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K Number
K973199
Device Name
AMSINO SUCTION CATHETER
Manufacturer
AMSINO INTL., INC.
Date Cleared
1997-09-10

(15 days)

Product Code
BSY
Regulation Number
868.6810
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Amsino Suction Catheter, tracheobronchial, is to be used to aspirate liquids or semisolids from a patient's upper airway.

Device Description

AMSINO® Suction Catheter

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "AMSINO® Suction Catheter." This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the letter does not contain any information regarding acceptance criteria or a study proving the device meets those criteria. The content is purely administrative, focusing on the regulatory clearance process.

Therefore, I cannot provide the requested information from the given text.

To be clear:

  1. Table of acceptance criteria and reported device performance: Not available.
  2. Sample size and data provenance: Not available.
  3. Number and qualifications of experts for ground truth: Not available.
  4. Adjudication method for test set: Not available.
  5. MRMC comparative effectiveness study: Not available.
  6. Standalone performance study: Not available.
  7. Type of ground truth used: Not available.
  8. Sample size for training set: Not available.
  9. How ground truth for training set was established: Not available.

§ 868.6810 Tracheobronchial suction catheter.

(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.