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.

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, Small-bore 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.

AI/ML Overview

The provided document is a 510(k) summary for the BD Alaris™ Pump Epidural Infusion Set. It describes non-clinical safety and performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding AI device evaluation is not applicable or available in this document.

However, I can extract information related to the general acceptance criteria and studies performed for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All testing met pre-established acceptance criteria and successfully demonstrated that the device... is safe for its intended use and performs as intended." However, it does not provide a specific table with detailed numerical acceptance criteria for each test and the corresponding device performance results. The testing was conducted according to various FDA recognized and internal consensus standards, implying that the acceptance criteria are inherent within these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes used for the various non-clinical safety and performance tests. It also does not mention data provenance in terms of country of origin or whether the tests were retrospective or prospective since these are non-clinical bench and lab tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable. This is a submission for a mechanical medical device (infusion set), not an AI device that requires expert-established ground truth for performance evaluation such as image interpretation.

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

This information is not applicable. Adjudication methods are typically relevant for clinical studies involving human interpretation or decision-making, which is not the case for this non-clinical submission.

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:

This information is not applicable. An MRMC study is relevant for AI devices assisting human readers/interpreters, which is not what the BD Alaris™ Pump Epidural Infusion Set is.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

For this device, "ground truth" would correspond to the established physical and chemical properties, functionality, and safety requirements defined by international standards (e.g., ISO, AAMI, ASTM) and FDA guidance documents. The device's performance was measured against these predefined specifications. For example, for biocompatibility, the ground truth is defined by the passing criteria of ISO 10993 tests.

8. The sample size for the training set:

This information is not applicable. This is not an AI device that requires a training set.

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

This information is not applicable. This is not an AI device that requires a training set or its associated ground truth establishment.

Summary of relevant information from the document (focused on device evaluation):

Acceptance Criteria: Implicitly defined by the numerous FDA recognized and internal consensus standards followed, including:
- Human Factors: ANSI/AAMI HE75: 2009 (R2013), IEC 62366-1: Edition 1.0 2015.
- Functional/Bench/System Testing: ISO 8536-4: 2010/Amd1: 2013(E), ISO 8536-8: 2015, ISO 80369-1: 2018, ISO 80369-6: 2016, ISO 80369-20: 2015. Specific tests listed: Flow Rate Accuracy, Bolus Accuracy, Air-in-Line, Upstream Occlusion Time-to-Alarm, Post Occlusion Bolus & Downstream Occlusion Time to Alarm.
- Biocompatibility: ISO 10993-1, ISO 10994-5, ISO 10993-10, ISO 10993-23, ISO 10993-11, ASTM F756-2017, ISO 10993-4, USP 41 General Chapter <788>, ISO 10993-3, ISO 10993-12, ISO 10993-17, ISO 10993-18.
- Sterilization and Shelf Life/Packaging: ISO 11137-1, ISO 11137-2, ISO 11737-1, ANSI/AAMI ST72, ASTM D4728-17, ASTM D4169-16, ASTM D5276-19, ASTM F1980-16, USP 41 General Chapter <161>, USP 41 General Chapter <85>.
Studies Performed: Non-clinical safety and performance testing were conducted to demonstrate substantial equivalence to the predicate device. These included:
- Human factors testing.
- Functional, bench, and system testing (e.g., flow rate accuracy, air-in-line, occlusion time-to-alarm).
- Biocompatibility testing.
- Sterilization and shelf life/packaging testing.
Device Performance: All testing met pre-established acceptance criteria, demonstrating that the device is safe for its intended use and performs as intended. Specific quantitative results are not provided in this summary.
Ground Truth: For non-clinical tests, the "ground truth" is defined by the pass/fail criteria and specifications outlined in the referenced national and international standards.
Clinical Data: No clinical data were included in the submission.

Summary

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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

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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

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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 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 EpiduralInfusion Set	CADD® Yellow HighVolumeAdministration Setwith NRFit™Connector	N/A
Model Numbers	NRF2208-0007NRF2206-0007	21-7684-24	N/A
ClassificationRegulation	21 CFR 880.5440	21 CFR 880.5440	Same
Regulation Name	Intravascular AdministrationSet	Intravascular AdministrationSet	Same
Device Class	II	II	Same
Product Code	PWH	PWH	Same
Indications for Use	The BD Alaris™ PumpEpidural Infusion Set isindicated for use by trainedhealthcare professionalswithin healthcare facilitiesthrough the epidural routefor adults, pediatrics andneonates.	CADD® Yellow HighVolumeAdministration Setwith NRFit™connectors areintended for use onlywith NRFit™components fordelivery of regionalanesthetics ornarcotics, excludingsubarachnoid / spinal block,and aredesigned for use withCADD® pumps (seeCADD® pump	Epidural administration(the administration routefor subject device) is atype of regionaladministration. Thesubject device has thesame intended use as thepredicate device. Boththe subject device andpredicate device areintended to be used withinfusion pumps and inthe same patientpopulations (adults andpediatrics (also includesneonates).
Characteristic	New Device	Predicate Device	Comparison
		Operator's Manual forcompatibility).
		The intended population ispediatrics and adults.
Rx or OTC?	Rx	Rx	Same
Utility	Disposable, for Single UseOnly	Disposable, Single Use Only	Same
Connection	ISO 80369-6 compliant maleconnector	ISO 80369-6 compliant maleconnector	Same
Bag Spike	AcrylonitrileButadiene Styrene (ABS)	Acrylonitrilebutadiene styrene(ABS) - ABS - HI121H-NaturalGranule 9700640000Colorant: Yellow	Different; safety ofmaterials that comprisethe finished device wasdemonstrated by thepassing results of ISO10993 biocompatibilitytesting.
Tubing	PVC, silicone	PVC	Different; safety ofmaterials that comprisethe finished device wasdemonstrated by thepassing results of ISO10993 biocompatibilitytesting.
Male NRFit™connector	ABS	Polycarbonate - MakrolonRX-1805-013771Colorant: White	Different; safety ofmaterials that comprisethe finished device wasdemonstrated by thepassing results of ISO10993 biocompatibilitytesting.
Check valve	No	Yes (part of male NRFit™connector)	Different; subject devicedoes not have a check-valve as part of the maleNRFit™ connector.Check valve is notrequired because noadditional infusion line
Characteristic	New Device	Predicate Device	Comparison
			will be connected forepidural infusions.
Flowstop	Yes (safety clamp)	Yes	Different; Verificationtesting was completed todemonstrate that thesafety clamp performs asintended
Set Length	NRF2208-0007: 117 inchesNRF2206-0007: 96 inches	130 inches	Different; system-levelperformance testing (flowrate and occlusion time-to-alarm) demonstratesthe subject deviceperforms as intended.
Priming Volume	NRF2208-0007: 14.4 mLNRF2206-0007: 13 mL	16-23 mL	Different; primingvolume of subject devicesis calculated based ontubing length and subjectdevice components, andverified throughperformance testing.
Flow Type	Pump Operated	Pump Operated	Same
Packaging Type	Perforated Pouch	Tyvek Pouch	Different; microbialbarrier testing wasconducted as part ofshelf-life performance todemonstrate the subjectdevice performs asintended
Sterilization	Provided fluid path sterile bygamma irradiation	Provided sterile by ethyleneoxide	Different; both CategoryA sterilization methods.CareFusion has validatedthat the sterilizationmethod and parametersare adequate to ensure aSterility Assurance Level(SAL) of 10-6.
Shelf Life	3 years	Unknown	Different; performancetesting on accelerated-aged devicesdemonstrates the subjectdevice performs as
Characteristic	New Device	Predicate Device	Comparison
			intended through itslabeled 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 <788> 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 <151>: 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 <161>: 2018, Medical ● Devices- Bacterial Endotoxin and Pyrogen Tests
USP 41, National Formulary 36 (USP), General Chapter <85>: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.

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.