K Number
K201460
Device Name
Closed System Transfer Device
Date Cleared
2022-11-23

(904 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Closed System Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.
Device Description
The Closed System Transfer Device is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Closed System Transfer Device consists of a piston syringe set (Dispensing Connector), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), and Infusion Set.
More Information

No
The summary describes a mechanical closed system transfer device and does not mention any AI or ML components or functionalities.

No.
This device is designed to safely transfer drugs and prevent exposure to hazardous substances, not to directly treat a medical condition.

No
The device is described as a Closed System Transfer Device (CSTD) used for the preparation, reconstitution, compounding, and administration of drugs, particularly antineoplastic and hazardous drugs. Its primary function is to prevent environmental contamination and drug escape, not to diagnose medical conditions or analyze patient data.

No

The device description clearly outlines physical components (piston syringe set, vial adaptor, spike adaptor, infusion set) which are hardware, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for the "preparation, reconstitution, compounding and administration of drugs". This involves handling and delivering medications, not performing diagnostic tests on biological samples.
  • Device Description: The description details components like syringes, adaptors for vials and IV bags, and infusion sets. These are all consistent with drug handling and administration, not in vitro diagnostic procedures.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
  • Predicate Device: The predicate device (Equashield Closed System Drug Transfer Device) is also a CSTD, which is a drug delivery/handling device, not an IVD.

Therefore, this device falls under the category of a medical device used for drug preparation and administration, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Closed System Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.

Product codes

ONB

Device Description

The Closed System Transfer Device is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Closed System Transfer Device consists of a piston syringe set (Dispensing Connector), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), and Infusion Set.

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

Licensed Pharmacists/Health Care Professionals in Hospitals Clinics

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)

Nonclinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
The test results demonstrated that the proposed device complies with the following standards:

  • A ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements;
  • A ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings;
  • A ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use:
  • A ISO 8536-2:2010 Infusion equipment for medical use - Part 2: Closures for infusion bottles;
  • A ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Systems for single use, gravity feed;
  • A ISO 8536-12:2007 Infusion equipment for medical use - Part 12: Check valves;
  • ISO 10555-5:2013 Intravascular catheters --Sterile and single-use Catheters---Part5: A Over-needle peripheral catheter
  • A ISO 22413:2010 Transfer sets for pharmaceutical preparations - Requirements and test methods;
  • A ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

Biocompatibility testing was conducted in accordance with ISO 10993-1, including Acute Systemic Toxicity Test, Cytotoxicity Test Report, Hemolysis Test (Indirect contact), Hemolysis Test (Direct Contact), Intracutaneous Reactivity Test, Platelet Activation Test, Material Mediated Pyrogen Test, Skin Sensitization (Guinea Pig Maximization Test), Subacute Systemic Toxicity Test. Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.

Simulated Transportation Testing was conducted in accordance with ASTM D4169-16. DC13. Sterile Barrier Packaging Testing performed on the proposed device: Seal strength testing was conducted in accordance with ASTM F88/F88M-15; Dye Penetration testing was conducted in accordance with ASTM F1929-15. Shelf-life life of 3 years is validated using the FDA recognized standard ASTM F1980-21 for Accelerated Aging of Sterile Barrier System for Medical Devices.

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Particulate matter testing met the USP acceptance criteria.

Predicate Device(s)

K170706

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.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

November 23, 2022

Shinva Ande Healthcare Apparatus Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K201460

Trade/Device Name: Closed System Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: October 28, 2022 Received: October 28, 2022

Dear Ray Wang:

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.

1

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 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.

David Walloschek

David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. 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

2

Indications for Use

510(k) Number (if known) K201460

Device Name Closed System Transfer Device

Indications for Use (Describe)

The Closed System Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.

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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K201460 510(k) Summary

    1. Date of Preparation
      11/27/2022
    1. Sponsor

SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.

No.77 Development Zone North Road, New&Hi-Tech Zone, 255086 Zibo, Shandong, People's Republic Of China

Contact Person: XiaoLei Tian Position: R & D Director Tel: +086-533-3917816 Fax: +086-533-3917813 Email:tianxiaolei@andemed.com

  • Submission Correspondent 3.
    Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com

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Identification of Proposed Device 4.

Trade Name: Closed System Transfer Device Common Name: Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System Classification Name: Intravascular Administration Set Classification: II; Product Code: ONB; Regulation Number: 21 CFR 880.5440; Review Panel: General Hospital;

    1. Identification of Proposed Device K170706 - Equashield Closed System Drug Transfer Device (CSTD)
    1. Device Description

The Closed System Transfer Device is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Closed System Transfer Device consists of a piston syringe set (Dispensing Connector), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), and Infusion Set.

The model of each component listed in Table 1.

Table 1 Models listing

Components NameModels
Vial AdapterCSTD-A13, CSTD-A28, CSTD-A20
Spike AdapterCSTD-B1, CSTD-B2, CSTD-B3, CSTD-B4
Dispensing ConnectorCSTD-C5, CSTD-C10, CSTD-C30
Closed Infusion SetMSQ-W1-P1, MSQ-W3-P1, MSQ-W4-P1

7. Operation Principle

Connection of Vial adaptor, Spike adaptor and dispensing connector

Vial and infusion bag are respectively connected with Vial adaptor and spike adaptor, then in order to realize the connection between Vial and infusion bag, the Vial adaptor and spike adaptor are correspondingly connected with each matching end of the dispensing connector. All system components are sealed with resealing membranes, and elastomeric double membrane technology is used to ensure that there is no drug leakage at the connecting parts during the dispensing process. As a

5

power device, the double sealed syringe provides positive and negative pressure for the CSTD to realize the closed transfer of liquid medicine from the Vial to the infusion bag in the system.

Closed Infusion Set

The working principle of the infusion set is gravity infusion, which is connected with the indwelling needle or other connector. Under the action of gravity, the medicine is infused into human blood vessels through the infusion tube.

Drug Vapor Seal

Vial adaptor contains spike end and assembly end, there is an inverted structure at the puncture end, and there is a sealing element at the assembly end. After the Vial adaptor is matched with the vial, it can ensure that there is no leakage, and it is not easy to separate.

No.Final Combination ModelComponents Included in the Final Combinations
Closed Infusion Set
ModelSpike Adapter
ModelDispensing Connector ModelVial Adapter
Model
001W1-P1/B1/C5/A13MSQ-W1-P1CSTD-B1CSTD-C5CSTD-A13
002W1-P1/B1/C5/A20MSQ-W1-P1CSTD-B1CSTD-C5CSTD-A20
003W1-P1/B1/C5/A28MSQ-W1-P1CSTD-B1CSTD-C5CSTD-A28
004W1-P1/B1/C10/A13MSQ-W1-P1CSTD-B1CSTD-C10CSTD-A13
005W1-P1/B1/C10/A20MSQ-W1-P1CSTD-B1CSTD-C10CSTD-A20
006W1-P1/B1/C10/A28MSQ-W1-P1CSTD-B1CSTD-C10CSTD-A28
007W1-P1/B1/C30/A13MSQ-W1-P1CSTD-B1CSTD-C30CSTD-A13
008W1-P1/B1/C30/A20MSQ-W1-P1CSTD-B1CSTD-C30CSTD-A20
009W1-P1/B1/C30/A28MSQ-W1-P1CSTD-B1CSTD-C30CSTD-A28
010W1-P1/B2/C5/A13MSQ-W1-P1CSTD-B2CSTD-C5CSTD-A13
011W1-P1/B2/C5/A20MSQ-W1-P1CSTD-B2CSTD-C5CSTD-A20
012W1-P1/B2/C5/A28MSQ-W1-P1CSTD-B2CSTD-C5CSTD-A28
013W1-P1/B2/C10/A13MSQ-W1-P1CSTD-B2CSTD-C10CSTD-A13
014W1-P1/B2/C10/A20MSQ-W1-P1CSTD-B2CSTD-C10CSTD-A20
015W1-P1/B2/C10/A28MSQ-W1-P1CSTD-B2CSTD-C10CSTD-A28
016W1-P1/B2/C30/A13MSQ-W1-P1CSTD-B2CSTD-C30CSTD-A13
017W1-P1/B2/C30/A20MSQ-W1-P1CSTD-B2CSTD-C30CSTD-A20
018W1-P1/B2/C30/A28MSQ-W1-P1CSTD-B2CSTD-C30CSTD-A28
019W3-P1/C5/A13MSQ-W3-P1/CSTD-C5CSTD-A13
020W3-P1/C5/A20MSQ-W3-P1/CSTD-C5CSTD-A20
021W3-P1/C5/A28MSQ-W3-P1/CSTD-C5CSTD-A28
022W3-P1/C10/A13MSQ-W3-P1/CSTD-C10CSTD-A13

Table 2 Final Combinations List

6

023W3-P1/C10/A20MSQ-W3-P1/CSTD-C10CSTD-A20
024W3-P1/C10/A28MSQ-W3-P1/CSTD-C10CSTD-A28
025W3-P1/C30/A13MSQ-W3-P1/CSTD-C30CSTD-A13
026W3-P1/C30/A20MSQ-W3-P1/CSTD-C30CSTD-A20
027W3-P1/C30/A28MSQ-W3-P1/CSTD-C30CSTD-A28
028W4-P1/B3/C5/A13MSQ-W4-P1CSTD-B3CSTD-C5CSTD-A13
029W4-P1/B3/C5/A20MSQ-W4-P1CSTD-B3CSTD-C5CSTD-A20
030W4-P1/B3/C5/A28MSQ-W4-P1CSTD-B3CSTD-C5CSTD-A28
031W4-P1/B3/C10/A13MSQ-W4-P1CSTD-B3CSTD-C10CSTD-A13
032W4-P1/B3/C10/A20MSQ-W4-P1CSTD-B3CSTD-C10CSTD-A20
033W4-P1/B3/C10/A28MSQ-W4-P1CSTD-B3CSTD-C10CSTD-A28
034W4-P1/B3/C30/A13MSQ-W4-P1CSTD-B3CSTD-C30CSTD-A13
035W4-P1/B3/C30/A20MSQ-W4-P1CSTD-B3CSTD-C30CSTD-A20
036W4-P1/B3/C30/A28MSQ-W4-P1CSTD-B3CSTD-C30CSTD-A28
037W4-P1/B4/C5/A13MSQ-W4-P1CSTD-B4CSTD-C5CSTD-A13
038W4-P1/B4/C5/A20MSQ-W4-P1CSTD-B4CSTD-C5CSTD-A20
039W4-P1/B4/C5/A28MSQ-W4-P1CSTD-B4CSTD-C5CSTD-A28
040W4-P1/B4/C10/A13MSQ-W4-P1CSTD-B4CSTD-C10CSTD-A13
041W4-P1/B4/C10/A20MSQ-W4-P1CSTD-B4CSTD-C10CSTD-A20
042W4-P1/B4/C10/A28MSQ-W4-P1CSTD-B4CSTD-C10CSTD-A28
043W4-P1/B4/C30/A13MSQ-W4-P1CSTD-B4CSTD-C30CSTD-A13
044W4-P1/B4/C30/A20MSQ-W4-P1CSTD-B4CSTD-C30CSTD-A20
045W4-P1/B4/C30/A28MSQ-W4-P1CSTD-B4CSTD-C30CSTD-A28
  • Indication for Use: 8.
    Table 3 Indication For Use
CharacteristicProposed DevicePredicate Device
Closed System Transfer Device
(CSTD)
K201460Equashield Closed System Drug
Transfer Device (CSTD)
K170706
Indication For
UseThe Closed System Transfer Device
(CSTD) for preparation,
reconstitution, compounding and
administration of drugs, including
antineoplastic and hazardous drugs.
This closed system mechanically
prohibits the transfer of environmental
contaminants into the system and the
escape of drug or vapor concentrations
outside the system, thereby
minimizing individual and
environmental exposure to drug vapor,Closed System drug Transfer Device
(CSTD) for safe preparation,
reconstitution, compounding and
administration of drugs, including
antineoplastic and hazardous drugs.
This closed system mechanically
prohibits the transfer of
environmental contaminants into the
system and the escape of drug or
vapor concentrations outside the
system, thereby minimizing
individual and environmental

7

aerosols, and spills and also preventsexposure to drug vapor, aerosols,
microbial ingress.and spills and also prevents
microbial ingress up to 7 days.
Prescription
Only or Over
the CounterPrescription OnlyPrescription Only

Discussions of differences in Indications for Use statement

There are only editorial differences to the indications for use statement between the predicate and the subject device which do not change the indications.

  • Technological Characteristics 9.
Table 4 Technological Characteristics Comparison
------------------------------------------------------
ITEMProposed DevicePredicate Device K170706Remark
BiocompatibilityExternally communicating medical device,
blood path, indirectExternally communicating medical device,
blood path, indirectSame
Device TypeRx/Single UseRx/Single UseSame
Target UsersLicensed Pharmacists/Health Care
ProfessionalsLicensed Pharmacists/Health Care
ProfessionalsSame
EnvironmentHospitals ClinicsHospitals ClinicsSame
SterilizationEO SAL 10-6EO and Gamma SAL 10-6Same
System ComponentsVial Adaptor
Dispensing Connector
Spike Adaptor
Infusion SetVial Adaptor
Syringe Unit
Spike Adaptor
Luer Lock Connectors
IV Tubing set
Protective PlugDifference
  • See
    Comments
    #1 | |
    | Type of vials the device is
    compatible with | 13 mm vial neck size;
    28 mm vial neck size;
    20 mm vial neck size; | 13 mm vial neck size;
    28 mm vial neck size;
    20 mm vial neck size;
    20 mm vial neck size, and extra thick vial
    rubber stoppers (Concave stoppers); | Same | |
    | Mechanism of connection | Vial Adaptor will connection with Vial
    Dispensing Connector will connect with
    Vial Adaptor and Spike Adaptor at same
    time | Vial Adaptor will connection with Vial
    Syringe Unit will connect with Vial
    Adaptor and Spike Adaptor separately | Same
    Difference
  • See
    Comments
    #2 | |
    | Safety features to prevent
    contamination | IV infusion will connect with the IV bag
    Leak proof connector with Membranes
    (Septum) seal | IV tubing set will connect with the IV bag
    Leak proof connector with Membranes
    (Septum) seal | Same
    Same | |
    | | | Connector (pull the plunger) will provide the power for drug transfer. | plunger) will provide the power for drug transfer. | |
    | Drug Path | | Vial - Vial Adaptor - Dispensing Connector (connector and tube) – Spike Adaptor - IV bag | Vial - Vial Adaptor - Syringe Unit (Connector and Barrel of Syringe) - Spike Adaptor - IV bag | Difference
    See Comments #3 |
    | Materials | Vial Adaptor | Synthetic Rubber (Sealing element); PP (Body); | Polypropylene (Protective Cap)
    Polyisoprene (Septum)
    POM (External guiding ring)
    Silicon (Lubricant)
    ABS (Body)
    Hydrophobic Membrane (Membrane) | Difference
    See Comments #4 |
    | | Dispensing Connector | PP (Single channel needle seat, Double channel needle seat, barrel, plunger);
    ABS (Guide sleeve, Rubber plug holder);
    Stainless Steel SUS304 (Needle, Stainless steel heads);
    Synthetic Rubber (Piston, Sealing Ring);
    TPE (Tube); | Polypropylene (Syringe body, connector and housing);
    Stainless Steel (Plunger rod, screw, cannulas);
    Polyisoprene (Piston, septum);
    POM (Syringe lid, lid disc, needle compartment);
    Silicon (Seal ring, seal tube, lubricant);
    EPDM (O-ring);
    ABS (Handle); | |
    | | Spike Adaptor | PE (Protection Cap);
    PVC/PP (Air inlet with air filter and closure);
    ABS (Spike adaptor)
    Synthetic Rubber (Sealing element, Rubber plug); | Polypropylene (Clamp, Luer Cap, Protective cap (Spike));
    Polyisoprene (Septum);
    Silicon (Valve);
    ABS (Male luer lock, Female luer lock, Y-site, regulator, body (Spike Adaptor), Body (Luer lock adaptor));
    PVC (Tubing, drip chamber);
    Hydrophobic membrane (Membrane); | |
    | | IV Infusion | PE (Protective cap);
    ABS (Closure-piecing device, fluid filter shell, Male conical fitting);
    PVC (Air inlet, drip chamber);
    PP(Air inlet);
    PA/PES (fluid filter shell);
    ABS/synthetic rubber (Injection site);
    POM (Robert clamp);
    ABS/Silicon rubber (Closed Male luer, Needle-free Y connector, Check Valve); | Polypropylene (Clamp, luercap, protective cap (spike));
    Polyisoprene (Septum);
    Silicon (Valve);
    ABS (Male luer lock, female luer lock, Y-site, Regulating clamp, body (spike adaptor), body (luer lock adaptor));
    PVC (Tubing, Drip chamber);
    Hydrophobic Membrane (Membrane) | |
    | | Specification | Vial Adaptor | CSTD-A13 is for 13 mm vial neck size;
    CSTD-A28 is for 28 mm vial neck size; | VA-13/2 is for 13 mm vial neck size;
    VA-28/2 is for 28 mm vial neck size; |
    | | CSTD-A20 is for 20 mm vial neck size; | VA-20/2 is for 20 mm vial neck size;
    VA-20C/2 is for 20 mm vial neck size, and
    extra thick vial rubber stoppers (Concave stoppers); | | |
    | Dispensing
    Connector | CSTD-C5 is for 5 ml volumes;
    CSTD-C10 is for 10 ml volumes;
    CSTD-C30 is for 30 ml volumes; | SU-1/2 is for 1 ml volumes;
    SU-3/2 is for 3 ml volumes;
    SU-5/2 is for 5 ml volumes;
    SU-10/2 is for 10 ml volumes;
    SU-20/2 is for 20 ml volumes;
    SU-35/2 is for 35 ml volumes;
    SU-60/2 is for 60 ml volumes; | Similar-
    See
    Comments
    #5 | |
    | IV Infusion | Length: 2.38 m/2.555 m/2.535 m
    ID: 3.0±0.05mm
    OD: 4.0±0.05mm | Length: 1.15 m/ 0.48 m/ 0.23 m
    ID: 3.0±0.05mm
    OD: 4.0±0.05mm | Similar-
    See
    Comments
    #5 | |

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Difference Analysis:

Comments #1:

The proposed device does not include exactly same system components with the predicate device, there two main differences about component,

    1. The Dispensing Connector of proposed device has different design feature with the Syringe Unit of predicate device. We have conducted detailed analysis about this difference in Analysis 5 below.
    1. The predicate device includes two more components than proposed device, Luer Lock Connectors and Protective Plug.
    • . The Luer Lock Connectors (Male and Female) provide closed system and contamination-free protection to any standard luer lock ports, by converting them into a membrane sealed port, such as required when connecting two IV tubing segments (Secondary to Primary) or for safe injection of medication using the Syringe Unit (IV Push/Bolus). The two pieces lock together and can be released by simply pushing the lever.

As the function description for the Luer Lock Connector above, this component is used to administer an IV push, but the proposed device does not have this function, and it would not affect the Indication for Use of proposed device.

  • The protective plug is an accessory providing additional protection for Female Luer Connector or Syringe Unit port, such as for safe transportation with disabled movement of the syringe plunger.
    As the function description for the Protective Plug above, this component is used to seal the port of syringe unit to provide protective for prepared compounding or drugs in the syringe unit from microbial ingress up to 7 days as the Indication For Use claimed by predicate device. But the proposed device does not have the function, and it would not affect the Indication for Use of proposed device.

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Comments #2

The Mechanism of connection of proposed device is different with the Syringe Unit of predicate device. Both components are syringe-like design, but the "Dispensing Connector" is designed as two connectors (adapter ends) used to connect with Vial Adaptor and Spike Adaptor and prevents leaks & drug residuals on its surfaces, one connector (the one used to connect with Vial Adaptor) is factory welded to the syringe, another connector is used to connect with Spike Adaptor, two connectors are connected by a factory welded TPE tube. The dispensing connector will connect the vial and IV bag via vial adaptor and spike adaptor at same time, the drug will be transferred from vial to IV bag without passing through syringe.

But the "Syringe Unit" of predicate is designed as single motion connector used to connect with Vial Adaptor and prevents leaks & drug residuals on its surfaces and is factory welded to the syringe.

The syringe unit will connect vial via vial adaptor and transfer the drug into syringe first, and then inject the drug in the syringe into infusion bag via spike adaptor.

The main difference between these two components is the design of connector, two connectors VS. one connector.

The Dispensing Adaptor use two connectors could be connected with vial adaptor and spike adaptor at same time, in this way, the drug in vial can be transferred directly from the vial to the infusion bag through the two connectors and the connecting tube in between under the power provided by pulling syringe barrel, without separating the Dispensing Adaptor from the vial and the drug does not need to be withdraw into the syringe during the transfer process. This way can always keep the drug in a closed environment in the process of drug transfer, thus reducing the probability and risk of contaminants entering the drug.

The Syringe Unit use one connector, the syringe unit need to connect with vial adaptor first for withdrawal of drug from vial to syringe, and then the syringe unit need to separating from vial adaptor and to connect with spike adaptor for injection of drug in syringe to infusion bag.

As the discussion above, the design difference of two components causes the different operation process. But they share same operation principle, they both withdraw the drug form vial and transfer the drug to infusion bag to complete their claimed Indication for Use, which is preparation, reconstitution. compounding and administration of drugs. Because the design feature of dispensing adaptor, the transferred drug in this way has more effectiveness in reducing chance of exposure to contaminants, then we believe that this method can more effectively prevent the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system during the process, thereby to accomplish clamed Indication for Use, which is minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.

We have conducted the performance testing for the proposed device, the results shown that the proposed device could accomplish the drug transfer without drug leakage or exposure to contaminants, so we believe the proposed device has same effectiveness and safety with predicate device.

Comments #3

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The drug path of proposed device is different with the predicate device, which because the different Mechanism of connection, as described in analysis 3, we believe the proposed device has same effectiveness and safety with predicate device.

Comments #4

The materials used in each components of proposed device are not exactly same with the materials used in predicate device, for these difference, we have conducted biological evaluation as the guidance of Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", as the endpoints of contact level and duration, we have conducted tests of Acute Systemic Toxicity, Skin Sensitization, Intracutaneous Reactivity, Hemolysis. In Vitro Cytotoxicity, Pyrogen and Chemical Characterization Study. The tests results shown that the materials used in proposed device would not raise safety concerns.

Comments #5

The specification of Dispensing Connector and IV Infusion are similar with the predicate device, for this difference we have conducted the performance testing to Vial Adaptor and Dispensing Connector as ISO 22413, ISO 7886-1 and ISO 8536-4, the test results shown that the proposed device could meet the requirements of claimed.

So, this difference would not raise safety or effectiveness concerns.

10. Non-Clinical Test Conclusion

Nonclinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

The test results demonstrated that the proposed device complies with the following standards:

  • A ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements;
  • A ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings;
  • A ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use:
  • A ISO 8536-2:2010 Infusion equipment for medical use - Part 2: Closures for infusion bottles;
  • A ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Systems for single use, gravity feed;
  • A ISO 8536-12:2007 Infusion equipment for medical use - Part 12: Check valves;
  • ISO 10555-5:2013 Intravascular catheters --Sterile and single-use Catheters---Part5: A Over-needle peripheral catheter
  • A ISO 22413:2010 Transfer sets for pharmaceutical preparations - Requirements and test methods;
  • A ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

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    1. Biocompatibility
      In accordance with ISO 10993-1, the Closed System Transfer Device is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hrs to 30days). The following testing was conducted:
  • . Acute Systemic Toxicity Test

  • . Cytotoxicity Test Report

  • . Hemolysis Test (Indirect contact)

  • Hemolysis Test (Direct Contact

  • . Intracutaneous Reactivity Test

  • . Platelet Activation Test

  • Material Mediated Pyrogen Test

  • Skin Sensitization (Guinea Pig Maximization Test)

  • . Subacute Systemic Toxicity Test

Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.

    1. Sterility, Shipping and Shelf-Life
    • Simulated Transportation Testing was conducted in accordance with ASTM D4169-16 . DC13
    • Sterile Barrier Packaging Testing performed on the proposed device: .
      • o Seal strength testing was conducted in accordance with ASTM F88/F88M-15
      • o Dye Penetration testing was conducted in accordance with ASTM F1929-15
    • Shelf-life life of 3 years is validated using the FDA recognized standard ASTM F1980-21 . for Accelerated Aging of Sterile Barrier System for Medical Devices
    1. Clinical Test Conclusion

No clinical study is included in this submission.

    1. Conclusion
      Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device (K170706 - Equashield Closed System Drug Transfer Device (CSTD)) with respect to the indications for use, target population, treatment methods and technological characteristics.