(204 days)
The CARE SU01A Suction aspirator is intended for professional use to remove infectious materials from wounds or fluids from a patient airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
The SU01 A Suction aspirator is designed to provide general suction for use in hospitals or clinics. This Suction aspirator is a professional medical suctioning device that produces a maximum vacuum of 560 mmHg. It is used with a power supply allowing operation on AC voltage (120 VAC, 60 Hz). The device is equipped with 850ml collection bottle and has been designed for convenient and reliable and reliable usages. The vacuum pump of the SU01A transmits negative pressure throughout the tubing-system and the collection bottle to patient tubing that aspirates secretions or liquid form the body. The vacuum pump can be manually adjusted using the regulating value and the vacuum gage. The aspirated fluids are collected in the collection bottle that is isolated from the pump by a bacteria filter. It also has a mechanical overflow protection in the lid of the collection bottle to further prevent the fluids from being sucked into the pump.
Here's a breakdown of the acceptance criteria and study information for the K130001 device, the Foshan Care Medical Technology Co., Ltd. SU01A Suction aspirator, based on the provided text:
Important Note: This device is a traditional medical suction unit and not an AI/ML-powered device. Therefore, many sections related to AI performance, ground truth establishment, reader studies, and training sets are not applicable (N/A) for this submission. The analysis below reflects this.
1. Table of Acceptance Criteria and Reported Device Performance
This device's "acceptance criteria" are based on compliance with established medical device standards and equivalence to a predicate device. Performance is demonstrated through meeting these standards and showing comparable attributes to the predicate device.
| Acceptance Criteria / Attribute | Reported Device Performance (SU01A Suction Pump) | Predicate Device (SUA01 Suction Unit) Performance | Results |
|---|---|---|---|
| Compliant with IEC 60601-1 (Electrical safety) | Meet the requirements | Meet the requirements | Pass |
| Compliant with IEC 60601-1-2 (Electromagnetic compatibility) | Meet the requirements | Meet the requirements | Pass |
| Compliant with ISO 10079-1 (Medical suction equipment) | Meet the requirements | Meet the requirements | Pass |
| Controls easily identifiable by user | Meet the requirements | Meet the requirements | Pass |
| Collection Bottle volume reference markings | 850ml | 800ml | Pass |
| Collection Bottle withstands maximum pressure delivered by pump | Meet the requirements | Meet the requirements | Pass |
| Degree of collapse of tubing (less than 0.5) | Less than 0.5 | Less than 0.5 | Pass |
| Resistance to implosion for collection container | Meet the requirements | Meet the requirements | Pass |
| Flow rate of maximum pumping power | Meet the requirements | Meet the requirements | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: N/A. No specific "test set" of patient data or images was used as this is a hardware device submission focused on engineering standards and equivalence.
- Data Provenance: N/A. The evaluation is based on engineering testing protocols for compliance with international standards, rather than clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: N/A. No ground truth was established by experts for a test set in the context of clinical performance, as no such clinical studies were performed.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. No test set requiring expert adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This device is a physical suction aspirator; MRMC studies are not applicable.
- Effect Size: N/A.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done? N/A. This is a hardware device; algorithm-only performance is not relevant.
7. Type of Ground Truth Used
- Type of Ground Truth: N/A. For hardware devices like this, the "ground truth" for performance is typically defined by adherence to engineering specifications and international performance and safety standards, rather than clinical outcomes or expert consensus on clinical findings.
8. Sample Size for the Training Set
- Sample Size for Training Set: N/A. This is a hardware device and does not involve AI or algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: N/A. No training set was used.
§ 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.