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K Number
K982628
Device Name
MEDWORKS INSEMINATION CATHETER
Manufacturer
MEDWORKS CORP.
Date Cleared
1998-08-21

(24 days)

Product Code
MFD
Regulation Number
884.5250
Type
Traditional
Panel
OB
Reference & Predicate Devices
K884696,K972823,K914150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Device Description

Malleable catheter with distal side ports and balloon to help position the catheter at the uterus. Balloon is filled with saline: insemination fluid is introduced using a syringe attached to the proximal luer.

AI/ML Overview

The provided text is for a 510(k) Premarket Notification for an Insemination Catheter. It explicitly states:

"Substantial equivalence for this device was based solely on design and performance characteristics, no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Insemination Catheter are equivalent to those of the predicate devices."

Therefore, the following information cannot be extracted from the given document as no performance or safety study was conducted or provided:

  1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance data is present.
  2. Sample size used for the test set and the data provenance: No test set information is available.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
  4. Adjudication method for the test set: No adjudication method is described.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool. No MRMC study was conducted.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool. No standalone performance study was conducted.
  7. The type of ground truth used: Not applicable, as no ground truth was established for performance testing.
  8. The sample size for the training set: Not applicable, as no training set was used for a performance study.
  9. How the ground truth for the training set was established: Not applicable, as no training set was used for a performance study.

In summary, the MedWorks Insemination Catheter's approval was based on demonstrating substantial equivalence to predicate devices through design and performance characteristics, without the need for new performance or safety studies involving acceptance criteria and clinical data.

§ 884.5250 Cervical cap.

(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).