Systems are
intended for use in today's growing professional
healthcare environment including healthcare facilities,
home care, and medical transport that utilize infusion
systems for the delivery of fluids, medications, blood
and blood products:
IVAC Signature Edition Infusion Pumps and
Administration SetsIVAC MedSystem III Multi-Channel
InfusionPump and IVAC MedSystem III Multi-
Channel Infusion Pump with DLE and
Administration SetsIMED Gemini Infusion Pumps/Controllers and
Administration SetsALARIS Medical Medley Medication Safety
System and Administration SetsIVAC, IMED, and ALARIS Gravity, Extension,
Components, and Secondary Administration Sets | 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 BD
Alaris infusion pumps. Updates
to specify patient populations as
adults, pediatrics, and neonates |
| Contact
Category Per
ISO 10993-1 | Externally communicating, indirect blood
path and indirect tissue contact, prolonged
exposure (>24 hours to 30 days);
Surface contacting, intact skin (gloved user),
and limited
duration (≤ 24 hours). | Same | Same |
| Parameters | SUBJECT DEVICE
BD Alaris™ Pump Infusion Sets
(K221327) | PREDICATE DEVICE
ALARIS Medical Infusion System Administration
Sets
(K022209) | Comparison |
| Pump
Compatibility | BD Alaris™ Pump Module | Same | Same |
| Method of
Administration | Gravity or Pump | Same | Same |
| Use Environment | Healthcare Facility | Same | Same |
| Set Lengths | 105 - 126 inches | Same | Same |
| Set Inner
Diameter (ID) | 0.118 in./ 0.107 in | 0.118 in./ 0.107 in | Same |
| Set Outer
Diameter (OD) | 0.164 in / 0.145 in | 0.164 in / 0.145 in | Same |
| Priming Volume | 2420-0007: 25 mL
2426-0007: 26 mL
2207-0007: 27 mL
10942011: 23 mL
11484001: 23 mL | 2420-0007: 25 mL
2426-0007: 26 mL
2207-0007: 27 mL
10942011: 23 mL
11484001: 23 mL | Same |
| Drip Chamber | Polyvinyl Chloride, Acrylonitrile Butadiene
Styrene, Polyethylene, and Acrylic
Copolymer | Polyvinyl Chloride | Different; safety of materials that
comprise the finished device was
demonstrated by the passing
results of ISO 10993
biocompatibility testing |
| Tubing | Polyvinyl Chloride | Same | Same |
| Check Valve | Silicone Rubber and Acrylic | Acrylonitrile Butadiene Styrene and Silicone | Different; safety of materials that
comprise the finished device was
demonstrated by the passing
results of ISO 10993
biocompatibility testing |
| Parameters | SUBJECT DEVICE
BD Alaris™ Pump Infusion Sets
(K221327) | PREDICATE DEVICE
ALARIS Medical Infusion System Administration
Sets
(K022209) | Comparison |
| SmartSite Valve | Acrylic, Polyurethane, Silicone Rubber,
Polyphenylmethyldimethylsiloxane, and
Fluorosilicone Fluid | Same | Same |
| Pump Segment | Acrylonitrile Butadiene Styrene,
Polycarbonate, Silicone Rubber,
Polyethylene, and Silicone | Polyvinyl Chloride, Silicone, Acrylic Polymer,
Acrylonitrile Butadiene Styrene | Different; safety of materials that
comprise the finished device was
demonstrated by the passing
results of ISO 10993
biocompatibility testing |
| Pinch Clamp | Acrylonitrile Butadiene Styrene | Not Applicable (slide clamp) | Same |
| Roller Clamp | Acrylonitrile Butadiene Styrene | Acrylonitrile Butadiene Styrene and Nylon | Different; safety of materials that
comprise the finished device was
demonstrated by the passing
results of ISO 10993
biocompatibility testing |
| Male Luer Lock | Polyethylene | Acrylonitrile Butadiene Styrene | Different; safety of materials that
comprise the finished device was
demonstrated by the passing
results of ISO 10993
biocompatibility testing |
| Male Luer Cap | Polyethylene | Same | Same |
| Tubing Adapter | Acrylonitrile Butadiene Styrene | Same | Same |
| Bonding Agents | Cyclohexanone and/or Cyclohexanone
/Methyl Ethyl Ketone | Same | Same |
| Non-DEHP | Yes | No | Different; safety of materials that
comprise the finished device was
demonstrated by the passing
results of ISO 10993
biocompatibility testing |
| Non-Pyrogenic | Yes | Same | Same |
| Device Usage | Single Use | Same | Same |
| Parameters | SUBJECT DEVICE
BD Alaris™ Pump Infusion Sets
(K221327) | PREDICATE DEVICE
ALARIS Medical Infusion System Administration
Sets
(K022209) | Comparison |
| Sterility | Gamma Radiation | Same | Same |
| Shelf Life | 3 years | Same | Same |
| Packaging | Individually Packaged | Same | Same |
Table 5-1. Comparison of the BD Alaris™ Pump Infusion Sets to the Predicate Device
6
7
8
9
Non-Clinical Data
Design verification testing was performed to demonstrate that the subject devices are equivalent to the predicate device. All test results met their acceptance criteria and support that the BD Alaris™ Pump Infusion Sets are as safe and effective as the predicate device and are appropriately designed for their intended use.
Performance testing completed on the subject device were limited to those tests required to support a substantial equivalence determination between the subject and predicate devices.
Human factors testing was performed in according to the following FDA recognized performance standards and guidelines:
- IEC 62366-1:2015, Medical devices-Part 1: Application of usability engineering ● to medical devices.
- IEC 62366-2:2016, Medical devices-Part 2: Guidance on the application of ● usability engineering to medical devices
- . ANSI/AAMI HE75:2009/ (R 2018), Human factors engineering Design of medical devices.
- AAMI TIR 101:2021 Fluid Delivery Performance Testing for Infusion Pumps. ●
- AAMI TIR17:2008 Compatibility of materials subject to sterilization. ●
- IEC 60601-1-6: 2013 Third Edition, Medical Electrical Equipment General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
- Guidance for Industry and FDA staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008
- Guidance for Industry and Food and Drug Administration Staff; Applying Human ● Factors and Usability Engineering to Medical Devices, February 3, 2016
- Guidance for Industry and FDA staff; Infusion Pumps Total Product Life Cycle, December 2, 2014
The following functional, bench and system testing have been performed:
- . Gravity Flow Rate utilizing ISO 8536-4 Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed
- . Microbial Ingress per FDA guidance document, Intravascular Administration Sets Premarket Notification Submissions [510(k)] Aerosol Challenge per internal protocol.
- Human Factors/Usability Engineering per standards listed above ●
- Flow Rate Accuracy ●
- AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps .
- FDA guidance document, Infusion Pumps Total Product Life Cycle .
10
- . 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 ●
Biocompatibility
A biocompatibility evaluation was conducted in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Biological evaluation and testing within a risk management process, FDA's guidance document, Use of ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Biological evaluation and testing within a risk management process'' (September 4, 2020), and FDA guidance document, Premarket Assessment of Pediatric Medical Devices (March 24, 2014). Contact classification per ISO 10993-1 is as follows:
- . Externally communicating, blood path indirect, and prolonged exposure (>24 hours to 30 days):
- Externally communicating, tissue contact (indirect), and prolonged exposure (>24 hours to ● 30 days); and
- Surface contacting, intact skin (gloved user), and limited duration (≤ 24 hours). ●
A Biological and Chemical Risk Assessment for BD Alaris™ Pump Infusion Sets was conducted, and the following tests were addressed:
- Cytotoxicity per ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests . for in vitro cytotoxicity
- . Irritation per ISO 10993-23:2021, Biological evaluation of medical devices – Part 23: Tests for irritation
- Sensitization per ISO 10993-10:2021 Biological evaluation of medical devices Part 10: ● Tests for skin sensitization
- Material Mediated Pyrogenicity per ISO 10993-11:2017, Biological evaluation of medical ● devices - Part 11: Tests for systemic toxicity
- System Toxicity per ISO 10993-11:2017, Biological evaluation of medical devices Part ● 11: Tests for systemic toxicity
- Hemolysis per ISO 10993-4:2017, Biological evaluation of medical devices Part 4: . Interactions with blood
- Genotoxicity per ISO 10993-3:2014, Biological evaluation of medical devices Part 3: . Tests for genotoxicity, carcinogenicity and reproductive toxicity
- Particulates per USP Particulate matter in injections ●
The subject BD Alaris™ Pump Infusion Sets met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility, and other performance criteria, including the essential system performance, which verify the sets to be substantially equivalent to the predicate
11
devices. Results of the testing demonstrate that there are no new issues of safety and efficacy that are raised with the BD Alaris™ Pump Infusion Sets. A risk assessment was completed, and no new or additional risks were identified.
Sterilization and Shelf Life
The subject device is radiation sterilized and data supports a shelf-life claim of 3 years. Sterilization and shelf-life testing were completed in accordance with the following FDA recognized guidelines:
Sterilization:
- ISO 11137-1:2006/AMD 1:2013 "Sterilization of health care products -. Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1"
- ISO 11137-2:2013 "Sterilization of health care products Radiation Part 2: ● Establishing the sterilization dose"
- United States Pharmacopeia, National Formulary (USP), General Chapter ● , Bacterial Endotoxins Test
- United States Pharmacopeia, National Formulary (USP), General Chapter , ● Medical Devices - Bacterial Endotoxin and Pyrogen Tests (2015)
- ANSI/AAMI ST72:2011 R:2016 Bacterial endotoxins Test methods, routine ● monitoring and alternatives to batch testing.
Shelf-Life:
- . ASTM D642-15 Standard Test Method for Determining Compressive RESISTANCE OF Shipping Containers, Components, and Unit Loads
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping . Containers and Systems
- ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or . Packaging Components for Testing
- ASTM D4728-06 Standard Test Method for Random Vibration Testing of . Shipping Containers
- . ISO 11607-1 First Edition 2006-04-15 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]; and
- ISO 11607-2 First Edition 2006-04-15 Packaging for Terminally Sterilized ● Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes [Including: Amendment 1 (2014)].
The subject BD Alaris™ Pump Infusion Sets meet all the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility, and other performance criteria which verify the sets to be substantially equivalent to the predicate devices. Results of the testing demonstrate that there are no new issues of safety and efficacy that are raised with the BD Alaris™ Pump Infusion
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Sets. A risk assessment was completed, and no new or additional risks were identified.
Clinical Data
There are no clinical data included in this submission.
Summary of Substantial Equivalence
The information provided above supports the BD Alaris™ Pump Infusion Sets substantial equivalence to the identified predicate device. Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The BD Alaris™ Pump Infusion Sets are as safe and effective as the predicate device.