(300 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid transfer properties, with no mention of AI or ML.
No.
The device is described as a 'fluid transfer device' used for reconstituting and transferring drugs, not for directly treating a medical condition or ailment in a patient.
No
The device is described as a "fluid transfer device" for reconstituting and transferring drugs, not for diagnosing a condition or disease.
No
The device description clearly states it is a "single use, fluid transfer device" consisting of a "body, male Luer lock and a safety ring," which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for reconstituting and transferring a drug from a vial to an IV bag for administration to a patient. This is a process related to drug preparation and delivery, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a fluid transfer device used for mixing and transferring drugs. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic, prognostic, or screening information
- Using reagents or calibrators
The device is clearly intended for the preparation and delivery of medication, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The freeflex®+ Transfer Adapter is indicated for reconstituting a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex®+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The freeflex®+ Transfer Adapter is a single use, fluid transfer device that allows for the reconstitution and transfer of powdered or liquid drugs from drug vials into the freeflex + IV Bag (NDA BN070012) through the IV bag medication port. The device consists of a body, male Luer lock and a safety ring. The device is provided as a sterile, non-pyrogenic product.
The device is intended to be used with standard drug vials with a seal diameter of 20mm. with an elastomeric membrane. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the freeflex®+ Transfer Adapter for the device to meet its intended purpose.
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
pediatric (newborn to 21 years) and adult populations.
Intended User / Care Setting
Not Found
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)
Functional performance bench testing was conducted to demonstrate that the freeflex®+ Transfer Adapter performs as intended. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
The following performance testing was conducted to support the substantial equivalence determination:
- ISO 22413:2013 Transfer sets for pharmaceutical preparations for Fragmentation
- USP Particulate Matter in Injections Test method 1 for Particulate Testing
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods for Luer Connector Leakage, Stress Cracking, Resistance Testing
- ISO 11607-1 (2019-02) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems for Sterile Barrier Systems Validation
- Internal device performance test methods for Visual Inspection, Penetration Force, Force to Remove Safety Ring, Separation under Tensile Force, Residual Volume in Adapter-Vial-System
Biocompatibility testing successfully conducted:
- Hemolysis
- Cytotoxicity
- Irritation
- Skin Sensitization
- Acute Systemic Toxicity
- Chemical Characterization
- Material Mediated Pyrogenicity
- Particulate Testing
Sterilization through ethylene oxide meets DIN EN ISO 11135:2014, achieving a Sterilization Assurance Level (SAL) of 10-6.
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.
Not Found
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 1, 2022
Fresenius Kabi AG % Keith Dunn Director Regulatory Affairs Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich, Illinois 60047
Re: K212445
Trade/Device Name: freeflex®+ Transfer Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: April 29, 2022 Received: May 2, 2022
Dear Keith Dunn:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
David Wolloscheck For Payal Patel 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) K212445
Device Name freeflex®+ Transfer Adapter
Indications for Use (Describe)
The freetlex@+ Transfer Adapter is indicated for reconstituting a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex®+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.
| 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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3
K212445 - 510(k) SUMMARY
1. Submitter Information
| Name: | Fresenius Kabi AG |
|---|---|
| Address: | Else-Kröner-Str. 1 |
| 61352 Bad Homburg | |
| Contact Person: | Keith Dunn |
| Director, Regulatory Affairs | |
| Fresenius Kabi USA, LLC | |
| Three Corporate Drive, 2nd Floor | |
| Lake Zurich, IL 60047 USA | |
| Telephone Number: | (224) 817-2430 |
| Fax Number: | (847) 550 2960 |
| E-mail: | keith.dunn@fresenius-kabi.com |
| Date Prepared: | April 21, 2022 |
| Secondary | |
| Contact Person: | Jason Ma |
| Sr. Manager, Regulatory Affairs | |
| Fresenius Kabi USA, LLC | |
| Three Corporate Drive, 2nd Floor | |
| Lake Zurich, IL 60047 USA | |
| Telephone Number: | 224-817-4100 |
| Fax Number: | 847 550 2960 |
2. Device Name and Classification
Device Trade Name: freeflex®+ Transfer Adapter Common Name: IV Fluid Transfer Set Classification Name: 21 CFR 880.5440 Intravascular administration set Regulatory Class: II Product Code: LHI 510(k) Number: K212445
3. Predicate Device
E-mail:
Device Trade Name: Vial2Bag Advanced™ 20mm Admixture Device Common Name: IV Fluid Transfer Set Classification Name: 21 CFR 880.5440 Intravascular administration set
4
| Regulatory Class: | II |
|---|---|
| Product Code: | LHI |
| 510(k) Number: | K201415 |
4. Device Description
The freeflex®+ Transfer Adapter is a single use, fluid transfer device that allows for the reconstitution and transfer of powdered or liquid drugs from drug vials into the freeflex + IV Bag (NDA BN070012) through the IV bag medication port. The device consists of a body, male Luer lock and a safety ring. The device is provided as a sterile, non-pyrogenicproduct.
The device is intended to be used with standard drug vials with a seal diameter of 20mm. with an elastomeric membrane. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the freeflex®+ Transfer Adapter for the device to meet its intended purpose.
5. Principle of Operation
The freeflex®+ Transfer Adapter is operated by manual manipulation. Initially, the vial opening that the transfer adaptor will connect to is disinfected with 70% isopropyl alcohol. Next the freeflex +transfer adaptor is removed from the package. The protective cap is removed from the freeflex®+ IV bag injection port and the injection port is disinfected with 70% isopropyl alcohol. The freeflex 4transfer adaptor is connected to the injection port, then attached to the drug vial. Fluid is transferred manually from the IV bag to the drug vial to reconstitute/dilute drug powder/liquid prior to being transferred back to the IV bag. Once the drug is transferred to the IV bag the transfer adapter is removed from the IV bag and discarded. Finally, the freeflex®HV bag injection port is capped with a protective cap.
6. Indication for Use/ Intended Use
Indication for Use:
The freeflex®+ Transfer Adapter is indicated for reconstituting and/or admixing a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex 9+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.
7. Substantial Equivalence
Intended Use/Indication for Use-Discussion of Differences
The subject and predicate devices have the same intended use. The indication for use of the subject and predicate device are equivalent and do not create a new intended use.
- . The indication for use for the subject device is limited to vials with a 20mm Fresenius Kabi
5
closure.
- The subject device is only indicated for use with the freeflex + IV Bag.
- The predicate device does not indicate the patient population for which it may be ● used.
Physical Characteristics
The subject and predicate devices share the following physical characteristics:
- Flanges on the device provide secure attachment to the drug vial.
- A spike pierces the IV bag and drug vial for fluid transfer, providing a needle-free connection.
Technological Characteristics-Discussion of Differences
-
- The predicate device is designed to attach to the administration port of a standard IV bag, size 50, 100 or 250 mL while the subject device is designed to attach only to the freeflex + IV Bag sizes 50, 100, 250, 500, or 1000 mL using the medication port.
-
- The predicate device allows connection of an external IV administration set using an IV port with a twist off feature while the subject device, freeflex + Transfer Adapter, does not connect to an external administration set.
-
- The predicate device allows connection of the Vial2Bag Advanced™ 20mm Admixture Device directly into the administration path while the subject device connects to the medication port of the IV Bag, which is not part of the administration path.
- The predicate device allows connection to 20mm device (or smaller). The proposed 4. device is designed for use with vials with 20mm opening only.
-
- The main body of both devices is made of polycarbonate. The subject device has an additional component made of polypropylene (nut) that is not fluid contacting
6
Conclusion on Substantial Equivalence
The freeflex®+ Transfer Adapter has the same intended use and equivalent indication for use as the predicate device. The subject device has similar technological characteristics to the predicate, and the descriptive and performance information provided within this premarket notification demonstrates that:
- any differences do not raise different questions of safety and . effectiveness compared to the predicate device; and
- the proposed device is at least as safe and effective as the legally . marketed predicate device.
Based on the comparison of the intended use and the technological characteristics, the subject device is substantially equivalent to the currently marketed predicate Vial2Bag Advanced™ 20mm Admixture Device.
8. Comparison of the Technological Characteristics with the Predicate Device
The technological characteristics of the subject device, freeflex®+ Transfer Adapter, are substantially equivalent to those of the predicate device, Vial2Bag Advanced™ 20mm Admixture Device, in regard to the following technological characteristics:
- Principle of operation and conditions of use of the subject device are equivalent to those of the predicate device.
- Material composition of the subject device is equivalent to that of the predicate device in that both devices are made from plastics used in medical devices of this type. Material composition of the proposed device does not raise new questions of safety and effectiveness, as demonstrated by performance testing and biocompatibility evaluation.
- Physical specifications of the subject device are equivalent to those of the predicate ● device. The freeflex®+ Transfer Adapter does not raise new questions of safety and effectiveness, as demonstrated by performance testing.
- Design features and interfaces are equivalent in that both devices connect to a drug vial and IV bag and allow for fluid transfer between the drug vial and IV bag. The subject device is limited for use with the freeflex + IV Bag only. Performance verification of the subject device does not raise new questions of safety and effectiveness.
- Sterilization method and SAL level are identical between the subject andpredicate ● device.
7
A comparison between the predicate device and the subject device is provided in Table 1.
| Areas for Comparison | Subject Device
K212445 | Predicate Device
K201415 | Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code and
Regulation | LHI
21 CFR 880.5440 | LHI
21 CFR 880.5440 | Same |
| Classification | Class II (non-exempt) | Class II (non-exempt) | Same |
| Review Panel | General Hospital | General Hospital | Same |
| Type of Use | Prescription use only | Prescription use only | Same |
| Conditions of Use | Single use only | Single use only | Same |
| Sterilization Method | Ethylene oxide | Ethylene oxide | Same |
| Indication for Use | The freeflex®+
Transfer Adapter is
indicated for
reconstituting and/or
admixing a drug in a
vial with a 20mm
closure and the transfer
of the drug into the
freeflex®+ IV Bag
prior to administration
to the patient. The
device may be used for
pediatric (newborn to
21 years) and adult
populations. | The Vial2Bag
AdvancedTM 20mm
Admixture Device is
indicated to serve as a
connection between a 50,
100, or 250ml IV bag,
vial with 20mm closure,
and an external IV
administration set. The
integrated Vial Adapter
makes it possible to
reconstitute and/or
admix drugs prior to
administration to the
patient. | Similar
The differences are
minimal and do not
impact the risk to
patient or user. Both
devices have the same
intended use for the
reconstitution and
transfer of drug content
from the vial into the
IV bag. The predicate
is indicated for use
with any standard IV
bag whereas the
freeflex®+ Transfer
Adapter is for use only
the freeflex®+ IV
Bags. |
| Operation Principle | Manual | Manual | Same |
| Areas for Comparison | Subject Device
K212445 | Predicate Device
K201415 | Comparison |
| Design | The freeflex®+
Transfer Adapter is
made of plastic
materials and is a
single use, sterile, non-
pyrogenic transfer
adapter device that
connects to a 20mm
seal diameter drug vial.
The spike of the
transfer device pierces
the seal of the drug vial
and allows for the
reconstitution/dilution
and transfer of drugs to
a 50, 100, 250, 500 or
1000 mL freeflex®+
IV bag. Fluid is
transferredfrom the IV
bag to the drug vial by
a manual process to
reconstitute/dilute the
drug prior to being
transferred back to the
IV bag. Once the drug
is transferred to the IV
bag the transfer adapter
is removed from the IV
bag and discarded. | The Vial2Bag
Advanced™ 20mm
Admixture Device is a
single use, fluid transfer
device that allows for the
reconstitution and
transfer of fluids from
drug vials into the IV
bag containing infusion
solution, through the IV
bag administration port.
The device consists of
the body, Protector, IV
Port, and an integrated
vial adapter. The
Vial2Bag connects the
IV bag and IV set and
creates a fluid path. The
Vial2Bag Advanced 20
mm Admixture Device's
integrated vial adapter
connects to the body of
the Vial2Bag and to a
20mm (or smaller) seal
diameter drug vial. The
vial adapter spike pierces
the seal of the drug vial.
Fluid from the IV bag is
transferred into the drug
vial by a manual process
to reconstitute/dilute the
drug. Once
reconstituted/diluted the
drug solution is
transferred to the IV bag.
The vial adapter can
remain attached to the
Vial2Bag during drug
delivery or alternatively
be removed and
discarded. The device
works with standard 50,
100, 250mL IV bags. | Different
The difference is
minimal and does not
impact the risk to
patient or user. The
Vial2Bag is a system
which contains a vial
adapter which is
attached to the
Vial2Bag system when
reconstituting/admixing
the drug and
transferring it to the IV
bag. The vial adapter
can stay attached to the
Vial2Bag device during
drug delivery to the
patient or be removed
from the Vial2Bag
device and discarded.
The freeflex®+
Transfer Adapter is
only the adapter. It is
attached to the IV bag
and drug vial. The drug
is
reconstituted/admixed
and then once the drug
has been transferred to
the IV bag the
freeflex®+ Transfer
Adapter is removed
from the IV bag and
discarded. |
| Materials | Body: Polycarbonate
Nut: Polycarbonate
Safety Ring:
Polypropylene | Body: Polycarbonate
Option for siliconized
spike
Vented adapter has PTFE
0.2 micron air filter | Different
The difference is
minimal and does not
impact the risk to patient
or user.
The main body of both
devices is made of |
| Areas for Comparison | Subject Device
K212445 | Predicate Device
K201415 | Comparison
Page 7 of 9 |
| | | | polycarbonate. The
subject device has an
additional component
made of polypropylene
(nut) that is not fluid
contacting |
| Biocompatibility | - Hemolysis
- Cytotoxicity
- Irritation
- Skin Sensitization
- Acute Systemic
Toxicity - Chemical
Characterization - Pyrogenicity
- Particulate Testing | - Hemolysis
- Cytotoxicity
- Irritation
- Skin Sensitization
- Acute Systemic
Toxicity - Sub-chronic Toxicity
- Pyrogenicity
- Particulate Testing | Similar
The difference is not
affecting the
determination of an
unacceptable adverse
biological response. The
subject device has
additional evidence in
chemical
characterization whereas
the predicate device was
tested on sub-chronic
toxicity. However, the
sub-chronic toxicity
testing is not required
because the subject
device is removed from
the IV Bag after a few
minutes and does not
remain attached. |
| Drug Form | Powdered or liquid | Powdered or liquid | Same |
| Vial Size | 20 mm | 20 mm (or smaller) | Similar
The difference is
minimal and does not
impact the risk to patient
or user. The predicate
device may be used with
smaller size drug vials |
| Bag System | freeflex® + IV Bag | Standard IV Bag | Different
The difference is
minimal and does not
impact the risk to patient
or user. The predicate
device may be used with
any standard IV bag
while the subject device
mayonly be used with
the freeflex® + IV Bag |
| Bag Size | 50, 100, 250, 500,
1000 mL | 50, 100, 250mL | Similar
The difference is
minimal and does not
impact the risk to patient
or user. The freeflex®+
Transfer Adapter can
connect toadditional |
| Page 8 of 9 | | | |
| Areas for Comparison | Subject Device
K212445 | Predicate Device
K201415 | Comparison |
| Performance Testing | USP
ISO22413
ISO80369-20
ISO11607-1
Internal Test Methods
for mechanical and
performance
characteristics. | ISO 8536-4
Internal Test Methods for
mechanical and
performance
characteristics. | Different
For particulate testing
the subject device
followed USP
versus ISO8536-4 for
the predicate. For other
performance tests the
subject device followed
FDA recognized
standards including
ISO22413, ISO80369-
20, ISO11607-1, as well
as in house test methods
versus in house test
methods were followed
for the predicate device. sizes of IV bags
compared to the
predicate. |
Table 1: Summary of Substantial Equivalence Comparison
8
9
10
9. Performance Testing—Bench
Functional performance bench testing was conducted to demonstrate that the freeflex®+ Transfer Adapter performs as intended. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
The following performance testing was conducted to support the substantial equivalence determination (Table 2):
| ISO 22413:2013 Transfer sets for pharmaceutical
| preparations | Fragmentation |
|---|---|
| USP Particulate Matter in Injections Test | |
| method 1 | Particulate Testing |
| ISO 80369-20:2015 Small-bore connectors for | |
| liquids and gases in healthcare applications - Part | |
| 20: Common test methods | Luer Connector Leakage |
| Stress Cracking | |
| Resistance Testing | |
| ISO 11607-1 (2019-02) Packaging for terminally | |
| sterilized medical devices - Part 1: Requirements | |
| for materials, sterile barrier systems | Sterile Barrier Systems Validation |
| Internal device performance test methods | Visual Inspection Penetration Force Force to Remove Safety Ring Separation under Tensile Force Residual Volume in Adapter-Vial-System |
Table 2: Performance Testing: Subject Device
11
Biocompatibility Testing 9.
Following the FDA Guidance: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process", the tests selected were for prolonged externally communicating devices. The following biocompatibility tests were successfully conducted on the freeflex®+ Transfer Adapter:
- Hemolysis ●
- Cytotoxicity
- Irritation ●
- Skin Sensitization ●
- Acute Systemic Toxicity ●
- Chemical Characterization ●
- Material Mediated Pyrogenicity ●
- Particulate Testing ●
10. Sterilization Validation
Sterilization was achieved by ethylene oxide and meets the requirements of DIN EN ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The ethylene oxide sterilization method achieves a Sterilization Assurance Level (SAL) of 10-6.
11. Conclusion
The freeflex®+ Transfer Adapter, has met all established acceptance criteria for performance testing and design verification testing. Results of functional performance and biocompatibility testing conducted with the freeflex + Transfer Adapter, demonstratethat the subject device supports a substantial equivalence determination to the predicate device. Vial2Bag Advanced™ 20mm Admixture Device (K201415), as described in Section 7.