Polyfusion NFV IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The set may include a vented or non-vented universal spike, drip chamber, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 µm inline filter, slide clamp, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 15 drops/ml and 60 drops/ml. Different lengths are available, from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.

Polyfusion Air Stop IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The inclusion of an air stop filter maintains a constant fluid level in fluid delivery tubing and reduces the possibility of air entering the line when the I.V. bottle/bag is empty. The set may include a vented or non-vented universal spike, drip chamber, air stop filter, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 um inline filter, slide clamps, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 20 drops/ml and 60 drops/ml. Different lengths are available from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.

AI/ML Overview

This document describes the Polyfusion IV Administration Sets, a medical device designed for administering fluids from a container into a patient's vascular system. The information provided outlines the device, its performance testing, and a comparison to a predicate device to establish substantial equivalence for FDA clearance.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily demonstrated through compliance with recognized international and national standards, and internal testing. The document presents a comparison of the subject device (Polyfusion IV Administration Sets) with a predicate device (Baxter Healthcare Corp.'s Intravascular Administration Set, K203609) to show substantial equivalence.

Since this is a 510(k) submission for an IV administration set, the acceptance criteria are not typically expressed as specific performance metrics with explicit pass/fail values in this summary. Instead, they are demonstrated by fulfilling the requirements of the referenced standards and showing comparable safety and effectiveness to the predicate device.

Acceptance Criteria (Demonstrated by Compliance)	Reported Device Performance (Compliance/Result)
Functional Performance (Fluid Delivery, Drip Rates)	Successful compliance testing with: - ISO 8536-4:2019 (Infusion equipment for medical use - Infusion sets for single use, gravity feed) - FDA recognized - ISO 8536-14:2016 (Infusion equipment for medical use - Infusion sets for single use with pressure infusion apparatus) - Not FDA recognized, but tested Comment #4 on Drip Rates: Subject device offers 10, 15, and 60 drops/ml. Predicate has 10 drops/ml. When used at 10 drops/min, both are similar. Comment #5 on Priming Volume: Subject device has approx. 25 ml. Predicate has 6.1 to 21.2 ml. Differences noted but do not raise new safety/effectiveness questions.
Connection Integrity (Luer Connectors)	Successful compliance testing with: - ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications - Connectors for intravascular or hypodermic applications) - FDA recognized
Particulate Matter Reduction (0.2 µm inline filter)	Successful compliance testing with: - USP <788> Method 1 (Particulate Matter in Injections) - Not FDA recognized, but tested
Packaging & Sterility Integrity (during Shipping & Shelf-life)	Successful compliance testing with: - ISTA-3A:2018 (Shipping performance test) - FDA recognized - ASTM F-1886 / F-1886M-16 (Seal integrity of flexible packaging) - FDA recognized - ASTM F-2096 (Detecting gross leaks in nonporous flexible packaging) - FDA recognized - ASTM F-1929 (Seal integrity of flexible packaging by dye penetration) - FDA recognized - EN 868-5:2018 (Sterile barrier systems for medical devices - Sealable pouches and reels) - Not FDA recognized, but tested - Microbial Ingress testing (to confirm sterility barrier) - Sterilization and shelf life confirmed by testing per ISO 8536-4:2019, ISO 8536-14:2016, ISO 80369-20:2015, USP <788> 2012, ASTM F-1929, ASTM F-2096, ASTM F-88 / F88M-15, USP <85> 2012, all following accelerated aging (ASTM F 1980-16).
Microbial Ingress Prevention	Microbial Ingress testing performed.
Biocompatibility	Biocompatibility established by testing in accordance with ISO 10993-1:2018 Annex A, considering relevant FDA guidance, including: - Cytotoxicity (ISO 10993-5:2009) - FDA recognized - Sensitization (ISO 10993-10:2010) - FDA recognized - Irritation or intracutaneous reactivity (ISO 10993-10:2010) - FDA recognized - Acute systemic toxicity (ISO 10993-11:2017) - FDA recognized - Subacute/subchronic toxicity (ISO 10993-11:2017) - FDA recognized - Material mediated pyrogenicity (ISO 10993-11:2017) - FDA recognized - Hemocompatibility (ISO 10993-4:2017) - FDA recognized Comment #2 on Material in Contact with Fluid: Non-DEHP PVC, TPE, TPO materials demonstrated not to raise new safety/effectiveness questions through bench tests.
Sterility Assurance Level (SAL)	Achieved SAL of 10^-6 through validated ethylene oxide sterilization process. Ethylene oxide residuals within specified limits. Comment #6 on Sterilization: Equivalent SAL to predicate's radiation sterilization.
Shelf-life	Validated shelf-life of 5 years. Comment #7 on Shelf life: Longer than predicate (2 years) but raises no new safety/effectiveness questions. Testing included accelerated aging per ASTM F 1980-16 and compliance with standards listed under "Packaging & Sterility Integrity."
Human Factors	A human factors study carried out in accordance with ISO 23908:2011, considering relevant FDA guidance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The performance data section broadly states "Non-clinical testing of the Polyfusion IV Administration Sets has included successful compliance testing with the following standards..." and "Biocompatibility of components...has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018...".

Medical device testing for regulatory submission typically involves internal validation data for each standard's requirements, conducted in a controlled lab environment. The provenance of such data would be the testing facility where the tests were carried out, likely located in the manufacturer's region (India, as per the manufacturer's address, with Donawa Lifescience Consulting in Italy handling some regulatory aspects). These are prospective tests conducted specifically for the device's regulatory clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For IV administration sets, "ground truth" typically refers to established and validated performance characteristics derived from testing against recognized standards. There isn't an explicit "expert panel" establishing ground truth in the way it might occur for AI/imaging devices. The "experts" are implicitly the technical personnel, quality assurance teams, and engineers who conduct the tests and ensure compliance with the specified standards.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/imaging devices where multiple human readers interpret data that is often subjective. For a physical medical device like an IV administration set, performance is measured against objective engineering and biocompatibility standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated across multiple cases. The Polyfusion IV Administration Sets are a physical fluid delivery device and do not involve human readers for diagnostic interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. Standalone algorithm performance studies are conducted for AI-based medical devices. The Polyfusion IV Administration Sets are a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with recognized international and national standards. This includes:

Engineering Standards: Such as ISO 8536-4 (gravity feed), ISO 80369-7 (Luer connectors), ISTA-3A (packaging integrity), ASTM F-series (packaging integrity), EN 868-5 (packaging).
Biocompatibility Standards: ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility).
Sterilization Standards: Validated ethylene oxide sterilization process achieving a SAL of 10^-6, with residuals within limits.
Pharmacopoeial Standards: USP <788> (particulate matter).
Human Factors Standards: ISO 23908.

Essentially, the "ground truth" is that the device, when tested against these prescribed methods and benchmarks, performs as expected and is safe and effective for its intended use, comparable to the predicate device.

8. Sample Size for the Training Set

This information is not applicable. "Training set" is a concept specific to machine learning and AI development. This device is a physical medical product. The "training" in this context would refer to the R&D and design iterations by the manufacturer, but not in the sense of a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As mentioned above, there is no "training set" in the AI sense for this type of device. The R&D and design process for such a device relies on established engineering principles, materials science, manufacturing processes, and adherence to relevant standards and regulations, rather than a data-driven "ground truth" for training.

In summary: The submission for the Polyfusion IV Administration Sets relies on extensive non-clinical bench testing for compliance with a wide array of recognized national and international standards. The substantial equivalence argument is built upon demonstrating that the subject device meets these standards and that any differences in features or materials compared to the predicate device do not raise new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 12, 2023

Poly Medicure Limited % Roger Gray VP Quality and Regulatory Donawa Lifescience Consluting Srl Piazza Albania 10 Rome, 00153 Italy

Re: K220312

Trade/Device Name: Polyfusion IV Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 13, 2023 Received: March 14, 2023

Dear Roger Gray:

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/cfdocs/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

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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 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,

Danil Walloschek

David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220312

Device Name Polyfusion IV Administration Sets

Indications for Use (Describe)

For administration of fluid from a container into the patient vascular system through a vascular access device.

Type of Use (Select one or both, as applicable)

Transaction with ID of 21 CFR 201 Subpart D	For Use Consistent with 21 CFR 201 Subpart D
------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a yellow circle containing a red cross in the middle of the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in a smaller font. Underneath that, the phrase "We Care As We Cure" is written in teal.

K220312 510(k) Summary

Device Name:	Polyfusion IV Administration Sets
Type of 510(k) submission:	Traditional
Preparation Date:	April 12, 2023
Manufacturer:	Poly Medicure LtdPA 010-018, 010-019,Mahindra World City (Jaipur) Ltd,Multi Product SEZ, JaipurRajasthan-302237India
Phone:	+91-129-3355070
FDA Establishment Reg. Number:	9616991
Owner/Operator Reg. Number:	9044462
510(k) Owner and Submitter:	Poly Medicure LtdPA 010-018, 010-019,Mahindra World City (Jaipur) Ltd,Multi Product SEZ, JaipurRajasthan-302237India
510(k) Contact:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItaly
Phone:Fax:Email:	+39 06 578 2665+39 06 574 3786rgray@donawa.com
FDA Product Code:	FPA
FDA Regulation Number:	21 CFR 880.5440
FDA Classification Name:	Intravascular administration set
Classification Panel:	General Hospital
Common Name:	Intravascular Administration Set
FDA Classification:	Class II
Submission Type:	510(k)
Indications for Use:	For administration of fluid from a container into the patient vascularsystem through a vascular access device.

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Image /page/4/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and features a red cross inside of a yellow circle. Below the logo is the text "We Care As We Cure".

Device Description:

The Polyfusion IV Administration Sets are available in multiple configurations. In more detail:

Performance data:

Non-clinical testing of the Polyfusion IV Administration Sets has included successful compliance testing with the following standards, most of which are FDA-recognized:

ISO 8536-4:2019, FDA recognition # 6-447
ISO 8536-14:2016, not FDA recognized
ISO 80369-7:2021, FDA recognition # 5-97 ●
USP <788> Method 1, not FDA recognized ●
ISTA-3A:2018, FDA recognition # 5-126 ●
ASTM F-1886 / F-1886-M-16, FDA recognition # 14-501 ●
. ASTM F-2096, FDA recognition # 14-359
ASTM F-1929, FDA recognition # 14-484 ●
EN 868-5:2018, not FDA recognized
. Microbial Ingress testing

Biocompatibility:

Biocompatibility of components in direct or indirect contact with the patient has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018, while taking into consideration relevant FDA guidance, including:

Cytotoxicity (ISO 10993-5:2009, FDA recognition # 2-245)
Sensitization (ISO 10993-10:2010, FDA recognition # 2-174)
Irritation or intracutaneous reactivity (ISO 10993-10:2010. FDA recognition # 2-174) ●
Acute systemic toxicity (ISO 10993-11:2017, FDA recognition # 2-255) ●
Subacute/subchronic toxicity (ISO 10993-11:2017, FDA recognition # 2-255) ●
Material mediated pyrogenicity (ISO 10993-11:2017, FDA recognition # 2-255) ●
Hemocompatibility (ISO 10993-4:2017, FDA recognition # 2-248) .

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Image /page/5/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a yellow circle containing a red cross in the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in smaller, gray letters. Underneath that is the phrase "We Care As We Cure" in teal.

Sterilization and shelf life:

Sterilization of the Polyfusion admin sets is achieved by use of a validated ethylene oxide gas cycle, achieving a sterilization assurance level (SAL) of 10-6. Ethylene oxide residuals are within specified limits

A shelf life of 5 years has been established by testing the sterile packaging following accelerated aging (per ASTM F 1980-16) in accordance with the following standards:

ISO 8536-4:2019, FDA recognition # 6-447 ●
ISO 8536-14:2016, not FDA recognized ●
ISO 80369-20:2015, FDA recognition # 5-97
USP <788> 2012, not FDA recognized ●
ASTM F-1929, FDA recognition # 14-484 ●
ASTM F-2096, FDA recognition # 14-359
ASTM F-88 / F88M-15, FDA recognition # 14-482 ●
USP <85> 2012, FDA recognition # 14-561 .

Human factors:

A human factors study has also been carried out in accordance with ISO 23908:2011, while taking into consideration relevant FDA guidance.

Substantial equivalence:

The predicate device selected for comparison with the Polyfusion IV administration Admin Sets is:

Predicate Device:	Intravascular Administration Set
Sponsor:	Baxter Healthcare Corp.
510(k) Number:	K203609
Clearance Date:	30 September 2021
FDA Product Code:	FPA
Classification Name:	Intravascular Administration Set
Regulation No:	21 CFR 880.5440
Class:	II

Predicate device comparison table:

The following Table 1 provides evidence of substantial equivalence of the subject device with the selected predicate device.

Table 1: Predicate device comparison table
Feature	Subject device	Predicate device	Similarity
Device name	Polyfusion IV Administration Sets	Intravascular Administration Sets	N/A
DeviceManufacturer	Poly Medicure, India	Baxter Healthcare Corporation	N/A
510(k) Reference	This submission	K203609	N/A
FDA Product Code	FPA	FPA	Same
FDA ClassificationName	Intravascular Administration Set	Intravascular Administration Set	Same
FDA RegulationNumber	21 CFR 880.5440	21 CFR 880.5440	Same

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Image /page/6/Picture/0 description: The image is a logo for Polymed Medical Devices. The logo is teal and features a yellow circle with a red cross in the center. Below the logo, the words "MEDICAL DEVICES" are written in a smaller font. Below that, the words "We Care As We Cure" are written in a slightly larger font.

Table 1: Predicate device comparison table
Feature	Subject device	Predicate device	Similarity
Device description:	Available in multiple configurationsthat may include different materialsin contact with delivered fluid,different lengths and drip rates anddifferent valves and secondaryaccess ports	Available in multiple configurationsthat may include different materialsin contact with delivered fluid,different lengths and drip rates anddifferent valves and secondaryaccess ports	Same
Gravity feed only?	Yes	No, maybe used with infusion pump	DifferentComment #1
Indications for use	For administration of fluid from acontainer into the patient vascularsystem through a vascular accessdevice.	For the administration of fluids froma container into the patient'svascular system through a vascularaccess device.	Same
Material in contactwith delivered fluid	Either PVC not made with DEHP, ormaterial not made with either PVC orDEHP (TPE and TPO)	Either PVC made with DEHP, orPVC not made with DEHP	DifferentComment #2
Vented/non-ventedspike	Option for both	Option for both	Same
Lengths	196 to 276 cm	175.26 to 339.09 cm	DifferentComment #3
Drip rates	10 to 60 drips per minute	10 drips per minute	DifferentComment #4
Priming volume	Approx 25 ml	6.1 to 21.2 ml	DifferentComment #5
Single use	Yes	Yes	Same
Sterile	Yes, SAL 10-6	Yes, SAL 10-6	Same
Sterilizationmethod	Ethylene oxide	Radiation	DifferentComment #6
Shelf life	5 years	2 years	DifferentComment #7
Biocompatibility	Biocompatible in accordance withISO 10993 series and FDA guidance	Biocompatible in accordance withISO 10993 series and FDA guidance	Same
Performancestandards	ISO 8536-4:2019ISO 8536-14:2016ISO 80369-20:2015USP <788> Method BMicrobial ingress	ISO 594-1ISO 594-2ISO 80369-7:2016USP <788> Method 1Microbial ingress	Similar
Prescription use?	Rx only	Rx only	Same

Substantial Equivalence discussion

The subject device and the predicate device have many identical, similar or substantially equivalent properties or features. The differences that exist and are identified in the above table are explained in the following paragraphs.

Comment #1: Gravity feed

The subject device is indicated for gravity feed use only, whereas the predicated for both gravity feed and feed via an infusion pump. While the predicate device offers an alternative to gravity feed use, when used for gravity feed, the two devices have very similar characteristics and specifications, with no new or different questions of safety or effectiveness being raised that would affect the substantial equivalence of the two devices.

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Image /page/7/Picture/0 description: The image is a logo for a company called POLYMED. The logo is composed of the word "POLYMED" in teal, with a yellow circle containing a red cross in the middle of the "O". Below the word "POLYMED" are the words "MEDICAL DEVICES" in a smaller, gray font. Below that is the phrase "We Care As We Cure" in a teal, cursive font.

Comment #2: Material in contact with delivered fluid

While both the subject device range and the predicate device range include sets in which the material in contact with delivered fluid is 'DEHP-free PVC', there is a material difference between the other sets in the two ranges. In this respect, the predicate device range includes material which is PVC manufactured with DEHP, while the subject device range includes non-PVC materials which do not include DEHP. These materials are a thermoplastic elastomer (TPE) and a thermoplastic polyolefin (TPO). This difference has been shown by the results of bench tests carried out in accordance with international, FDA-recognized, standards, to not raise any new or different questions of safety or effectiveness that would affect the substantial equivalence of the two device ranges.

Comment #3: Available lengths

The predicate device range includes admin sets that have shortest lengths and longer longest lengths than the subject device range, but these differences are not significant in terms of safety and effectiveness, with the set lengths being substantially equivalent.

Comment #4: Drip rates

The subject device range includes a variety of drip rates, whereas the predicate device range has only one stated drip rate, which is equivalent to the lowest drip rate available within the subject device range. While the subject device offers alternative drip rates, when used at 10 drips/min, the two devices have very similar characteristics and specifications, with no new or different questions of safety or effectiveness being raised that would affect the substantial equivalence of the two devices.

Comment #5: Priming volume

There is a difference in priming volume between the subject device range and predicate device range, with the subject device range having a single stated priming volume for all variants, while the predicate device range includes different priming volumes for different variants. No new or different questions of safety or effectiveness are raised by this difference that would affect the substantial equivalence of the two device ranges.

Comment #6: Sterilization

The subject device is sterilized by means of ethylene oxide, whereas the predicate device is sterilized by means of radiation. Both sterilization methods result in a validated Sterility Assurance Level (SAL) of 10-6, so the devices are substantially equivalent in this respect with no new or different questions of safety or effectiveness being raised.

Comment #7: Shelf life

The subject device has a validated shelf life of five years, compared with the two year shelf life validated for the predicate device. This difference in shelf life raises no new or different questions of safety or effectiveness that would affect the substantial equivalence of the two devices.

Performance standards

The subject device has been tested in accordance with newer international standards than the predicate device, but the purposes and scope of the standards used for both subject and predicate devices are the same or similar, with no new or different questions of safety or effectiveness being raised that would affect the substantial equivalence of the two devices.

Conclusion

The subject and predicate devices have very similar indications for use and fundamental technological characteristics. Any differences in technological characteristics between subject and predicate devices are addressed by means of specific features present in the reference devices. These differences do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to 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.