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K Number
K161106
Device Name
PANPAC DISPOSABLE VACUUM CURETTES
Manufacturer
PANPAC MEDICAL CORPORATION
Date Cleared
2017-01-13

(269 days)

Product Code
HGH
Regulation Number
884.5070
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For transcervical aspiration of the uterine cavity.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and the study details for a device. The document is an FDA 510(k) premarket notification letter for "Panpac Disposable Vacuum Curettes," indicating its substantial equivalence to a predicate device. It defines the device's indications for use but does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size or data provenance for a test set.
  3. Number or qualifications of experts used for ground truth.
  4. Adjudication method for a test set.
  5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
  6. Results from a standalone algorithm-only performance study.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

Therefore, I cannot fulfill your request based on the provided input.

§ 884.5070 Vacuum abortion system.

(a)
Identification. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.(b)
Classification. Class II (performance standards).