Predicate Devices

Reference Devices

K240171, K222929, K230343, K241823, K240433

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and physical properties for containment and transfer, with no mention of AI or ML.

Therapeutic

No.
The device is described as a Closed System Drug Transfer Device (CSTD) intended for the preparation, reconstitution, compounding, and administration of drugs, minimizing exposure to hazardous substances and preventing microbial contamination. It does not directly treat or diagnose a medical condition in a patient, which is the primary function of a therapeutic device.

Diagnostic

No

The device is a closed system drug transfer device (CSTD) that mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations. It is used for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs, and to prevent microbial contamination. This functionality does not involve diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (bag access, injector, membranes, cannula) and bench performance studies related to mechanical integrity and fluid transfer, indicating it is a hardware device. There is no mention of software as a component or function.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the device is for the "preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs." This describes a process related to handling and delivering medications, not performing tests on biological samples to diagnose or monitor a medical condition.
Device Description: The description focuses on the mechanical function of the device to prevent contamination and exposure during drug transfer. It describes components for connecting to IV bags and facilitating fluid transfer. This aligns with a drug delivery or handling system, not an IVD.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information. The performance studies listed are related to the physical integrity and functionality of the device for drug handling, not diagnostic accuracy.

In summary, the ProSeal™ Closed System Drug Transfer Device is designed to facilitate the safe handling and administration of drugs, which falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ProSeal™ Closed System drug Transfer Device (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.

Product codes (comma separated list FDA assigned to the subject device)

ONB

Device Description

The ProSeal™ CSTD is a sterile, single-use, pyrogen-free CSTD for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs, intended for use in clinical settings by trained health care professionals and/or pharmacists.

The ProSeal™ Closed System Bag Access is a component of the ProSeal™ CSTD system which is intended for connection to a standard I.V. bag and appropriate ProSeal™ CSTD component devices for the injection and infusion of I.V. infusion fluids. It is an adaptor between IV bags and ProSeal™ CSTD components for closed system fluid transfer into and out of the I.V. bag. The Subject bag access is compatible with the ProSeal™ Injector or the ProSeal™ Injector Plus (cleared K240171) and other ProSeal™ component devices, e.g. ProSeal™ Closed System Administration Set (for infusion from the I.V. bag). The ProSeal™ Closed System Bag Access and all its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component device and its appropriate ProSeal CSTD connecting component device reduces the risk of microbial ingress for up to 168 hours or 7 days, when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector Plus housing perforates the double membranes for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination, when used as intended.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Adequately trained health care professionals including pharmacists/clinical setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A. Functional Performance
The Subject device in this Summary was evaluated to be in conformance with the following ISO and FDA recognized standards and FDA guidance document:

ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
ISO 8536-4: 019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 22413:2010, Transfer sets for pharmaceutical preparations Requirements and test ● methods
Intravascular-Administration-Sets-Premarket-Notifications-J510(k)]---Guidancefor-Industry-and-FDA-Staff

Bench performance verifications and validations referred-to and performed:

Leak integrity test (functional) per ISO 8536-4:2019, paragraph 7.2 and Annex A.3, performed on Subject devices
Tensile strength test (functional) per ISO 8536-4:2019, paragraph 7.3 and Annex A.4, . performed on Subject devices
Penetration force test (functional) - per ISO 22413:2021, Section 6.6, Annex A.7, performed on Subject devices
Protective caps test (functional) - per ISO 8536-4:2019, Section 7.13, performed on Subject devices
Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data on devices cleared under K222929
Microbial ingress test per FDA guidance and ANSI AAMI CN27:2021 (functional) from testing data on devices cleared under K222929

B. Biocompatibility
In accordance with ISO 10993-1: 2018, the Subject device just like the existing ProSeal™ CSTD devices, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were performed on referred-to cleared devices:

Cytotoxicity to ISO 10993-5 under K222929
Sensitization to ISO 10993-10 under K222929
Intracutaneous Reactivity to ISO 10993-10 under K222929
Acute Systemic Toxicity to ISO 10993-11 under K222929 .
14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K222929 .
In-vitro Hemolysis Assessment to ISO 10993-4 under K222929
Material Mediated Pyrogenicity to ISO 10993-11 under K222929
Particulate matter testing was conducted on the Subject device, in accordance with ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed and USP Particulate Matter in Injections.

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 conducted devices cleared under K222929;

Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing . of Shipping Containers and Systems
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
Pyrogen Tests per ANSI/AAMI ST72/2019, Bacterial endotoxins Test methods, routing . monitoring, and alternatives to batch testing, USP 40 , Pyrogen test (USP rabbit test), USP-NF , Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF , Bacterial Endotoxins Test 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K201460

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K240171, K222929, K230343, K241823, K240433

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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October 23, 2024

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

Re: K241988

Trade/Device Name: ProSeal™ Closed System Bag Access Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: September 23, 2024 Received: September 23, 2024

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" (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).

1

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 OS 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 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-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 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-device-advicecomprehensive-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-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).

2

Sincerely,

Porsche Bennett

Porsche Bennett For 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

3

Indications for Use

510(k) Number (if known) K241988

Device Name ProSeal™ Closed System Bag Access

Indications for Use (Describe)

The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from 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)

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CDIL

K241988 – 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: October 23, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Traditional

II. Subject Device

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:	21 CFR 880.5440
Regulation Name:	Intravascular administration set
Regulatory Class:	Class: II
Product Code:	ONB

III. Predicate

510(k) Number:	K201460
Trade/ Device Name:	Closed System Transfer Device
Common/ Usual Name:	Closed Antineoplastic and Hazardous Drug Reconstitution and
Transfer System
Regulation Number:	21 CFR 880.5440
Regulation Name:	Intravascular administration set
Regulatory Class:	Class: II
Product Code:	ONB

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IV. Device Description

The ProSeal™ CSTD is a sterile, single-use, pyrogen-free CSTD for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs, intended for use in clinical settings by trained health care professionals and/or pharmacists.

The ProSeal™ Closed System Bag Access is a component of the ProSeal™ CSTD system which is intended for connection to a standard I.V. bag and appropriate ProSeal™ CSTD component devices for the injection and infusion of I.V. infusion fluids. It is an adaptor between IV bags and ProSeal™ CSTD components for closed system fluid transfer into and out of the I.V. bag. The Subject bag access is compatible with the ProSeal™ Injector or the ProSeal™ Injector Plus (cleared K240171) and other ProSeal™ component devices, e.g. ProSeal™ Closed System Administration Set (for infusion from the I.V. bag). The ProSeal™ Closed System Bag Access and all its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component device and its appropriate ProSeal CSTD connecting component device reduces the risk of microbial ingress for up to 168 hours or 7 days, when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector Plus housing perforates the double membranes for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination, when used as intended.

V. Indications for Use Statement

The ProSeal™ Closed System drug Transfer Device (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.

6

Comparison of Intended Use & Technological Characteristics VI.

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

Intended Use comparison

1. Indications for use statements
1. Primary product code and regulation number
1. Intended user population/ intended use environment

Technological characteristics comparison Equivalencies - Technology & Design

The ProSeal" Closed System Bag Access and the Predicate device share the following similar design characteristics, and from the evaluation in the comparison table, there was no substantial difference from the Predicate device identified, that would raise a different question of safety or effectiveness:

1. Principles of operation
1. Number of access points
1. Intended connector type to be used with the bag spike adapter
1. Safety feature to prevent microbial contamination
An overview table summarizing the comparison between the Subject and the Subject and the Predicate device is provided hereunder.

| Characteristic
compared | Predicate Device (K201460)
CSTD - Spike Adapter | Subject Device (K241988)
ProSeal™ Closed System Bag Access | Comment/
Discussion |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended use
and
Indications for Use
statement | "The Closed System Transfer Device (CSTD) for
preparation, reconstitution, compounding and
administration of drugs, including
antineoplastic and hazardous drugs. This closed
system mechanically prohibits the transfer of
environmental contaminants into the system
and the escape of drug or vapor concentrations
outside the system, thereby minimizing
individual and environmental exposure to drug
vapor, aerosols, and spills and also prevents
microbial ingress." | "The ProSeal™ Closed System drug Transfer
Device (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." | Similar |
| Characteristic
compared | Predicate Device (K201460)
CSTD - Spike Adapter | Subject Device (K241988)
ProSeal™ Closed System Bag Access | Comment/
Discussion |
| 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 including pharmacists/
clinical setting | Adequately trained
health care professionals including pharmacists/
clinical setting | Same |
| Intended drug type | Parenteral drugs | Parenteral drugs | Same |
| Single use or reusable | Single use only | Single use only | Same |
| Principles
of operation | Infusion bag is connected with spike adapter,
then in order to realize the connection
between infusion bag and spike adaptor, they
are connected with the matching end of the
dispensing connector.
All system components are sealed with
resealing membranes, and elastomeric double
membrane technology is used to ensure that
there is no drug leakage at the connecting
parts during the dispensing process. As closed
Infusion Set, the working principle of the
infusion set is gravity infusion, which is
connected with the indwelling needle or other
connector(s). Under the action of gravity, the
medicine is infused into human blood vessels
through the infusion tube. | 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 indwelling needle of the
ProSeal Injector (or Injector Plus) connector,
e.g. the ProSeal Closed System Administration
Set (cleared K230343), into the human veins. | Same |
| Components | • Vial Adapter
• Spike Adapter
• Dispensing Connector
• Closed Infusion Set | • Spike Adapter | Different,
See Comment #1 |
| Characteristic
compared | Predicate Device (K201460)
CSTD - Spike Adapter | Subject Device (K241988)
ProSeal™ Closed System Bag Access | Comment/
Discussion |
| Number
of access points | Device has 2 access points:

Closed system port
Spiking/ administration port, IV spike bag
access | Device has 2 access points:
Closed system port
Spiking/ administration port, IV spike bag
access | Same |
| Composition
of fluid path materials | ABS (spike), synthetic rubber
(sealing element/ membrane/ septum) | Polypropylene (PP) (spike), polyisoprene
(IR) (sealing element/ membrane/ septum) | Different,
See Comment #2 |
| Intended
connector type to be
used with the bag
spike adapter | Image: Shiva Ande Healthcare Apparatus manufacturer's dedicated Dispensing Connector (K201460) male Luer lock tip, connected to an external standard MLL syringe | Image: Epic Medical Pte Ltd manufacturer's cleared ProSeal™ Injector or Injector Plus (K240433) male Luer lock tip, connected to an external standard MLL syringe | Same |
| Safety feature to
prevent microbial
contamination | Leak proof connector with membranes
(septums) seal – elastomeric resealing
double membrane | Airtight and leakage-proof adaptor with
membranes (septums) seal – elastomeric
resealing double membrane – closed system
technology | Same |
| 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 |

4) Intended drug type

1. Single use or reusable, single patient use
1. Sterile barrier packaging
1. Sterilization process
1. Shelf-life

7

8

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Image /page/9/Picture/0 description: The image shows the word "EPIC" in a stylized, bold, sans-serif font. The "E" has a circular dot in the upper left corner, and a horizontal line underlines the entire word. The letters are closely spaced, giving the word a compact appearance.

Discussion of difference in technological characteristics

Comment #1

Submission K241988 is to include an authorization of the ProSeal™ Closed System Vial Access, a single component device, to the existing ProSeal™ CSTD system of 11 component devices (K241823). Compared to Predicate K201460, the application was for 4 component devices. The different questions of safety and effectiveness as the Subject device of the Predicate device component devices. Bench top, biocompatibility, and sterility data demonstrate the difference does not raise different questions in safety and effectiveness as described in section VII.

Comment #2

Though the Subject device's bag spike and membrane material differ with the Predicate, both the PP and IR materials are the same in type, make, grade and manufacturer source as those used in the cleared ToxiSeal™ Vial Adaptor with External Balloon (K222929) that have been tested to demonstrate biocompatibility. In addition, performance testing demonstrates the difference in material does not raise different questions of safety and effectiveness.

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 and FDA recognized standards and FDA guidance document:

ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated ● into medical devices for intravascular applications
. ISO 8536-4: 019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 22413:2010, Transfer sets for pharmaceutical preparations Requirements and test ● methods
. Intravascular-Administration-Sets-Premarket-Notifications-J510(k)]---Guidancefor-Industry-and-FDA-Staff

Bench performance verifications and validations referred-to and performed:

Leak integrity test (functional) per ISO 8536-4:2019, paragraph 7.2 and Annex A.3, performed ● on Subject devices
Tensile strength test (functional) per ISO 8536-4:2019, paragraph 7.3 and Annex A.4, . performed on Subject devices
. Penetration force test (functional) - per ISO 22413:2021, Section 6.6, Annex A.7, performed on Subject devices
. Protective caps test (functional) - per ISO 8536-4:2019, Section 7.13, performed on Subject devices
Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data ● on devices cleared under K222929
Microbial ingress test per FDA guidance and ANSI AAMI CN27:2021 (functional) from testing ● data on devices cleared under K222929

10

e Dio

B. Biocompatibility
In accordance with ISO 10993-1: 2018, the Subject device just like the existing ProSeal™ CSTD devices, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were performed on referred-to cleared devices:
Cytotoxicity to ISO 10993-5 under K222929 ●
Sensitization to ISO 10993-10 under K222929 ●
Intracutaneous Reactivity to ISO 10993-10 under K222929 ●
Acute Systemic Toxicity to ISO 10993-11 under K222929 .
14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K222929 .
In-vitro Hemolysis Assessment to ISO 10993-4 under K222929 ●
. Material Mediated Pyrogenicity to ISO 10993-11 under K222929

Particulate matter testing was conducted on the Subject device, in accordance with ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed and USP Particulate Matter in Injections.

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 conducted devices cleared under K222929;

Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing . of Shipping Containers and Systems
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
Pyrogen Tests per ANSI/AAMI ST72/2019, Bacterial endotoxins Test methods, routing . monitoring, and alternatives to batch testing, USP 40 , Pyrogen test (USP rabbit test), USP-NF , Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF , Bacterial Endotoxins Test 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.

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 device - ProSeal™ Closed System Bag Access is substantially equivalent to the Predicate device, CSTD-Spike Adapter (manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.), (K201460) - with respect to its indications for use, principles of operation and technological characteristics.