(307 days)
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.
This FDA Submission is to include an authorization to legally market the ProSeal" Vented Universal Vial Adaptor to the existing ProSeal™ CSTD devices system of eleven (11) devices that were cleared for sales in the US, the most recent being the ToxiSeal™ Vial Adaptor (K241823).
The ProSeal™ Vented Universal Vial Adaptor is a component of the ProSeal™ CSTD system intended for connection with the interface membranes between any standard vials and ProSeal™ CSTD component devices for close system fluid transfer. When connected to a standard vial and engaged with a ProSeal™ Injector (Syringe Adaptor), fluid can be transferred to and from the connecting component device in a closed system. The ProSeal™ Vented Universal Vial Adaptor 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 (or 7 days). when used as intended.
The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:
- A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector housing 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, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and also minimizing the risk of microbial contamination.
The provided text is a 510(k) summary for the ProSeal™ Vented Universal Vial Adaptor. It outlines the device description, indications for use, comparison to a predicate device, and performance data supporting substantial equivalence. However, it does not describe acceptance criteria for an AI/ML-enabled medical device performance study, nor does it provide details on the specific study that would prove such a device meets acceptance criteria.
The document pertains to a physical medical device (a vial adaptor) and its mechanical, material, and sterility performance, not a software-based AI/ML device for which metrics like sensitivity, specificity, or AUC would be relevant. Therefore, most of the requested information (sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission.
The closest analogous information in this document relates to functional performance testing and biocompatibility testing for the physical device.
Here's how to interpret the available information in the context of the prompt, acknowledging the mismatch:
The document effectively describes the "acceptance criteria" and "study" for a physical medical device based on regulatory standards and comparison to a predicate, not an AI/ML device.
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of quantitative acceptance criteria in the typical AI/ML sense (e.g., target AUC, sensitivity). Instead, it states that the device was tested and demonstrated to be in conformance with recognized ISO and FDA standards, and that "Performance testing demonstrates that this difference [in air-vent size] does not raise new questions regarding safety and effectiveness." The acceptance criteria for this physical device are the successful completion and conformance to these standards and the demonstration of substantial equivalence to the predicate.
Here's a reinterpretation of their "acceptance criteria" based on the provided text, focusing on the functional performance tests listed:
| Acceptance Criteria (Reinterpreted from Standards) | Reported Device Performance (Implied "Meets Criteria") |
|---|---|
| Conformance to ISO 8536-4:2019 (Positive/Negative pressure leakage) | Tested and demonstrated conformance |
| Conformance to ISO 8536-4:2019 (Positive pressure water leak integrity) | Tested and demonstrated conformance |
| Conformance to ISO 22413:2021 & ISO 8871-5:2016 (Penetration force) | Tested and demonstrated conformance |
| Conformance to ISO 22413:2021 & ISO 8871-5:2016 (Fragmentation) | Tested and demonstrated conformance |
| Conformance to NIOSH CSTD 2016 draft protocol (Vapor containment) | Tested and demonstrated conformance (from K241823 data) |
| Conformance to FDA guidance, ANSI AAMI CN27:2021 & ISO 80369-7:2021 (Microbial ingress) | Tested and demonstrated conformance (from K222929 data) |
| Conformance to ISO 8536-4:2019 Ann. A.2 & USP <788> (Particulate matter) | Tested and demonstrated conformance |
| Conformance to ISO 11135:2014 & various ASTM/EN standards (Sterility, Package Integrity, Shelf-Life) | Tested and demonstrated conformance |
| Conformance to ISO 10993 series (Biocompatibility) | Tested and demonstrated conformance (referenced from predicate devices) |
| Non-pyrogenic per ANSI/AAMI ST72/2019, USP methods | Tested and demonstrated conformance |
| Shelf-life of 3 years validated per ASTM 1980-16 | Validated for 36 months |
| Residual fluid <0.05 mL | Achieved <0.05 mL |
| Mechanical prohibition of environmental contaminants/drug escape | Demonstrated (mechanism of action) |
| Prevention of microbial contaminations for up to 7 days | Demonstrated (mechanism of action and microbial ingress test) |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated as a numerical sample size for each functional test. The document mentions "testing data on devices cleared under K241823" and "testing data on device cleared under K222929," implying samples were used according to the referenced standards. For physical device testing, sample sizes are usually quite small compared to AI/ML datasets (e.g., n=3-10 per test for validation).
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing would have been done retrospectively based on the device design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device's performance is assessed against physical and biological characteristics, not subjective interpretations requiring human expert consensus. The "ground truth" is defined by the objective measurements and parameters outlined in the referenced international standards (e.g., ISO, ASTM, USP).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a human-in-the-loop or interpretation-based study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical device, not an AI-enabled diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by objective measurements and chemical/physical/biological testing according to highly detailed and recognized pre-defined international standards (ISO, ASTM, USP, ANSI/AAMI, NIOSH protocols). It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be. For instance, the "ground truth" for microbial ingress is whether microbes actually ingress, measured per specified test protocols.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML algorithm requiring a "training set." The design and manufacturing processes are validated, but there's no data training in the AI sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set."
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.
December 26, 2024
Epic Medical Pte. Ltd. Freddie Lee CEO/md 105 Cecil Street #20-04, The Octagon Singapore, SG 069534 Singapore
Re: K240517
Trade/Device Name: ProSeal™ Vented Universal Vial Adaptor Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: November 25, 2024 Received: November 25, 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.
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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).
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 Rule"). 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-regulatory
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assistance/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,
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) K240517
Device Name ProSeal™ Vented Universal Vial Adaptor
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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으며 미
K240517 – 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: December 26, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Traditional
II. Subject Device
| 510(k) Number: | K240517 |
|---|---|
| Trade/ Device Name: | ProSeal™ Vented Universal Vial Adaptor |
| Common/ Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution andTransfer Device |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Product Code: | ONB |
Predicate III.
| 510(k) Number: | K201422 |
|---|---|
| Trade/ Device Name: | Arisure® Closed System Drug Transfer Device (CSTD) |
| Common/ Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution andTransfer Device |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Product Code: | ONB |
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다이다
IV. Device Description
This FDA Submission is to include an authorization to legally market the ProSeal" Vented Universal Vial Adaptor to the existing ProSeal™ CSTD devices system of eleven (11) devices that were cleared for sales in the US, the most recent being the ToxiSeal™ Vial Adaptor (K241823).
The ProSeal™ Vented Universal Vial Adaptor is a component of the ProSeal™ CSTD system intended for connection with the interface membranes between any standard vials and ProSeal™ CSTD component devices for close system fluid transfer. When connected to a standard vial and engaged with a ProSeal™ Injector (Syringe Adaptor), fluid can be transferred to and from the connecting component device in a closed system. The ProSeal™ Vented Universal Vial Adaptor 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 (or 7 days). when used as intended.
The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:
- A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector housing 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, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and also minimizing the risk of microbial contamination.
v. 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.
Comparison of Technological Characteristics VI.
The ProSeal™ Vented Universal Vial Adaptor, a system component of the ProSeal™ CSTD and the Predicate, the Arisure® CSTD's Vial Adaptor, share the following key characteristics:
- Role of the CSTD system component devices ●
- Residual fluid
- Close system technology/ mechanism of action ●
- Biocompatibility ●
- Sterile barrier packaging top web and base web ●
- Pvrogenicitv .
- Validated shelf-life .
An overview table summarizing the comparison of key characteristics between the Subject ProSeal™ Vented Universal Vial Adaptor and the Predicate Arisure® CSTD's Vial Adaptor is provided hereunder.
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| Characteristics | Predicate Device (K201422) | Subject Device (K240517) | Comments,discussions | |
|---|---|---|---|---|
| compared | Arisure® CSTD - Vial Adaptor | ProSeal™ Vented Universal Vial Adaptor | ||
| Intended use andIndications for Usestatement | Arisure® is a Closed System Drug TransferDevice (CSTD) that mechanically prohibitsthe release of drugs in vapor, aerosol orliquid form during preparation andadministration, and prevents the introductionof microbial and airborne contaminants intothe drug or fluid path, allowing the system tominimize exposure of individuals, healthcarepersonnel, and the environment to hazardousdrugs. | The ProSeal™ Closed System drug TransferDevice (CSTD) mechanically prohibitsenvironmental contaminants from enteringthe system and the escape of drug or vaporconcentrations from the system, therebyminimizing individual and environmentalexposure to drug vapor, aerosols, and spills.The ProSeal™ system also prevents theintroduction of microbial contaminationsinto the drug or fluid path for up to 7 days,when used as intended. | Same | |
| Intended userpopulation | Adequately trained health care professionalsor pharmacists | Adequately trained health care professionalsor pharmacists | Same | |
| Intended useenvironment | Clinical setting | Clinical setting | Same | |
| Intended drug type | Antineoplastic and hazardous drug | Antineoplastic and hazardous drug | Same | |
| Intended Injector | Syringe adapter – a component of theArisure® CSTD | ProSeal™ Injector – a component of theProSeal™ CSTD (cleared K192075) | DifferentSee Comment #1 | |
| Single use or reusable | Single use only | Single use only | Same | |
| Role of the CSTD systemcomponent devices | Connector (Fluid transfer interface to standardexternal vials) self-sealing elastomericmembrane on all system components | Connector (Fluid transfer interface to standardexternal vials), self-sealing elastomericmembrane on all system components | Same | |
| Device subcomponents and materials | Injection siteprotective sealtab | N/A (injection site not present) | Protective seal tab for injection site (PP348N) | DifferentSee Comment #1 |
| Septum/seal | Flat, split septum of elastomeric membrane –TPE Medalist 145 | Injection site & its polyisoprene membrane(cleared K241823)(fluid path) | DifferentSee Comment #2 | |
| Vial adaptorclaws | Acrylonitrile butadiene styrene (ABS),Terlux 2802 | Polypropylene (PP, P705JM) integratedwhole subcomponent with vial adaptorspike | Different | |
| Vial adaptorspike | Polycarbonate | Polypropylene (PP, P705JM)(fluid path)integrated whole subcomponent with vialadaptor claws | See Comment #3 | |
| Filter | PTFE membrane, 0.2 micron | PTFE membrane, 0.1 micron | DifferentSee Comment #4 | |
| Characteristicscompared | Predicate Device (K201422)Arisure® CSTD - Vial Adaptor | Subject Device (K240517)ProSeal™ Vented Universal Vial Adaptor | Comments,discussions | |
| Device dimensions | External dimensions (L×W) mm (inch):· Vial adapter: 63.50 × 57.15 (2.5 × 2.25)· Vial spike: 101.40 × 12.70 (4.0 × 0.5) | External dimensions (L×W) mm (inch):· Vial adaptor claws: 34.4 × 34.0 (1.4 × 1.3)· Total L×W: 54.4 × 34.0 (2.1 × 1.3) | DifferentSee Comment #1 | |
| Residual fluid | <0.05 mL for 13 mm & 20 mm<1 mL for 28 mm | <0.05 mL | Same | |
| Drug vial interface | Arisure™ Vial Adaptor snap lock andelastomeric membrane - TPE Medalist 145 | ProSeal™ Vented Universal Vial Adaptor: snaplock and elastomeric membrane -polyisoprene | DifferentSee Comment #2 | |
| Closed systemtechnology/mechanism of action | Physical barrier to prevent all mass fromcrossing the system boundary | Physical barrier to prevent all mass fromcrossing the system boundary | Same | |
| Design configuration andfunction of drug vialperforator | Arisure™ Vial Adaptor: plastics, ABS Terlux2802 vial adaptor claws andpolycarbonate vial adapter spikePredicate vial adaptor incorporates theUniversal vial spike - a dual lumen spike -that makes for smooth fluid transfers while itminimizes the drug residue left in the vial.When used with the Arisure™ SyringeAdaptor, the system provides transfer ofcompounds safely and efficiently whilemaintaining a closed system | ProSeal™ Vented Universal Vial Adaptor:plastic, polypropylene integrated vialadaptor claws and vial adaptor spikeSubject vial adaptor incorporates theUniversal vial spike - a dual lumen spike -that makes for smooth fluid transfers while itminimizes the drug residue left in the vial.When used with the ProSeal™ Injector, thesystem provides transfer of compoundssafely and efficiently while maintaining aclosed system | DifferentSee Comment #3 | |
| Pressure equalization indrug vial | Integrated PTFE air-vent for air equalizationinto and out of the drug vialPredicate vented adaptor incorporates aventing mechanism incorporating a 0.2micron air filter that minimizes aerosols andsurface contamination and allows for therelease of pressure, thus neutralizing vialpressure during drug transferThe venting mechanism enables pressureequalization within the vial, reducing the riskof vial collapse or spray-back during drugwithdrawal, while maintaining a closedsystem | Integrated PTFE air-vent for air equalizationinto and out of the drug vialSubject vented adaptor incorporates aventing mechanism incorporating a 0.1micron air filter that minimizes aerosols andsurface contamination and allows for therelease of pressure, thus neutralizing vialpressure during drug transferThe venting mechanism enables pressureequalization within the vial, reducing the riskof vial collapse or spray-back during drugwithdrawal, while maintaining a closedsystem | DifferentSee Comment #4 | |
| Characteristicscompared | Predicate Device (K201422)Arisure® CSTD - Vial Adaptor | Subject Device (K240517)ProSeal™ Vented Universal Vial Adaptor | Comments,discussions | |
| Biocompatibility | Externally Communicating Device, BloodPath Indirect, Prolonged Contact (>24hr to30d) | Externally Communicating Device, BloodPath Indirect, Prolonged Contact (>24hr to30d) | Same | |
| Sterile barrier packagingtop web and base web | Medical grade paper and medical plastic film,heat sealed. Form, fill, seal packaging with topweb material sealed to bottom web material | Medical grade paper and medical plastic film,heat sealed. Form, fill, seal packaging with topweb material sealed to bottom web material | Same | |
| Sterilization process | Gamma Irradiation, SAL 10-6 | Ethylene Oxide (EO), SAL 10-6 | DifferentSee Comment #5 | |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same | |
| Prescription use or over-the-counter use | R only | R only | Same | |
| Shelf-life validation | 36 months | 36 months | Same |
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Discussion of differences in technological characteristics
Comment #1
Differences in subcomponents (noted in Comments #1 to #4) related to their subcomponent types, dimensions and materials, as well as the different intended injectors, are considered, noting that all these aspects achieve the same intended use. Key differences in materials are addressed individually in Comment #2 and Comment #3, and difference in air-vent size, in Comment #4. Biocompatibility evaluations and functional performance testing demonstrate that all the differences do not raise new questions regarding safety and effectiveness.
Comment #2
Polyisoprene vs. TPE: The Subject device's elastomeric membrane is made of the same polyissoprene as cleared K241823 ToxiSeal" Vial Adaptor subcomponent membrane. Biocompatibility and performance testing demonstrate that the difference does not raise new questions regarding safety and effectiveness.
Comment #3
Polypropylene vs. ABS Terlux 2012 & polycarbonate: The Subject device's vial spike material is made of the same polypropylene as cleared K241823 ToxiSeal" Vial Adaptor's subcompatibility evaluation and performance testing demonstrate that the difference does not raise new questions regarding safety and effectiveness.
Comment #4
0.1 micron air-vent vs 0.2 micron air-vent The difference in 0.2 micron air-vent in Subject device is vice is noted. The cleared ToxiSeal" Vial Adaptor incorporates the same air-vent (0.1 micron) (K241823). Performance testing demonstrates that this difference does not raise new questions regarding safety and effectiveness.
Comment #5
EO sterilization vs. gamma sterilization: Use of gamma versus EO processes does not raise any new questions regarding safety and effectiveness. Both are assured to the same SAL as demonstrated by adequate sterility testing.
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VII. Performance Data Supporting Substantial Equivalence
A. Functional Performance
The ProSeal™ Vented Universal Vial Adaptor described in this Summary were tested and demonstrated to be in conformance with the following ISO and FDA recognized standards:
- ISO 8871-5:2016, Elastomeric parts for parenterals and for devices for pharmaceutical use Part ● 5: Functional requirements and testing
- ISO 8536-2:2010, Infusion equipment for medical use Part 2: Closures for infusion bottles ●
- ISO 8536-4:2019, Infusion equipment for medical use Part 4: Infusion sets for single use, ● gravity feed
- . ISO 22413:2010, Transfer sets for pharmaceutical preparations – Requirements and test methods
- Intravascular-Administration-Sets-Premarket-Notification-Submissions-[510(k)]---● Guidance-for-Industry-and-FDA-Staff
- NIOSH 2016, Performance Test (draft) Protocol for Closed System Transfer Devices ● Used During Pharmacy Compounding and Administration of Hazardous Drugs
Bench performance verifications and validations performed on the Subject device and cleared device:
- Positive and negative air pressure leakage test to ISO 8536-4:2019
- Positive pressure water leak integrity test to ISO 8536-4:2019 .
- Penetration force test of vial perforator to ISO 22413:2021 ●
- Fragmentation test to ISO 22413:2021 and to ISO 8871-5:2016 ●
- Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data . on devices cleared under K241823
- Microbial ingress test per FDA guidance, ANSI AAMI CN27:2021 and ISO 80369-7:2021 . (functional) from testing data on device cleared under K222929
- B. Biocompatibility
In accordance with ISO 10993-1:2018, the ProSeal™ Vented Universal Vial Adaptor is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing are referenced from testing on cleared devices of ProSeal™ CSTD:
- Cytotoxicity to ISO 10993-5 under K192075 ●
- Sensitization to ISO 10993-10 under K192075 ●
- Intracutaneous Reactivity to ISO 10993-10 under K192075 .
- Acute Systemic Toxicity to ISO 10993-11 under K192075
- . 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K222929
- In-vitro Hemolysis Assessment to ISO 10993-4 under K192075 and K192075/S001 ●
- . Material Mediated Pyrogenicity to ISO 10993-11 under K192075
- . Chemical Characterization and Toxicological Risk Management to ISO 10993-18 and ISO 10993-17 under K192075/S001 and K222929
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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6010
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C. Sterility, Shipping, and Shelf-Life
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: -
Simulated shipping testing per ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and System under K192075
-
-Package Integrity Tests per ASTM F1980-16, 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, ASTM F1929-15, Standard test method for detecting seal leaks in porous medical device packaging by dye penetration, EN 868-5:2018, 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
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। 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 and testing will be conducted on every lot
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Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-16, -Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
VIII. Clinical Tests
Not applicable.
IX. Conclusion
The differences between the Predicate and the Subject device do not raise any new or different questions of safety or effectiveness. The ProSeal" Vented Universal Vial Adaptor is substantially equivalent to the Predicate, the Arisure "CSTD - Vial Adaptor, cleared under K201422 with respect to the indications for use, principles of operation and technological characteristics.
§ 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.