The proposed device consists of an IV Extension Set (Light Resistant Extension Set). It is a single use disposable, non-pyrogenic, sterile device intended for the administration of fluids from a container into the patient's vascular system. This IV extension set can be directly attached to a syringe but also used as an extension set to a primary set that is connected to a syringe (primarily to add length). The Light Resistant Extension Set consists of non-DEHP (<0.1% DEHP) PVC tubing, a notch clamp, female Luer, non-vented cap for female Luer, and filter vented cap for male Luer. It is used to administer fluids from a syringe into the patient's vascular system through a vascular access device, specifically fluids/drugs sensitive to light to the patients of all ages ranges - neonatal, pediatric, and adult.

AI/ML Overview

The provided text describes the regulatory clearance of the Baxter Healthcare Corporation's Intravascular Extension Set (Light Resistant Extension Set) (K210430). The focus is on demonstrating substantial equivalence to a predicate device (K192366) through non-clinical testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
ISO 80369-7 Luer Tests on male Luer Lock Connector	ISO 80369-7:2016, Clause 6.1.2 or 6.1.3, ISO 80369-7:2016, Clause 6.2, ISO 80369-7:2016, Clause 6.3, ISO 80369-20:2015, Annex E, ISO 80369-7:2016, Clause 6.4, ISO 80369-7:2016, Clause 6.5, ISO 80369-7:2016, Clause 6.6, ISO 80369-7:2016, Clause 5	All tests met the acceptance criteria.
ISO 80369-7 Luer Tests on female Luer Lock Connector	ISO 80369-7:2016, Clause 6.1.2 or 6.1.3, ISO 80369-7:2016, Clause 6.2, ISO 80369-7:2016, Clause 6.3, ISO 80369-20:2015, Annex E, ISO 80369-7:2016, Clause 6.4, ISO 80369-7:2016, Clause 6.5, ISO 80369-7:2016, Clause 6.6, ISO 80369-7:2016, Clause 5	All tests met the acceptance criteria.
Tensile Strength Test	BS EN ISO 8536-9, Clause 5.3	All tests met the acceptance criteria.
Leak Test	BS EN ISO 8536-9: 2015, Section A.4	All tests met the acceptance criteria.
Notch Clamp Activation Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Notch Clamp Shut-Off Test	Per Baxter Test Method	All tests met the acceptance criteria.
Non-DEHP Claim Verification (< 0.1% DEHP)	Per Baxter Test Method (as tested in K161808)	All tests met the acceptance criteria.
Particulate Matter Test	USP 788	All tests met the acceptance criteria.
Light Transmissivity Test	Per Baxter Test Method	All tests met the acceptance criteria.
Biocompatibility (Cytotoxicity)	ISO 10993-5	Demonstrated biocompatibility for intended use and contact duration.
Biocompatibility (Sensitization)	ISO 10993-10	Demonstrated biocompatibility for intended use and contact duration.
Biocompatibility (Intracutaneous (Irritation) Reactivity)	ISO 10993-10	Demonstrated biocompatibility for intended use and contact duration.
Biocompatibility (Systemic Toxicity)	ISO 10993-11	Demonstrated biocompatibility for intended use and contact duration.
Biocompatibility (Materials Mediated Pyrogen)	ISO 10993-11	Demonstrated biocompatibility for intended use and contact duration.
Biocompatibility (Hemolysis)	ISO 10993-4 and ASTMF756	Demonstrated biocompatibility for intended use and contact duration.
Sterility (Sterility Assurance Level - SAL)	Minimum Sterilizing Dose (MSD) required to provide a 10^-6^ SAL for the "General Sets Labeled Sterile" bioburden category as described in ANSI/AAMI/ISO 11137-2. MSDs generally between 14.2 - 25.0 kGy.	Established, validated, and confirmed via periodic dose audit studies. Routine periodic pre-sterilization bioburden testing performed.
Shelf-Life	Supported by aging testing for 3 years.	3 (three) years
Microbial Ingress Testing	Per Baxter test method (as tested in K192366), all test results meet their acceptance criteria.	All test results met the acceptance criteria.

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

The document explicitly states that the studies were non-clinical bench tests. Therefore, the concept of "sample size for the test set" as applied to human subjects or medical imagery doesn't directly apply here. Instead, samples refer to manufactured units of the device tested in a laboratory setting. Specific numbers of units tested are not provided in this summary.

Data Provenance: The tests are internal to Baxter Healthcare Corporation ("Per Baxter Test Method") or adhere to international standards (ISO, BS EN ISO, USP, ANSI/AAMI/ISO). There is no mention of country of origin for the data (beyond the standard bodies) or whether it's retrospective or prospective, as these terms are generally applicable to clinical or observational studies involving patients.

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

Not applicable. This report details non-clinical bench testing for device performance and safety, guided by engineering standards and internal protocols. There is no concept of "ground truth" established by medical experts for these types of tests.

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

Not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of medical data to resolve discrepancies. This document describes objective bench testing with predefined acceptance criteria.

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. This is not a study involving AI assistance for human readers or interpretation of medical cases. It is a submission for a physical medical device (intravascular extension set).

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" in this context is defined by the objective pass/fail criteria outlined in the referenced international standards (e.g., ISO 80369-7, BS EN ISO 8536-9, USP 788) and Baxter's internal validated test methods. Meeting these established criteria confirms the device's functional performance, material properties, and safety.

8. The sample size for the training set:

Not applicable. There is no training set in the context of this physical device's non-clinical testing. Training sets are relevant to machine learning or AI models.

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

June 18, 2021

Baxter Healthcare Corporation Meaghan Bonn Senior Specialist Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073

Re: K210430

Trade/Device Name: Intravascular Extension Set (Light Resistant Extension Set) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 11, 2021 Received: May 21, 2021

Dear Meaghan Bonn:

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 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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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,

CAPT Alan M. Stevens Acting 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 Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K210430

Device Name

Intravascular (IV) Extension Set (Light Resistant Extension Set)

Indications for Use (Describe)

For the administration of fluids from a container into a patient's vascular system through a vascular access device.

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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Image /page/3/Picture/0 description: The image shows the word "Baxter" in a blue, sans-serif font. Below the word "Baxter" is the alphanumeric code "K210430" in a smaller, serif font. The code is left-aligned and positioned directly beneath the word "Baxter".

Section 5. 510(k) Summarv

February 10, 2021

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Meaghan Bonn Senior Specialist, Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, IL 60073 Telephone: (224) 270 6470

IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Intravascular Extension Set (Light Resistant Extension Set) Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration

Regulatory Class: Class II Product Code: FPA

Image /page/3/Figure/10 description: The image shows a medical device labeled as 'Light Resistant Micro-Volume Extension Set, 59" (150 cm), Vol 0.47 mL' with the code 2N3363. The device consists of a red tube with several components labeled with numbers 1 through 6. These components are identified as 'Non-Vented Cap for Female Luer', 'Female Luer Lock', 'Notch Clamp', 'Light Resistant Microbore Tubing', 'Male Luer Lock', and 'Filter Vented Cap for Male Luer'.

Table 1. Proposed IV Extension Set Configuration

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PREDICATE DEVICE:

Device	Company	Predicate 510(k)	Clearance Date
Intravascular ExtensionSets and Accessories	Baxter HealthcareCorporation	K192366 (Model 2N3380)	July 20, 2020

REASON FOR SUBMISSION:

The basis for this premarket notification is the intent to market an Intravascular (IV) Extension Set (Light Resistant Extension Set). The proposed device is a single use disposable device, intended for the administration of fluids from a container into the patient's vascular system through a vascular access device.

DESCRIPTION OF THE DEVICE:

The Light Resistant Extension Set consists of non-DEHP (<0.1% DEHP) PVC tubing, a notch clamp, female Luer, non-vented cap for female Luer, and filter vented cap for male Luer. It is used to administer fluids from a syringe into the patient's vascular system through a vascular access device, specifically fluids/drugs sensitive to light to the patients of all ages ranges - neonatal, pediatric, and adult.

Figure 1. Clinical Use Set Up of Proposed Device when used directly with a Syringe as a Primary Syringe Set

Image /page/4/Figure/10 description: The image shows a medical setup with several labeled components. A syringe, labeled as 'Syringe (Container),' is connected via a 'Female Luer Lock' to a tube. The tube has a 'Shut Off' valve in the middle and connects to a 'Male Luer Lock' on the other end, which is attached to a person's arm.

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Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly slanted to the right. The word is centered in the image and takes up most of the space. The background is white.

Figure 2. Clinical Use Set Up of Proposed Device when used as an Extension to a Primary Syringe Set

Image /page/5/Figure/2 description: This image shows a diagram of a medical setup for administering fluids or medication to a patient. The setup includes a syringe connected to a primary syringe set, which is then connected to an extension set. The extension set is connected to a male luer lock that connects to the patient's vascular access device. The diagram also labels a shut-off clamp and female luer locks that connect to the syringe and primary set.

INDICATIONS FOR USE:

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed device is substantially equivalent to the predicate device (model 2N3380), previously cleared under 510(k) premarket notification K192366 on July 20, 2020. The intended use and function of the proposed device is equivalent to the predicate device.

Table 3 is a device comparison table outlining the differences between the predicate and proposed devices.

Features	Predicate DeviceCleared underK192366 (2N3380)	Proposed Device	Assessment of Differences
Intended Use	For the administrationof fluids from acontainer into thepatient's vascularsystem through avascular access device	Same	N/A
Indication for Use	For the administrationof fluids from acontainer into thepatient's vascularsystem through avascular access device.	Same	N/A

Table 3. Device Comparison

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Features	Predicate DeviceCleared underK192366 (2N3380)	Proposed Device	Assessment of Differences
RegulationNumber	21 CFR 880.5440	Same	N/A
Product Code	FPA	Same	N/A
Sterile	Yes	Same	N/A
Non-Pyrogenic	Yes	Same	N/A
Single Use	Yes	Same	N/A
Length	59" (150cm)(2N3380)	Same	N/A
Fluid Path Components/Materials
Tubing	Polyvinyl Chloride(2N3380)	Same	N/A
Female Luer Lock	Polymethylmethacrylate (Acrylic)(2N3380)	Same	N/A
Male Luer Lock	AcrylonitrileButadiene Styrene(2N3380)	Same	N/A
Filter Vented Capfor Male Luer	High DensityPolyethylene (Cap)Hydrophobic Filter,Acrylic (W/Non-Woven NylonSubstrate) (FilterMembrane)(2N3380)	Same	N/A

Table 3. Device Comparison

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Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is slightly italicized, giving it a dynamic appearance. The word is the logo for the healthcare company Baxter International.

DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed device is appropriately designed for its intended use.

Performance Data:

The following bench tests (Table 4) were conducted to evaluate the functional performance of the proposed device:

Test	Acceptance Criteria
ISO 80369-7 Luer Tests on male Luer Lock Connector	ISO 80369-7:2016, Clause 6.1.2 or6.1.3,ISO 80369-7:2016, Clause 6.2,ISO 80369-7:2016, Clause 6.3,ISO 80369-20:2015, Annex E,ISO 80369-7:2016, Clause 6.4,ISO 80369-7:2016, Clause 6.5,ISO 80369-7:2016, Clause 6.6,ISO 80369-7:2016, Clause 5
ISO 80369-7 Luer Tests on female Luer Lock Connector	ISO 80369-7:2016, Clause 6.1.2 or6.1.3,ISO 80369-7:2016, Clause 6.2,ISO 80369-7:2016, Clause 6.3,ISO 80369-20:2015, Annex E,ISO 80369-7:2016, Clause 6.4,ISO 80369-7:2016, Clause 6.5,ISO 80369-7:2016, Clause 6.6,ISO 80369-7:2016, Clause 5
Tensile Strength Test	BS EN ISO 8536-9, Clause 5.3
Leak Test	BS EN ISO 8536-9: 2015, Section A.4
Notch Clamp Activation Force Test	Per Baxter Test Method
Notch Clamp Shut-Off Test	Per Baxter Test Method
Non-DEHP Claim Verification (< 0.1% DEHP)	Per Baxter Test Method (as tested in K161808)
Particulate Matter Test	USP 788
Light Transmissivity Test	Per Baxter Test Method

Table 4. Performance Data

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All tests met the acceptance criteria.

Biocompatibility:

Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged duration, external communicating device, indirect blood path and FDA-2013-D-0350 Guidance for Industry and FDA Staff, "Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," as recommended in the Intravascular Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] " Biocompatibility assessments were conducted on a worst case/representative final, finished device for all fluid path materials of the proposed device. The following tests were conducted as part of the biocompatibility assessment for the proposed device:

Cytotoxicity ISO 10993-5
Sensitization ISO 10993-10
Intracutaneous (Irritation) Reactivity ISO 10993-10
Systemic Toxicity (acute and repeat dose) ISO 10993-11
Materials Mediated Pyrogen ISO 10993-11
Hemolysis ISO 10993-4 and ASTMF756

Based upon the results of the data supports the ISO 10993-1 categorization of external communicating device, indirect blood path, prolonged contact duration. The proposed device is biocompatible and appropriate for its intended use.

Sterility:

The proposed device is sterilized with gamma radiation. The product is in the bioburden (sub) category "General Sets Labeled Sterile". The Minimum Sterilizing Dose (MSD) required to provide a 106 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO 11137-2. "Sterilization of health care products – Radiation-Part 2: Establishing the sterilization dose." The dose setting method used includes, but is not limited to, Method 1 or VDmax. Generally, the MSDs are between 14.2 - 25.0 kGy. The continued validity of the MSD for this (sub) category is confirmed via periodic dose audit studies. In addition, routine periodic pre-sterilization bioburden testing is performed for each (sub) category.

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Image /page/9/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is slightly italicized, giving the word a sense of movement. The word is the logo for the healthcare company Baxter International.

Shelf-Life:

Baxter has performed aging testing to support a shelf-life claim of 3 (three) years.

Microbial Ingress Testing:

Baxter has conducted testing on all the potential points of microbial entry into the sterile fluid pathway of the proposed device (per Baxter test method - as tested in K192366). The potential microbial entry points consist of male and female Luer connector sites. All test results meet their acceptance criteria and support that the proposed device is appropriately designed for its intended use.

CONCLUSION:

The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is legally marketed for the same intended use.

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.