S dispensing line

K192770 · Aea Srl · FMF · Dec 17, 2020 · General Hospital

Device Facts

• Record ID: K192770
• Device Name: S dispensing line
• Applicant: Aea Srl
• Product Code: FMF · General Hospital
• Decision Date: Dec 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The S Dispensing Line is intended for transfer of liquid drug from bag to syringes through the APOTECAsyringe automated system. The device is used inside an automatic system APOTEC Asyringe that tightens the tube with the syringe, while the connection with the bag is done manually. The transfer of liquid takes place by depression through the mechanical action on the piston of the syringe of a manipulator equipped with a gripping device.

Device Story

S Dispensing Line is a single-use, non-vented infusion set for transferring liquid drugs from bags to syringes. It is designed for use exclusively within the APOTECAsyringe automated compounding system. The device consists of a vented spike, PVC tubing, a check valve, and connectors. During operation, the spike is manually connected to a drug bag, while the automated system manipulates the syringe piston to create depression, drawing liquid through the line. A check valve prevents backflow. The device ensures secure connection to the syringe via a pressure connector. It is intended for use in clinical or pharmacy settings where automated compounding is performed. By automating the transfer process, the device reduces manual handling, potentially improving accuracy and sterility during drug preparation.

Clinical Evidence

No clinical data. Bench testing only. Performance testing confirmed connection integrity, absence of leakage, and durability after 100 usages. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility, all complying with ISO 10993 standards. Sterilization validation performed per ISO 11135.

Technological Characteristics

Non-vented infusion set. Materials: ABS (spike, connector), LDPE (cap), Polyethylene (vent), PVC D.E.H.P. Free (tubing, elbow), Silicone (check valve), Acrylic (check valve), Polycarbonate (luer slip). Complies with ISO 10993 series. Sterilized via ethylene oxide. Single-use, blister-packaged. Mechanical operation via automated system vacuum/piston manipulation.

Indications for Use

Indicated for the transfer of liquid drugs from a bag to syringes within the APOTECAsyringe automated system. No specific patient population, age, or disease state is defined.

Regulatory Classification

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.

Predicate Devices

• Rapid-Fill™ Tubeset (K022523)
• Exacta-Mix Administration Set (K002705)

Submission Summary (Full Text)

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December 17, 2020

AEA srl Michele Mengoni Quality & Regulatory via Fiume 16 Angeli di Rosora, 60030 It

Re: K192770

Trade/Device Name: S dispensing line Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: December 10, 2020 Received: December 16, 2020

Dear Michele 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. 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 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

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CAPT Alan Stevens Acting 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) K192770

Device Name S Dispensing Line

#### Indications for Use (Describe)

The S Dispensing Line is intended for transfer of liquid drug from bag to syringes through the APOTECAsyringe automated system. The device is used inside an automatic system APOTEC Asyringe that tightens the tube with the syringe, while the connection with the bag is done manually. The transfer of liquid takes place by depression through the mechanical action on the piston of the syringe of a manipulator equipped with a gripping device.

| Type of Use (Select one or both, as applicable) |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

Thefollowing510(k)summaryhasbeenpreparedpursuanttorequirementsspecifiedin21 CFR807.92.

# I SUBMITTER

AEA SRL ViaFiume, 16AngelidiRosa60030AnconaItaly Phone: [phone] Contact Person: Michele Mengoni Date prepared: December 10th , 2020

## II DEVICE

| TradeNames: | S dispensing line |
|-----------------------|----------------------------------------------------------|
| CommonorUsualNames: | Intravascular administration set |
| Classification Names: | Set, IV Fluid Transfer |
| Regulation Numbers: | Sdispensingline: 880.5440-Intravascularadministrationset |
| Regulatory Class: | II |
| ProductCodes: | S dispensing line: LHI |
| PanelIdentification: | General Hospital |

## III PREDICATE DEVICES

| S dispensing line | Predicate device | Predicate device |
|-------------------|---------------------|----------------------------------|
| Trade Name: | Rapid-Fill™ Tubeset | Exacta-Mix<br>Administration Set |
| 510(k) number: | K022523 | K002705 |

# IV DEVICE DESCRIPTION

Sdispensinglineisadevice for the transferofiquids, with the purpose of preparation of in drugs. The device is intended to be used with APOTECAsyringe automatic compoundingsystem.

Thedeviceissingleuse, sterilizedbyEOandsingle-packagedinablister. The device is not manufactured with natural rubber latex.

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Medical grade plastics are used, according to ISO 10993 series standards.

The device has the same intended use and the same technological characteristics as its predicate devices.

Sdispensingline is a non-vented infusion setused as a connecting part be rock syringe without hypodermic needle. The tip in contact with the syringe must perfectly by means of a pressure connector (not by screwind). in ordertoavoidloss ofmedication; the connectoris to be assembled atthe endof the line.

The short line enables the transfer of drug from a bag to a luer lock syringe through the APOTECAsyringe automated system.

The line is intended for the connection of the spike perforator; a check valve prevents the flow back towards thebag. Components and materials are reported in the following table.

| COMPONENT | MATERIAL |
|----------------------------------|----------------------------------------------------------------|
| Vented spike with protective cap | ABS (vented spike), LDPE (protective cap), Polyethylene (vent) |
| Tubing | PVC D.E.H.P. Free |
| Check valve | Silicone (internal part), Acrylic (upper and lower parts) |
| Straight connector | ABS |
| Elbow connector | PVC D.E.H.P. Free |
| Female luer slip connector | Polycarbonate |

## V INTENDED USE AND INDICATIONS FOR USE

The S dispensing line is intended for transfer of liquid drug from a bag to syringes through the APOTECAsyringe automated system.

The device is used inside an automatic system APOTECAsyringe that tightens the tube with the connection with the bagis done manually. The transfer of liquid takes place by depression through the piston of the syringe of a manipulator equipped with a gripping device.

## VI comparison of technological characteristics with The Predicate devices

S dispensing line has the intended use and the same technological characteristics of its predicate devices:

- . The S dispensing line has the same intended use of the predicated devices (K022523 and K002705).
- The S dispensing line and the predicate devices (K022523 and K002705) component materials comply with ISO 10993 ● as applicable to the intended use of the device.
- The S dispensing line hasvery similar design and materials of predicated devices (K022523 and K002705). .

The differences between the predicate devices and the subject devices include:

- The proximal end connector of the S dispensing line has been appropriately designed to be managed by APOTECAsyringe . compoundingsystemandatthesametimetofitwiththeluerlockofthesyringe used inside the automaticsystem.

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AEA srl Via Fiume 16,60030 Angelidi Rosora, AN (Italy) R.I. - C.F. - P. Iva 00686250424 [e-mail]

- The sterilization method for the proposed device S dispensing line is ethylene oxide whereas the sterilization method . for the predicate device is gamma irradiation.
The differences between proposed device and predicate devices do not raise any issues of safety and effectiveness.

#### VII. PERFORMANCE DATA

#### Non-Clinical Testing

AEA srl has performed non-clinicalion testing based on the risk analysis conducted, as summarized in the following tables. The favourable outcome of this testing demonstrates that the AEA proposed device performs in an equivalent manner to the predicate devices.

| Performance Characteristic | Acceptance Criteria/Standard | |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------|
| Performance Testing Ref.<br>Section 018<br>"Performance Testing-<br>Bench" | Right connection/absence of<br>ruptures between syringe tip and<br>connector after 100 usages | Right connection, no ruptures |
| | Absence of leakage during filling after<br>100 usages | No leakage |
| | Right disconnection/absence of<br>ruptures between syringe tip and<br>connector after 100 usages | Right disconnection, no ruptures |
| | Absenceofspillingafterthe<br>disconnection | No spilling |
| | Performance testing after real aging<br>(ongoing) | No change in performances after 3 years |
| | Test for particulate contamination | ISO 8536-4:2010 |
| | Test for leakage | ISO 8536-4:2010 |
| | Test for tensile strength | ISO 8536-4:2010 |
| | Test for the closure-piercing device | ISO 8536-4:2010 |
| | Test for transparency | ISO 8536-4:2010 |
| Biocompatibility Testing Ref.<br>Section 015<br>"Biocompatibility" | Cytotoxicity MEM | ISO 10993-5:2009, ISO 10993-12:2012 |
| | Elution test | |
| | Sensitization | ISO 10993-10:2010, ISO 10993-12:2012 |

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# AEA srl Via Fiume 16,60030 Angelidi Rosora, AN (Italy) R.I. - C.F. - P. Iva 00686250424 [e-mail]

| Performance Characteristic | | Acceptance Criteria/Standard |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | Guinea Pig Sensitization Test | |
| | Irritation or Intracutaneous Reactivity<br>Rabbit Intracutaneous reactivity | ISO 10993-10:2010, ISO 10993-12:2012 |
| | Acute Systemic Toxicity | ISO 10993-11:2017, ISO 10993-12:2012 |
| | Material-Mediated Pyrogenicity<br>Pyrogen Test (USP Rabbit Test) | USP 41-NF36:2018 <151> Pyrogen Test<br>(USP Rabbit Test) |
| | Hemocompatibility<br>Haemolysis test indirect contact | ISO 10993-4:2017, ISO 10993-12:2012 |
| | Particulate matters testing | USP 788 |
| | Sterilization Validation | ISO 11135:2014 |
| Sterilization and Shelf Life<br>Ref. Section 014<br>"Sterilization and Shelf Life" | Packaging Validation | Effective microbiological barrier, product sterility and<br>integrity preservation |
| | Shelf life - 3 years | Sterility and product integrity maintained over the<br>entire shelf life |
| | | Sterility and product integrity maintained over 3 year<br>shelf life |
| | | 3 year Real Time Study (Ongoing)<br>Accelerated Ageing Study completed |

## Clinical Testing

Clinical testing was not required for this submission.

#### Substantial Equivalence

The S dispensing line is substantially equivalent to the predicate devices in intended use, principles of operation, technology, design, materials and performance.

## VII CONCLUSION

Results of performance and biocompatibility testing conducted on the proposed devices demonstrate that the is substantially equivalent to the predicate devices.