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.

AI/ML Overview

Based on the provided document, the device in question is a "Vial Adapter Ø20 mm", which is a medical device for transferring and mixing drugs contained in vials. The document is a 510(k) summary submitted to the FDA for market clearance.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing to demonstrate performance and substantial equivalence to a predicate device. There are no specific "acceptance criteria" presented in a table with numerical goals and actual performance values for each, but rather the document states that "All testing met the required acceptance criteria." The tests performed are primarily related to mechanical function, fluid dynamics, filter performance (for some configurations), and Luer lock characteristics.

Here is a table summarizing the tests, standards, and the general statement of performance:

Category	Test	Testing Standard	Reported Device Performance
A: Packaging	A1: Seal integrity test by dye penetration	ISO 11607-1	Met required criteria
	A2: Sealing strength (resistance)	ISO 11607-1	Met required criteria
	A3: Peeling open characteristics test	ISO 11607-1	Met required criteria
B: Mechanical tests and leaks	B1: VA Snapping force	Internal performance standards	Met required criteria
	B2: VA Unsnapping force	Internal performance standards	Met required criteria
	B3: Leak Spike/Vial	ISO 8871-5:2016(F)	Met required criteria
	B6: Spike ductility	Internal performance standards	Met required criteria
D: Fluid flow	D1: Flow injection from syringe to Vial	Internal performance standards	Met required criteria
	D2: Flow aspiration from Vial to syringe	Internal performance standards	Met required criteria
	D3: Dead volume	Internal performance standards	Met required criteria
E: Filter	E1: Filter integrity	Internal performance standards	Met required criteria
	E2: Filter holding force / VA	Internal performance standards	Met required criteria
	E3: Leak external filter / internal VA	Internal performance standards	Met required criteria
	E3: Particle Filtration Efficiency (Particulate)	Internal specification	Met required criteria
F: Luer Lock	F1: Gauging	ISO 80369-7	Met required criteria
	F2: Liquid leak checking of the liquid-tightness of the cone Luer	ISO 80369-7	Met required criteria
	F3: Air leak checking of the air-tightness of the cone Luer	ISO 80369-7	Met required criteria
	F4: Separation force	ISO 80369-7	Met required criteria
	F5: Unscrewing torque force	ISO 80369-7	Met required criteria
	F6: Friendly assembly	ISO 80369-7	Met required criteria
	F7: Thread resistance	ISO 80369-7	Met required criteria
	F8: Cracks and change color	ISO 80369-7	Met required criteria
Other	Particulate Testing	USP <788>	Met required criteria
	Biocompatibility (Cytotoxicity, Sensitization, Hemolysis, Intracutaneous Reactivity, Systemic Toxicity, Rabbit Pyrogen Test)	ISO 10993 series, ASTM F756	Successfully completed
	Sterilization Validation	ISO 11137-1, ISO 11137-2, AAMI TIR 33	Validated to minimum SAL 10-6
	LAL Testing (Bacterial Endotoxin)	Validated LAL method	Successfully tested

Study Details:

This document describes a 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy trials. The "study" here refers to the non-clinical testing performed to support this claim.

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (N) for each of the non-clinical tests performed. It only lists the types of tests conducted.
- Data Provenance: The submitter is Avenir Performance Européenne Medical (APEM), located in Château Landon, France. The testing standards are international (ISO, ASTM) and US-based (USP). The document does not explicitly state whether the data is retrospective or prospective, but for device testing, it would generally be prospective (tests conducted specifically for this submission).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. The "ground truth" for the non-clinical performance of a device like a vial adapter is established through standardized engineering and laboratory testing protocols, not through expert consensus or clinical interpretation of data. The "acceptance criteria" are derived from these standards or internal specifications, not expert diagnostic agreement.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for establishing ground truth in image analysis or diagnostic tasks where human interpretation is involved and subject to variability. For engineering performance testing of a physical device, the outcome is measured against predefined physical/chemical standards, not adjudicated by experts.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a mechanical vial adapter, not an AI diagnostic tool.
- The document explicitly states: "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."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a mechanical adapter, not an algorithm or AI. The tests performed are on the physical device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established engineering and medical device standards (ISO, USP, ASTM) and internal performance specifications. For example, "Leak Spike/Vial" is tested against ISO 8871-5:2016(F), and "Particulate Testing" against USP <788>. Biocompatibility is tested against ISO 10993. These standards define the acceptable range or limits for specific performance parameters.
The sample size for the training set:
- This is not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a mechanical medical device, not an AI.
How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.

Summary

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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

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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

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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 Souppes77570 Château LandonFranceTel : +330164785100Fax : +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 1000Washington, 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

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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:

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 MedicalProject Ltd.)	Comparison
RegulationNumber	21 CFR 880.5440	21 CFR 880.5440	Same
Regulation Name	Intravascularadministration set	Intravascularadministration set	Same
Regulatory Class	II	II	Same
Product Code	LHI	LHI	Same
Indications forUse	Vial Adapter Ø20 mmare indicated for thetransfer and mixing ofdrugs contained invials.	The Vial Adapter15mm is indicated forthe transfer andmixing of drugscontained in vials.	Size difference
SterilizationMethod	Gamma Irradiation	Gamma Irradiation	Same
SterilityAssurance 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 devicelabeling (IFU) includestransfer and mixinginstructions	Predicate devicelabeling (IFU) includestransfer and mixinginstructions	Same
Piercing Spike	Plastic - Single Lumen	Plastic - Single Lumen	Same
Vial Adapter Fit(Vial Side)	Snap Fit to Vial “TightGrip”	Snap Fit to Vial“Tight Grip” Feature	Same
Packaging Size	Dimensioned for VA20mm	Dimensioned for VA15mm	Different
Filtration	5-micron or 15-micron disc filterconfiguration	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 fromsyringe to Vial	Internal performance standards
D2	Flow aspiration from Vialto 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 <788>

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.

Regulation Number and Section

§ 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.