(79 days)
This device is an accessory for a syringe or infusion pump (not manufactured by AIV, Inc.). The healthcare worker connects the device to the corresponding pump. The patient uses the switch on the cable to signal the pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker.
Connects to designated syringe or infusion pump model used in hospital, ambulatory and home care environments.
AIV's Patient Pendant Bolus Cables are a replacement for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective syringe and infusion pumps. AIV does not manufacture the pumps. These Patient Pendant Bolus Cables are an accessory for the pump and are also available as a replacement part. These cables include a switch and are plugged into a mating connector on the syringe or infusion pump to allow the patient to request medication within the parameters entered into the syringe pump by the healthcare provider and the designed limits on the pumps.
The AIV Patient Pendant Bolus Cables use the same type of construction and have the same technological characteristics as the predicate device – the accessory supplied with the original pump. These are passive devices that contain no electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.
AIV Patient Pendant Bolus Cables use Biocompatible PVC for the cables, cable jackets and over molded connectors with an integral strain relief.
The provided document describes the predicate devices as "Patient Controlled Analgesia (PCA) Button Cables," and focuses on demonstrating that the AIV Patient Pendant Bolus Cables are substantially equivalent to these existing, legally marketed devices. It is explicitly stated that this device "is not sterile, has no software component, has no electronic components and is not a kit." Therefore, the details requested about clinical studies, MRMC studies, training/test sets, and ground truth are not applicable to this type of device and submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Features) | Reported Device Performance |
|---|---|
| Verification Testing: Construction and operation consistent with technical specifications. | Consistent with technical specifications. |
| Storage and Cleaning Tests: Operation remains consistent with technical specifications after repeated cycles. | Operation remains consistent with technical specifications after repeated cleaning cycles and exposure to storage environmental limits. |
| Performance Testing: | A switch activation test pattern and pump test program were used, showing that under identical activation patterns and pump programs, the number of dose requests is equivalent to the predicate devices, and the fluid dispensed is consistent with the accuracy of the target pump (which implies the cable accurately transmits the patient's request). |
| Safety: Double insulation of conductors. | Same as predicate devices. |
| Operating Principle: Patient presses button to signal medication request to pump. | Same as predicate devices. The device functions as intended: registering a patient request when the button is pressed and not registering one when it is not activated. |
| Operating Voltage: 3.3 VDC to 5 VDC. | Same as predicate devices. |
| Biocompatibility: Use of Biocompatible PVC. | Biocompatible PVC used for cables, jackets, and over-molded connectors with integral strain relief. (Referenced Section F for biocompatibility test reports, which were not provided in the excerpt but are stated as completed). |
| Intended Use & Indications for Use: As an accessory/replacement part for syringe/infusion pumps. | Same as predicate devices; connects to designated syringe or infusion pump models in various healthcare environments. The patient uses the switch to signal the pump to deliver medication consistent with entered parameters and pump limitations. |
| Technological Characteristics: Same construction and passive nature. | Uses the same type of construction and has the same technological characteristics as the predicate devices. These are passive devices with no electronic components, powered by mating equipment using low voltages to detect push-button state changes. Shielding and insulation are substantially equivalent to the predicate device. |
| Device Failure Consequences: Same as OEM devices. | Due to extreme similarities, the consequences of a modified device and a device failure are the same for both AIV and OEM devices. (A risk management file was developed and used throughout the development process, referenced Section G, not provided here). |
| Clinical Testing: Not performed. | The non-clinical testing demonstrated the AIV Patient Pendant Bolus Cables are as safe, as effective, and perform as well as the legally marketed accessories for syringe and infusion pumps. No clinical testing was performed as the device is an accessory with no direct patient interaction other than the button press, and its function relies on the primary pump's accuracy, not its own. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a distinct "test set" sample size in terms of patient numbers or data records. The testing described focuses on the physical devices themselves. The tests involved "each of the AIV Patient Pendant Bolus Cables models" with specific test patterns and programs. This implies testing each manufactured cable model rather than a statistical sample size of patient data.
- Data Provenance: The tests were conducted by AIV at their facility in Harmans, MD, USA. The testing is non-clinical, involving device verification and performance testing, not patient data. Therefore, the concept of "data provenance" related to patient data (e.g., country of origin, retrospective/prospective) is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable. The device is a simple mechanical accessory (a cable with a button). The "ground truth" for its operation is whether the button press is correctly registered by the connected pump and whether it withstands cleaning/storage. This would be verified through engineering tests rather than expert interpretation of complex data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. The device validation involves objective pass/fail criteria for physical and functional performance, not subjective review 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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. The AIV Patient Pendant Bolus Cable is a non-AI, non-diagnostic accessory.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a cable with a button; it does not contain an algorithm or software. Its function is to facilitate human-in-the-loop interaction (patient presses button) with the main infusion pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is its direct functional operation according to engineering specifications and its equivalence to predicate devices. This includes:
- Functional Correspondence: Verification that when the button is pressed, the signal is sent, and when not pressed, no signal is sent.
- Durability and Environmental Stability: Performance remains consistent after cleaning and storage cycles.
- Material Biocompatibility: Conformance to biocompatibility standards (referenced in Section F).
- Physical and Electrical Equivalence: Matching construction, operating voltage, and safety features of predicate devices.
8. The sample size for the training set
- This information is not applicable. There is no AI component or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable, as there is no training set for this 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).