(28 days)
No
The 510(k) summary describes a mechanical device for drug vial adaptation and pressure equalization, with no mention of AI or ML capabilities.
No.
The device is described as a drug vial adaptor that minimizes exposure to drug vapor, aerosols, and spills, and prevents microbial contamination. It is used as an interface for injecting diluents or withdrawing liquids from drug vials, not directly for treating patients.
No
The device is described as a "single-use, sterile, nonpyrogenic CSTD drug vial adaptor" used to transfer drugs safely, not to diagnose a condition.
No
The device description clearly describes a physical, mechanical device (vial adaptor with an external flip balloon) and the performance studies listed are bench tests on a physical product, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for mechanically preventing contamination and exposure to drugs during preparation and administration. This is a function related to drug handling and delivery, not the diagnosis of disease or conditions based on in vitro examination of specimens.
- Device Description: The device description details a vial adaptor used as a sterile interface for injecting diluents and withdrawing liquids from drug vials. This is a medical device used in the preparation and administration of medications.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) outside of the body to obtain information for diagnostic purposes. The performance studies focus on mechanical integrity, leakage, pressure equalization, and microbial ingress, which are relevant to drug handling devices, not IVDs.
Therefore, the ToxiSeal™ Vial Adaptor with External Flip Balloon is a medical device used in the preparation and administration of drugs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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 (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 a modified design of a ToxiSeal™ Vial Adaptor - the Subject ToxiSeal™ Vial Adaptor with External Flip Balloon. 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 Balloon (cleared K222929).
The ToxiSeal™ Vial Adaptor with External Flip Balloon devices are single-use, sterile, nonpyrogenic 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.
In addition, the ToxiSeal™ Vial Adaptor with External Flip Balloon devices equalize the pressure difference which occurs when fluid or air is added to or removed from the drug vial. This neutral pressure is maintained utilizing an external balloon/ expansion chamber.
The ToxiSeal™ Vial Adaptor with External Flip Balloon 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:
- Change of material of vial spike to polypropylene from Tritan copolyester
- Non-fluid path changes in retention method to external flip balloon, removal of carbon filter and the positioning of its one-way valve
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 health care professionals or 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 are referred to or were performed on the Subject device as detailed hereunder:
- Fragmentation study to ISO 22413 & ISO 8871-5, performed on the Subject device
- Vial Adaptor penetration force testing to ISO 22413, performed on the Subject device
- Tests for leakages to ISO 8536-4:2019, Annex A.3, performed on the Subject device
- Volume of pressure equalization study under K222929
- Testing to (draft) NIOSH CSTD Test Protocol on existing devices under K222929
- Microbial ingress/ microbiological integrity testing on existing devices under K222929
The Subject device, just like the existing 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 existing devices cleared as listed hereunder:
- 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
- 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.
The Subject device, like the existing device cleared under K222929, 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 F1980-16, 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: 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 1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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, K192075, K192075/S001, K240171, K241071
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
June 21, 2024
Epic Medical Pte. Ltd. Freddie Lee CEO/MD 105 Cecil Street #20-04, The Octagon Singapore, SG 069534 Singapore
Re: K241476
Trade/Device Name: ToxiSeal™ Vial Adaptor with External Flip Balloon Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: May 24, 2024 Received: May 24, 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.
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,
Persache 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
2
Indications for Use
510(k) Number (if known) K241476
Device Name
ToxiSeal™ Vial Adaptor with External Flip Balloon
Indications for Use (Describe)
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 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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o il
K241476 – 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: June 20, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special
II. Subject Device
| 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 |
III. Predicate
| 510(k) Number: | K222929 |
|---|---|
| Trade/ Device Name: | ToxiSeal™ Vial Adaptor with External 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 with External Flip Balloon. 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 Balloon (cleared K222929).
The ToxiSeal™ Vial Adaptor with External Flip Balloon devices are single-use, sterile, nonpyrogenic 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.
In addition, the ToxiSeal™ Vial Adaptor with External Flip Balloon devices equalize the pressure difference which occurs when fluid or air is added to or removed from the drug vial. This neutral pressure is maintained utilizing an external balloon/ expansion chamber.
The ToxiSeal™ Vial Adaptor with External Flip Balloon 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:
- · Change of material of vial spike to polypropylene from Tritan copolyester
- · Non-fluid path changes in retention method to external flip balloon, removal of carbon filter and the positioning of its one-way valve
V. Indications for Use Statement (unchanged)
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.
VI. Comparison of Technological Characteristics
The Subject device and the Predicate device share the following key characteristics:
- . Principles of operation
- Expansion film of External Balloon .
- Sterile barrier packaging .
- . Sterilization process
- Shelf-life
An overview table summarizing the comparison between the key characteristics between the Subject and the Predicate device is provided hereunder.
5
| Characteristic
compared | Predicate Device
ToxiSeal™ Vial Adaptor with External Balloon
(K222929) | Subject Device
ToxiSeal™ Vial Adaptor with External Flip
Balloon (K241476) | Comment/
Discussion |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
statement | "The ToxiSeal™ Vial Adaptor with External
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 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." | Same |
| Primary product code
and regulation
number | ONB
21 CFR 880.5440 | ONB
21 CFR 880.5440 | Same |
| Intended user
population/ intended
use environment | Adequately trained
health care professionals
or pharmacists/ clinical setting | Adequately trained
health care professionals
or pharmacists/ clinical setting | Same |
| Intended
drug type | Parenteral drugs | Parenteral drugs | Same |
| R/
Prescription use | R only | R only | Same |
| Characteristic
compared | Predicate Device
ToxiSeal™ Vial Adaptor with External Balloon
(K222929) | Subject Device
ToxiSeal™ Vial Adaptor with External Flip
Balloon (K241476) | Comment/
Discussion |
| System component
devices | 1. ProSeal™ Injector (model 421010)
(K240433)
2. ProSeal™ Injector Plus (model 421050)
(K240433)
3. ProSeal™ Connector (model 422010)
(K240433)
4. ProSeal™ Injection Site Extended Male Luer
Lock (K240433)
5. ProSeal™ Vial Adaptor (3 models 4200X0,
for options of vial neck sizes and pressure
equalizations) (K240433)
6. ToxiSeal™ Vial Adaptor with External
Balloon (K222929)
7. ProSeal™ Assembly Fixture (Fixture for
ProSeal™ Vial Adaptor assembly, model
424010) (K240433) | 1. ProSeal™ Injector (model 421010) (K240433)
2. ProSeal™ Injector Plus (model 421050)
(K240433)
3. ProSeal™ Connector (422010) (K240433)
4. ProSeal™ Injection Site Extended Male Luer
Lock (K240433)
5. ProSeal™ Vial Adaptor (3 models 4200X0, for
options of vial neck sizes and pressure
equalizations) (K240433)
6. ToxiSeal™ Vial Adaptor with External Balloon
(K222929)
7. ToxiSeal™ Vial Adaptor with External Flip
Balloon (K241476) the Subject device )
8. ProSeal™ Assembly Fixture (Fixture for
ProSeal™ Vial Adaptor assembly, model
424010) (K240433) | Different,
the Subject system
component device
(#7 in the column
|
| 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 |
| Drug vial
air pressure
equalization | Integrated
pressure equalization chamber | Integrated
pressure equalization chamber | Same |
| Characteristic
compared | Predicate Device
ToxiSeal™ Vial Adaptor with External Balloon
(K222929) | Subject Device
ToxiSeal™ Vial Adaptor with External Flip
Balloon (K241476) | Comment/
Discussion |
| Interface
between system
components | Elastomeric
resealing double-membrane | Elastomeric
resealing double-membrane | Same |
| Membrane material | Isoprene rubber (IR) | Isoprene rubber (IR) | Same |
| Intended Injector for
use with the Subject
device | ProSeal™ Injector (model 421010)
(cleared K192075, K222929, K240171)
Male Luer Lock tip | ProSeal™ Injector (model 421010) or
ProSeal™ Injector Plus (model 421050)
(cleared K241071 & K240433)
both Male Luer Lock tip | Same
both the ProSeal™
Injector Plus and
ProSeal™ Injector are
cleared devices that
may be used with the
Subject device |
| Vial adaptor spike | Plastic (all 12 models, copolyester) | Plastic (all 6 models, polypropylene) | Different
See Comment #1 |
| Characteristic
compared | Predicate Device
ToxiSeal™ Vial Adaptor with External Balloon
(K222929) | Subject Device
ToxiSeal™ Vial Adaptor with External Flip
Balloon (K241476) | Comment/
Discussion |
| Design configuration
of External Balloon
(non-fluid path) | Retention method of external balloon with 2
options of clip-on or sticker features
(resulting in 12 REFs/ models) | Non-fluid path changes: retention method to
external flip balloon, removal of carbon filter and
the positioning of its one-way valve (resulting in
6 REFs/ models) | Different
See Comment #2 |
| | Image: clip-on balloon retainer and sticker on balloon retainer | Image: external flip balloon retainer | |
| | 12 models:
clip-on balloon retainer (left picture)
and sticker on balloon retainer (right picture) | 6 models:
external flip balloon retainer | |
| Hydrophobic filter
(non-fluid path) | Polytetrafluoroethylene (PTFE) | Polytetrafluoroethylene (PTFE) | Same |
| Expansion films
(non-fluid path) | Polyethylene terephthalate - Polyethylene
(PET/PE) laminate
and Polyethylene (PE) | Polyethylene terephthalate - Polyethylene
(PET/PE) laminate
and Polyethylene (PE) | Same |
| 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 |
| Characteristic
compared | Predicate Device
ToxiSeal™ Vial Adaptor with External Balloon
(K222929) | Subject Device
ToxiSeal™ Vial Adaptor with External Flip
Balloon (K241476) | Comment/
Discussion |
| 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 |
6
7
8
9
Discussion of differences in technological characteristics
Comment #1
The formulation (type, make, grade) manufacturer source of polypropylene, manufacturing, processing, sterilization, and addivives are the same as the polypropylene material included in the cleared ProSeal™ Injection Site (K240433) and the cleared ProSeal"" Comector (K192075). Therefore, biocompatibility was leveraged from K240433 and K192075. In additional bench top performance vertification testing over the shelf life was conducted to ISO 8536-4:2019, ISO 22413:2021, and ISO 8871-5:2016 to demonstrate that the difference in technological characteristic (i.e., material) does not raise different questions of safety and effectiveness.
Comment #2
The differences arising out of the proposed chave been functionally verified to the standards listed in Comment #1, and to the standards listed in section VII.B hereunder, on test samples in their finished form aged to the intention i the Subject device validation lots and these differences were found not to raise any new or safety or effectiveness. Further details are provided in sections VII.A and VII.B hereunder.
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Performance Data Supporting Substantial Equivalence VII.
A. Functional Performance
The sterile, single-use, non-pyrogenic flexible IV container devices/ bags 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, ● gravitv 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 are referred to or were performed on the Subject device as detailed hereunder:
- Fragmentation study to ISO 22413 & ISO 8871-5, performed on the Subject device ●
- Vial Adaptor penetration force testing to ISO 22413, performed on the Subject device
- Tests for leakages to ISO 8536-4:2019, Annex A.3, performed on the Subject device ●
- Volume of pressure equalization study under K222929
- Testing to (draft) NIOSH CSTD Test Protocol on existing devices under K222929 ●
- . Microbial ingress/ microbiological integrity testing on existing devices under K222929
B. Biocompatibility
In accordance with ISO 10993-1: 2018, the Subject device, just like the existing 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 existing devices cleared as listed hereunder:
- 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
- . 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.
11
ani t
C. Sterility, Shipping, and Shelf-Life
The Subject device, like the existing device cleared under K222929, 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 F1980-16, 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: 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 1980-16, ● 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 Subject ToxiSeal™ Vial Adaptor with External Flip Balloon is substantially equivalent to the Predicate, the ToxiSeal™ Vial Adaptor with External Balloon, with respect to the indications for use, principles of operation and technological characteristics.