STERILE WATER & STERILE 0.9% SODIUM CHLORIDE

• K Number: K992732
• Device Name: STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
• Manufacturer: DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
• Date Cleared: 2000-04-20 ( 251 days)
• Product Code: FOZ
• Regulation Number: 880.5200
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

• For Irrigation of Medical Device Only .
• Not for Injection or Flushing of Skin Tissues .

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary from the FDA for a medical device (Sterile Water & Sterile 0.9% Sodium Chloride) and does not describe a study or specific acceptance criteria and performance related to an AI/ML powered device. The document is a clearance letter indicating the device is substantially equivalent to previously marketed devices.

Therefore, I cannot provide the requested information. The document does not contain details about:

1. Acceptance criteria or device performance data.
2. Sample sizes for test or training sets.
3. Data provenance.
4. Expert qualifications or the number of experts.
5. Adjudication methods.
6. MRMC comparative effectiveness studies.
7. Standalone performance.
8. Type of ground truth.
9. How ground truth was established for training data.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).