The Halo® system is an airtight and leak proof closed system drug (CSTD) that 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. The Halo® system also prevents microbial ingress for up to 7 days.

Device Description

The Halo® is a Closed System Transfer Device (CSTD) for the safe handling of hazardous drugs, especially for the compounding and administering of hazardous drugs according to the National Institute for Occupational Safety and Health (NIOSH) definition of an airtight and leak proof closed system transfer device. It is a sterile singleuse device. There are five components of the Halo® system, Closed Vial Adaptor (CVA), Closed Syringe Adaptor (CSA), Closed Bag Adaptor (CBA), Closed Line Adaptor (CLA), and Closed Vial Converter (CVC). These components integrate with industry standard luer-lock syringes, IV bags, infusion sets, and other patient connections to form a complete closed system. This system 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. In addition, the components are designed to prevent microbial ingress into the system, including maintaining sterility of drugs in the vial for up to 7 davs. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

The system uses industry compatible luer locks, bag spikes and spike ports, dual lumen spikes, single lumen needles, and dry to dry compression fit seals when connecting Halo® components together. A single lumen needle perforates the dry-to-dry compression fit seals for the transfer of drugs between Halo® components. Upon separation the needle is retracted and the seal membrane prevents transfer of environmental contaminants into the system and/or escape of drug or vapor.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance testing for various aspects of the Halo® system. The acceptance criteria are generally qualitative ("No Leaks," "Pass") or by reference to established standards.

Acceptance Criteria / Test	Reported Device Performance
Product Functional Testing
Fluorescein Leak Test	No Leaks
Alcohol Vapor Leak Test	No Leaks
Pressure Test	No Leaks
Insertion (Connection) and Retention Force	Pass
ISO 594-1 Part 1: General Requirements	Pass
ISO 594-2 Part 2: Lock Fittings	Pass
ISO 8536-4 Infusion equipment for medical use: Part 4	Pass
Package Integrity and Shelf Life
ASTM F2096: Detecting Gross Leaks	All testing passed
ASTM F1886: Integrity of Seals	All testing passed
ASTM F88: Seal Strength	All testing passed
Biocompatibility
Cytotoxicity (ISO 10993-5)	All testing passed
Sensitization (ISO 10993-10)	All testing passed
Irritation (ISO 10993-10)	All testing passed
Systemic Toxicity (ISO 10993-11)	All testing passed
Hemocompatibility (ISO 10993-4)	All testing passed
Sterility
Pyrogenicity (AAMI/ANSI ST72)	All testing passed
Bioburden (ISO 11737-1)	All testing passed
EO Residuals (ISO 10993-7)	All testing passed
DMA Compatibility	Halo® was found to be compatible
Microbial Ingress Protection	Protected against microbial ingress for 7 days after 14 penetrations
Particulate Testing (USP 788)	Particulate levels are low and meet USP 788 requirements

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes (number of devices or tests performed) for each individual test conducted on the Halo® system. It implies that these tests were conducted as part of the regulatory submission (K180574 and referencing K150486).

Sample Size: Not explicitly stated for each test.
Data Provenance: The studies were conducted by J & J Solutions, Inc. d/b/a Corvida Medical and their testing partners for regulatory submission to the FDA. This is considered prospective data for the purpose of demonstrating substantial equivalence. The document doesn't specify the country of origin of the labs, but given the FDA submission, it's typically within the US or by labs adhering to US regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this type of device and study. The Halo® system is a medical device (Closed System Transfer Device) for safe handling of hazardous drugs. Its performance is evaluated through laboratory-based, objective performance testing against established engineering, biological, and chemical standards (e.g., ISO, ASTM, USP). There is no "ground truth" to be established by human experts in the context of diagnostic interpretation, as this is not a diagnostic device.

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as point 3. Adjudication methods are typically used in studies where human interpreters (e.g., radiologists, pathologists) determine a "ground truth" or make diagnoses, and discrepancies need to be resolved. The performance of the Halo® device is measured by quantitative and qualitative outcomes against predefined technical and safety specifications.

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

This section is not applicable. The Halo® system is a physical medical device, not an AI or diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. As stated above, this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Halo® device's performance is established through:

Engineering and Physical Test Standards: Compliance with ISO (e.g., ISO 594, ISO 8536), ASTM (e.g., F2096, F1886, F88), and USP (e.g., USP 788) standards. These standards define the expected physical and chemical properties and performance limits.
Biological Test Standards: Compliance with ISO 10993 series for biocompatibility and ISO 11135, ISO 11737-1, AAMI/ANSI ST72 for sterility.
Direct Measurement of Device Functionality: Observing and quantifying performance metrics like "no leaks" in fluorescein or alcohol vapor tests, "pass" for force measurements, and direct measurement of microbial ingress protection (e.g., 7 days protection after 14 penetrations).

8. The Sample Size for the Training Set

This section is not applicable. The Halo® system is a mechanical and biological device that is validated through physical and chemical testing, not through machine learning or AI. Therefore, there is no "training set" in the context of data-driven model development.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

August 17, 2018

J & J Solutions, Inc. d/b/a/ Corvida Medical Dana Schramm Chief Operating Officer 2945 Lone Oak Drive, Suite 150 Eagan, Minnesota 55121

Re: K180574

Trade/Device Name: Halo System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: July 2, 2018 Received: July 9, 2018

Dear Dana Schramm:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180574

Device Name Halo®

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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510(K) SUMMARY K180574

SUBMITTER

J & J Solutions, Inc. d/b/a Corvida Medical 2945 Lone Oak Drive, Suite 150 Eagan, Minnesota 55121

ESTABLISHMENT REGISTRATION NUMBER

3012235045

CONTACT

Dana Schramm Chief Operating Officer Ph. 319-335-2547 x103 Fax. 319-250-4135 dana.schramm@corvidamedical.com

DATE PREPARED

August 8, 2018

NAME OF MEDICAL DEVICE

Trade Name:	Halo®
Common/Usual Name:	Closed Antineoplastic and Hazardous Drug Reconstitutionand Transfer System
Classification Name:	Intravenous Administration Set

DEVICE CLASSIFICATION

Classification Panel:	General Hospital
Regulatory Class:	II
Product Code:	ONB
Regulation Number:	21 CFR 880.5440

MANUFACTURER

Corvida Medical 2945 Lone Oak Drive, Suite 150 Eagan, Minnesota 55121

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PREDICATE DEVICE

Trade Name:	Halo® (K150486)
Common/Usual Name:	Closed Antineoplastic and Hazardous Drug Reconstitutionand Transfer System
Classification Name:	Intravenous Administration Set

DEVICE DESCRIPTION

INDICATION FOR USE

The Halo® system is an airtight and leak proof closed system drug transfer device (CSTD) that 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. The Halo® system also prevents microbial ingress for up to 7 days.

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES

Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects. The proposed modified device is substantially equivalent to the predicate device and does not raise

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different questions of safety or effectiveness.

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	Proposed Device (K180574)	Predicate Device (K150486)
Indications for Use	The system is an airtight andleak proof closed system drugtransfer device (CSTD) thatmechanically prohibits thetransfer of environmentalcontaminants into the systemand the escape of drug orvapor concentrations outsidethe system, therebyminimizing individual andenvironmental exposure todrug vapor, aerosols andspills. The Halo® system alsoprevents microbial ingress forup to 7 days.	The system is an airtight andleak proof closed system drugtransfer device (CSTD) thatmechanically prohibits thetransfer of environmentalcontaminants into the systemand the escape of drug orvapor concentrations outsidethe system, therebyminimizing individual andenvironmental exposure todrug vapor, aerosols andspills. The Halo® system alsoprevents microbial ingress forup to 168 hours.
Classification	Class II	Class II
RegulationNumber	888.5440	888.5440
Product Code	ONB	ONB

Regulatory Classification, Risk, and Indications for Use

No differences in Regulatory Classification, Risk, or Indications for Use except for the conversion of 168 hours to 7 days for microbial ingress prevention claim.

Technological Characteristics

	Proposed Device (K180574)	Predicate Device (K150486)
SystemComponents	13mm Vial Adaptor (CVA130)	13mm Vial Adaptor (CVA130)
	20mm Vial Adaptor (CVA200)	20mm Vial Adaptor (CVA200)
	28mm Vial Adaptor (CVA280)	28mm Vial Adaptor (CVA280)
	Closed Syringe Adaptor (CSA100)	Closed Syringe Adaptor (CSA100)
	Closed Bag Adaptor (CBA100)	Closed Bag Adaptor (CBA100)
	Closed Line Adaptor (CLA100)	Closed Line Adaptor (CLA100)
	Closed Line Adaptor (CLA200G)	NA
	Closed Line Adaptor (CLA200B)	NA
	Closed Vial Converter(CVC130)	NA

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Characteristics	Closed System used to reconstitute, transfer, and administer antineoplastic and other hazardous drugs in healthcare setting. Indicated to reduce exposure of healthcare personnel and the surrounding environment to chemotherapy agents.	Closed System used to reconstitute, transfer, and administer antineoplastic and other hazardous drugs in healthcare setting. Indicated to reduce exposure of healthcare personnel and the surrounding environment to chemotherapy agents.
Principles of Operation	Multi-components intended to be used as a system.	Multi-components intended to be usedas a system.
Technological Characteristics	The proposed system consists of four main components that attach to standard drug vials, syringes, patient lines or secondary sets, and standard IV bags.	The predicate system consists of four main components that attach to standard drug vials, syringes, patient lines or secondary sets, and standard IV bags.
	The proposed CSTD system uses industry compatible luer lock, spike, and needle safe connections to form the closed systems for drug transfer.	The predicate CSTD system uses industry compatible luer lock, spike, and needle safe connections to form the closed systems for drug transfer.
	The proposed CSTD system uses polymer seals that prevent environmental contaminants from entering into the system and/or escape of drug or vapor. When system components are joined together the seals are pressed together and then pierced by needles. When disconnected, the polymer reseals to create a leak-proof and drug residual-free connection.	The proposed CSTD system uses polymer seals that prevent environmental contaminants from entering into the system and/or escape of drug or vapor. When system components are joined together the seals are pressed together and then pierced by needles. When disconnected, the polymer reseals to create a leak-proof and drug residual-free connection.
Device Type	Rx/Single Use	Rx/Single Use
Target Users	Licensed Pharmacists/Health Care Professionals	Licensed Pharmacists/Health Care Professionals
Environment	Hospitals and clinics	Hospitals and clinics
Sterilization	EtO / SAL 10-6	EtO / SAL 10-6

No differences in technological characteristics, system function, user
populations, use environment, or sterilization method.

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ChangedComponent	Change Description	Change Discussion on SE
Closed LineAdaptor (CLA)	Material -Polyethylene toPolypropylene	Changed component material to take advantage ofmolding and assembly productivity.Polypropylene's use in medical devices andCSTD's is well documented. This material changehas been fully tested for liquid escape, vaporescape, and biocompatibility. No differentquestions of safety or effectiveness are raised.
	Components –AddedLocking LineAdaptors CLA200G CLA200B	The CLA200 models incorporate a locking clip toprovide added retention to a patient's line. All otherdimensions are the same as the existing predicateCLA. No different questions of safety oreffectiveness are raised.
	Assembly CLA100 CLA200G CLA200B	The luer lock threads are now created by aninjection molded insert that is ultrasonicallywelded into the body. The predicate deviceconsisted of a single piece injection molded bodywith luer lock threads. No different questions ofsafety or effectiveness are raised.
Closed SyringeAdaptor (CSA)	Assembly	To take advantage of productivity andmanufacturing economies, changed CSA needlebond from injection over mold to UV curableadhesive. This design and manufacturing changehas been tested for liquid escape, vapor escape,and adhesive bond tensile and compressionstrength. No different questions of safety oreffectiveness are raised. All other features anddimension remain the same as the existingpredicate CSA.
13mm VialConverter(CVC130)	Component Addition	Added 13mm Vial Converter as an accessorycomponent that enables the use of the 20mmClosed Vial Adaptor with a 13mm capped vial.Test results establish that the CVC130 connectionperforms in a similar fashion to the referencedevices (CVA130 and CVA200). Assemblies weretested for liquid escape, vapor escape, attachmentand detachment force. No different questions ofsafety or effectiveness are raised.
Labeling	Labels and IFU's	Added labels and directions for the newcomponents. No different questions of safety oreffectiveness are raised.

Discussion of Design/Manufacturing Differences

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SUMMARY OF PERFORMANCE TESTING

Results from tests completed on the Halo® components demonstrate it to be an easy to use device that prevents microbial ingress and/or escape of drug or vapor through multiple reconnections of components up to 14 times and are substantially equivalent with respect to operational performance. Product testing consisted of the following:

Product Functional Testing	Results
• Fluorescein Leak Test	No Leaks
• Alcohol Vapor Leak Test	No Leaks
• Pressure Test	No Leaks
• Insertion (Connection) and Retention Force	Pass
• ISO594-1 Part 1: General Requirements	Pass
• ISO 594-2 Part 2: Lock Fittings	Pass
• ISO 8536-4 Infusion equipment for medical use: Part 4	Pass

Package Integrity and Shelf Life

Packaging and Shelf Life validation was performed on aged Halo® packaging according to ASTM F2096: Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization, ASTM F1886: Standard Test Method for Determining Integrity of Seals for Medical Device Packaging by Visual Inspection, and ASTM F88 standard test method for seal strength of flexible barrier materials. All testing passed.

Biocompatibilitv

Biocompatibility testing was performed on the Halo® materials according to FDA Guidance and ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility according to standards set forth in ISO 10993- 4, Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood, ISO 10993- 5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, and ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity. All testing passed. A chemical characterization and toxicological risk assessment was used to evaluate the subchronic systemic toxicity endpoint (see Extractables Screening section below).

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Sterility

Sterilization validation was performed on the finished Halo® components according to ISO 11135 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices. Testing included pyrogenicity, bioburden, and EO residuals to standards set forth in ISO 10993-7 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals, ISO 11737-1 Sterilization of medical devices --Microbiological methods -- Part 1: Determination of a population of microorganisms on products, and AAMI/ANSI ST72 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing. All testing passed.

DMA Compatibility

Compatibility testing was performed to validate Halo® compatibility with antineoplastic drugs and DMA(N,N-dimethylacetamid). Halo® was found to be compatible.

Extractables Screening

Extractables screening was completed to determine what compounds and their estimated concentrations are extracted from the Halo® Closed System Transfer Device for hazardous drugs (CSTD) under the conditions of the extractions (72 hours at 37°C) when extracted in the following solvents: hexane, 50% ethanol, pH 3 (HCI adjusted) 0.9% saline, and 33% aqueous dimethylacetamide (DMA). A toxicological risk assessment was performed on the extracted compounds.

Microbial Ingress Protection

Microbial ingress testing was performed on Halo® to validate microbial ingress protection after repetitive needle penetration of the seal. These test results were originally reported in K150486. Testing results demonstrate Halo® was protected against microbial ingress for a period of 7 days after breaching the seal 14 times with the CSA needle. All sealing features remain the same as the predicate devices and the design changes do not modify any of the sealing properties from the original predicate devices. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

Particulate Testing

Particulate contamination testing was performed on the Halo® system according to USP 788 to demonstrate lack of contamination. Testing results demonstrated particulate levels in the Halo system are low and meet USP 788 requirements.

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Substantial Equivalence Conclusion

Performance testing established that the proposed Halo® devices performed substantially equivalent (SE) to the performance testing on the predicate Halo® devices. Equivalence was determined using a side by side tabular comparison between the predicate and proposed Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects. The proposed devices are Substantially Equivalent to the predicate devices.

Based on the analysis of the comparison between the predicate and proposed devices regarding risk analysis, design controls, and performance evaluation the data shows the modifications do not raise different questions of safety or efficacy and demonstrates substantial equivalence to the predicate device.

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.