(200 days)
The Halo Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. The device is intended for subcutaneous, perineural, epidural and intravenous infusion. The device is intended for 240 hours or 1500mL of infusion, whichever limit is reached first.
The Halo Ambulatory Infusion System includes Halo Ambulatory Infusion Pump ("Halo Pump'') and Halo Administration Set. The system provides measured drug / fluid therapy for subcutaneous, perineural, evidural and intravenous delivery to patient under the direction or supervision of physician or other certified health care professional. The design philosophy was "Simplicity = Safety". Verification and validation data have demonstrated that this is a simple, safe and reliable infusion device for patient in the clinical and non-clinical environments, including but not limited to hospital, homecare, and outpatient settings.
Halo Ambulatory Infusion Pump: The Halo Ambulatory Infusion Pump ("Halo Pump") has a microprocessor controlled motor that drives a mechanical pumping mechanism to deliver fluid at a controlled rate, same as the CADD-Legacy PCA 6300 Ambulatory Infusion Pump (K982839) and ambIT Continuous Ambulatory Infusion Pump (K033325). The Halo Pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for Halo Pump components are widely used in the medical industry. The Halo Pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA).
Halo Administration Set: The Halo Administration Set is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient. The Halo Administration Set can be used with Halo Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets(K120685), which can be used with Z-800 Infusion Pump or gravity infusion.
This document is a 510(k) summary for the Halo Ambulatory Infusion System, encompassing the Halo Ambulatory Infusion Pump and the Halo Administration Set. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established for each test based on relevant standards (ISO, AAMI, ASTM, IEC) and FDA guidance documents. The document states that "All testing met pre-established specifications," and provides a summary table of the verification and validation tests performed.
| Testing Performed | Acceptance Criteria Source (Implicit) | Reported Device Performance |
|---|---|---|
| Halo Administration Set testing (Biocompatibility, Pyrogenicity, Physical & Mechanical, Chemical, Sterility, Aging, DEHP, Integration with Halo Pump) | Reference B (Intravascular Administration Sets Premarket Notification Submissions), ISO / AAMI / ASTM standards | Pass |
| Halo Pump software verification and validation testing | Reference E (Software Contained in Medical Device) | Pass |
| Halo Ambulatory Infusion System basic safety and essential performance testing | IEC 60601-1 and 60601-2-24 | Pass |
| Halo Pump Electromagnetic Compatibility Testing | IEC 60606-1-2 | Pass |
| Halo Ambulatory Infusion System Alarm System Testing | IEC 60601-1-8 | Pass |
| Verification and Validation of Halo Ambulatory Infusion System used in the home healthcare environment | Reference C (Design Considerations for Devices Intended for Home Use), IEC 60601-1-11 | Pass |
| Additional Testing for Verification of Safety and Effectiveness | Reference A (Infusion Pump Premarket Notification Submissions), design requirements, hazard analysis | Pass |
| Usability Validation Testing of Halo Ambulatory Infusion System | References A, B, C, D (Human Factors and Usability Engineering), E; IEC 6060-1-6; IEC 62366 | Pass |
| Volumetric Accuracy (Halo Ambulatory Infusion Pump) | Predicate Devices (CADD-Legacy, ambIT, CADD-Solis VIP) all have +/- 6% | +/- 5% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of infusion sets tested for biocompatibility, number of pumps for volumetric accuracy). It only mentions that "Zyno Medical performed extensive verification and validation testing."
The provenance of the data is implicit: it was generated through the manufacturer's (Zyno Medical, LLC, Natick, MA, USA) own verification and validation testing, which is generally conducted under controlled, prospective conditions for a new device submission. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical studies, as clinical studies were "deemed unnecessary."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that the testing was primarily lab-based verification and validation against technical standards and safety requirements, clinical "experts" in the traditional sense for establishing ground truth on patient data were not involved as "Human clinical studies were deemed unnecessary." The "ground truth" for these tests would be the established performance specifications and regulatory standards.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple readers, which was not performed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Halo Ambulatory Infusion System." Therefore, there is no information on the effect size of human readers improving with or without AI assistance, as AI is not mentioned as a component.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical device (infusion pump and administration set), not an algorithm or AI system. Its performance is inherent to its mechanical and electrical function.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established via:
- Technical Specifications and Regulatory Standards: Compliance with various international standards (ISO, AAMI, ASTM, IEC) and FDA guidance documents related to infusion pumps and administration sets.
- Predicate Device Performance: The "Equivalency Matrix" tables (Table 1 and 2) compare the Halo system's features and performance parameters (e.g., volumetric accuracy) against legally marketed predicate devices, implying that the established performance of these predicates served as a benchmark for equivalence.
- Design Requirements and Hazard Analysis: The testing included verification against internal design requirements and findings from hazard analysis.
8. The Sample Size for the Training Set
This question is not applicable. The Halo Ambulatory Infusion System is a conventional medical device (infusion pump), not a machine learning or AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).