(67 days)
No
The document describes a mechanical device for drug handling and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device is a vial adaptor designed to minimize exposure to drugs and prevent microbial contamination; it is not intended to treat or diagnose medical conditions.
No
The device is described as a sterile adaptor for drug vials, designed to prevent contamination and exposure to drugs, and is used for injecting diluents or withdrawing liquids. It does not perform any diagnostic function.
No
The device description clearly describes a physical, single-use, sterile, non-pyrogenic CSTD drug vial adaptor with mechanical components (seals, activated carbon filter). The performance studies also focus on physical and biological properties, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for mechanically protecting against exposure to hazardous drugs and preventing microbial contamination during drug preparation and administration. This is a function related to drug handling and delivery, not diagnostic testing of biological samples.
- Device Description: The description details a vial adaptor used as a sterile interface for injecting diluents into drug vials and withdrawing liquids from them. This is consistent with drug preparation and administration, not diagnostic procedures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device's function is to ensure the safe and sterile handling of drugs, which falls under the category of medical devices used in drug delivery and preparation, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ToxiSeal™ Vial Adaptor mechanically prohibits environments 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 device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.
Product codes
ONB
Device Description
The ToxiSeal™ Vial Adaptor devices are single-use, sterile, non-pyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials.
The ToxiSeal™ Vial Adaptor devices, designed to be used with the cleared ProSeal™ Injector or Injector Plus within the ProSeal™ CSTD system (K240433), are variants of CSTD vial adaptor component device offerings to the ProSeal™ CSTD system. The additions enhance the completeness of the portfolio of ProSeal™ CSTD devices system.
Changes proposed in this Special 510(k) Submission are as follow:
- Removed external balloon and added activated carbon filter .
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
Intended user population: Adequately trained health care professionals or pharmacists
Intended use environment: 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)
A. Functional Performance
The sterile, single-use, non-pyrogenic ToxiSeal™ Vial Adaptor devices described in this Summary were evaluated to be in conformance with the following ISO and FDA recognized standards:
- . 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 8871-5:2016, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing
- ISO 22413:2021, Transfer sets for pharmaceutical preparations – Requirements and test methods
Bench performance verifications and validations referred to and performed on the Subject device as detailed hereunder:
- Leak integrity testing (air- and liquid-tightness) per ISO 8536-4:2019, paragraph 7.2 and ● Annex A.3 performed on the Subject devices, and on devices under K241476
- Fragmentation study to ISO 22413 & ISO 8871-5, performed on device under K241476
- . Vial Adaptor penetration force testing to ISO 22413, on device under K241476
- Tests for leakages to ISO 8536-4:2019, Annex A.3.3, performed on the Subject device ●
- . Testing to (draft) NIOSH CSTD Test Protocol, performed on the Subject device, and on device under K222929
- . Microbial ingress/ microbiological integrity testing conducted on device under K222929
B. Biocompatibility
In accordance with ISO 10993-1: 2018, the Subject devices, are classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing are referred to, from testing on existing devices of the ProSeal™ CSTD system:
- 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 K192075 and 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
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections, and found to have met the acceptance criteria therein, on devices under K192075 and K222929.
C. Sterility, Shipping, and Shelf-Life
The Subject devices, comply 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 conducted under K222929:
- . 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 and testing will be conducted on every lot
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K240433, K241071, K230343, K192075, K192075/S001, K222929
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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.
August 30, 2024
Epic Medical Pte. Ltd. Freddie Lee CEO/md 105 Cecil Street #20-04, The Octagon Singapore, 069534 Singapore
Re: K241823
Trade/Device Name: ToxiSeal™ Vial Adaptor Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: June 24, 2024 Received: July 31, 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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, 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
2
Indications for Use
510(k) Number (if known) K241823
Device Name ToxiSeal™ Vial Adaptor
Indications for Use (Describe)
The ToxiSeal™ Vial Adaptor mechanically prohibits environments 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 device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 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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cp10
K241823 – 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: August 30, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special
II. Subject Device
| 510(k) Number: | K241823 |
|---|---|
| Trade/ Device Name: | ToxiSeal™ Vial Adaptor |
| Common/Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and |
| Transfer Device | |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Classification Product Code: | ONB |
III. Predicate
| 510(k) Number: | K241476 |
|---|---|
| Trade/ Device Name: | ToxiSeal™ Vial Adaptor with External Flip Balloon |
| Common/Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and |
| Transfer Device | |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Classification Product Code: | ONB |
4
IV. Device Description
The purpose of this Special 510(k) Submission is to seek FDA clearance prior to the introduction in the US, of a modified design of a ToxiSeal™ Vial Adaptor - the Subject ToxiSeal™ Vial Adaptor. This device is an addition to the ProSeal™ CSTD system of devices (cleared K240433). The nominated Predicate device is the existing ToxiSeal™ Vial Adaptor with External Flip Balloon (cleared K241476).
The ToxiSeal™ Vial Adaptor devices are single-use, sterile, non-pyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials.
The ToxiSeal™ Vial Adaptor devices, designed to be used with the cleared ProSeal™ Injector or Injector Plus within the ProSeal™ CSTD system (K240433), are variants of CSTD vial adaptor component device offerings to the ProSeal™ CSTD system. The additions enhance the completeness of the portfolio of ProSeal™ CSTD devices system.
Changes proposed in this Special 510(k) Submission are as follow:
- Removed external balloon and added activated carbon filter .
V. Indications for Use Statement
The ToxiSeal™ Vial Adaptor 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 device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.
VI. Comparison of Technological Characteristics
The Subject device and the Predicate device share the following key characteristics:
- System components of the ProSeal™ CSTD .
- Closed System Technology
- Interface between system components ●
- Membrane material ●
- Hydrophobic filter ●
- Intended Injectors ●
- Sterile barrier packaging ●
- Sterilization process ●
- Shelf-life .
- . Single-use
An overview table summarizing the comparison between the key characteristics between the Subject and the Predicate device is provided hereunder.
5
| Side-by-side comparison of technology & design characteristics | |||
|---|---|---|---|
| Characteristics | |||
| compared | Predicate Device (K241476) | ||
| ToxiSeal™ Vial Adaptor | |||
| with External Flip Balloon | Subject Device (K241823) | ||
| ToxiSeal™ Vial Adaptor | Detailed discussion and | ||
| comparative evaluation | |||
| Intended use | |||
| and | |||
| Indications for Use | |||
| statement | "The ToxiSeal™ Vial Adaptor with | ||
| External Flip Balloon 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 device | |||
| also prevents the introduction of | |||
| microbial contaminations into the drug or | |||
| fluid path for up to 168 hours (or 7 days) | |||
| when used as intended." | "The ToxiSeal™ Vial Adaptor | ||
| 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 device also prevents the | |||
| introduction of microbial contaminations | |||
| into the drug or fluid path for up to 168 | |||
| hours (or 7 days) when used as intended." | Same | ||
| Intended user | |||
| population | Adequately trained | ||
| health care | |||
| professionals or pharmacists | Adequately trained | ||
| health care | |||
| professionals or pharmacists | Same | ||
| Intended use | |||
| environment | Clinical setting | Clinical setting | Same |
| Intended drug type | Parenteral drugs | Parenteral drugs | Same |
| Single use or reusable | Single use only | Single use only | Same |
| Prescription use or | |||
| over-the-counter use | R only | R only | Same |
| Labeling | |||
| specifications | Meets the requirements | ||
| specified in 21 CFR 801 | Meets the requirements | ||
| specified in 21 CFR 801 | Same | ||
| Characteristics | |||
| compared | Predicate Device (K241476) | ||
| ToxiSeal™ Vial Adaptor | |||
| with External Flip Balloon | Subject Device (K241823) | ||
| ToxiSeal™ Vial Adaptor | Detailed discussion and | ||
| comparative evaluation | |||
| System component | |||
| devices | 1. ProSeal™ Injector (model 421010) | ||
| (K241476) |
- ProSeal™ Injector Plus (model 421050)
(K241476) - ProSeal™ Connector (422010)
(K241476) - ProSeal™ Injection Site Extended Male
Luer Lock (K241476) - ProSeal™ Vial Adaptor (3 models
4200X0, for options of vial neck sizes
and pressure equalizations) K241476) - ToxiSeal™ Vial Adaptor with External
Balloon (K241476) - ToxiSeal™ Vial Adaptor with External
Flip Balloon (K241476) - eZSURE™ Empty Fluid Container with
ProSeal™ Injection Site (K241476) - ProSeal™ Closed System Administration
Set (K230343) - ProSeal™ Assembly Fixture (Fixture for
ProSeal™ Vial Adaptor assembly,
model 424010) (K241476) | 1. ProSeal™ Injector (model 421010)
(K241476) - ProSeal™ Injector Plus (model 421050)
(K241476) - ProSeal™ Connector (422010)
(K241476) - ProSeal™ Injection Site Extended Male
Luer Lock (K241476) - ProSeal™ Vial Adaptor (3 models
4200X0, for options of vial neck sizes
and pressure equalizations) (K241476) - ToxiSeal™ Vial Adaptor with External
Balloon (K241476) - ToxiSeal™ Vial Adaptor with External
Flip Balloon (K241476) - ToxiSeal™ Vial Adaptor (the Subject
device) - eZSURE™ Empty Fluid Container with
ProSeal™ Injection Site (K241476) - ProSeal™ Closed System
Administration Set (K230343) - ProSeal™ Assembly Fixture (Fixture for
ProSeal™ Vial Adaptor assembly,
model 424010) (K241476) | Different,
the Subject system
component device (#8 in
the column Subject
Device ), is an addition to
the existing ten (10)
cleared component
devices of ProSeal™
CSTD (K241476) and the
ProSeal™ Closed System
Administration Set
(K230343), indicated in
bold face texts .
Differences are addressed
in Comments #1 and #2
under this table. |
| Closed System
Technology | 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 |
| Interface
between system
components | Elastomeric
resealing double-membrane | Elastomeric
resealing double-membrane | Same |
| Intended Injector for
use with the Subject
device | ProSeal™ Injector (model 421010) or
ProSeal™ Injector Plus (model 421050)
(cleared K241071 & K240433),
both Male Luer Lock tip | ProSeal™ Injector (model 421010) or
ProSeal™ Injector Plus (model 421050)
(cleared K241071 & K240433),
both Male Luer Lock tip | Same |
| Characteristics
compared | Predicate Device (K241476)
ToxiSeal™ Vial Adaptor
with External Flip Balloon | Subject Device (K241823)
ToxiSeal™ Vial Adaptor | Detailed discussion and
comparative evaluation |
| Membrane material | Isoprene rubber (IR) | Isoprene rubber (IR) | Same |
| Hydrophobic filter
(non-fluid path) | Polytetrafluoroethylene (PTFE) | Polytetrafluoroethylene (PTFE) | Same |
| Activated carbon
filter | None (carbon filter was removed in
ToxiSeal™ Vial Adaptor with External
Flip Balloon (K241476)) | Activated carbon | Different.
See Comment #1 |
| External balloon
(non-fluid path) | Polyethylene terephthalate -Polyethylene
(PET/PE) laminate
and Polyethylene (PE) | None | Different.
See Comment #2 |
| 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 |
Side-by-side comparison of technology & design characteristics
6
Side-by-side comparison of technology & design characteristics
7
Side-by-side comparison of technology & design characteristics
Discussion of differences in technological characteristics Comment #1
An activated carbon filter, which was not predicate (K241476) is now included for the Subject device. The filter adsorbs drug vapors within the vial adaptor, ensuring safety for healthcare workers and minimizing contamination risk. This differed and addressed in the verification testing of the Subject device over the shell life, to the following standards: 1.3 and NIOSH 2016, Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs, and found it did not raise any new or different questions of safety or effectiveness. Details are provided in section VII.
Comment #2
The Subject device does not include an external balloon - a pressure equalization mechanism. This difference of not having an external balloon together with the inclusion of an activated and addressed in the verfication tests described in Comment #1. Bench performance verification testing of the Subject device over the shelf life was conducted to the following standards: 180 8556-42019, subclause A.3.3 and NOSH 2016, Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. Testing found it did not raise any new or effectiveness. Further details are provided in section VII hereunder.
8
Performance Data Supporting Substantial Equivalence VII.
A. Functional Performance
The sterile, single-use, non-pyrogenic ToxiSeal™ Vial Adaptor devices described in this Summary were evaluated to be in conformance with the following ISO and FDA recognized standards:
- . 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 8871-5:2016, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing
- ISO 22413:2021, Transfer sets for pharmaceutical preparations – Requirements and test methods
Bench performance verifications and validations referred to and performed on the Subject device as detailed hereunder:
- Leak integrity testing (air- and liquid-tightness) per ISO 8536-4:2019, paragraph 7.2 and ● Annex A.3 performed on the Subject devices, and on devices under K241476
- Fragmentation study to ISO 22413 & ISO 8871-5, performed on device under K241476
- . Vial Adaptor penetration force testing to ISO 22413, on device under K241476
- Tests for leakages to ISO 8536-4:2019, Annex A.3.3, performed on the Subject device ●
- . Testing to (draft) NIOSH CSTD Test Protocol, performed on the Subject device, and on device under K222929
- . Microbial ingress/ microbiological integrity testing conducted on device under K222929
B. Biocompatibility
In accordance with ISO 10993-1: 2018, the Subject devices, are classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing are referred to, from testing on existing devices of the ProSeal™ CSTD system:
- 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 K192075 and 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
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections, and found to have met the acceptance criteria therein, on devices under K192075 and K222929.
9
C. Sterility, Shipping, and Shelf-Life
The Subject devices, comply 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 conducted under K222929:
- . 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 and testing will be conducted on every lot
- 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 differences between the Predicate and the Subject device do not raise any new or different questions of safety or effectiveness. The Subject ToxiSeal™ Vial Adaptor is substantially equivalent to the Predicate, the ToxiSeal™ Vial Adaptor with External Flip Balloon, with respect to the indications for use, principles of operation and technological characteristics.