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 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 168 hours.

Device Description

The Halo™ is a Closed System Transfer Device (CSTD) for the 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 single-use device. There are four components of the Halo TM system, Closed Vial Adaptor (CVA), Closed Syringe Adaptor (CSA), Closed Bag Adaptor (CBA) and Closed Line Adaptor (CLA). 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 168 hours. The ability to prevent microbial ingress for 168 hours should not be interpreted as modifying, extending, or superseding a drug manufacturers labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations for shelf life and sterilityinformation.

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

The provided document for the Halo™ Closed System Drug Transfer Device (CSTD) does not contain a study of a device that meets acceptance criteria in the typical sense of an AI/ML medical device submission.

Instead, this is a 510(k) premarket notification for a traditional medical device, primarily demonstrating substantial equivalence to a predicate device (BD PhaSeal CSTD). The "acceptance criteria" here refer to performance tests demonstrating the device's functional and safety characteristics, rather than diagnostic accuracy metrics.

Therefore, many of the requested fields regarding AI/ML device studies, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and data provenance, are not applicable to the information provided in this document.

However, I can extract information related to the performance testing described.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted on the Halo™ system. It states that the "Results from tests completed on the Halo TM components demonstrates that the system 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."

Acceptance Criteria/Test Type	Reported Device Performance
Prevent Microbial Ingress	Prevents microbial ingress for up to 168 hours
Prevent Escape of Drug or Vapor Concentrations / Airtight & Leak-proof	Prevents escape of drug or vapor concentrations outside the system.
	Mechanically prohibits transfer of environmental contaminants into the system and escape of drug/vapor.
Durability/Multiple Reconnections	Prevents microbial ingress and/or escape of drug or vapor through multiple reconnections of components up to 14 times.
Biocompatibility (ISO 10993-1)	Passed tests including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility and pyrogenicity.
Operational Performance (Overall)	Substantially equivalent to predicate device (BD PhaSeal CSTD).
Pressure Test (System, CLA)	(Passed, implied by "substantially equivalent" and "demonstrates that the system prevents...")
Vapor Test	(Passed, implied by "substantially equivalent" and "demonstrates that the system prevents...")
Leakage (CBA)	(Passed, implied by "substantially equivalent" and "demonstrates that the system prevents...")
Insertion and Retention Force (CVA, CBA, CBA Spike Port)	(Passed, implied by "substantially equivalent")
Connection Force (CSA)	(Passed, implied by "substantially equivalent")
Residual Volume (CLA, CBA)	(Passed, implied by "substantially equivalent")
Human Factors / Comparative Testing	(Passed, confirmed no new questions regarding safety/efficacy)
ISO594 Luer Fitting Compliance Test	(Passed, implied by "substantially equivalent")
Particulate Contamination	(Passed, implied by "substantially equivalent")
Extended Beyond-use-date drug vial sterility testing	(Passed, implied by "substantially equivalent" and microbial ingress claim)
Chemical Tests (Extractables/Leachables)	(Passed, implied by "substantially equivalent")
Packaging Testing	(Passed, implied by "substantially equivalent")

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

Not Applicable in the AI/ML sense. The document describes performance testing for a physical device. Details on specific sample sizes for tests like fluorescein tests, pressure tests, or microbial ingress tests are not provided in this summary. The data provenance would be laboratory testing of the manufactured devices.

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

Not Applicable. This is not an AI/ML device where expert ground truth is established for diagnostic accuracy. Performance tests typically rely on established protocols, measurement devices, and technical standards.

4. Adjudication method for the test set

Not Applicable. This is not an AI/ML device with diagnostic outputs requiring adjudication.

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. This is not an AI/ML device. "Human Factors / Comparative testing" is mentioned, likely comparing user interaction with Halo™ vs. the predicate, but not in the context of an MRMC study with AI assistance.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established engineering principles, physical measurements, chemical analysis, and microbiological testing according to recognized standards (e.g., ISO 10993-1, ISO594). For instance, microbial ingress testing results (sterility) would be confirmed via microbiology assays.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

Summary of the Study:

The studies described are a series of laboratory and bench tests designed to demonstrate the functional performance and safety of the Halo™ CSTD. These tests collectively aimed to prove that the device is "as safe, as effective, and performs as well as the predicate devices" (BD PhaSeal CSTD), thereby demonstrating "substantial equivalence." The tests covered aspects such as:

Containment: Preventing the escape of hazardous drugs/vapors and the entry of environmental contaminants (e.g., Fluorescein Test, System Pressure Test, Vapor Test, Leakage tests).
Microbial Integrity: Preventing microbial ingress, specifically up to 168 hours for drug vial sterility (Microbial Ingress Testing, Extended Beyond-use-date drug vial sterility testing).
Mechanical Integrity and Durability: Ensuring components connect securely, withstand forces, and maintain function over multiple reconnections (Insertion and Retention Force, Connection Force, ISO594 Luer Fitting Compliance Test).
Biocompatibility: Ensuring materials are safe for human contact (ISO 10993-1 tests).
Residual Volume: Minimizing drug waste.
Chemical Properties: (Extractables/Leachables Testing).
User Interface: (Human Factors / Comparative testing)

The document explicitly states that "Comparative testing against the predicate device confirmed there were no new questions raised regarding safety or efficacy of the Halo™device." The results from these tests demonstrated that the device performs as intended and is "substantially equivalent" to already marketed devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three faces overlapping to represent the department's focus on health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2015

J & J Solutions, Inc. d/b/a/Corvida Medical Mr. Dana Schramm Vice President of Manufacturing/Operations 2261 Crosspark Road, Suite 127 Coralville, IA 52241

Re: K150486 Trade/Device Name: Halo TM Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ONB Dated: June 12, 2015 Received: June 17, 2015

Dear Mr. 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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang-S

for Erin I. Keith, M.S. 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)

K150486

Device Name Halo тм

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

図Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY - K150486

SUBMITTER:

J & J Solutions, Inc. d/b/a Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, Iowa 52241

CONTACT:

Dana Schramm Vice President of Manufacturing/Operations Ph. 319-335-2547 x103 Fax. 319-250-4135 dana.schramm@corvidamedical.com

DATE PREPARED:

July 23, 2015

NAME OF MEDICAL DEVICE:

Trade Name:	HaloTM
Common/Usual Name:	Closed Antineoplastic and Hazardous Drug Reconstitutionand Transfer System
Classification Name:	Intravascular Administration Set

DEVICE CLASSIFICATION:

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

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MANUFACTURER:

Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, Iowa 52241

PREDICATE DEVICES:

Proprietary Name:	BD PhaSeal CSTD (K123213, K130197, K140591)
Common/Usual Name:	Closed System Transfer Device
Classification Name:	Closed Antineoplastic and Hazardous Drug Reconstitutionand Transfer System

DEVICE DESCRIPTION:

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INTENDED USE / INDICATION FOR USE:

Halo™

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 168 hours.

BD PhaSeal (Predicate) from K140591

The PhaSeal system is an airtight and leakproof 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 PhaSeal system also prevents microbial ingress.

The Intended Use / Indication for Use statements are identical except for the inclusion of "for up to 168 hours" at the end of the Halo " statement. This was included based on the microbial ingress testing performed on the Halo system.

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES

Technologically, the Halo™ system is similar to the predicates in terms of design and performance. The predicate system consists of four main components that attach to standard drug vials, syringes, patient lines or secondary sets, and standard IV bags. Both the subject and predicate CSTD systems use industry compatible luer lock, spike, and needle safe connections to form the closed systems for drug transfer. Both systems have seals that prevent environmental contaminants from entering into the system and/or escape of drug or vapor. Comparative testing against the predicate device confirmed there were no new questions raised regarding safety or efficacy of the Halo™device.

Differences between the Halo TM and the predicate CSTD exist in the following:

. The Halo The Closed Syringe Adaptor and mating components connections are made utilizing a push-on, pull-off coupling action to engage seals where the predicate injector employees a push and twist together connection.
The push-on, pull-off connection was validated through performance testing completed on the Halo TM and predicate devices establishing substantial equivalence with respect to operational performance. This comparative testing against the predicate device confirmed there were no new questions raised regarding safety and effectiveness of the Halo™ device.

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SUMMARY OF PERFORMANCE TESTING

Results from tests completed on the Halo TM components demonstrates that the system 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. Testing consisted of the following:

Fluorescein Test
System Pressure Test ●
Vapor Test
Closed Bag Adapter (CBA) Leakage
o Closed Line Adapter (CLA) Pressure Test
Closed Vial Adaptor (CVA) ● Insertion and Retention Force
Closed Syringe Adaptor (CSA) Connection Force
CLA and CBA Residual Volume ●
o Human Factors / Comparative testing
ISO594 Luer Fitting Compliance Test
CBA Spike Port Insertion and Retention Force (IV set)
Particulate Contamination ●
CBA Insertion and Retention Force (IV bag)
Microbial Ingress Testing ●
. Comparative testing against the predicate
Extended Beyond-use-date drug vial sterility testing
Chemical Tests ●
o Extractables/Leachables Testing
Packaging testing
The Halo™ was tested for biocompatibility per ISO 10993-1, tests included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility and pyrogenicity.

SUBSTANTIAL EQUIVALENCE

Based on the information contained in this submission, it is concluded that the Halo TM is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.

CONCLUSIONS

Equivalence for the Halo™ is based on similarities in indications for use, design features, materials, operational principals, and technological characteristics as compared to the predicate devices. Results of performance testing for the Halo™ system demonstrates the device is as safe, as effective, and performs as well as the predicate devices.

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.