(150 days)
Not Found
No
The description focuses on the mechanical design and performance of a closed system drug transfer device, with no mention of AI or ML capabilities.
No.
The document describes the Halo system as a Closed System Transfer Device (CSTD) designed to prevent environmental contamination and exposure to hazardous drugs, not to treat a disease or condition in a patient.
No
The device is a closed system drug transfer device (CSTD) designed to prevent the transfer of environmental contaminants and the escape of hazardous drugs. Its primary function is to minimize exposure to hazardous drugs and maintain sterility, not to diagnose medical conditions.
No
The device description clearly outlines physical components (Closed Vial Adaptor, Closed Syringe Adaptor, Closed Bag Adaptor, Closed Line Adaptor) and their mechanical functions (luer locks, bag spikes, needles, seals). The performance studies also focus on physical and chemical properties and performance, not software validation.
Based on the provided text, the Halo system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Halo system is a Closed System Drug Transfer Device (CSTD) designed to minimize exposure to hazardous drugs and prevent microbial ingress during the handling and administration of these drugs. This is a function related to drug preparation and delivery, not diagnostic testing performed on samples taken from the human body.
- Device Description: The description reinforces its function as a CSTD for handling hazardous drugs, integrating with standard medical components like syringes, IV bags, and infusion sets. It focuses on maintaining a closed system for drug transfer and preventing contamination.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is entirely external to the patient's body and related to the handling of the drug itself.
Therefore, the Halo system falls under the category of a medical device used for drug handling and administration, not an IVD.
N/A
Intended Use / Indications 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 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.
Product codes
ONB
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.
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BD PhaSeal CSTD (K123213, K130197, K140591)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/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.
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 (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
2
Indications for Use
510(k) Number (if known)
K150486
Device Name Halo тм
Indications for Use (Describe)
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.
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 Reconstitution |
| and 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 |
4
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 Reconstitution |
| and Transfer System |
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.
5
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.
6
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.