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.

Device Description

The ProSeal™ CSTD is a sterile, single-use, closed system drug transfer device for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs intended for use in clinical settings by trained healthcare providers and/or pharmacists. The ProSeal™ CSTD consists of three system components and one accessory: ProSeal Vial Adaptor, ProSeal Injector, ProSeal Connector, and ProSeal Assembly Fixture. The closed transfer of liquid takes place through a double membrane septum utilizing self-sealing elastomeric membranes and a cannula.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA for the ProSeal™ Closed System Drug Transfer Device (CSTD). However, it does not contain a detailed study report with specific acceptance criteria and reported device performance values in a table or the breakdown of sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on establishing substantial equivalence to a predicate device (BD PhaSeal® CSTD, K123213) by comparing technological characteristics and listing the types of performance tests conducted.

Here is a breakdown of the information that can be extracted or inferred from the provided text, and what is missing:

Information Provided/Inferred:

Device Name: ProSeal™ Closed System drug Transfer Device (CSTD)
Predicate Device: BD PhaSeal® Closed System Drug Transfer Device (K123213)
Indications for Use: 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. It also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
Types of Performance Tests Conducted (listed without specific results or acceptance criteria):
- Biocompatibility studies (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Material mediated pyrogenicity, Chemical characterization/Toxicological Risk Assessment)
- Sterilization validation (ISO 11137-1:2006, ISO 11137-2:2013, ISO 11135:2014, AAMI TIR28:2016)
- Bacterial Endotoxin test (USP <85>)
- Accelerated aging (ASTM F1980-16)
- Infusion equipment closures (ISO 8536-2:2010)
- Sterile hypodermic needles requirements (ISO 7864:2016)
- Particulate Matter in Injections (USP <788>)
- Sharps injury protection (ISO 23908:2011)
- Small-bore connectors (ISO 80369-7:2016)
- Internal specifications testing: volume of pressure equalization, leak integrity, vapor containment testing with titanium tetrachloride (visual indicator), Fluorescein testing - dry connections, microbial ingress testing, Assembly fixture validation.
Ground Truth for performance tests (Inferred): For many of these tests (e.g., sterilization, bacterial endotoxin, particulate matter), the "ground truth" is defined by compliance with the specified ISO, ASTM, or USP standards and their pass/fail criteria. For internal tests like "microbial ingress testing" and "vapor containment testing," the ground truth would be the absence of microbial contamination or vapor escape, respectively.
Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/ML algorithm.
How Ground Truth for Training Set was Established: Not applicable.

Information NOT Provided (Required by the prompt):

A table of acceptance criteria and the reported device performance: The document lists the types of tests, but does not provide the specific acceptance criteria for each test or the quantitative or qualitative results that demonstrate the device met those criteria. For example, it mentions "microbial ingress testing" but doesn't state the acceptance criterion (e.g., "no microbial growth after X days") or the result (e.g., "no microbial growth observed").
Sample sizes used for the test set and the data provenance: No sample sizes are provided for any of the performance tests. Data provenance (country of origin, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert involvement in establishing ground truth for the performance tests is provided. For tests based on international standards, the "ground truth" is typically defined by the standard itself rather than expert consensus on individual test results.
Adjudication method for the test set: Not applicable, as detailed test results and any need for adjudication are not described.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a physical medical device, not an AI system being evaluated with human readers.
Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Conclusion based on the provided text:

The document describes the regulatory submission for a physical medical device (ProSeal™ CSTD) and lists various non-clinical performance tests conducted to support its substantial equivalence to a predicate device. While it indicates that performance testing was done to address technological differences and support safety and effectiveness, it does not provide the level of detail requested regarding specific acceptance criteria, reported performance values, sample sizes, or the methodology of establishing ground truth for individual test results within the context of a study report. The information provided is typical for a 510(k) summary, which generally summarizes the types of testing rather than presenting full study reports.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

August 7, 2020

Epic Medical Pte. Ltd. % Roshana Ahmed Senior Director, Regulatory Affairs, Medical Devices G&L Scientific, Inc. 25 Independence Blvd. Warren, New Jersey 07059

Re: K192075

Trade/Device Name: ProSeal CSTD Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: July 7, 2020 Received: July 8, 2020

Dear Roshana Ahmed:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

for Payal Patel Acting 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

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Indications for Use

510(k) Number (if known) K192075

Device Name

ProSealTM Closed System drug Transfer Device (CSTD)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K192075

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

U.S. Contact

Roshana Ahmed, M.A., RAC Sr. Director Regulatory Affairs Medical Devices

G&L Scientific Inc. 25 Independence Blvd. Warren, NJ, 07059 Email: rahmed@gandlscientific.com Phone: 657-248-7361

Date Prepared: August 6, 2020

II. Device

Device Proprietary Name:	ProSeal™ Closed System drug Transfer Device (CSTD)
Common or Usual Name:	Closed System drug Transfer Device (CSTD)
Classification Name:	Intravascular Administration Set
Regulation Number:	21 CFR 880.5440
Product Code:	ONB
Device Classification:	II

III. Predicate Device

BD PhaSeal® Closed System Drug Transfer Device, K123213, Becton Dickinson & Company

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IV. Device Description

The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying. extending, or superseding manufacturer's labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

The ProSeal™ CSTD consists of three system components and one accessory:

ProSeal Vial Adaptor (adaptor to the drug vial)
ProSeal Injector (adaptor to the Luer Lock tip syringe)
ProSeal Connector (adaptor for the injection site of IV lines)
ProSeal Assembly Fixture (an accessory that is non-sterile reusable mechanical ● device to enable the user to consistently and simply attach the ProSeal Vial Adaptor onto the drug vial)

The closed transfer of liquid takes place as follows:

Sterile air contained inside a flexible chamber integrated into the ProSeal Vial ● Adaptor provides pressure equalization of the drug vial in a closed system.
A double membrane septum utilizing self-sealing elastomeric membranes tightly fits together when the system components engage. A cannula perforates the double membrane 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 (tested for 10X transfers performed in 7 days), thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination.

V. 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 when used as intended for up to 7 days.

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VI. Comparison of Technological Characteristics

The ProSeal™ CSTD and the predicate device share the following characteristics:

similar system components, including an assembly fixture which enables the user to . attach the vial adaptor to the drug vial;
use of closed system technology;
use of an integrated pressure equalization chamber;
same interface between system components;
use of luer lock connection to fit to syringe and external IV line;
use of sharps protection features;
same materials of construction for vial access spike and cannula; and
same sterilization method for the syringe access and IV line access device components. ●

The ProSeal™ CSTD and the predicate device are technologically different with respect to the materials of construction for the fluid path and the sterile barrier, as well as the sterilization method for the Vial Access Device component of the system.

The table below compares key technological features between the subject and predicate devices.

ComparisonElement	Subject Device	Predicate Device	Comparison
	ProSeal™ CSTD	BD PhaSeal® Closed SystemDrug Transfer Device(K123213)
Indications forUse 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.	The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that 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. The Phaseal system also prevents microbial ingress.	Same
Intended UserPopulation	Trained healthcare providers or pharmacists	Trained healthcare providers or pharmacists	Same
ComparisonElement	Subject DeviceProSeal™ CSTD	Predicate DeviceBD PhaSeal® Closed SystemDrug Transfer Device(K123213)	Comparison
Intended UseEnvironment	Clinical Setting	Clinical Setting	Same
Intended Drug	Antineoplastic and hazardousdrug	Antineoplastic and hazardousdrug	Same
Intended DrugVial Size	ProSeal Vial AdaptorStandard vial with 20 mm and28mm neck diameter	PhaSeal ProtectorStandard vial with 13 mm,20mm, and 28mm neck diameter	DifferentThe subjectdevice is notintended foruse with drugvials with a13 mm neckdiameter.This does notraise newquestions ofsafety andeffectiveness.
IntendedSyringe	ProSeal InjectorMale Luer Lock tip	PhaSeal InjectorMale Luer Lock tip	Same
IntendedAdministrationSite	ProSeal ConnectorFemale Luer Lock injection siteon IV line	PhaSeal ConnectorFemale Luer Lock injection siteon IV line	Same
Single Use	Single Use Only	Single Use Only	Same
Rx	Rx Only	Rx Only	Same
SystemComponents	ProSeal Vial AdaptorProSeal InjectorProSeal ConnectorProSeal Assembly Fixture	PhaSeal ProtectorPhaSeal InjectorPhaSeal ConnectorPhaSeal Assembly Fixture	Same
SystemComponentsInterface	Self-Sealing ElastomericMembrane on all systemcomponents.	Self-Sealing ElastomericMembrane on all systemcomponents.	Same
Drug VialInterface	ProSeal Vial AdaptorSnap lock and elastomericmembrane	PhaSeal ProtectorSnap lock and elastomericmembrane	Same
PressureEqualizationChamber	Integrated into ProSeal VialAdaptor	Integrated into PhaSeal Protector	Same
	Flexible film	Flexible film	Same
	20 ml	20 ml	Same
	Subject Device	Predicate Device
ComparisonElement		BD PhaSeal® Closed SystemDrug Transfer Device(K123213)	Comparison
	ProSeal™ CSTD
	50 mL60 mL	50 mL60 mL
Drug VialPerforator	ProSeal Vial AdaptorPlastic	PhaSeal ProtectorStainless Steel or Plastic	Same
InjectorPerforator	ProSeal InjectorStainless Steel Cannula	PhaSeal InjectorStainless Steel Cannula	Same
Connection toExternalStandardSyringe	ProSeal InjectorFemale Luer Lock	PhaSeal InjectorFemale Luer Lock	Same
Connection toIV Line	ProSeal ConnectorMale Luer Lock	PhaSeal ConnectorMale Luer Lock or Spike Port	Same
Needle SafetyFeature	Needle inaccessible to user whenengaged and disengaged	Needle inaccessible to user whenengaged and disengaged	Same
Sterile BarrierPackaging	Coated medical paper and plasticforming film, heat sealed	Tyvek® and plastic forming film,heat sealed	Similar
Sterilization,Vial AccessDevice	Gamma, SAL 10-6	EO, SAL 10-6	DifferentUse ofgammaversus EOdoes notraise anynewquestions ofsafety oreffectiveness.



Sterilization,Syringe Access	EO, SAL 10-6	EO, SAL 10-6	Same
Sterilization,IV Line AccessDevice	EO, SAL 10-6	EO, SAL 10-6	Same
Shelf-Life	35 months	3 years	Similar

Technological comparison

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There are slight differences between the subject and predicate devices with respect to the indications for use statement; however, these differences do not alter the overall intended use of the subject device. Both devices are Closed System drug Transfer Devices which protect the drug inside the system from environmental contamination; protect healthcare providers from exposure to drug vapor, aerosols, and spills; protect from microbial ingress into the system; and are intended to be used for drug preparation and administration.

The subject and predicate devices are technologically different with respect to the materials of construction for the fluid path and the sterile barrier, the as well as the sterilization method for the Vial Access Device component of the system. In addition, the subject device is not intended for use with drug vials that have a 13 mm neck diameter. These technological differences do not raise different questions of safety or effectiveness and are addressed by performance data identified below.

Performance Data VII.

The following non-clinical data were provided in support of the substantial equivalence determination.

Biocompatibility studies per ISO 10993-1:2009
- o Cytotoxicity
- Sensitization o
- Intracutaneous reactivity O
- Acute systemic toxicity O
- Hemocompatibility O
- Material mediated pyrogenicity O
- Chemical characterization/Toxicological Risk Assessment o

Performance testing in accordance with the following standards was conducted on the system components as applicable:

. ISO 11137-1:2006, "Sterilization of Healthcare Products Radiation - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices"
ISO 11137-2:2013, "Sterilization of Healthcare Products Part 2 Establishing the . Sterilization Dose"
. ISO 11135:2014, "Sterilization of health care product - Ethylene Oxide - Requirement, validation and routine control of a sterilization process for medical devices"
AAMI TIR28:2016, "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"

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ISO 8536-2:2010, "Infusion Equipment for medical use Part 2: Closures for infusion ● bottles"
ISO 7864:2016, "Sterile hypodermic needles for single use Requirements and test ●
methods"
USP <788>, "Particulate Matter in Injections" ●
ISO 23908:2011, "Sharps injury protection Requirements and test methods Sharps ● protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling"
ISO 80369-7:2016, "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications"

The following performance tests were conducted to internal specifications:

volume of pressure equalization ●
leak integrity ●
vapor containment testing with titanium tetrachloride (visual indicator) ●
Fluorescein testing - dry connections
microbial ingress testing
Assembly fixture validation ●

VIII. Conclusion

The information provided above supports that the ProSeal™ CSTD is substantially equivalent to the predicate device. Although minor technological differences with respect to the materials of construction for the fluid path and the sterile barrier, the sterilization method for the Vial Access Device component of the system, and the drug vial sizes exists between the subject and predicate devices, the performance testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the ProSeal™ CSTD is substantially equivalent to the predicate device.

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.