ProSeal™ Injection Site Extended Male Luer Lock (422140)

K240433 · Epic Medical Pte. , Ltd. · ONB · May 21, 2024 · General Hospital

Device Facts

• Record ID: K240433
• Device Name: ProSeal™ Injection Site Extended Male Luer Lock (422140)
• Applicant: Epic Medical Pte. , Ltd.
• Product Code: ONB · General Hospital
• Decision Date: May 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended 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.

Device Story

ProSeal™ Injection Site Extended Male Luer Lock is a component of the ProSeal™ Closed System Transfer Device (CSTD). It facilitates closed-system fluid transfer between standard female Luer lock ports and ProSeal™ CSTD components (Injectors/Syringe Adaptors). The device utilizes a double-membrane septum design with self-sealing polyisoprene to create an airtight, leak-proof seal during engagement. Used in clinical settings by trained professionals, it prevents environmental contamination, drug vapor escape, and microbial ingress for up to 7 days. The device acts as a physical barrier to maintain system integrity during hazardous drug handling, reducing exposure risks for clinicians and patients.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via positive/sub-atmospheric pressure leakage, stress cracking, axial load/unscrewing/overriding resistance, vapor containment (NIOSH 2016), and microbial ingress testing. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, reactivity, systemic toxicity, hemolysis, pyrogenicity). Particulate matter testing per USP <788>.

Technological Characteristics

Materials: Polypropylene (PP) and polyisoprene (IR). Interface: Elastomeric resealing double membrane. Connection: ISO 80369-7:2021 compliant male Luer lock. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Shelf-life: 3 years. Single-use. Mechanical closed-system barrier.

Indications for Use

Indicated for trained healthcare professionals and pharmacists in clinical settings for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous parenteral drugs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ProSeal™ CSTD (with the Injector Plus (model no. 421050)) (K240171)

Reference Devices

• ProSeal™ Injector (K192075)
• ProSeal™ Connector (K192075)
• ProSeal™ Vial Adaptor (K192075)
• ProSeal™ Assembly Fixture (K192075)
• ToxiSeal™ Vial Adaptor with External Balloon (K222929)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# K240433 – 510(k) Summary

#### I. Submitter

Epic Medical Pte. Ltd. 105 Cecil Street #20-04, The Octagon, Singapore 069534 Phone: [phone]

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 and<br>Transfer 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 and<br>Transfer 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.

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.

#### 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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| Characteristic<br>compared | Predicate Device<br>ProSeal™ CSTD's<br>ProSeal™ Connector (cleared K240171) | Subject Device<br>ProSeal™ CSTD, ProSeal™ Injection Site<br>Extended Male Luer Lock (K240433) | Comment/ Discussion |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use<br>statement | "The ProSeal™ Closed System drug Transfer<br>Device (CSTD) mechanically prohibits<br>environmental contaminants from entering the<br>system and the escape of drug or vapor<br>concentrations from the system, thereby<br>minimizing individual and environmental<br>exposure to drug vapor, aerosols, and spills.<br>The ProSeal™ system also prevents the<br>introduction of microbial contaminations into<br>the drug or fluid path for up to 7 days, when<br>used as intended." | "The ProSeal™ Closed System drug Transfer<br>Device (CSTD) mechanically prohibits<br>environmental contaminants from entering the<br>system and the escape of drug or vapor<br>concentrations from the system, thereby<br>minimizing individual and environmental<br>exposure to drug vapor, aerosols, and spills.<br>The ProSeal™ system also prevents the<br>introduction of microbial contaminations into<br>the drug or fluid path for up to 7 days, when<br>used 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 | |
| Intended<br>drug type | Parenteral drugs | Parenteral drugs | Same |
| R/<br>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 | |
| Characteristic<br>compared | Predicate Device<br>ProSeal™ CSTD's<br>ProSeal™ Connector (cleared K240171) | Subject Device<br>ProSeal™ CSTD, ProSeal™ Injection Site<br>Extended Male Luer Lock (K240433) | Comment/ Discussion |
| Fitting to external<br>Luer Lock syringe | Female Luer Lock<br>conforms to ISO 80369-7:2016 | Female Luer Lock<br>conforms to ISO 80369-7:2016 | Same |
| System component<br>devices | 1. ProSeal™ Injector (model 421010)<br>(K192075)<br>2. ProSeal™ Injector Plus (addition of model<br>421050 – K240171, cleared on March 28,<br>2024)<br>3. ProSeal™ Connector (model 422010)<br>(K192075)<br>4. ProSeal™ Vial Adaptor (3 models 4200X0,<br>for vial neck sizes and pressure equalization)<br>(K192075)<br>5. ProSeal™ Assembly Fixture (Fixture for<br>ProSeal™ Vial Adaptor assembly, model<br>424010) (K192075) | 1. ProSeal™ Injector (model 421010)<br>2. ProSeal™ Injector Plus (model 421050)<br>3. ProSeal™ Connector (422010)<br>4. Proposed ProSeal™ Injection Site<br>Extended Male Luer Lock (Subject device,<br>K240433)<br>5. ProSeal™ Vial Adaptor (3 models 4200X0,<br>for vial neck sizes and pressure equalization)<br>6. ProSeal™ Assembly Fixture (Fixture for<br>ProSeal™ Vial Adaptor assembly, model<br>424010) | Different,<br>the Subject system<br>component device (#4 in<br>the column Subject<br>Device), is an addition<br>to the five (5) existing<br>component devices of<br>ProSeal™ CSTD<br>(K240171), and is<br>indicated in <b>bold face</b><br>texts. Differences are<br>addressed in the two<br>rows hereunder |
| Fluid path materials<br>of construction<br>(ProSeal™<br>Connector) | Polypropylene (PP),<br>thermoplastic elastomer (TPE) | Polypropylene (PP),<br>polyisoprene (IR) | Different,<br>See Comment #1 |
| Geometric design –<br>unlock ring and<br>protective cap | Image: ProSeal Connector with unlock ring and protective cap<br>provided with unlock ring and<br>without removable protective cap | Image: ProSeal Injection Site Extended Male Luer Lock without unlock ring and protective cap<br>without unlock ring and<br>provided with removable protective cap | Different,<br>See Comment #2 |
| Characteristic<br>compared | Predicate Device<br>ProSeal™ CSTD's<br>ProSeal™ Connector (cleared K240171) | Subject Device<br>ProSeal™ CSTD, ProSeal™ Injection Site<br>Extended Male Luer Lock (K240433) | Comment/ Discussion |
| Primary<br>package top web | Medical grade paper<br>and medical plastic film, heat sealed | Medical grade paper<br>and medical plastic film, heat sealed | Same |
| Sterilization method | Ethylene Oxide, EO, SAL 10-6 | Ethylene Oxide, EO, SAL 10-6 | Same |
| Validated<br>Shelf life | 3 years (36 months) | 3 years (36 months) | Same |
| Reuse<br>or single-use | Single-use only | Single-use only | Same |
| Labeling<br>specifications | Meets the requirements<br>specified in 21 CFR 801 | Meets the requirements<br>specified 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.