Callaly Tampliner

• K Number: K211469
• Device Name: Callaly Tampliner
• Manufacturer: Calla Lily Personal Care, Ltd.
• Date Cleared: 2021-06-10 ( 30 days)
• Product Code: HEB
• Regulation Number: 884.5470
• Type: Special
• Panel: OB
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid.

Device Description

Not Found

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": null,
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": null,
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
  "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": null,
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
  "8. The sample size for the training set": null,
  "9. How the ground truth for the training set was established": null
}

Regulation Number and Section

§ 884.5470 Unscented menstrual tampon.

(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).