The APOTECA® Drug Compounding Dosing Device is indicated for use by pharmacists or other healthcare professionals for the preparation of chemotherapy drugs, for the transfer of drug from vials to IV bag for infusion. The drug transfer through the device can be performed manually or through an automatic pharmacy compounding system. The specific assembly configuration of the needle allows a robotic arm to manage the device and an automatic dosing device to transfer drug from a vial to a bag by applying pressure on the syringe plunger. The APOTECA® Drug Compounding Dosing Device is intended for use with APOTECAchemo automatic compounding system or for manual drug compounding.

The APOTECA® I.V. Transfer Set is a non-vented infusion set indicated to be used as a connecting part between the IV bag and an external IV line when the drug preparation is performed through an automatic pharmacy compounding system. The APOTECA® I.V. Transfer Set is intended for use with APOTECAchemo automatic compounding system.

Device Description

The APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set is a system for preparation and administration of drugs intended for use with APOTECAchemo automatic compounding system.

APOTECA® Drug Compounding Dosing Device: a single use piston syringe that consists of a syringe (3ml, 5ml, 10ml, 20ml, 50ml) with a luer lock connector bonded to a needle. The syringe consists of a plastic barrel with a graduated scale, a synthetic rubber stopper and a plastic plunger rod. The needle is a Huber point non-coring needle with 16G thin wall cannula (0.5" plus 0.5" inside the vented hub). The device is not manufactured with natural rubber latex. The device is designed to be handled manually or by automatic pharmacy compounding system for the preparation and admixture of drugs in healthcare establishments.

APOTECA® I.V. Transfer Set: a non-vented infusion set used as a connecting part between an IV bag and an external infusion line. The device comprises of the following components: Non-vented spike, Connecting tube, Spike port adaptor with Twist-Off cap and safety membrane, Luer lock adaptor with protective cap.

AI/ML Overview

The provided 510(k) summary for the APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set details performance data primarily related to biocompatibility and basic physical properties, rather than diagnostic accuracy or comparative effectiveness with human readers. This device is a medical fluid transfer system, not an AI/ML-based diagnostic tool. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable to the information provided.

However, I can extract the acceptance criteria and reported performance for the characteristics that were evaluated.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Test	Acceptance Criteria	Reported Device Performance
Hemolysis	ISO 10993-4:2002/A:2006	Non-Toxic	Non-Toxic
Cytotoxicity	ISO 10993-5:1999	Non-Toxic	Non-Toxic
EO Residual	ISO 10993-7:2008	< Limit per device	< Limit per device
Systemic Toxicity, Pyrogenicity	ISO 10993-11:2006	Non-Toxic	Non-Toxic
Intracutaneous Reactivity	ISO 10993-10:2002	Non-Irritant	Non-Irritant
Leak proof Connections	Fluorescein Test	No Leaks	No Leaks
Airtight Connections	TiCl4 Test	No Visible Smoke	No Visible Smoke
Sterilization Assurance Level	ISO 11135-1:2007	SAL of 10^-6	SAL of 10^-6
Bacterial Endotoxins	USP <85>	Pass	Pass

2. Sample sized used for the test set and the data provenance:
The document does not specify the exact sample sizes for each bench test conducted for the APOTECA® devices. The tests were "bench tests" performed based on risk analysis to verify the device's compatibility with the APOTECAchemo automatic pharmacy compounding system and general safety. Data provenance (country of origin, retrospective/prospective) is not applicable to these types of bench tests, as they are laboratory evaluations of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/ML-based diagnostic device requiring expert consensus for ground truth. The performance data relates to material biocompatibility and physical integrity, evaluated through standardized laboratory tests.

4. Adjudication method for the test set:
Not applicable. See point 3.

5. 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:
Not applicable. This is not an AI/ML-based diagnostic device, so MRMC studies involving human readers and AI assistance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system. Its performance relates to its physical and material properties.

7. The type of ground truth used:
For biocompatibility tests (Hemolysis, Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, EO Residual, Bacterial Endotoxins), the "ground truth" is defined by the objective pass/fail criteria established by international standards (ISO, USP) for specific biological responses or chemical levels. For physical tests (Leak proof, Airtight), the "ground truth" is observable evidence of passage (leaks, smoke) or lack thereof.

8. The sample size for the training set:
Not applicable. This is not a machine learning device and therefore does not have a "training set."

9. How the ground truth for the training set was established:
Not applicable. See point 8.

Summary

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APOTECA

510(k) Summary K132011

1.	Submitter Information
	Company Name:	AEA SRL
	Company Address:	Via Fiume 16, Angeli di Rosora, Ancona, 60030, Italy
	Company Phone:	0039-0731-8161
	Company Fax:	0039-0731-816700
	Contact Person:	Michele MengoniQuality Assurance & Regulatory AffairsLoccioni Humancare
	Date Summary Prepared:	June 6, 2013
2.	Device Identification
	Trade Name:	APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set
	Common Name:	IV Fluid Transfer Set
	Classification Name	Set, IV Fluid Transfer
	Regulatory Class:	Class II
	Regulation Number:	APOTECA® Drug Compounding Dosing Device: 21 CFR 880.5860APOTECA® I.V. Transfer Set: 880.5440
	Product Code:	APOTECA® Drug Compounding Dosing Device: FMFAPOTECA® I.V. Transfer Set: LHI
	Panel Identification	General Hospital
3.	Predicate Devices
	Trade Name:	Becton Dickinson Single Use Hypodermic Syringes
	Manufacturer:	Becton, Dickinson and Company
	510(k) Number	K110771, K980987
	Trade Name:	Two-Fer™ Non-Coring Huber Point Needle
	Manufacturer:	BAXA CORP. Englewood CO
	510(k) Number	K832347
	Trade Name:	TEVADAPTOR™ Spike Port Adaptor
	Manufacturer:	Teva Medical Ltd. (Migada Plant)
	510(k) Number	K071741
	Trade Name:	TEVADAPTOR™ Connecting Set
	Manufacturer:	Teva Medical Ltd. (Migada Plant)
	510(k) Number	K071741
	Trade Name:	PhaSeal® Secondary Set
	Manufacturer:	Carmel Pharma AB.
	510(k) Number	K980381
	Trade Name:	Exacta-Mix 2400 Compounding System Administration Set
	Manufacturer:	BAXA CORP. Englewood CO
	510(k) Number:	K002705

LOCCIONI

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4. Device Description

The APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set is a system for preparation and administration of drugs intended for use with APOTECAchemo automatic compounding system.

APOTECA® Drug Compounding Dosing Device

The APOTECA® Drug Compounding Dosing Device is a single use piston syringe that consists of a syringe (3ml, 5ml, 10ml, 20ml, 50ml) with a luer lock connector bonded to a needle. The syringe consists of a plastic barrel with a graduated scale, a synthetic rubber stopper and a plastic plunger rod. The needle is a Huber point non-coring needle with 16G thin wall cannula (0.5" plus 0.5" inside the vented hub). The device is not manufactured with natural rubber latex. The device is designed to be handled manually or by automatic pharmacy compounding system for the preparation and admixture of drugs in healthcare establishments.

The change from the predicate devices is limited to its assembly configuration.

The APOTECA® Drug Compounding Dosing Device is provided sterile by EO sterilization method.

APOTECA® I.V. Transfer Set is a non-vented infusion set used as a connecting part between an IV bag and an external infusion line.

The device comprises of the following components:

. Non-vented spike
Connecting tube .
. Spike port adaptor with Twist-Off cap and safety membrane
. Luer lock adaptor with protective cap

The APOTECA® I.V. Transfer Set with a spike port adaptor is intended for the connection to the spike port of an IV infusion line. The short tubing enables the transfer of drug in a bag to a delivery set in the hospital ward.

The APOTECA® I.V. Transfer Set with a luer lock adaptor enables the connection of the female luer port of an intravenous infusion line for direct drug transfer.

The APOTECA® I.V. Transfer Set with UV resistant connecting tube is indicated to be used with photosensitive drugs,

All devices are packaged sterile.

5. Intended Use

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APOTECA

Technological Characteristics Comparison to Predicate Device 6.

A comparison of the technological characteristics of APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set and the predicate devices has been performed. The APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set is Substantially Equivalent to the predicate devices, qiven that:

The APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set has the same V intended use as the predicate device.
The APOTECA® Drug Compounding Dosing Device syringe use an identical design and > identical materials as the predicate device.
The APOTECA® Drug Compounding Dosing Device needle use an identical design and > identical materials as the predicate device.
V The APOTECA® Drug Compounding Dosing Device and the predicate devices meet the requirements for manual use and use with power-driven pumps as defined by ISO 7886-1 and ISO 7886-2 respectively.
The APOTECA® Drug Compounding Dosing Device and the predicate devices are made of medical grade polypropylene compatible with cytotoxyc drugs.
The APOTECA® Drug Compounding Dosing Device and the predicate device cannula are made of stainless steel AISI 304.
The APOTECA® I.V. Transfer Set has the same components and materials as the predicate devices
The APOTECA® I.V. Transfer Set has the same fitting connection to external standard IV bag as the predicate devices
The APOTECA® I.V. Transfer Set has the same fitting connection to external standard IV line as > the predicate devices
The materials of the components of the APOTECA® Drug Compounding Dosing Device and I.V. > Transfer and of the predicate devices comply with ISO 10993 as applicable to the intended use of the devices.
The APOTECA® Drug Compounding Dosing Device and I.V. Transfer demonstrated > equivalence performances to the predicate devices.

7. Performance Data

A product risk analysis was conducted according to ISO 14971:2007 and there were no new issues of safety and effectiveness. Bench tests were performed based on risk analysis to verify that the APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set can be handled by the APOTECAchemo automatic pharmacy compounding system for drug preparation.

Performance Characteristic	Test	Acceptance Criteria
Hemolysis	ISO 10993-4:2002/A:2006	Non-Toxic
Cytotoxicity	ISO 10993-5:1999	Non-Toxic
EO Residual	ISO 10993-7:2008	< Limit per device
Systemic Toxicity, Pyrogenicity	ISO 10993-11:2006	Non-Toxic
Intracutaneous Reactivity	ISO 10993-10:2002	Non-Irritant

Biocompatibility testing included the following:

The additional tests referenced in the table below have been provided. AEA has included the additional airtight and leak proof requirements as both of these requirements are cited by the National Institute of Occupational Safety and Health (NIOSH) and the International Society Of Oncology Pharmacy Practioners (ISOPP)

Performance Characteristic	Test	Result
Leak proof Connections	Fluorescein Test	No Leaks
Airtight Connections	TiCl4 Test	No Visible Smoke

Document : 510(k) Summary - APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set

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Conformance of Standards 8.

In terms of Physical Specification, Chemical Specification, Biological Specification, Packaging & Sterilization Specification, the submitted device conforms to applicable standards as described in the Conformance of Standards Summary Report

Additional Safety Information ക്

Sterilization conditions have been validated in accordance with ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. The device is sterilized to a SAL of 10 °. Bacterial Endotoxins test has been performed according to USP <85>.

10 Conclusion

The APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set has the same intended use as the predicate devices for the preparation and administration of parenteral drugs and has equivalent performance characteristics. The device submitted is therefore substantially equivalent to predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2014

AEA SRL C/O Mr. Michele Mengoni Quality Assurance & Regulatory Affairs Via Fiume 16, Angeli di Rosora Ancona, 60030 ITALY

Re: K132011

Trade/Device Name: APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set

Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, LHI Dated: March 10, 2014 Received: March 13, 2014

Dear Mr. Mengoni:

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. 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.

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Page 2 - Ms. Mengoni

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a bold, sans-serif font. Below the name, there is some faded text that is difficult to read. The letter "-S" is on the bottom left of the image.

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ K132011

APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set Device Name:

Indications For Use:

APOTECA® Drug Compounding Dosing

APOTECA® I.V. Transfer Set

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman Date: 2014.03.21 08:22:53 -04'00'

Page 1 of

Document : Indicable for Use - APOTECA® Drug Compounding Dosing Device and LV. Transfer Sel

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).