(115 days)
No
The description focuses on mechanical and physical properties of a drug transfer device, with no mention of AI or ML.
No.
The device is described as a drug transfer device designed to minimize exposure to hazardous drugs and prevent microbial contamination, rather than directly treating a disease or condition.
No
The device is a Closed System Drug Transfer Device (CSTD) designed to prevent environmental contamination and exposure to hazardous drugs during transfer, and to prevent microbial contamination of drugs. It facilitates the safe transfer of liquids and does not perform any diagnostic function.
No
The device description clearly describes physical components (mechanically prohibits, fitted to each other, sterile interfaces, adapter/connector) and the performance studies detail bench testing on physical attributes (leak integrity, flow rate, Luer lock connection tests, sharps injury protection tests, etc.), indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes a device that mechanically prevents contamination and exposure to hazardous drugs during preparation and administration. It focuses on maintaining a closed system for drug handling and delivery.
- Device Description: The description details components used for transferring liquids into and from containers, connecting to IV sets, and providing protection during drug administration.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, or other bodily fluids.
- Performance Studies: The performance studies focus on the physical integrity, leakage prevention, flow rate, and microbial impermeability of the device, which are relevant to its function as a closed system for drug handling, not for diagnostic testing.
Therefore, the ProSeal™ Closed System Drug Transfer Device (CSTD) is a medical device used for drug preparation and administration, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days, when used as intended.
Product codes (comma separated list FDA assigned to the subject device)
ONB
Device Description
The 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Adequately trained healthcare professionals including pharmacists/ clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 unscrewing test
- Resistance to overriding
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K240433, K241442, K241823, K223674
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K241735 – 510(k) Summary
I. Submitter
Epic Medical Pte. Ltd. 105 Cecil Street #20-04, The Octagon, Singapore 069534 Phone: +65 9635 2618 / +66 81 761 5292
Contact Person: Mr. Freddie LEE, Chief Executive Officer/ Managing Director Date Prepared: October 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 |
| 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 |
| 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
compared | Predicate Device (K240171)
ProSeal™ Injector Plus | Subject Device (K241735)
ProSeal™ In Line Pump Set | Comment/
Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended Use and
Indications for Use
statement | "The ProSeal" Closed System drug Transfer
Device (CSTD) mechanically prohibits
environmental contaminants from entering the
system and the escape of drug or vapor
concentrations from the system, thereby
minimizing individual and environmental
exposure to drug vapor, aerosols, and spills.
The ProSeal™ system also prevents the
introduction of microbial contaminations into
the drug or fluid path for up to 7 days, when
used as intended." | "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." | Same |
| Common name | Closed Antineoplastic and Hazardous Drug
Reconstitution and Transfer System | Closed Antineoplastic and Hazardous Drug
Reconstitution and Transfer System | Same |
| Primary
product code | ONB | ONB | Same |
| Primary regulation
number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Intended user
population/ intended
use environment | Adequately trained
health care professionals
including pharmacists/ clinical setting | Adequately trained
health care professionals
including pharmacists/ clinical setting | Same |
| Intended drug type | Parenteral drugs | Parenteral drugs | Same |
| R/ Prescription use | R only | R only | Same |
| Principles of
operation | A component device of a multi-component
system; devices are intended to be used in
combination with other component devices of
the ProSeal™ CSTD, manually manipulated | A component device of a multi-component
system; devices are intended to be used in
combination with other component devices of
the ProSeal™ CSTD, manually manipulated | Same |
| Characteristic
compared | Predicate Device (K240171)
ProSeal™ Injector Plus | Subject Device (K241735)
ProSeal™ In Line Pump Set | Comment/
Discussion |
| Closed system
technology | Mating ProSeal™ devices are sealed with
resealing membranes. When devices are joined
together, the two membranes are pressed, thus
creating a secured fluid path | Mating ProSeal™ devices are sealed with
resealing membranes. When devices are joined
together, the two membranes are pressed, thus
creating a secured fluid path | Same |
| | Physical barrier to prevent all drug masses from
crossing the system boundary | Physical barrier to prevent all drug masses from
crossing the system boundary | Same |
| Preventing
needlestick injuries | The ProSeal™ Injector Plus (K240171) Predicate
device, is encapsulated with a cannula and
inaccessible to users | The ProSeal™ Injector Plus (K240171), a
component/subassembly of the Subject
device, is encapsulated with a cannula and
inaccessible to users | Same |
| Components | ProSeal™ Injector Plus | ProSeal™ Injector Plus and I.V. bag spike port | Different,
See Comment #1 |
| Access
port/connector to
external transfer
device | Access to ProSeal™ Injector Plus is a female
Luer lock port by which an external MLL
syringe without needle could be connected | Access to ProSeal™ In Line Pump Set is a TPE
spiking port stopper, through which a bag
spike of an external administration set could be
connected | Different.
See Comment #2 |
| Spike port
subcomponent &
material | Epic Medical Pte Ltd's cleared eZSURE™ Empty
Fluid Container (K223674), 2-port sub-
assembly for IV Bag (consisting of an
integrated spike port) | Subject device's spike port is of the same
configuration as the eZSURE™ Empty Fluid
Container (K223674), 2-port sub-assembly for
IV Bag's integrated spike port | Same |
| | PP without DEHPin K240433, MLL connector
of ProSeal™ Injection Site | PP without DEHP, same as K240433, MLL
connector of ProSeal™ Injection Site | Same |
| | eZSURE™ EFC's spiking port stopper is made of
TPE | Subject device's spiking port stopper is made
of the same TPE | Same |
| Characteristic
compared | Predicate Device (K240171)
ProSeal™ Injector Plus | Subject Device (K241735)
ProSeal™ In Line Pump Set | Comment/
Discussion |
| Primary
package top web | Medical grade paper and
medical plastic film, heat sealed | Medical grade paper and
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
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 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 , Pyrogen test (USP rabbit test), USP-NF , Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF , 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.