The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

Device Description

The ProSeal™ Bag Spike with Additive Port (or "and Seal Tab" (suffixed ST model no.)) serves as an adaptor between I.V. bags and ProSeal™ CSTD components, facilitating closed system fluid transfer. The spiking port of this device is compatible with generic I.V. spikes. Additionally, the additive port (injection site) allows medication to be added to the bag using the cleared ProSeal™ Injector or Injector Plus (both Syringe Adaptors).

The injection site of the ProSeal™ Bag Spike with Additive Port (or "and Seal Tab") and all corresponding interface membranes ensure a dry connection during fluid transfer. Utilizing this component and its appropriate ProSeal™ CSTD connecting component reduces the risk of microbial ingress for up to 168 hours (7 days).

AI/ML Overview

This document describes a 510(k) clearance for a medical device called "ProSeal™ Bag Spike with Additive Port." 510(k) clearances are for medical devices that are substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Important Note: The provided FDA 510(k) clearance letter and summary do not describe a study involving a medical device with Artificial Intelligence (AI) or machine learning (ML) capabilities. The document pertains to a physical medical device (an intravascular administration set) and its mechanical and material properties. Therefore, the questions related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, AI assistance) are not applicable to this specific clearance.

I will focus on the acceptance criteria and performance data provided for this physical medical device.

Acceptance Criteria and Device Performance for ProSeal™ Bag Spike with Additive Port

Since this 510(k) is for a physical medical device and not an AI/ML device, the "acceptance criteria" are based on meeting established national and international standards for medical device safety and performance, as well as demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

The device performance is demonstrated by conformance to various ISO standards and validation testing. The table below summarizes the key performance areas and the general nature of the reported performance, as specific quantitative acceptance criteria or detailed results are not explicitly listed in this type of summary document, but rather conformance to the standards is stated.

Acceptance Criterion (Standard/Test)	General Performance Reported
Functional Performance
Leak integrity test (ISO 8536-4:2019, 7.2 & Annex A.3)	Met standard requirements.
Tensile strength test (ISO 8536-4:2019, 7.3 & Annex A.4)	Met standard requirements.
Flow rate test (ISO 8536-4:2019, Annex A.5.1)	Met standard requirements.
Protective caps test (ISO 8536-4:2019, 7.13)	Met standard requirements.
IV Bag Spike penetration force test (ISO 22413:2021, Annex A.7)	Met standard requirements.
Spiking port penetration ability (K223674)	Met standard requirements.
Spiking port adhesion strength (K223674)	Met standard requirements.
Impermeability to microorganism (ISO 15747:2018, Annex C.2) (7-days)	Prevents microbial ingress for up to 7 days.
Vapor containment test (NIOSH CSTD 2016 draft protocol)	Successfully contains drug vapor/aerosols/spills.
Microbial ingress test (FDA guidance & ANSI AAMI CN27:2021) (7-days)	Prevents microbial ingress for up to 7 days.
Biocompatibility (ISO 10993 series)	Acceptable biological risks established.
Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, 14-day subacute/subchronic systemic toxicity, In-vitro hemolysis, Material mediated pyrogenicity	All tests performed on component materials, demonstrating acceptable biocompatibility.
Chemical characterization & toxicological risk management (ISO 10993-18, -17)	Acceptable chemical properties and risk profile.
Chemical requirements testing (ISO15747:2018, Annex B)	Met standard requirements.
Particulate matter analysis (ISO 8536-4:2019, USP <788>)	Met standard requirements for particulate matter.
Sterility (ISO 11135:2014)	Complies with sterilization requirements (SAL 10⁻⁶).
Pyrogen tests (ANSI/AAMI ST72/2019, USP standards)	Met pyrogenicity requirements.
Shipping & Shelf-Life
Simulated shipping testing (ASTM D 4169-16)	Met standard requirements.
Package integrity tests (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009)	Met standard requirements for package integrity.
Shelf-life validation (ASTM 1980-21)	Validated for 3 years (36 months).

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

Sample Size: The document does not specify the exact sample sizes used for each individual functional, biocompatibility, sterility, shipping, or shelf-life test. This level of detail is typically found in the full test reports, not in the 510(k) summary. For device clearances, compliance is often demonstrated by testing a statistically significant number of units to ensure performance within specifications, but the exact number isn't usually summarized here.
Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is Epic Medical Pte. Ltd. based in Singapore, suggesting the testing could have been conducted there or by affiliated labs. The testing refers to "bench performance verifications and validations" and "existing 510(k) cleared referred-to devices (K222929, K223674, K241988)" for leveraging data. This indicates the data is retrospective, drawing from previous tests on related and cleared devices, as well as specific new tests for the subject device. There is no indication of prospective clinical studies.

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

Not Applicable: This criterion relates to AI/ML model validation, where human experts (e.g., radiologists) establish ground truth for image interpretation. For a physical medical device like an intravascular administration set, "ground truth" is established through engineering and biological testing against predefined performance standards and specifications, not through expert consensus on qualitative data. The "experts" would be the engineers, microbiologists, and other scientific and quality control personnel conducting the rigorous lab tests and validations.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or AI/ML model validation to resolve discrepancies in expert interpretations of data. For a physical device, performance is objectively measured against quantifiable technical specifications and standards (e.g., no leaks observed, flow rate within X range, microbial ingress count below threshold).

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: MRMC studies are specific to evaluating the diagnostic performance of AI-assisted systems where human readers interpret medical images or data. This device is a physical product, not an AI system.

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

Not Applicable: This criterion is for AI/ML algorithms. The performance of this device is inherently its standalone physical function.

7. The Type of Ground Truth Used

Objective Test Results / Conformance to Standards: The "ground truth" for this device's performance is established by objective engineering measurements, chemical analyses, and biological assays that demonstrate compliance with recognized industry standards (ISO, ASTM, ANSI, USP) and the device's design specifications. Examples include:
- Absence of leaks under specified pressure.
- Maintaining sterility and preventing microbial ingress for 7 days.
- Meeting pre-defined flow rates.
- No evidence of cytotoxicity, sensitization, or pyrogenicity in biocompatibility tests.
- Successful vapor containment.

8. The Sample Size for the Training Set

Not Applicable: There is no "training set" in the context of a physical medical device. This term applies to machine learning models.

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

Not Applicable: As there is no training set for a physical device, this question is not relevant.

Summary of Study that Proves the Device Meets Acceptance Criteria for this Physical Device:

The study proving the device meets acceptance criteria is a comprehensive set of bench performance verifications and validations, along with biocompatibility, sterility, shipping, and shelf-life testing.

Purpose: To demonstrate that the ProSeal™ Bag Spike with Additive Port is safe and effective for its intended use as an intravascular administration set component, and that any differences from its predicate device (ProSeal™ Closed System Bag Access, K241988) do not raise new questions of safety or effectiveness.
Methodology:
- Functional Testing: The device was subjected to various mechanical and functional tests based on ISO standards (e.g., ISO 8536-4, ISO 22413, ISO 15747, ANSI AAMI CN27), including leak integrity, tensile strength, flow rate, protective cap strength, IV bag spike penetration force, and impermeability to microorganisms (demonstrated for 7 days). Vapor containment was also assessed using a NIOSH CSTD draft protocol.
- Biocompatibility Testing: In accordance with ISO 10993-1:2018 for externally communicating devices (blood path indirect, prolonged contact), various biocompatibility tests were performed on the device's materials, leveraging data from previously cleared predicate and similar devices (K222929, K223674, K241988). These included cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, chemical characterization, and particulate matter analysis.
- Sterility Validation: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization (SAL 10⁻⁶) was demonstrated, along with pyrogen testing.
- Shipping and Shelf-Life Validation: Simulated shipping (ASTM D 4169-16) and package integrity tests (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009) were conducted. Shelf-life of 3 years was validated using accelerated aging (ASTM 1980-21).
Data Sourcing: Data was obtained from new tests performed on the subject device and by leveraging data from previously cleared devices (K222929, K223674, K241988) that share similar components or materials, indicating a retrospective data approach for certain aspects.
Conclusion: The results of these tests and validations confirmed that the subject device meets all relevant performance standards and does not raise new questions of safety or effectiveness compared to the predicate device, thus demonstrating substantial equivalence.

Summary

FDA 510(k) Clearance Letter - ProSeal™ Bag Spike with Additive Port

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 29, 2025

Epic Medical Pte. Ltd.
Freddie Lee
CEO/MD
105 Cecil Street #20-04, The Octagon
Singapore, SG 069534
Singapore

Re: K251340
Trade/Device Name: ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular Administration Set
Regulatory Class: Class II
Product Code: ONB
Dated: April 30, 2025
Received: April 30, 2025

Dear Freddie Lee:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K251340 - Freddie Lee Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251340 - Freddie Lee Page 3

Sincerely,

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 Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K251340

Device Name
ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

Indications for Use (Describe)
The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

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."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

K251340 – 510(k) Summary

I. Submitter

Epic Medical Pte. Ltd.
105 Cecil Street #20-04,
The Octagon,
Singapore 069534
Phone: +65 9635 2618 / +66 81 761 5292
Contact Person: Mr. Freddie LEE, Chief Executive Officer/ Managing Director
Date Prepared: May 26, 2025
Content and Format: Prepared in accordance with 21 CFR 807.92
Type of Submission: Special

II. Subject Device

510(k) Number: K251340
Trade/ Device Name: ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
Common/ Usual Name: Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System
Regulation Number: Set, Administration, Intravascular
Regulation Name: 21 CFR 880.5440
Regulatory Class: Class: II
Product Code: ONB

III. Predicate

510(k) Number: K241988
Trade/ Device Name: ProSeal™ Closed System Bag Access
Common/ Usual Name: Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System
Regulation Number: Set, Administration, Intravascular
Regulation Name: 21 CFR 880.5440
Regulatory Class: Class: II
Product Code: ONB

Page 1 of 7

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IV. Purpose of Submission and Device Description

This special 510(k) Submission is to comply with FDA requirements, ensuring the ProSeal™ Bag Spike with Additive Port (or "and Seal Tab") is safe and effective for use in closed system fluid transfer applications.

V. Indications for Use Statement

VI. Comparison of Intended Use & Technological Characteristics

The Subject device and the Predicate device share the following characteristics:

Intended Use comparison

Indications for use statements
Primary product code and regulation number
Intended user population/ intended use environment
Intended drug type
Prescription use or over-the-counter use

Technological characteristics comparison

Equivalencies – Technology & Design

The Subject device and the Predicate device share the following design characteristics, and from the evaluation in the comparison table, there was no substantial difference from the Predicate device identified, that would raise a safety or performance issue/ concern:

Connection between component devices within the CSTD system
Transfer mechanism (role: to facilitate airtight & leak-proof connections to prevent microbial contamination)
Sterile barrier packaging
Sterilization process
Shelf-life validation
Reuse or single-use
Labeling specifications

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Comparison of intended use characteristics and the technological characteristics

An overview table summarizing the comparison of the key characteristics between the Subject and the Predicate device is provided hereunder:

Characteristic compared	Predicate Device (K241988) ProSeal™ Closed System Bag Access	Subject Device (K251340) ProSeal™ Bag Spike with Additive Port	Comment/Discussion
Intended use and Indications for Use statement	The ProSeal™ CSTD system mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminants into the drug or fluid path for up to 7 days when used as intended.	The ProSeal™ CSTD system mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminants into the drug or fluid path for up to 7 days when used as intended.	Same
Primary product code and regulation number	ONB 21 CFR 880.5440	ONB 21 CFR 880.5440	Same
Intended user population/ intended use environment	Adequately trained health care professionals/ clinical setting	Adequately trained health care professionals/ clinical setting	Same
Intended drug type	Parenteral drugs	Parenteral drugs	Same
Prescription use or over-the-counter use	℞ only	℞ only	Same

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Page 8

Characteristic compared	Predicate Device (K241988) ProSeal™ Closed System Bag Access	Subject Device (K251340) ProSeal™ Bag Spike with Additive Port	Comment/Discussion
Principles of operation	The infusion bag is connected with the bag access and, in order to create a fluid path connection between the infusion bag and the bag access, they are connected with the matching end of the ProSeal Injector or Injector Plus (K240171). All system components are sealed with self-resealing membranes incorporating elastomeric double membrane technology that features airtight and leakage-proof connections during the fluid transfer process. Transfer is performed through the connection of an I.V. set with an indwelling needle of the ProSeal Injector (or Injector Plus) connector, e.g. the ProSeal Closed System Administration Set (cleared K230343), into the human veins.	The infusion bag is connected with the bag access and, in order to create a fluid path connection between the infusion bag and the bag access, they are connected with the matching end of the ProSeal Injector or Injector Plus (K240171). All system components are sealed with self-resealing membranes incorporating elastomeric double membrane technology that features airtight and leakage-proof connections during the fluid transfer process. Transfer is performed through the connection of an I.V. set with an indwelling needle of the ProSeal Injector (or Injector Plus) connector. The spiking port of the ProSeal™ Bag Spike with Additive Port (or and Seal Tab (suffixed ST model)) is compatible with generic I.V. spikes connected to I.V. Administration Sets for dispensing into the human veins.	Different see Comment #1
Number of access points	1 Device has 2 access points: 1. Closed system port (injection site) 2. Spike port, I.V. (bag spike (integrated with injection site MLL))	2 Device has 3 access points: 1. Closed system port (injection site) 2. Spike port, I.V. (bag spike (integrated with injection site MLL & spiking/ administration port)) 3. Spiking port stopper	Different see Comment #1

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Characteristic compared	Predicate Device (K241988) ProSeal™ Closed System Bag Access	Subject Device (K251340) ProSeal™ Bag Spike with Additive Port	Comment/Discussion
Principles of operation	The infusion bag is connected with the bag access and, in order to create a fluid path connection between the infusion bag and the bag access, they are connected with the matching end of the ProSeal Injector or Injector Plus (K240171). All system components are sealed with self-resealing membranes incorporating elastomeric double membrane technology that features airtight and leakage-proof connections during the fluid transfer process. Transfer is performed through the connection of an I.V. set with an indwelling needle of the ProSeal Injector (or Injector Plus) connector, e.g. the ProSeal Closed System Administration Set (cleared K230343), into the human veins.	The infusion bag is connected with the bag access and, in order to create a fluid path connection between the infusion bag and the bag access, they are connected with the matching end of the ProSeal Injector or Injector Plus (K240171). All system components are sealed with self-resealing membranes incorporating elastomeric double membrane technology that features airtight and leakage-proof connections during the fluid transfer process. Transfer is performed through the connection of an I.V. set with an indwelling needle of the ProSeal Injector (or Injector Plus) connector. The spiking port of the ProSeal™ Bag Spike with Additive Port (or and Seal Tab (suffixed ST model)) is compatible with generic I.V. spikes connected to I.V. Administration Sets for dispensing into the human veins.	Different see Comment #1
Number of access points	Device has 2 access points: 1. Closed system port (injection site) 2. Spike port, I.V. (bag spike (integrated with injection site MLL))	Device has 3 access points: 1. Closed system port (injection site) 2. Spike port, I.V. (bag spike (integrated with injection site MLL & spiking/ administration port)) 3. Spiking port stopper	Different see Comment #1

Submitter's Comments

Comment #1
Subject devices are different from the Predicate device in having a third access point – the spiking port (with its TPE stopper) for connection to standard I.V. spikes of I.V. Administration Sets. The differences between the Subject devices and Predicate device did not raise different questions of safety and effectiveness as functional and analytical testing have been conducted and data evaluated. These data are summarized in section VII.A, and section VII.B of this 510(k) Summary, and in Comment #2 hereunder. The differences were determined to be insignificant as performance results were determined to have met the intended use

Comment #2
Subject device's spiking port stopper is same subcomponent part (made of the same material and of the same configuration) used in the cleared K223674 eZSURE™ Empty Fluid Container's spiking port stopper

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Page 10

Characteristic compared	Predicate Device (K241988) ProSeal™ Closed System Bag Access	Subject Device (K251340) ProSeal™ Bag Spike with Additive Port	Comment/Discussion
Composition of fluid path materials	• Polyisoprene (IR) (membrane of injection site) • Polypropylene (PP) (spike port, I.V.)	• Polyisoprene (IR) (membrane of injection site) • Polypropylene (PP) (spike port, I.V.) • Thermoplastic elastomer (TPE) (spiking port stopper)	Different see Comment #2
Connection between component devices within the CSTD system	Collet-style fitting with elastomeric double membranes	Collet-style fitting with elastomeric double membranes	Same
Transfer mechanism (role: to facilitate airtight & leak-proof connections to prevent microbial contamination)	Elastomeric double membrane	Elastomeric double membrane	Same
Biocompatibility	Acceptable biological risks established	Acceptable biological risks established	Same see Comments #2
Sterile barrier packaging	Medical grade paper and medical plastic film, heat sealed	Medical grade paper and medical plastic film, heat sealed	Same
Sterilization process	Ethylene Oxide (EO), SAL 10⁻⁶	Ethylene Oxide (EO), SAL 10⁻⁶	Same
Shelf-life validation	3 years (36 months)	3 years (36 months)	Same
Reuse or single-use	Single use only	Single use only	Same
Labeling specifications	Met the requirements specified in 21 CFR 801	Met the requirements specified in 21 CFR 801	Same

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VII. Performance Data Supporting Substantial Equivalence

A. Functional Performance

The Subject device in this Summary was evaluated to be in conformance with the following ISO standards document:

ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 15747: 2018, Plastic containers for intravenous injections
ISO 22413:2010, Transfer sets for pharmaceutical preparations — Requirements and test methods
ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare application - Part 7, Connectors for intravascular or hypodermic applications
Intravascular-Administration-Sets-Premarket-Notification-Submissions-[510(k)]---Guidance-for-Industry-and-FDA-Staff

Bench performance verifications and validations performed on the Subject device and referred-to from existing devices (K222929 (data of isoprene membrane in cleared Injection Site w/Extended MLL (K240433), the same membrane part used in Predicate K241988) and K223674):

Leak integrity test (functional) – per ISO 8536-4:2019, paragraph 7.2 and Annex A.3, performed on Subject device
Tensile strength test (functional) – per ISO 8536-4:2019, paragraph 7.3 and Annex A.4, performed on Subject device
Flow rate test (functional) – per ISO 8536-4:2019, Annex A.5.1 performed on Subject device
Protective caps test (functional) – per ISO 8536-4:2019, Section 7.13, performed on Subject device
IV Bag Spike penetration force test (functional) – per ISO 22413:2021, Annex A.7 on Subject device
Spiking port penetration ability (functional) on device cleared under K223674
Spiking port adhesion strength (functional) on device cleared under K223674
Impermeability to microorganism (Annex C.2 ISO 15747:2018)(functional) on device cleared under K223674
Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data on device cleared under K222929
Microbial ingress test per FDA guidance and ANSI AAMI CN27:2021 (functional – 7-days) from testing data on devices cleared under K222929 and K223674

B. Biocompatibility

In accordance with ISO 10993-1:2018, the Subject device is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were conducted on the existing 510(k) cleared referred-to devices (K222929 (data of isoprene membrane in cleared Injection Site w/Extended MLL (K240433)), K223674 (data of polypropylene 2-port sub-assembly for IV bag, as well as for TPE spiking port stopper) and Predicate K241988):

Cytotoxicity to ISO 10993-5 performed on devices cleared under K222929 and K223674
Sensitization to ISO 10993-10 performed on devices cleared under K222929 and K223674
Intracutaneous reactivity to ISO 10993-10 performed on devices cleared under K222929 and K223674
Acute systemic toxicity to ISO 10993-11 performed on devices cleared under K222929 and K223674
14-day subacute/subchronic systemic toxicity to ISO 10993-11 performed on devices cleared under K222929 and K223674
In-vitro hemolysis assessment to ISO 10993-4 performed on device cleared under K222929 and K223674
Material mediated pyrogenicity to ISO 10993-11 performed on devices cleared under K222929 and K223674
Chemical characterization and toxicological risk management to ISO 10993-18 and ISO 10993-17 on device cleared under Predicate K241988 (leveraging data of polypropylene spike port, I.V. as well as for isoprene membrane)
Chemical requirements testing to ISO15747:2018, Annex B – Chemical requirements performed on device cleared under K223674
Particulate matter analysis to ISO 8536-4:2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed and USP <788> Particulate Matter in Injections were conducted on devices cleared under K223674 Predicate K241988

C. Sterility, Shipping, and Shelf-Life

The Subject device complies with sterilization requirements of ISO 11135:2014, Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices and the following testing/evaluations:

Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems (leveraging data under K151650)
Package integrity tests per ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems for medical devices and Sterile Barrier Packaging Testing performed on the proposed device: Seal strength – ASTM F88/F88M-21, Standard test method for seal strength of flexible barrier materials; Dye Penetration – ASTM F1929-23, Standard test method for detecting seal leaks in porous medical device packaging by dye penetration; EN 868-5:2009, Packaging materials and systems for medical devices which are to be sterilized – Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction – Requirements and test methods on Subject device
Pyrogen tests per ANSI/AAMI ST72/2019, Bacterial endotoxins – Test methods, routing monitoring, and alternatives to batch testing, USP 42-NF 37 <151>, Pyrogen test (USP rabbit test), USP 42-NF 37 <161>, Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP 42-NF 37 <85>, Bacterial Endotoxins Test under K151650 and testing will be conducted on every lot
Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices on Subject device

VIII. Clinical Tests

Not applicable

IX. Conclusion

The difference between the Predicate and the Subject device does not raise any new or different questions of safety or effectiveness. The Subject ProSeal™ Bag Spike with Additive Port (K251340) is substantially equivalent to the Predicate, ProSeal™ Close System Bag Access (K241988), with respect to the indications for use, principles of operation and technological characteristics

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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.