(259 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid flow properties, with no mention of AI or ML.
No.
Explanation: The device is intended for the transfer and mixing of drugs, not for directly treating a disease or condition. It is an accessory to aid in the preparation and delivery of drugs, not a therapeutic device itself.
No
The device is described as a Vial Adapter used for the transfer and mixing of drugs, allowing easy transfer of fluids into and out of drug vials. Its function is to facilitate drug reconstitution and removal. There is no mention of the device being used to diagnose a medical condition or disease.
No
The device description clearly outlines a physical, sterile polycarbonate molded device with a spike and luer fitting, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "transfer and mixing of drugs contained in vials." This describes a process related to drug administration and preparation, not the diagnosis of a disease or condition using in vitro methods.
- Device Description: The description details a mechanical device for accessing and transferring fluids from drug vials. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a biological sample to provide diagnostic information.
- Performance Studies: The performance studies focus on the mechanical integrity, fluid flow, and filtration capabilities of the device, which are relevant to its function in drug preparation, not diagnostic testing.
In summary, the device's purpose and function are entirely focused on facilitating the handling of drugs in vials, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Vial Adapter Ø20mm are indicated for the transfer and mixing of drugs contained in vials.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The vial adapter (VA) are sterile polycarbonate molded devices that allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of the vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in Ø20mm to accommodate Ø20 drug vials and is available in 3 configurations, no filter, inline 5-micron or 15-micron disc filter sub- assembly for particulate filtration.
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
Vial Adapter are intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
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)
The vial adapter was evaluated, and risk assessment was performed to ensure that the device modifications did not introduce any new potential risks. The following tests were performed as a result of the risk assessment to ensure that all potential risks associated with the device design are mitigated to acceptable levels.
Performance Testing Summary:
A: Packaging
- A1: Seal integrity test by dye penetration (Testing standard: ISO 11607-1)
- A2: Sealing strength (resistance) (Testing standard: ISO 11607-1)
- A3: Peeling open characteristics test (Testing standard: ISO 11607-1)
B: Mechanical tests and leaks - B1: VA Snapping force (Testing standard: Internal performance standards)
- B2: VA Unsnapping force (Testing standard: Internal performance standards)
- B3: Leak Spike/Vial (Testing standard: ISO 8871-5:2016(F))
- B6: Spike ductility (Testing standard: Internal performance standards)
D: Fluid flow - D1: Flow injection from syringe to Vial (Testing standard: Internal performance standards)
- D2: Flow aspiration from Vial to syringe (Testing standard: Internal performance standards)
- D3: Dead volume (Testing standard: Internal performance standards)
E: Filter - E1: Filter integrity (Testing standard: Internal performance standards)
- E2: Filter holding force / VA (Testing standard: Internal performance standards)
- E3: Leak external filter / internal VA (Testing standard: Internal performance standards)
- E3: Particle Filtration Efficiency (Particulate) (Testing standard: Internal specification)
F: Luer Lock - F1: Gauging (Testing standard: ISO 80369-7)
- F2: Liquid leak checking of the liquid-tightness of the cone Luer (Testing standard: ISO 80369-7)
- F3: Air leak checking of the air-tightness of the cone Luer (Testing standard: ISO 80369-7)
- F4: Separation force (Testing standard: ISO 80369-7)
- F5: Unscrewing torque force (Testing standard: ISO 80369-7)
- F6: Friendly assembly (Testing standard: ISO 80369-7)
- F7: Thread resistance (Testing standard: ISO 80369-7)
- F8: Cracks and change color (Testing standard: ISO 80369-7)
Particulate Testing per USP . All testing met the required acceptance criteria.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2019
Avenir Performance Europeenne Medical (APEM) % Om Singh Senior Scientific Consultant Technology Sciences Group, Inc. 1150 18th Street NW, Suite 1000 Washington, District of Columbia 20036
Re: K190149
Trade/Device Name: Vial Adapter Ø20 mm Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: September 12, 2019 Received: September 13, 2019
Dear Om Singh:
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
1
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 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 (QS) 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,
for Geeta Pamidimukkala Acting 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) K190149
Device Name Vial Adapter Ø20mm
Indications for Use (Describe)
Vial Adapter Ø20mm are indicated for the transfer and mixing of drugs contained in vials.
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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Image /page/3/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' in blue and the 'PE' in a slightly darker shade of blue. Below the letters, the word 'MEDICAL' is written in a smaller font size. Above the letters, there is a red curved line with a red circle at the end, creating a swoosh-like effect.
510(K) Summary – K190149
| 1. Submitter: | Avenir Performance Européenne Medical (APEM)
ZI route de Souppes
77570 Château Landon
France
Tel : +330164785100
Fax : +330164785109 |
| --------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Contact Person: | Mrs. Fatoumata DAO | |
|---|---|---|
| Quality Manager | ||
| Office phone: 0033164785106 | ||
| Cell Phone: 0033643953528 | ||
| Fax: 0033164785109 | ||
| E-mail: raq@ape-medical.fr |
Preparing Date: Oct 15, 2019
US Agent:
| Contact: | Om V. Singh, Ph.D. Senior Regulatory Consultant |
|---|---|
| Address: | 1150 18th Street NW, Suite 1000 |
| Washington, DC 20036, USA | |
| Office Phone: +1 202-828-8983 | |
| Fax: +1 202-872-0745 | |
| Email: om.singh@tsgconsulting.com |
2. Device name and classification:
| Regulation Name: | Intravascular Administration Set |
|---|---|
| Trade Name: | Vial Adapter Ø20mm |
| Common/ Usual Name: | Vial Adapter |
| Product Code: | LHI |
| Product Code: | LHI |
|---|---|
| Regulation No.: | 880.5440 |
4
Image /page/4/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' having a red, curved accent mark underneath it. The word 'MEDICAL' is written in a smaller font size below 'APE'. A red sphere is positioned above the letters, connected by a thin red line that curves over the top of the logo.
| Regulatory Class: | II |
|---|---|
| Panel identification: | General Hospital Panel |
| 3. Predicate Device: | Vial Adapter 15mm - K171796 (Medimop Medical Project Ltd.) |
4. Device Description:
The vial adapter (VA) are sterile polycarbonate molded devices that allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of the vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in Ø20mm to accommodate Ø20 drug vials and is available in 3 configurations, no filter, inline 5-micron or 15-micron disc filter sub- assembly for particulate filtration.
5. Indication for use:
Vial Adapter Ø20mm are indicated for the transfer and mixing of drugs contained in vials.
6. Intended use:
Vial Adapter are intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
7. Technological Characteristics and Substantial Equivalence:
The proposed device, Vial Adapter Ø20mm has similar indications for use and the same principle of operation as the predicate device, Vial Adapter (K171796). However, the following differences were noted in device design:
The proposed device is offered in different size, i.e., Ø20mm, however this difference is for a different diameter vial, but the intended use is the same. The size difference of proposed device led to the difference in packaging size from the predicate. However, the sterilization process is validated to a minimum SAL 106. The proposed device can be equipped with an in-line 5-micron or 15-micron disc filter sub- assembly for particulate filtration. The performance testing of the filters met required acceptable criteria. These differences in device design do not raise different questions of safety and effectiveness.
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Image /page/5/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with 'APE' in blue. Below 'APE' is the word 'MEDICAL' in a smaller font size, also in blue. A red curved line extends from the bottom left of the 'A' and arches over the top of the logo, ending in a red circle.
The predicate and proposed device share the same principle of operation and fundamental technology when utilizing the proposed device. The following table compares the Vial Adapter Ø20 mm to the Predicate Device Vial Adapter 15 mm with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
The vial size to be used with the subject device is different than that of the predicate, however this difference does not raise any different questions of safety or effectiveness.
Comparison of proposed Vial Adaptor Ø20 mm to the predicate device Vial Adapter 15 mm (K171796)
| Parameter | Subject Device
(K190149)
Vial Adapter Ø20 mm | Predicate (K171796)
Vial Adapter 15mm
(Medimop Medical
Project Ltd.) | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------|
| Regulation
Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Regulation Name | Intravascular
administration set | Intravascular
administration set | Same |
| Regulatory Class | II | II | Same |
| Product Code | LHI | LHI | Same |
| Indications for
Use | Vial Adapter Ø20 mm
are indicated for the
transfer and mixing of
drugs contained in
vials. | The Vial Adapter
15mm is indicated for
the transfer and
mixing of drugs
contained in vials. | Size difference |
| Sterilization
Method | Gamma Irradiation | Gamma Irradiation | Same |
| Sterility
Assurance Level | SAL 10-6 | SAL 10-6 | Same |
| Single use | Yes | Yes | Same |
| Body Material | Polycarbonate | Polycarbonate | Same |
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Image /page/6/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' in a darker shade of blue and the 'PE' in a lighter shade. A red swoosh underlines the 'A' and extends upwards, culminating in a red dot. Below the letters, the word 'MEDICAL' is written in a smaller, lighter font.
| Expiration Date | 5 years | 5 years | Same |
|---|---|---|---|
| Vial Adapter Size | 20 mm | 15 mm | Different |
| Labeling | Proposed device | ||
| labeling (IFU) includes | |||
| transfer and mixing | |||
| instructions | Predicate device | ||
| labeling (IFU) includes | |||
| transfer and mixing | |||
| instructions | Same | ||
| Piercing Spike | Plastic - Single Lumen | Plastic - Single Lumen | Same |
| Vial Adapter Fit | |||
| (Vial Side) | Snap Fit to Vial “Tight | ||
| Grip” | Snap Fit to Vial | ||
| “Tight Grip” Feature | Same | ||
| Packaging Size | Dimensioned for VA | ||
| 20mm | Dimensioned for VA | ||
| 15mm | Different | ||
| Filtration | 5-micron or 15- | ||
| micron disc filter | |||
| configuration | No filter | Different |
8. Substantial Equivalence:
The proposed device, Vial Adapter Ø20mm, has the same intended use and substantially similar indications for use, technological characteristics and principles of operation as the identified predicate devices. Difference in the size of vial adapter Ø20mm is for a different diameter vial, but intended use is the same. Based on the size difference, the packaging size differ from the predicate device. The sterilization process is validated to a minimum SAL 10°. The configurations with in-line 5-micron or 15-micron disc filter sub-assembly for particulate filtration is different from the predicate. However, the performance testing of the filters met required acceptable criteria. There are no significant differences between the Vial Adapter Ø20mm and the predicate device that would adversely affect the use of the product. Any differences in technological characteristics do no raise new questions of safety or effectiveness. Further, testing demonstrates substantially equivalent performance between the device and the predicates. Accordingly, the Vial Adapter Ø20mm is substantially equivalent to the predicate device in design, function, material, and intended use.
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Image /page/7/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' having a red, curved accent mark underneath it. Below the letters, the word 'MEDICAL' is written in a smaller font size. Above the letters, there is a red curved line with a red circle at the end.
9. Summary of Non-Clinical Testing:
The vial adapter was evaluated, and risk assessment was performed to ensure that the device modifications did not introduce any new potential risks.
The following tests were performed as a result of the risk assessment to ensure that all potential risks associated with the device design are mitigated to acceptable levels.
Non-Clinical/ Performance testing Summary
Performance Testing Summary
| A: Packaging | Testing standard | |
|---|---|---|
| A1 | Seal integrity test by dye penetration | ISO 11607-1 |
| A2 | Sealing strength (resistance) | ISO 11607-1 |
| A3 | Peeling open characteristics test | ISO 11607-1 |
| B: Mechanical tests and leaks | Testing standard | |
| B1 | VA Snapping force | Internal performance standards |
| B2 | VA Unsnapping force | Internal performance standards |
| B3 | Leak Spike/Vial | ISO 8871-5:2016(F) |
| B6 | Spike ductility | Internal performance standards |
| D: Fluid flow | Testing standard | |
| D1 | Flow injection from | |
| syringe to Vial | Internal performance standards | |
| D2 | Flow aspiration from Vial | |
| to syringe | Internal performance standards | |
| D3 | Dead volume | Internal performance standards |
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Image /page/8/Picture/1 description: The image shows the logo for APE Medical. The logo features the word "APE" in large, bold, blue letters. Below the word "APE" is the word "MEDICAL" in smaller, red letters. Above the word "APE" is a red curved line with a red circle at the end.
| E: Filter | Testing standard | |
|---|---|---|
| E1 | Filter integrity | Internal performance standards |
| E2 | Filter holding force / VA | Internal performance standards |
| E3 | Leak external filter / internal VA | Internal performance standards |
| E3 | Particle Filtration Efficiency | |
| (Particulate) | Internal specification | |
| F: Luer Lock | Testing standard | |
| F1 | Gauging | ISO 80369-7 |
| F2 | Liquid leak checking of the liquid- | |
| tightness of the cone Luer | ISO 80369-7 | |
| F3 | Air leak checking of the air- | |
| tightness of the cone Luer | ISO 80369-7 | |
| F4 | Separation force | ISO 80369-7 |
| F5 | Unscrewing torque force | ISO 80369-7 |
| F6 | Friendly assembly | ISO 80369-7 |
| F7 | Thread resistance | ISO 80369-7 |
| F8 | Cracks and change color | ISO 80369-7 |
Particulate Testing per USP
All testing met the required acceptance criteria.
10. Clinical Testing:
There was no clinical testing required to support the medical device as the Indications for Use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing.
11. Sterilization:
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Image /page/9/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' being slightly larger than the other letters. Below the letters, the word 'MEDICAL' is written in a smaller font. A red curved line with a red circle at the end arches over the letters, adding a dynamic element to the design.
Vial Adapter Ø20mm are sterilized by Gamma irradiation in accordance to standard ISO 11137-1, ISO 11137-2 and AAMI TIR 33. The sterilization subcontractor is STERIS AST (Applied Sterilization Technologies). The sterilization process is validated to a minimum SAL 10-6.
12. Biocompatibility:
- LAL Testing via Bacterial Endotoxin
Vial Adapter Ø20mm was tested for bacterial endotoxin by a validated Limulus Amoebocyte Lysate (LAL) method.
The biocompatibility assessments were conducted according to ISO 10993-1
The following biocompatibility testing has been successfully completed.
- a. Cytotoxicity (Tested to ISO 10993-5)
- b. Sensitization (Tested to ISO 10993-10)
- c. ASTM Hemolysis (Tested to ASTM F756 and ISO 10993-4)
- d. Intracutaneous Reactivity (Tested to ISO 10993-10)
- e. Systemic Toxicity (Acute Systemic Injection) (Tested to ISO 10993-11)
- f. Rabbit Pyrogen Test (Tested to ISO 10993-11)
13. Conclusion:
The evaluation of the Vial Adapter Ø20mm through performance testing demonstrates that the device is substantially equivalent to the predicate device.