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.

Device Description

The ProSeal™ Injection Site Extended Male Luer Lock (ProSeal™ Injection Site) is a new component device for the ProSeal™ Closed System (drug) Transfer Device (CSTD) system. It is intended for connection with interface membranes between any standard female Luer lock port and ProSeal™ CSTD component devices for closed system fluid transfer. It is a variant of the cleared ProSeal™ Connector, a component of the ProSeal™ CSTD system. When connected to a female Luer lock port and engaged with a ProSeal™ Injector or a ProSeal™ Injector Plus (K240171) (Syringe Adaptor), fluid can be transferred to the connecting device in a closed system. The ProSeal™ Injection Site and its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component and its appropriate ProSeal™ CSTD component device reduces the risk of microbial ingress for up to 168 hours of 7 days, when use as intended. The closed transfer of liquid utilizes a double membrane septum design with self-sealing elastomeric membranes. Modifications from the existing ProSeal™ Connector include a geometric design change and a material change of the membrane from TPE to polyisoprene.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically the ProSeal™ Injection Site Extended Male Luer Lock (model 422140). The document asserts "substantial equivalence" of this device to a previously cleared predicate device, the ProSeal™ CSTD's Connector (K240171).

The provided text does not contain any information about a study proving the device meets acceptance criteria related to AI/algorithm performance (e.g., sensitivity, specificity, or human reader improvement with AI assistance). This document concerns a physical medical device (an intravascular administration set component) and its functional, biocompatibility, and sterility performance, comparing it to an already cleared similar device.

Therefore, the requested information regarding acceptance criteria and a study proving an AI/algorithm device meets these criteria cannot be extracted from this document. The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC study," and "standalone algorithm performance" are not applicable to the type of device and submission described in this FDA clearance letter.

The document discusses "functional performance acceptance criteria" for the physical device, which are met through conformance to various ISO and FDA recognized standards.

Here's an interpretation of the document's content relevant to "acceptance criteria" for this physical device:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Acceptance Criteria (Met by Conformance to Standards)	Reported Device Performance (Demonstrated Conformance)
Functional Performance:	Bench Performance Verification and Validation conducted:
- Conformance to AAMI CN27: 2021 (General requirements for Luer activated valves)	- Positive pressure fluid leakage test
- Conformance to ISO 8536-4: 2019 (Infusion equipment for medical use)	- Sub-atmospheric pressure air leakage test
- Conformance to ISO 80369-7: 2021 (Small-bore connectors for intravascular/hypodermic applications)	- Stress cracking test
- Conformance to US FDA Guidance for Intravascular Administration Sets Premarket Notification Submissions	- Resistance to separation from axial load test
- Mechanical prohibition of environmental contaminants entering system	- Resistance to separation from unscrewing test
- Prohibition of drug or vapor escape	- Resistance to overriding
- Prevention of microbial contaminations into drug/fluid path for up to 7 days	- Device leakage integrity test
	- Vapor containment test per NIOSH 2016 draft protocol
	- Microbial ingress test per FDA guidance and AAMI CN27: 2021
Biocompatibility:	Testing referenced from existing/referred-to device:
- Conformance to ISO 10993-1: 2018 (Biological evaluation of medical devices - Part 1)	- Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, 14-day Subacute/Subchronic Acute Systemic Toxicity, In-vitro Hemolysis Assessment, Material Mediated Pyrogenicity, Chemical characterization and Toxicological Risk Assessment.
	- Particulate matter testing conducted on Subject device in accordance with ISO 8536-4: 2019 and USP <788>.
Sterility & Shelf-Life:	Compliance/Testing:
- Conformance to ISO 11135: 2014 (Ethylene Oxide Sterilization)	- Device complies with sterilization requirements, supported by evaluations including AAMI TIR 28: 2016, USP <85> (Bacterial endotoxin), ASTM F1980-16 (Accelerated aging), ASTM F88/ F88M-21 (Seal strength), and ISO 10993-7: 2008/ Amd 1: 2019 (Ethylene oxide sterilization residuals).
- Validated shelf life of 3 years (36 months)	- Shelf-life validated as 3 years (36 months).

Regarding the other requested points (not applicable to this document's content):

Sample size used for the test set and data provenance: Not applicable. This document refers to bench testing of a physical device, not a performance study on an ML model's test set.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for an AI model is not relevant to the evaluation of this physical medical device.
Adjudication method for the test set: Not applicable.
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 an AI/ML powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML model for this device. For the physical device, "ground truth" would be the objective measurement against established ISO/FDA standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

May 21, 2024

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

Re: K240433

Trade/Device Name: ProSeal™ Injection Site Extended Male Luer Lock (model 422140) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: April 19, 2024 Received: April 19, 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).

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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.

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,

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General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240433

Device Name

ProSeal™ Injection Site External Male Luer Lock (model 422140)

Indications for Use (Describe)

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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K240433 – 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 20, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Traditional

Subject Device II.

510(k) Number:	K240433
Trade/ Device Name:	ProSeal™ Injection Site Extended Male Luer Lock (model 422140)
Common/ Usual Name:	Closed Antineoplastic and Hazardous Drug Reconstitution andTransfer Device
Regulation Number:	21 CFR 880.5440
Regulation Name:	Intravascular administration set
Regulatory Class:	Class: II
Product Code:	ONB

III. Predicate

510(k) Number:	K240171
Trade/ Device Name:	ProSeal™ CSTD (with the Injector Plus (model no. 421050))
Common/ Usual Name:	Closed Antineoplastic and Hazardous Drug Reconstitution andTransfer Device
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 purpose of this 510(k) Submission is to seek FDA clearance prior to the introduction in the US, of a new ProSeal™ Closed System (drug) Transfer Device (CSTD) component device - the Subject ProSeal™ Injection Site Extended Male Luer Lock (ProSeal™ Injection Site). This device is an addition to the ProSeal™ CSTD system of devices. The existing system component device, in the same subgrouping, and also the nominated Predicate device, is the ProSeal™ CSTD's Connector.

The ProSeal™ CSTD (cleared K240171) is a sterile, single-use 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™ Injection Site is a component of the ProSeal™ CSTD system intended for connection with the interface membranes between any standard female Luer lock port and ProSeal™ CSTD component devices, for close system fluid transfer. It is one variant of the cleared ProSeal™ Connector, a component device of the ProSeal™ CSTD system. When connected to a female Luer lock port and engaged with a ProSeal™ Injector or a ProSeal™ Injector Plus (K240171) (Syringe Adaptor), fluid can be transferred to the connecting device in a closed system. The ProSeal™ Injection Site and its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component and its appropriate ProSeal™ CSTD component device reduces the risk of microbial ingress for up to 168 hours of 7 days, when use as intended.

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

the double membrane septum design utilizes self-sealing elastomeric membranes, tightly fit . together, when the system components engage, creating an air-tight and leak proof seal.
The modifications to the existing ProSeal™ Connector, proposed in this Submission, are:
Geometric design change ●
Material change of membrane from TPE to polyisoprene .

Indications for Use Statement V.

VI. Comparison of Technological Characteristics

The ProSeal™ Injection Site Extended Male Luer Lock, a system component of the ProSeal™ CSTD and the predicate system component of interest, the ProSeal™ Connector, share the following key characteristics:

same closed system technology .
same interface between system components ●
same of Luer lock connection to fit any female Luer lock port ●
same sterile barrier packaging
. same sterilization method
. same shelf-life

An overview table summarizing the comparison of key characteristics between the Subject ProSeal™ Injection Site and the predicate ProSeal™ CSTD's ProSeal™ Connector, is provided hereunder.

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Characteristiccompared	Predicate DeviceProSeal™ CSTD'sProSeal™ Connector (cleared K240171)	Subject DeviceProSeal™ CSTD, ProSeal™ Injection SiteExtended Male Luer Lock (K240433)	Comment/ Discussion
Indications for Usestatement	"The ProSeal™ Closed System drug TransferDevice (CSTD) mechanically prohibitsenvironmental contaminants from entering thesystem and the escape of drug or vaporconcentrations from the system, therebyminimizing individual and environmentalexposure to drug vapor, aerosols, and spills.The ProSeal™ system also prevents theintroduction of microbial contaminations intothe drug or fluid path for up to 7 days, whenused as intended."	"The ProSeal™ Closed System drug TransferDevice (CSTD) mechanically prohibitsenvironmental contaminants from entering thesystem and the escape of drug or vaporconcentrations from the system, therebyminimizing individual and environmentalexposure to drug vapor, aerosols, and spills.The ProSeal™ system also prevents theintroduction of microbial contaminations intothe drug or fluid path for up to 7 days, whenused as intended."	Same
Product code and	ONB	ONB	Same
regulation number	21 CFR 880.5440	21 CFR 880.5440
Intended user	Adequately trained	Adequately trained	Same
population/ intended	health care professionals	health care professionals
use environment	or pharmacists/ clinical setting	or pharmacists/ clinical setting
Intendeddrug type	Parenteral drugs	Parenteral drugs	Same
R/Prescription use	R only	R only	Same
Closed system	Physical barrier to prevent all mass from	Physical barrier to prevent all mass from	Same
technology	crossing the system boundary	crossing the system boundary
Interface between	Elastomeric	Elastomeric	Same
system components	resealing double membrane	resealing double membrane
Characteristiccompared	Predicate DeviceProSeal™ CSTD'sProSeal™ Connector (cleared K240171)	Subject DeviceProSeal™ CSTD, ProSeal™ Injection SiteExtended Male Luer Lock (K240433)	Comment/ Discussion
Fitting to externalLuer Lock syringe	Female Luer Lockconforms to ISO 80369-7:2016	Female Luer Lockconforms to ISO 80369-7:2016	Same
System componentdevices	1. ProSeal™ Injector (model 421010)(K192075)2. ProSeal™ Injector Plus (addition of model421050 – K240171, cleared on March 28,2024)3. ProSeal™ Connector (model 422010)(K192075)4. ProSeal™ Vial Adaptor (3 models 4200X0,for vial neck sizes and pressure equalization)(K192075)5. ProSeal™ Assembly Fixture (Fixture forProSeal™ Vial Adaptor assembly, model424010) (K192075)	1. ProSeal™ Injector (model 421010)2. ProSeal™ Injector Plus (model 421050)3. ProSeal™ Connector (422010)4. Proposed ProSeal™ Injection SiteExtended Male Luer Lock (Subject device,K240433)5. ProSeal™ Vial Adaptor (3 models 4200X0,for vial neck sizes and pressure equalization)6. ProSeal™ Assembly Fixture (Fixture forProSeal™ Vial Adaptor assembly, model424010)	Different,the Subject systemcomponent device (#4 inthe column SubjectDevice), is an additionto the five (5) existingcomponent devices ofProSeal™ CSTD(K240171), and isindicated in bold facetexts. Differences areaddressed in the tworows hereunder
Fluid path materialsof construction(ProSeal™Connector)	Polypropylene (PP),thermoplastic elastomer (TPE)	Polypropylene (PP),polyisoprene (IR)	Different,See Comment #1
Geometric design –unlock ring andprotective cap	Image: ProSeal Connector with unlock ring and protective capprovided with unlock ring andwithout removable protective cap	Image: ProSeal Injection Site Extended Male Luer Lock without unlock ring and protective capwithout unlock ring andprovided with removable protective cap	Different,See Comment #2
Characteristiccompared	Predicate DeviceProSeal™ CSTD'sProSeal™ Connector (cleared K240171)	Subject DeviceProSeal™ CSTD, ProSeal™ Injection SiteExtended Male Luer Lock (K240433)	Comment/ Discussion
Primarypackage top web	Medical grade paperand medical plastic film, heat sealed	Medical grade paperand medical plastic film, heat sealed	Same
Sterilization method	Ethylene Oxide, EO, SAL 10-6	Ethylene Oxide, EO, SAL 10-6	Same
ValidatedShelf life	3 years (36 months)	3 years (36 months)	Same
Reuseor single-use	Single-use only	Single-use only	Same
Labelingspecifications	Meets the requirementsspecified in 21 CFR 801	Meets the requirementsspecified in 21 CFR 801	Same

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Discussion of difference in technological characteristics

Comment #1

The membrane material of Subject device is polyisoprene with thermoplastic elastomer (TPE) in the Predicate device (cleared K240171). The same IR membrane subcomponent is present in Epic Medical Pte Ltd - the applicant's - ToxiSeal" Vid. Adaptor with External Balloon (cleared K222929) and it had been validated to have conformed with ISO 10993-1: 2018, and to the functional performance requirements in section VII hereunder.

Comment #2

The differences in design - the removal of the inclusion of a protective cap, have been evaluated through ISO 80369-7: 2021 testing and ISO 8536-4: 2019 testing respectively. The unlock ring and the inclusion of the protective cap - both changes not in the fluid path - were found to have met the functional performance acceptance criteria therein. Further details are summarized in section VII.A.

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VII. Performance Data Supporting Substantial Equivalence

A. Functional Performance

The ProSeal™ Injection Site Extended Male Luer Lock with modifications described in section IV in this Summary - geometric design change, and material change of membrane from TPE to polyisoprene were tested and demonstrated to be in conformance with the following ISO and FDA recognized standards/ FDA guidance document:
- 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, gravitv feed
- ISO 80369-7: 2021, Small-bore connectors for liquids and gases in healthcare application -. Part 7, Connectors for intravascular or hypodermic applications
- US FDA Guidance for Industry and FDA Staff, Intravascular Administration Sets Premarket ● Notification Submissions [510(k)], Issued on July 11, 2008

Bench performance verifications and validations conducted:

Positive pressure fluid leakage test ●
. Sub-atmospheric pressure air leakage test
Stress cracking test
. Resistance to separation from axial load test
Resistance to separation from unscrewing test
Resistance to overriding ●
. Device leakage integrity test
Vapor containment test per NIOSH 2016 draft protocol
Microbial ingress test per FDA guidance and AAMI CN27: 2021 ●

B. Biocompatibility

In accordance with ISO 10993-1: 2018, the ProSeal™ Injection Site Male Luer Lock, just like the existing device, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing are referenced from testing device and referred-to device:

. Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
. 14-day Subacute/ Subchronic Acute Systemic Toxicity
. In-vitro Hemolysis Assessment
Material Mediated Pyrogenicity ●
. Chemical characterization and Toxicological Risk Assessment

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, Annex A.2 and USP <788> Particulate Matter in Injections.

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Image /page/10/Picture/0 description: The image shows a logo with the word "EPIC" in a stylized, bold font. The "E" has a circular dot in the upper left corner, and the "P" and "I" are connected by a horizontal line at their base. The entire word is underlined with a thick, solid line. The logo is black and white.

C. Sterility, Shipping, and Shelf-Life

The Subject device, like the existing 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:

AAMI TIR 28: 2016, Product Adoption and process equivalence for ethylene oxide sterilization ●
USP <85>, Bacterial endotoxin test
ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical ● devices
ASTM F88/ F88M-21, Sterile barrier packaging Testing performed on the existing device: Seal ● strength
. ISO 10993-7: 2008/ Amd 1: 2019, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals; Amendment 1: Applicability of allowable limits for neonates and infants

Clinical Tests VIII.

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 ProSeal™ Injection Site Extended Male Luer Lock is substantially equivalent to the Predicate, ProSeal™ CSTD's Connector, with respect to the indications for use, principles of operation and technological characteristics.

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.