ProSeal™ In Line Pump Set (423850)

K241735 · Epic Medical Pte. , Ltd. · ONB · Oct 10, 2024 · General Hospital

Device Facts

• Record ID: K241735
• Device Name: ProSeal™ In Line Pump Set (423850)
• Applicant: Epic Medical Pte. , Ltd.
• Product Code: ONB · General Hospital
• Decision Date: Oct 10, 2024
• Decision: SESE
• Submission Type: Special
• 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™ In Line Pump Set is a single-use, sterile, non-pyrogenic closed system transfer device (CSTD) component. It functions as an in-line IV infusate/drug transfer adapter. The device features an IV bag spike port at the proximal end and connects to a mating ProSeal™ Injection Site on other CSTD components; the distal end connects to a standard IV set. Operation involves manual manipulation to join mating devices, which are sealed with resealing membranes; pressing these membranes together creates a secured, closed fluid path. This physical barrier prevents environmental contaminants from entering and drug/vapor from escaping, minimizing exposure to hazardous drugs and preventing microbial ingress for up to 7 days. Used by healthcare professionals in clinical settings to facilitate safe drug administration and prevent needlestick injuries.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench performance testing, including leak integrity (ISO 8536-4), flow rate, biocompatibility (ISO 10993), and sterility/packaging validation (ASTM F1980, ASTM F88, ASTM F1929).

Technological Characteristics

Materials: PP (without DEHP), TPE. Sensing/Actuation: Mechanical resealing membranes. Form factor: In-line IV adapter with IV bag spike port. Connectivity: None. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Shelf-life: 3 years. Standards: ISO 8536-4, ISO 80369-7, ISO 15747, ISO 23908, ANSI AAMI CN27.

Indications for Use

Indicated for use by adequately trained healthcare professionals, including pharmacists, in clinical settings for the closed transfer of parenteral drugs. Contraindications not specified.

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™ Injector Plus (K240171)

Reference Devices

• eZSURE™ Empty Fluid Container (K223674)
• ProSeal™ Injection Site (K240433)
• ProSeal™ CSTD system (K241823)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

October 10, 2024

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

Re: K241735

Trade/Device Name: ProSeal™ In Line Pump Set (423850) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: September 12, 2024 Received: September 12, 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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 Rue"). 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 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).

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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

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# Indications for Use

510(k) Number (if known) K241735

Device Name ProSeal™ In Line Pump Set (423850)

#### 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) |
|-----------------------------------------------------------------------------------------|
| <span style="unicode-bidi:embed;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# cp10

#### K241735 – 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: October 10, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special

#### II. Subject Device

| 510(k) Number: | K241735 |
|------------------------------|--------------------------------------------------------------------------------|
| Trade/ Device Name: | ProSeal™ In Line Pump Set (423850) |
| Common/Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and<br>Transfer System |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Classification Product Code: | ONB |

### III. Predicate

| 510(k) Number: | K240171 |
|---------------------|--------------------------------------------------------------------------------|
| Trade/ Device Name: | ProSeal™ Injector Plus (Model no. 421050) |
| Common/ Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and<br>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 purpose of this Special 510(k) Submission is to seek FDA clearance prior to the introduction in the US, of an additional device in the ProSeal™ CSTD sub-grouping - ProSeal™ Adaptor/Connector - the Subject ProSeal™ In Line Pump Set. This device is an addition to the ProSeal™ CSTD system of devices (cleared K241823), enhancing the completeness of the portfolio of ProSeal™ CSTD system.

The ProSeal™ CSTD devices are single-use, sterile, non-pyrogenic CSTD component devices that are fitted to each other. They are used as sterile interfaces for the closed injections and withdrawals of liquids into and from the ProSeal™ CSTD component devices and external transfer devices.

The ProSeal™ In Line Pump Set is a closed system in-line IV infusate/drug transfer adapter/ connector for providing closed system protection during hazardous drug administration when connected to a standard IV set at its distal end, with the proximal end attached to a mating ProSeal™ Injection Site (K240433) of a ProSeal™ CSTD component device such as the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442).

The change proposed in this 510(k) Submission to the existing ProSeal™ CSTD devices is as follows:

- Addition of I.V. bag spike port
## V. Indications for Use Statement (unchanged)

The ProSeal™ Closed System drug Transfer (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 Predicate device (and a component/subassembly of the Subject device) is the ProSeal™ Injector Plus (cleared K240171). The Subject device and the Predicate device share the following key characteristics:

- . Principles of operation
- Closed system technology
- Preventing needlestick injuries ●
- Spike port subcomponent & material .
- Primary package top web ●
- Sterilization method
- Validated shelf-life
- Single-use only 0
- Labelling specifications .

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

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| Characteristic<br>compared | Predicate Device (K240171)<br>ProSeal™ Injector Plus | Subject Device (K241735)<br>ProSeal™ In Line Pump Set | Comment/<br>Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended Use and<br>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 |
| Common name | Closed Antineoplastic and Hazardous Drug<br>Reconstitution and Transfer System | Closed Antineoplastic and Hazardous Drug<br>Reconstitution and Transfer System | Same |
| Primary<br>product code | ONB | ONB | Same |
| Primary regulation<br>number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Intended user<br>population/ intended<br>use environment | Adequately trained<br>health care professionals<br>including pharmacists/ clinical setting | Adequately trained<br>health care professionals<br>including pharmacists/ clinical setting | Same |
| Intended drug type | Parenteral drugs | Parenteral drugs | Same |
| R/ Prescription use | R only | R only | Same |
| Principles of<br>operation | A component device of a multi-component<br>system; devices are intended to be used in<br>combination with other component devices of<br>the ProSeal™ CSTD, manually manipulated | A component device of a multi-component<br>system; devices are intended to be used in<br>combination with other component devices of<br>the ProSeal™ CSTD, manually manipulated | Same |
| Characteristic<br>compared | Predicate Device (K240171)<br>ProSeal™ Injector Plus | Subject Device (K241735)<br>ProSeal™ In Line Pump Set | Comment/<br>Discussion |
| Closed system<br>technology | Mating ProSeal™ devices are sealed with<br>resealing membranes. When devices are joined<br>together, the two membranes are pressed, thus<br>creating a secured fluid path | Mating ProSeal™ devices are sealed with<br>resealing membranes. When devices are joined<br>together, the two membranes are pressed, thus<br>creating a secured fluid path | Same |
| | Physical barrier to prevent all drug masses from<br>crossing the system boundary | Physical barrier to prevent all drug masses from<br>crossing the system boundary | Same |
| Preventing<br>needlestick injuries | The ProSeal™ Injector Plus (K240171) Predicate<br>device, is encapsulated with a cannula and<br>inaccessible to users | The ProSeal™ Injector Plus (K240171), a<br>component/subassembly of the Subject<br>device, is encapsulated with a cannula and<br>inaccessible to users | Same |
| Components | ProSeal™ Injector Plus | ProSeal™ Injector Plus and I.V. bag spike port | Different,<br>See Comment #1 |
| Access<br>port/connector to<br>external transfer<br>device | Access to ProSeal™ Injector Plus is a female<br>Luer lock port by which an external MLL<br>syringe without needle could be connected | Access to ProSeal™ In Line Pump Set is a TPE<br>spiking port stopper, through which a bag<br>spike of an external administration set could be<br>connected | Different.<br>See Comment #2 |
| Spike port<br>subcomponent &<br>material | Epic Medical Pte Ltd's cleared eZSURE™ Empty<br>Fluid Container (K223674), 2-port sub-<br>assembly for IV Bag (consisting of an<br>integrated spike port) | Subject device's spike port is of the same<br>configuration as the eZSURE™ Empty Fluid<br>Container (K223674), 2-port sub-assembly for<br>IV Bag's integrated spike port | Same |
| | PP without DEHP*in K240433, MLL connector<br>of ProSeal™ Injection Site | PP without DEHP*, same as K240433, MLL<br>connector of ProSeal™ Injection Site | Same |
| | eZSURE™ EFC's spiking port stopper is made of<br>TPE | Subject device's spiking port stopper is made<br>of the same TPE | Same |
| Characteristic<br>compared | Predicate Device (K240171)<br>ProSeal™ Injector Plus | Subject Device (K241735)<br>ProSeal™ In Line Pump Set | Comment/<br>Discussion |
| Primary<br>package top web | Medical grade paper and<br>medical plastic film, heat sealed | Medical grade paper and<br>medical plastic film, heat sealed | Same |
| Sterilization method | Ethylene Oxide, EO, SAL 10-6 | Ethylene Oxide, EO, SAL 10-6 | Same |
| Validated shelf life | 3 years (36 months) | 3 years (36 months) | Same |
| Reuse or single-use | Single-use only | Single-use only | Same |
| Labeling<br>specifications | Meets the requirements specified in 21 CFR 801 | Meets the requirements specified in 21 CFR 801 | Same |
| * DEHP - Di (2-ethylhexyl) phthalate (DEHP), a plasticizer to make PVC soft and flexible. It is a substance known to cause cancer or reproductive toxicity, | | | |

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#### Discussion of difference in technological characteristic Comment #1

Submission K241735 is for an FDA clearance of the Pump Set, a single component device to the ProSeal" CSTD system of component devices. Compared to Predication was for the addition of another single component device to the ProSeal" Injector Plus, to the same ProSeal" CSTD system of component devices. This dessions of safety and effectiveness as the Subject device is designed to and validated for use with other appropriate component devices of the same intended use. Bench top, biocompatibility, and sterility data defference does not raise different questions in safety and effectiveness. Further details are described in section VII.

#### Comment #2

Subject device's spiking port and spiking port stopper are materials and of the same configurations (design and dimensions) as the eZSURE™ Empty Fluid Container (K223674), 2-port sub-assembly for IV bag's integrated spiking port stopper. Subject device's ProSeal™ Injector Plus is the ProSeal™ Injector Plus (K240171) with no differences in material, design, and dimensions.

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#### Performance Data Supporting Substantial Equivalence VII.

#### A. Functional Performance

The sterile, single-use, non-pyrogenic ProSeal™ In Line Pump Set described in this Summary was determined to be in conformance with the following ISO and FDA recognized standards:

- ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) . incorporated into medical devices for intravascular applications
- . ISO 7864: 2016, Sterile hypodermic needles for single use – Requirements and test methods.
- ISO 8536-4:2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- . ISO 15747: 2018, Plastic containers for intravenous injections
- ISO 22413:2010, Transfer sets for pharmaceutical preparations — Requirements and test methods
- ISO 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 application -Part 7, Connectors for intravascular or hypodermic applications
- . Intravascular-Administration-Sets-Premarket-Notifications-[510(k)]---Guidancefor-Industry-and-FDA-Staff

Bench performance verifications and validations referred to and performed on the Subject device are as follows:

- . Leak integrity testing per ISO 8536-4:2019, paragraph 7.2 and Annex A.3 performed on the Subject device
- . Liquid leakage testing, per ISO 8536-4:2019, paragraph 7.2, performed on the Subject device using NaCl 0.9%
- . Testing of flow rate, infusion set without air-inlet device per ISO 8536-4:2019, paragraph 7.1 and Annex A.5.1, performed on the Subject device
- The following performance testing were performed under K240171, per Luer lock connection ● tests specified in ISO 80369-7: 2021:
- 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

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Image /page/10/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. The letters are connected by a thick horizontal line at the bottom, giving the word a solid, unified appearance. The overall design is simple and modern.

- . The following sharps injury protection tests were performed under K240171 per ISO 23908:2011,
- Drop test ●
- Flexural force test ●
- Tensile force test
- Compression force test
- Testing access to the sharp in safe mode ●
- Device leakage integrity tests were performed under K240171 per ISO 8536-4:2019 ●
- Needle bonding strength test was performed under K240171 per ISO 7864:2016
- Injector Plus cap removal force test was performed under K240171 per ISO 8536-4: 2019
- The following performance testing were performed under K223674, per standards specified . hereunder:
- Resistance to temperature, pressure and leakage, per ISO 15747: 2018, Annex A.3 .
- . Resistance to dropping, per ISO 15747: 2018, Annex A.4
- Water vapor impermeability, per ISO 15747: 2018, Annex A.6
- Spiking port penetration ability, per ISO 15747: 2018, Annex A.8 ●
- Spiking port adhesion strength, per ISO 15747: 2018, Annex A.9 ●
- Particulate non-contamination, per ISO 15747: 2018, Annex A.6 ●
- Impermeability to microorganism, per ISO 15747: 2018, Annex C.2 ●
- Testing to (draft) NIOSH CSTD Test Protocol under K240171 ●
- Microbial ingress/ microbiological integrity testing, per the FDA guidance listed in paragraph ● 1 in this sub-section, and ANSI AAMI CN27:2021 (functional) from testing data on the existing devices, cleared under K240171 and K223674

#### B. Biocompatibility

In accordance with ISO 10993-1: 2018, the Subject device is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing are referred to from testing on the devices, under K240171 and K223674:

- . Cytotoxicity to ISO 10993-5
- Sensitization to ISO 10993-10 ●
- Intracutaneous Reactivity to ISO 10993-10 .
- Acute Systemic Toxicity to ISO 10993-11 .
- 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 .
- In-vitro Hemolysis Assessment to ISO 10993-4 ●
- Material Mediated Pyrogenicity to ISO 10993-11 ●
- Chemical Characterization and Toxicological Risk Assessment to ISO 10993-18 and ISO 10993-● 17
- . Particulate matter testing to USP <788> Particulate Matter in Injections

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Image /page/11/Picture/0 description: The image shows a logo for EPIC. The logo is black and white and features the word "EPIC" in a stylized font. The "E" is capitalized and has a circular dot in the upper left corner. A horizontal line runs beneath the letters "E," "P," and "I," connecting them. The "C" is also capitalized and is connected to the horizontal line.

### C. Sterility, Shipping, and Shelf-Life

The Subject device, like the Predicate device and the I.V. bag spike (a component/subassembly of 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:

- 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 <151>, Pyrogen test (USP rabbit test), USP-NF <161>, Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF <85>, Bacterial Endotoxins Test
- 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 Subject device was determined to be substantially equivalent to the Predicate, and there were no new questions of its safety or effectiveness. The Subject ProSeal™ In Line Pump Set is substantially equivalent to the Predicate, the ProSeal™ Injector Plus, with respect to the indications for use, principles of operation and technological characteristics.