(285 days)
Not Found
No
The summary describes a disposable tubing set for automated pharmacy compounding, focusing on material properties, sterilization, and performance metrics related to fluid transfer accuracy and integrity. There is no mention of AI or ML.
No
The device is described as a disposable medical device used for the transfer of liquids for pharmacy compounding, not for direct therapeutic treatment or diagnosis of a condition.
No
The device is described as a disposable medical device used for the transfer of liquids for pharmacy compounding, not for diagnosing medical conditions.
No
The device description explicitly states it is a "disposable medical device" and describes physical components like a "sterile tube" and "terminal connectors," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the transfer of liquids (solvent, drug) for pharmacy compounding within an automated system (APOTECAbag). This is a process related to preparing medications for administration to patients.
- Device Description: The description reinforces this, stating it's a "disposable medical device used for the transfer of liquids from an initial container to a final one" for "pharmacy compounding."
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to perform tests on biological samples (like blood, urine, tissue) to gain information about a person's health status. This device's function is purely for the preparation of medications, not for diagnostic testing.
N/A
Intended Use / Indications for Use
B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system.
B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system.
B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system.
B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system.
B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device. These devices are not to be used for the compounding of chemotherapy and oncology drugs.
Product codes
LHI, NEP
Device Description
B Dispensing Line is a disposable medical device used for the transfer of liquids from an initial container to a final one, by means of the action of a peristaltic pump. It is a sterile tube, with sections designed to be inserted in peristaltic pump and with specific terminal connectors for the connection of the device with the different containers.
The tube section to be inserted in the peristaltic pump presents a larger diameter than the other sections of tube.
The device is intended to be used with the purpose of pharmacy compounding in the automated system APOTECAbag.
The device is manufactured with biocompatible materials and it is provided sterile by EO sterilization method.
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
Health-care personnel, specifically trained in injectable drug manipulation and compounding
Hospital pharmacy, inside APOTECAbag (PCD). ISO 5 environment
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)
Non-Clinical Testing:
Performance test (in APOTECAbag) - PASS, Acceptable dosage time and accuracy, No leakage, Right disconnection, no ruptures, Ability to maintain acceptable performances after prolonged used, Dosage accuracy
Dose accuracy and repeatability - PASS, Acceptable dosage accuracy, mean and maximum error in the limits imposed by US Pharmacopoeia, Ability to maintain performances after prolonged use
Leakage test - PASS, standard ISO 8536-9
Tensile stress test - PASS, standard ISO 8536-9
Test for transparency - PASS, standard ISO 8536-9
Drug Compatibility - PASS, No adverse compatibility effects
Biocompatibility Testing:
Cytotoxicity MEM Elution - PASS, standards ISO 10993-5:2009, ISO 10993-12:2012
Acute Systemic Toxicity - PASS, standards ISO 10993-11:2017, ISO 10993-12:2012
Guinea Pig Sensitization Test - PASS, standards ISO 10993-10:2010, ISO 10993-12:2012
Haemolysis test direct and indirect contact - PASS, standards ISO 10993-4:2017, ISO 10993-12:2012
Pyrogen Test on rabbits - PASS, standard USP 41-NF36:2018 Pyrogen Test (USP Rabbit Test)
Rabbit Intracutaneous injection test - PASS, standards ISO 10993-10:2010, ISO 10993-12:2012
Bacterial Endotoxins Test - PASS, standard USP 41-NF36:2019 Bacterial Endotoxins Test;
Particulate contamination - PASS, standard ISO 8536-4
Chemical characterization - PASS, standard ISO 8536-4
Particulate Matter for Injections - PASS, standard USP (Method 1 Light Obscuration Particle Count Test)
Sterilization and Shelf Life Testing:
Packaging Validation - PASS, Effective microbiological barrier, product sterility and integrity preservation
Sterilization Validation - PASS, standard ISO 11135:2014
Shelf life, Real time - Ongoing, Sterility and product integrity maintained over the entire shelf life
Labelling validation - PASS, Correctness and completeness of labeling
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
September 27, 2021
AEA srl Michele Mengoni Quality Assurance & Regulatory Affairs Via Fiume 16 Angeli de Rosora, Ancona 60030 Italy
Re: K203674
Trade/Device Name: B Dispensing Line Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI, NEP Dated: August 5, 2021 Received: August 26, 2021
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
1
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 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) K203674
Device Name B Dispensing Line
Indications for Use (Describe)
B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system.
B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system.
B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system.
B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system.
B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device. These devices are not to be used for the compounding of chemotherapy and oncology drugs.
| 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
LOCCIONI
510k K203674 - Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.
I. SUBMITTER
AEA SRL Via Fiume, 16 Angeli di Rosa 60030 Ancona Italy Phone: 0039-0731-816689 Contact Person: Michele Mengoni Date prepared: September 27th, 2021
II. DEVICE
| Name of device: | B Dispensing Line |
|---|---|
| Common or Usual Name: | IV Fluid Transfer Set |
| Classification Name: | Set, IV Fluid Transfer |
| Regulation Number: | 880.5440 - Intravascular administration set |
| Regulatory Class: | II |
| Product Code: | LHI – NEP (Secondary product code) |
| Panel Identification: | General Hospital |
III. PREDICATE DEVICE
KIRO Set (510k Number: K152441, Regulation number: 880.5440, Product code: LHI)
| Subject device: B Dispensing Line |
|---|
| Traditional 510(k) |
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LOCCIONI
IV. DEVICE DESCRIPTION
B Dispensing Line is a disposable medical device used for the transfer of liquids from an initial container to a final one, by means of the action of a peristaltic pump. It is a sterile tube, with sections designed to be inserted in peristaltic pump and with specific terminal connectors for the connection of the device with the different containers.
The tube section to be inserted in the peristaltic pump presents a larger diameter than the other sections of tube.
The device is intended to be used with the purpose of pharmacy compounding in the automated system APOTECAbag.
The device is manufactured with biocompatible materials and it is provided sterile by EO sterilization method.
| List of products/variants | Code | UDI-DI |
|---|---|---|
| B Recon Line | BDL-01 | 5060304050830 |
| B Double Filling Line | BDL-02 | 5060304050847 |
| B Filling Line | BDL-03 | 5060304050854 |
| B Recon Line with needle | BDL-04 | 5060304050878 |
| B Double Filling Line with vial needle | BDL-05 | 5060304050885 |
| B Filling Line for bag | BDL-06 | 5060304050892 |
Six different variants of the device are available:
V. INDICATION FOR USE
B Recon Line (BDL-01)
B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line (BDL-02)
B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system.
B Filling Line (BDL-03)
B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system.
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B Recon Line with needle (BDL-04)
B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line with vial needle (BDL-05)
B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system.
B Filling Line for bag (BDL-06)
B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system.
B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device.
These devices are not to be used for the compounding of chemotherapy and oncology drugs.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
| | B Dispensing Line (BDL-01,
BDL-02, BDL-03, BDL-04, BDL-
05, BDL-06) | KIRO set | Differences |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BRIEF
DESCRIPTION
AND INTENDED
USE | B Dispensing Line is a single-use
transfer set device intended to
be used by pharmacists as
disposable in an automated
drug compounding systems,
called APOTECAbag. Six
different variants of the device
exist:
B Recon Line (BDL-01) and B
Recon Line with vial needle
(BDL-04) for the transfer of
solvent inside drug vials with
the purpose of
reconstitution of lyophilized
drugs B Double Filling Line (BDL-
02) and B Double Filling Line
with vial needle (BDL-05) for
the transfer inside a bag of
liquid drug and solvent B Filling Line (BDL-03) for the
transfer of drug from a vial
to a bag B Filling Line for bag (BDL-
06) for the transfer of liquid
drug from a bag to another
bag B Dispensing Line is provided of
a section compatible with a
peristaltic pump. | The KIRO Set is a sterile,
single-use disposable
ancillary device used with the
peristaltic pump in the KIRO
Oncology pharmacy
compounding device for the
transfer of fluids in the
preparation of final
medication containers and
the reconstitution of drug
vials in hospital pharmacies. | Same intended use:
transfer of fluids in
the preparation of
final medication
containers and the
reconstitution of drug
vials in hospital
pharmacies by means
of peristaltic pumps |
| PRODUCT CODE | LHI, NEP (Secondary Product
Code) | LHI, NEP (Secondary Product
Code) | Same |
| PHARMACY
COMPOUNDING
DEVICE
SPECIFIED | APOTECAbag | KIRO Oncology | Different |
| USE
ENVIRONMENT | Hospital pharmacy, inside
APOTECAbag (PCD). ISO 5
environment | Hospital pharmacy inside the
KIRO Oncology PCD ISO 5
environment | Same use
environment |
| | B Dispensing Line (BDL-01,
BDL-02, BDL-03, BDL-04, BDL-
05, BDL-06) | KIRO set | Differences |
| TARGET USERS | Health-care personnel,
specifically trained in injectable
drug manipulation and
compounding | Trained health-care
personnel | Same |
| TUBING | Medical Grade Polyvinylchloride
(PVC) | Medical Grade
Polyvinylchloride (PVC) and
Medicale Grade Silicone | Different |
| CONNECTOR
MATERIAL | ABS | ABS | Same |
| INFUSION
METHOD | Peristaltic pump | Peristaltic pump | Same |
| STERILIZATION | Ethylene Oxide | Gamma Radiation | Different |
| SINGLE USE | Yes | Yes | Same |
| INPUT
LINE
CONNECTOR(S) | B Recon Line: Vented Spike
B Double Filling Line: Vented Spike and Vented Microspike
B Filling Line: Vented Microspike
B Recon Line with vial: Vented Spike
B Double Filling Line with vial needle: Vented Spike and needle
B Filling Line for bag: Vented spike | Vented Spike or Male Luer | Same |
| OUTPUT
LINE
CONNECTOR(S) | B Recon Line: Vented Microspike
B Double Filling Line: Needle
B Filling Line: Needle
B Recon Line with vial: Needle
B Double Filling Line with vial needle: Needle
B Filling Line for bag: Needle | Male Luer Connector | Different |
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Differences discussion
B Dispensing Line and KIRO set have the same purpose, both are used for the compounding of drugs and reconstitution of vials containing lyophilized drugs by means of peristaltic pumps. The liquid transfer method is therefore the same. Reference and subject device have product code. The use environment and target users are the same except the systems in which they have to be used. To address this difference, performance tests of B Dispensing Line with APOTECAbag system have been performed.
KIRO Set and B Dispensing Line are both for single use and provided sterile. Both devices are provided of vented spikes and mini-spikes as input line connector
| Subject device: B Dispensing Line
| Traditional 510(k) | Section: 510 (k) Summary Rev.04 | VOL#:005 |
|---|---|---|
| ---------------------------------------------------------- | --------------------------------- | ---------- |
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Image /page/8/Picture/0 description: The image shows the word "LOCCIONI" in a bold, sans-serif font. The letters are all capitalized and are a dark red color. The background is white, which makes the text stand out.
The sterilization method is different, B Dispensing Line is provided sterile by means of EO sterilization cycle, while KIRO Set is sterilized using gamma radiations. A complete validation of sterilization method of B Dispensing Line has been performed according to standard ISO 11135.
The tube material is different, B Dispensing Line is made of PVC, while KIRO Set is made of PVC and silicone. To address this difference a drug compatibility analysis has been performed and a biocompatibility test campaign according to ISO 10993 has been performed.
The connector material (spikes, mini-spikes and luer connection) is the same.
As input connector B Double Filling Line with vial needle and a spike, KIRO Set is provided with spike and with male luer connectors. The material of connector in both devices is the same. As output line connector, KIRO Set is provided of male luer connector and B Dispensing Line is provided of a mini-spike (only B Recon Line) or needle (all the other models). The material of connector in both devices is the same. To address the difference of the output line connector performance tests according to ISO 8536-9 have been performed.
9
VII. PERFORMANCE DATA
Non-Clinical Testing
AEA srl has performed the following non-clinical/design verification testing based on the risk analysis conducted and the favourable outcome of these tests demonstrate that the AEA proposed devices perform in an equivalent manner to the predicate devices.
| TEST | CONCLUSIONS | ACCEPTANCE CRITERIA / STANDARD |
|---|---|---|
| Performance Testing | ||
| Performance test (in APOTECAbag) | PASS | Acceptable dosage time and accuracy |
| • No leakage | ||
| • Right disconnection, no ruptures | ||
| • Ability to maintain acceptable performances after prolonged used | ||
| • Dosage accuracy | ||
| Dose accuracy and repeatability | PASS | Acceptable dosage accuracy, mean |
| • and maximum error in the limits imposed by US Pharmacopoeia | ||
| • Ability to maintain performances after prolonged use | ||
| Leakage test | PASS | ISO 8536-9 |
| Tensile stress test | PASS | ISO 8536-9 |
| Test for transparency | PASS | ISO 8536-9 |
| Drug Compatibility | PASS | No adverse compatibility effects |
| Biocompatibility Testing | ||
| Cytotoxicity MEM Elution | PASS | ISO 10993-5:2009, ISO 10993-12:2012 |
| Acute Systemic Toxicity | PASS | ISO 10993-11:2017, ISO 10993-12:2012 |
| Guinea Pig Sensitization Test | PASS | ISO 10993-10:2010, ISO 10993-12:2012 |
| Haemolysis test direct and indirect contact | PASS | ISO 10993-4:2017, ISO 10993-12:2012 |
| Pyrogen Test on rabbits | PASS | USP 41-NF36:2018 Pyrogen Test |
| (USP Rabbit Test) | ||
| Rabbit Intracutaneous injection test | PASS | ISO 10993-10:2010, ISO 10993-12:2012 |
| Bacterial Endotoxins Test | PASS | USP 41-NF36:2019 Bacterial |
| Endotoxins Test; | ||
| Particulate contamination | PASS | ISO 8536-4 |
| Chemical characterization | PASS | ISO 8536-4 |
| Particulate Matter for Injections | PASS | USP (Method 1 Light Obscuration |
| Particle Count Test) | ||
| Sterilization and Shelf Life Testing | ||
| Packaging Validation | PASS | Effective microbiological barrier, product |
| sterility and integrity preservation | ||
| Sterilization Validation | PASS | ISO 11135:2014 |
| Subject device: B Dispensing Line
| Traditional 510(k) | Section: 510 (k) Summary Rev.04 | VOL#:005 |
|---|---|---|
| --------------------------------------------------------- | --------------------------------- | ---------- |
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| TEST | CONCLUSIONS | ACCEPTANCE CRITERIA / STANDARD |
|---|---|---|
| Shelf life, Real time | Ongoing | Sterility and product integrity maintained |
| over the entire shelf life | ||
| Labelling validation | PASS | Correctness and completeness of labeling |
Clinical Testing
Clinical testing was not required for this submission.
Substantial Equivalence
B Dispensing Line is substantially equivalent to the predicate device in its intended use, principles of operation, technology, design, materials and performance.
VIII. CONCLUSION
Results of performance and biocompatibility testing conducted on the proposed devices demonstrate that B Dispensing Line is substantially equivalent to the predicate devices.
| Subject device: B Dispensing Line
| Traditional 510(k) | Section: 510 (k) Summary Rev.04 | VOL#:005 |
|---|---|---|
| --------------------------------------------------------- | --------------------------------- | ---------- |