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.

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.

AI/ML Overview

The BD Alaris™ Pump Infusion Sets are infusion sets used by healthcare professionals for administering fluids and medications. The device's performance was evaluated through non-clinical design verification testing, including functional, bench, system, and biocompatibility tests. No clinical data was included in the submission.

Here is a summary of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Functional Testing	All functional tests were required to demonstrate equivalent performance to the predicate device and safe and effective design for intended use. Specific acceptance criteria are implied to be derived from referenced standards (e.g., ISO 8536-4, AAMI TIR101:2021).	All test results met their acceptance criteria.
Microbial Ingress	Acceptance criteria as per FDA guidance document, Intravascular Administration Sets Premarket Notification Submissions [510(k)] and internal protocol for Aerosol Challenge.	Met acceptance criteria.
Human Factors/Usability Engineering	Compliance with IEC 62366-1:2015, IEC 62366-2:2016, ANSI/AAMI HE75:2009/(R 2018), AAMI TIR 101:2021, AAMI TIR17:2008, IEC 60601-1-6: 2013, and relevant FDA guidance documents.	Met acceptance criteria.
Flow Rate Accuracy	Compliance with AAMI TIR101:2021 and FDA guidance document, Infusion Pumps Total Product Life Cycle.	Met acceptance criteria.
Bolus Accuracy	Compliance with AAMI TIR101:2021 and FDA guidance document, Infusion Pumps Total Product Life Cycle.	Met acceptance criteria.
Air-in-Line	Specific criteria not detailed, but implied to demonstrate safe operation.	Met acceptance criteria.
Upstream Occlusion Time-to-Alarm	Specific criteria not detailed, but implied to demonstrate safe operation and timely alarm.	Met acceptance criteria.
Post Occlusion Bolus & Downstream Occlusion Time to Alarm	Specific criteria not detailed, but implied to demonstrate safe operation and timely alarm.	Met acceptance criteria.
Biocompatibility	Acceptance criteria as per ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-4:2017, ISO 10993-3:2014, USP <788>, and relevant FDA guidance documents.	All tests (Cytotoxicity, Irritation, Sensitization, Material Mediated Pyrogenicity, System Toxicity, Hemolysis, Genotoxicity, Particulates) met acceptance criteria.
Sterilization	Compliance with ISO 11137-1:2006/AMD 1:2013, ISO 11137-2:2013, USP <85>, USP <161>, and ANSI/AAMI ST72:2011 R:2016.	Met acceptance criteria.
Shelf-Life	3 years shelf-life claim, established through compliance with ASTM D642-15, ASTM D4169-16, ASTM D4332-14, ASTM D4728-06, ISO 11607-1, and ISO 11607-2.	Achieved 3-year shelf-life claim.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the specific sample sizes for each non-clinical test performed. It generally refers to "Design verification testing" and "Performance testing completed on the subject device." The testing would have been conducted internally by CareFusion/BD.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as this was a non-clinical premarket notification (510(k)) for a medical device (infusion set), not an AI/software device requiring expert interpretation of results for ground truth establishment. The "ground truth" here is defined by engineering standards, physical measurements, and biological compatibility test results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this was not a study involving human reader interpretation or clinical adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study was conducted as this device is an infusion set, not an AI or imaging device requiring human-in-the-loop performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device, not a software algorithm. The "standalone performance" would be the device functioning according to its specifications, which was evaluated through the functional and performance tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical testing was based on:

Established engineering and performance standards: e.g., ISO 8536-4 for gravity flow rate, AAMI TIR101:2021 for flow rate and bolus accuracy.
Biocompatibility standards: e.g., ISO 10993 series and USP <788>.
Sterilization and shelf-life standards: e.g., ISO 11137 series and ASTM standards.
FDA guidance documents: for various aspects like microbial ingress and general infusion pump lifecycle.
Internal protocols: where specific external standards might not cover all aspects.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there was no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the Department of Health & Human Services logo.

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the word "CareFusion" in gray text. Below the word "CareFusion" is the phrase "has joined B" in a smaller font.

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 MedicalInfusion SystemAdministration Sets	ALARIS Medical Systems,Incorporated (now owned by BectonDickinson)	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

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 DEVICEBD Alaris™ Pump Infusion Sets(K221327)	PREDICATE DEVICEALARIS Medical Infusion System AdministrationSets(K022209)	Comparison
Manufacturer	CareFusion	CareFusion(formerly ALARIS Medical Systems)	Same
Indications forUse	The BD Alaris™ Pump Infusion Set isindicated for use by trained healthcareprofessionals within healthcare facilitiesthrough intravenous, intra-arterial andsubcutaneous routes for adults, pediatrics andneonates or irrigation of fluid spaces foradults.	The following ALARIS Medical Infusion Systems areintended for use in today's growing professionalhealthcare environment including healthcare facilities,home care, and medical transport that utilize infusionsystems for the delivery of fluids, medications, bloodand blood products:IVAC Signature Edition Infusion Pumps andAdministration SetsIVAC MedSystem III Multi-ChannelInfusionPump and IVAC MedSystem III Multi-Channel Infusion Pump with DLE andAdministration SetsIMED Gemini Infusion Pumps/Controllers andAdministration SetsALARIS Medical Medley Medication SafetySystem and Administration SetsIVAC, IMED, and ALARIS Gravity, Extension,Components, and Secondary Administration Sets	The subject device has the sameintended use as the predicatedevice. Both the subject deviceand predicate device areintended to be used with BDAlaris infusion pumps. Updatesto specify patient populations asadults, pediatrics, and neonates
ContactCategory PerISO 10993-1	Externally communicating, indirect bloodpath and indirect tissue contact, prolongedexposure (>24 hours to 30 days);Surface contacting, intact skin (gloved user),and limitedduration (≤ 24 hours).	Same	Same
Parameters	SUBJECT DEVICEBD Alaris™ Pump Infusion Sets(K221327)	PREDICATE DEVICEALARIS Medical Infusion System AdministrationSets(K022209)	Comparison
PumpCompatibility	BD Alaris™ Pump Module	Same	Same
Method ofAdministration	Gravity or Pump	Same	Same
Use Environment	Healthcare Facility	Same	Same
Set Lengths	105 - 126 inches	Same	Same
Set InnerDiameter (ID)	0.118 in./ 0.107 in	0.118 in./ 0.107 in	Same
Set OuterDiameter (OD)	0.164 in / 0.145 in	0.164 in / 0.145 in	Same
Priming Volume	2420-0007: 25 mL2426-0007: 26 mL2207-0007: 27 mL10942011: 23 mL11484001: 23 mL	2420-0007: 25 mL2426-0007: 26 mL2207-0007: 27 mL10942011: 23 mL11484001: 23 mL	Same
Drip Chamber	Polyvinyl Chloride, Acrylonitrile ButadieneStyrene, Polyethylene, and AcrylicCopolymer	Polyvinyl Chloride	Different; safety of materials thatcomprise the finished device wasdemonstrated by the passingresults of ISO 10993biocompatibility testing
Tubing	Polyvinyl Chloride	Same	Same
Check Valve	Silicone Rubber and Acrylic	Acrylonitrile Butadiene Styrene and Silicone	Different; safety of materials thatcomprise the finished device wasdemonstrated by the passingresults of ISO 10993biocompatibility testing
Parameters	SUBJECT DEVICEBD Alaris™ Pump Infusion Sets(K221327)	PREDICATE DEVICEALARIS Medical Infusion System AdministrationSets(K022209)	Comparison
SmartSite Valve	Acrylic, Polyurethane, Silicone Rubber,Polyphenylmethyldimethylsiloxane, andFluorosilicone 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 thatcomprise the finished device wasdemonstrated by the passingresults of ISO 10993biocompatibility 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 thatcomprise the finished device wasdemonstrated by the passingresults of ISO 10993biocompatibility testing
Male Luer Lock	Polyethylene	Acrylonitrile Butadiene Styrene	Different; safety of materials thatcomprise the finished device wasdemonstrated by the passingresults of ISO 10993biocompatibility 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 thatcomprise the finished device wasdemonstrated by the passingresults of ISO 10993biocompatibility testing
Non-Pyrogenic	Yes	Same	Same
Device Usage	Single Use	Same	Same
Parameters	SUBJECT DEVICEBD Alaris™ Pump Infusion Sets(K221327)	PREDICATE DEVICEALARIS Medical Infusion System AdministrationSets(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 <788> 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 ● <85>, Bacterial Endotoxins Test
United States Pharmacopeia, National Formulary (USP), General Chapter <161>, ● 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

{12}------------------------------------------------

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.

Regulation Number and Section

§ 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.