The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

Device Description

The ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442).

This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs.

The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).

AI/ML Overview

The provided FDA 510(k) summary (K243976) for the ZeroClear™ Bag Access details the device and its intended use as a component of a Closed System Drug Transfer Device (CSTD). However, it does not contain the specific information requested regarding acceptance criteria and the comprehensive study details as outlined in the prompt (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, ground truth establishment, training set size).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (ProSeal™ Closed System Bag Access, K241988), primarily through functional performance, biocompatibility, and sterility testing against recognized standards. It highlights that no animal or clinical tests were deemed applicable for this submission.

Therefore, many of the requested fields cannot be directly populated from the provided text. Based on the document, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (as demonstrated by conformance to standards)
Functional Performance:
Airtightness & water leak integrity	Conforms to ISO 8536-4:2019, paragraph 7.2 and Annex 3
Tensile strength	Conforms to ISO 8536-4:2019, paragraph 7.3 and Annex A.4
Spike penetration force	Conforms to ISO 22413:2021, Section 6.6, Annex A.7
Spike protective cap integrity	Conforms to ISO 8536-4:2019, Section 7.13
Vapor containment	Conforms to NIOSH CSTD 2016 draft test protocol (from testing data on Subject device's NFV (LAV) connector)
Microbial ingress	Conforms to FDA guidance, ANSI AAMI CN27:2021 and ISO 80369-7:2021 (from testing data on device cleared under K223674/S001)
Particulate matter	Conforms to ISO 8536-4:2019 and USP <788>
Biocompatibility:	All tests performed on devices cleared under K151650, K223674/S001, demonstrating conformance to ISO 10993 series standards.
Cytotoxicity	Conforms to ISO 10993-5
Sensitization	Conforms to ISO 10993-10
Intracutaneous Reactivity	Conforms to ISO 10993-10
Acute Systemic Toxicity	Conforms to ISO 10993-11
14-day Subacute/Subchronic Acute Systemic Toxicity	Conforms to ISO 10993-11 (under K223674)
In-vitro Hemolysis Assessment	Conforms to ISO 10993-4
Material Mediated Pyrogenicity	Conforms to ISO 10993-11
Chemical Requirements	Conforms to ISO 15747, Annex B (on device under K223674)
Chemical Characterization and Toxicological Risk Assessment	Performed (under K151650)
Sterility, Shipping, & Shelf-Life:
Sterilization	Conforms to ISO 11135:2014 (evaluations conducted on devices cleared under K222929)
Simulated shipping	Conforms to ASTM D 4169-16
Package integrity (Seal strength)	Conforms to ASTM F88/F88M-21
Package integrity (Dye Penetration)	Conforms to ASTM F1929-23 and EN 868-5:2009
Pyrogen Tests	Conforms to ANSI/AAMI ST72/2019, USP 40 <151>, USP-NF <161>, USP-NF <85> (tests conducted on every lot)
Shelf-life	3 years, validated with ASTM 1980-21

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text for individual tests. The document mentions "testing data" but does not give specific numbers of devices or samples tested.
Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective. The manufacturer is Singapore-based, but testing could occur elsewhere.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the types of performance and safety tests conducted for this device (bench testing, biocompatibility, sterility). These tests do not involve expert interpretation or "ground truth" in the diagnostic or AI sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used for studies involving human interpretation or subjective assessment, which is not the case for the physical and biological tests described.

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. The device is a physical medical device (component of a CSTD), not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The ZeroClear™ Bag Access is a physical component, not an algorithm or software. Its performance is inherent to its design and materials, not a standalone algorithmic output. The performance tests mentioned (e.g., airtightness, microbial ingress) evaluate the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the functional, biocompatibility, and sterility tests, the "ground truth" is defined by the pass/fail criteria of the referenced international and national standards (ISO, ANSI AAMI, ASTM, USP, NIOSH). For example, a device either leaks or it doesn't, based on predefined measurable thresholds in the standards.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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January 22, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.

Epic Medical Pte. Ltd. Freddie Lee CEO/MD 105 Cecil Street #20-04, The Octagon Singapore, SG 069534 Singapore

Re: K243976

Trade/Device Name: ZeroClear™ Bag Access (423100) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: December 20, 2024 Received: December 23, 2024

Dear Freddie Lee:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Daniel Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243976

Device Name ZeroClear™ Bag Access (423100)

Indications for Use (Describe)

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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으킨 미

K243976- 510(k) Summary

I. Submitter

Epic Medical Pte. Ltd. 105 Cecil Street #20-04, The Octagon, Singapore 069534. Phone: +65 9635 2618 / +66 81 761 5292 Contact Person: Mr. Freddie LEE, Chief Executive Officer/ Managing Director Date Prepared: December 20, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special

II. Subject Device

510(k) Number:	K243976
Trade/ Device Name:	ZeroClearTM Bag Access
Common/ Usual Name:	Closed Antineoplastic and Hazardous Drug Reconstitution andTransfer System
Regulation Number:	21 CFR 880.5440
Regulation Name:	Intravascular administration set
Regulatory Class:	Class: II
Product Code:	ONB

Predicate III.

510(k) Number:	K241988
Trade/ Device Name:	ProSeal™ Closed System Bag Access
Common/ Usual Name:	Closed Antineoplastic and Hazardous Drug Reconstitution andTransfer System
Regulation Number:	21 CFR 880.5440
Regulation Name:	Intravascular administration set
Regulatory Class:	Class: II
Product Code:	ONB

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IV. Device Description

V. Indications for Use Statement

VI. Comparison of Intended Use & Technological Characteristics

The Subject device and the Predicate device share the following characteristics:

Intended Use comparison

1. Indications for use statements (similar)
1. Intended drug type

Single use or reusable, single patient use

1. Primary product code and regulation number
1. Intended user population/ intended use environment

Technological characteristics comparison Equivalencies - Technology & Design

The ZeroClear™ Bag Access and the Predicate device share the following design characteristics, and from the evaluation in the comparison table, there was no substantial difference from the Predicate device identified, that would raise a different question:

1. Principles of operation
1. Number of access points
1. Sterilization process
1. Shelf-life
1. Sterile barrier packaging

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GDIC

An overview table summarizing the comparison between the key characteristics between the Subject and the Predicate device is provided hereunder.

Characteristiccompared	Predicate Device (K241988)ProSeal™ Closed System Bag Access	Subject Device (K243976)ZeroClear™ Bag Access	Comment/Discussion
Intended useandIndications for Usestatement	"The ProSeal™ Closed System drug Transfer Device(CSTD) mechanically prohibits environmentalcontaminants from entering the system and theescape of drug or vapor concentrations from thesystem, thereby minimizing individual andenvironmental exposure to drug vapor, aerosols,and spills. The ProSeal™ system also prevents theintroduction of microbial contaminations into thedrug or fluid path for up to 7 days when used asintended."	"The ZeroClear™ Bag Access is a component of theProSeal™ Closed System drug Transfer Device(CSTD) system. The ProSeal™ CSTD mechanicallyprohibits environmental contaminants from enteringthe system and the escape of drug or vaporconcentrations from the system, thereby minimizingindividual and environmental exposure to drug vapor,aerosols, and spills. The ProSeal™ system alsoprevents the introduction of microbial contaminationsinto the drug or fluid path for up to 7 days when usedas intended."	Similar,Subject componentdevice's brand nameZeroClear™ isincluded in the IFUstatement
Primary product codeand regulation number	ONB21 CFR 880.5440	ONB21 CFR 880.5440	Same
Intended userpopulation/ intended useenvironment	Adequately trainedhealth care professionals including pharmacists/clinical setting	Adequately trainedhealth care professionals including pharmacists/clinical setting	Same
Intended drug type	Parenteral drugs	Parenteral drugs	Same
Single use or reusable	Single use only, single patient use	Single use only, single patient use	Same
Principlesof operation	The infusion bag is connected with the bagaccess and, in order to create a fluid pathconnection between the infusion bag and thebag access, they are connected with amatching component device incorporated witha compatible connector.All system components when connected, aresealed airtight and leakage-proof during thefluid transfer process. Transfer is performedthrough the connection of a matchingcomponent device incorporated with acompatible connector, for dispensing into thehuman veins.	The infusion bag is connected with the bag accessand, in order to create a fluid path connectionbetween the infusion bag and the bag access, theyare connected with a matching component deviceincorporated with a compatible connector.All system components when connected, are sealedairtight and leakage-proof during the fluidtransfer process. Transfer is performed throughthe connection of a matching component deviceincorporated with a compatible connector, fordispensing into the human veins.	Same
Characteristiccompared	Predicate Device (K241988)ProSeal™ Closed System Bag Access	Subject Device (K243976)ZeroClear™ Bag Access	Comment/Discussion
Numberof access points	Device has 2 access points:1. Spiking/ administration port, IV spike bagaccess2. Injection port/administration port, medicationaccess	Device has 2 access points:1. Spiking/ administration port, IV spike bagaccess2. Injection port/administration port, medicationaccess	Same
Compositionof fluid path materials	Spike material: Polypropylene (PP)Medication port material: polyisoprene (IR)and polypropylene (PP)	Spike material: Acrylonitrile Butadiene Styrene( (ABS) )Medication port material: acrylonitrilebutadiene styrene, polycarbonate, and silicone	Different,See Comment #1
Intendedconnector type to beused with the bag spikeadapter	Its ProSeal™ Injection Site port is intendedto be connected to Epic Medical Pte Ltdmanufacturer's cleared ProSeal™ Injectoror Injector Plus (K240433) male Luer locktip, connected to an external standardMLL syringe	The needle-free Luer activated valve port isdirectly connected to a component deviceincorporated with a standard male Luerconnector e.g. syringe without needle thatcomplies with ISO 80389-7:2021	Different,See Comment #1
Sterile barrier packaging	Medical grade paper andmedical plastic film, heat sealed	Medical grade paper andmedical plastic film, heat sealed	Same
Sterilization process	Ethylene Oxide (EO), SAL 10-6	Ethylene Oxide (EO), SAL 10-6	Same
Shelf-life validation	3 years (36 months)	3 years (36 months)	Same

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Discussion of difference in technological characteristics

Comment #1

Though the Subject device's bag spice and materials differ from the Predicat, the spile is of the same material the same subcomponents of the same materials) as the incorporated LAV in the cleared eZSURE " Empty Fluid Container (K223674). The materials of the spike and the LAV subasemby's subcomponents are with their corresponding cleared devices in formulation, processing, sterlization, and geometry. Pocessing is performed at the same modely processes at our US HDA registered establishment - Epo international (Thailand) Co. Ltd. - and no other chemicals are being additives, cleaning agents, mold release agents,

Functional tests, viz. the microbial ingress test per the ANSI AAM CN27:2021 and the ISO 80369-7:2021 had been conducted on the cleared device (K223674/800); and the leak megnty test per 130 8536-4:2019 had also been performed on the Subject device. Vapor contament test to NOSH 2016, Performance Test (draft) Protocol for Closed System Transfer Devices Used During Pharmacy and Administration of Hazardous Drugs had also been conducted for the Subject device 's the difference was considered and addressed in the vertication testing of the Subject device over its shelf life, to the aforementioned standards, and found it did not raise any new or different questions, its safety and effectiveness are assured.

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VIL. Performance Data Supporting Substantial Equivalence

A. Functional Performance

The Subject device in this Summary was evaluated to be in conformance with the following ISO and FDA recognized standards, and FDA guidance document:

ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated . into medical devices for intravascular applications
ISO 8536-4: 019, Infusion equipment for medical use Part 4: Infusion sets for single use, ● gravity feed
ISO 15747: 2018, Plastic containers for intravenous injections ●
ISO 22413:2010, Transfer sets for pharmaceutical preparations Requirements and test ● methods
ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare application -● Part 7, Connectors for intravascular or hypodermic application
. NIOSH 2016, Performance Test (draft) Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs
. Intravascular-Administration-Sets-Premarket-Notifications-[510(k)]---Guidancefor-Industry-and-FDA-Staff

Bench performance verifications and validations referred-to and performed:

Airtightness & water leak integrity tests (functional) per ISO 8536-4:2019, paragraph 7.2 and ● Annex 3, performed on Subject device
Tensile strength test (functional) per ISO 8536-4:2019, paragraph 7.3 and Annex A.4, . performed on Subject device
. Spike penetration force test (functional) - per ISO 22413:2021, Section 6.6, Annex A.7, performed on Subject device
Spike protective cap tests (functional) per ISO 8536-4:2019, Section 7.13, performed on ● Subject device
Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data . on the Subject device's NFV (LAV) connector
. Microbial ingress test per FDA guidance, ANSI AAMI CN27:2021 and ISO 80369-7:2021 (functional) from testing data on device cleared under K223674/S001
B. Biocompatibility

In accordance with ISO 10993-1:2018, the Subject device just like the existing ProSeal™ CSTD devices, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were performed on devices cleared under K151650,K223674/S001:

Cytotoxicity to ISO 10993-5 ●
Sensitization to ISO 10993-10 ●
. Intracutaneous Reactivity to ISO 10993-10
Acute Systemic Toxicity to ISO 10993-11 ●
14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K223674 ●
In-vitro Hemolysis Assessment to ISO 10993-4
Material Mediated Pyrogenicity to ISO 10993-11
. Chemical Requirements to ISO 15747, Annex B on device under K223674
Chemical Characterization and Toxicological Risk Assessment under K151650 .

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다. 이 대

Particulate matter testing was conducted on the Subject device, in accordance with ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed and USP <788> Particulate Matter in Injections.

C. Sterility, Shipping, and Shelf-Life

The Subject device complies with sterilization requirements of ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices and the following testing/ evaluations conducted on devices cleared under K222929;

Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing ● of Shipping Containers and Systems
Package Integrity Tests per ASTM F1980-21, Standard guide for accelerated aging of sterile . barrier systems for medical devices and Sterile Barrier Packaging Testing performed on the proposed device: Seal strength – ASTM F88/F88M-21. Standard test method for seal strength of flexible barrier materials: Dye Penetration - ASTM F1929-23. Standard test method for detecting seal leaks in porous medical device packaging by dye penetration: EN 868-5:2009, Packaging materials and systems for medical devices which are to be sterilized – Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction – Requirements and test methods
Pyrogen Tests per ANSI/AAMI ST72/2019, Bacterial endotoxins Test methods, routing . monitoring, and alternatives to batch testing, USP 40 <151>, Pyrogen test (USP rabbit test), USP-NF <161>, Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF <85>, Bacterial Endotoxins Test and testing will be conducted on every lot
Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

VIII. Clinical Tests

Not applicable.

IX. Conclusion

The difference between the Predicate and the Subject device does not raise any new or different questions of safety or effectiveness. The Subject device - ZeroClear™ Bag Access - is substantially equivalent to the Predicate device, ProSeal™ Closed System Bag Access (K241988) - with respect to its indications for use, principles of operation and technological characteristics.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.