(30 days)
ZOOM Aspiration Pump
The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics.
ZOOM Canister
The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump.
ZOOM Aspiration Tubing
The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
The ZOOM™ Aspiration Pump (ZOOM Pump) is an AC powered oil-less positive displacement pump capable of consistently delivering vacuum (0-29 inHg) for the removal of bodily fluids. The ZOOM Pump housing is fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and sliding canister shelf. The ZOOM Pump is provided non-sterile.
There are two accessories for the ZOOM Pump, the ZOOM™ Canister and ZOOM™ Aspiration Tubing. The ZOOM™ Canister is a non-sterile, single use 1000 mL canister which collects the removed bodily fluids. The ZOOM Canister is positioned in the sliding canister shelf and connected to the ZOOM Pump via the canister tubing and connectors. The ZOOM Aspiration Tubing is sterile, single use and connects to the blue connector on the canister lid.
Here's a breakdown of the acceptance criteria and study information for the ZOOM™ Aspiration Pump, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ZOOM™ Aspiration Pump | ||
| Compliance with ANSI/AAMI ES60601-1 and CAN/CSA C22.2 NO. 60601-1 | 100% Pass | YES (implies 100% Pass) |
| Compliance with IEC 60601-1-2 | 100% Pass | YES (implies 100% Pass) |
| Compliance with ISO 10079-1 | 100% Pass | YES (implies 100% Pass) |
| Compliance with IEC 60529 for IP Code | The requirement for the IP 21 marking should be met. | YES (implies met the requirement for IP 21 marking) |
| ZOOM™ CANISTER (COMPLIANCE WITH ISO 10079-1) | ||
| Design and Operational Requirements for ZOOM™ Canister and its Components | 100% Pass | YES (implies 100% Pass) |
| ZOOM™ ASPIRATION TUBING | ||
| Operational Requirements for ZOOM™ Aspiration Tubing and its Components (Compliance with ISO 10079-1) | 100% Pass | YES (implies 100% Pass) |
| Compliance ISO 10993-1 | Biocompatible | YES (implies biocompatible) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing for the device. For these types of tests (e.g., electrical safety, electromagnetic compatibility, performance standards), the concept of "sample size" in the same way as a clinical study (e.g., number of patients) isn't directly applicable. Instead, it refers to the number of units tested. However, the document does not specify the number of units of the ZOOM™ Aspiration Pump, ZOOM™ Canister, or ZOOM™ Aspiration Tubing that were tested for each criterion.
The data provenance is non-clinical bench testing conducted by the manufacturer, Taiwan Biomaterial Co., Ltd. (TWBM). There is no mention of country of origin for specific test data in terms of patient populations or retrospective/prospective studies, as these are not relevant for the described tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of testing described. The listed acceptance criteria are based on established international and national standards (e.g., IEC, ISO, ANSI/AAMI). Compliance with these standards is determined by objective measurements and test procedures, not expert consensus on labels or diagnoses.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., images) requires reconciliation among experts to establish a "ground truth" or reference standard. The testing here involves objective measurements against predefined engineering and performance standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with or without AI assistance, which is irrelevant for a hardware device like an aspiration pump.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, a standalone study in the context of an algorithm's performance was not done. "Standalone" refers to the performance of an AI algorithm intrinsically, without human interaction. The ZOOM™ Aspiration Pump is a physical medical device, not an AI algorithm. Its performance is measured directly against physical and functional standards.
7. The Type of Ground Truth Used:
The "ground truth" for the performance criteria is defined by the specifications and acceptable ranges established within the referenced national and international standards (e.g., IEC 60601-1-2, ISO 10079-1, IEC 60529, ANSI/AAMI ES60601-1, ISO 10993-1). Compliance is determined by objective measurements meeting these predefined limits.
8. The Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to train machine learning models. The ZOOM™ Aspiration Pump is a physical device, and its development and testing do not involve machine learning training sets.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.