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510(k) Data Aggregation
(186 days)
Classification Name: | Medical Ultraviolet Water Purifier
80KMG, Class II, Regulation 880.6710
General Hospital and Personal Use
(per 21 CFR 880.6710)
Street Somerset, Wisconsin 54025
Re: K012029
Trade/Device Name: Remedy Model 2Z12 Regulation Number: 880.6710
Apollo's Remedy® is intended for use as an optional accessory with Apollo whinpool bathing systems in which patients in healthcare facilities are bathed. This device is not intended to be sold as a separate, stand-alone device. The Remedy UV Water Purifier 2Z12 is a device that is intended for use only as an accessory on Apollo whirlpool bathing systems.
The Apollo Remedy® is designed to reduce bacteria levels in bath water during the bathing cycle.
Apollo's Remedy® is a device designed to kill bacteria in water that is used to bathe patients in health care facilities. The unit contains quartz tubes which house and isolate germicidal ultraviolet lights from the water in a disinfecting chamber.
The Remedy® has no moving parts and is constructed of PVC piping, and the Remedy® is safe for users and the environment since no UV light is transmitted outside the disinfecting chamber.
Sensors are provided in the device to signal that the ultraviolet lights are on.
Apollo's Remedy® is intended for use only with Apollo whirlpool bathing systems in health care facilities where patients are bathed.
Apollo's Remedy® is intended for use in killing bacteria bio-load in bath water. The Apollo Remedy® consists of a disinfecting chamber housing two ultraviolet bulbs at power and wattage levels known to destroy various microorganisms at specific exposure times.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Apollo's Remedy® Model 2z12 (UV Water Purifier)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction of bacteria bio-load in bath water | 99.9% kill factor on Pseudomonas aeruginosa at the end of a 15-minute cycle. 100% kill factor on total coliform (E. coli) at the end of a 15-minute cycle. |
| Compliance with established UV disinfection standards | Meets/Exceeds the minimum dosage of 16,000 microwatt seconds per squared centimeter for bacteria reduction established by the Department of Health, Education and Welfare, Public Health Service in 1966 and accepted by the FDA (21 CFR 179.39). Device uses power source at or above 30,000 uW/second squared. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific experiments. However, the text refers to "water samples from bacterial contaminated water" for the non-clinical testing and "independent government recognized laboratory" for In-Vitro testing without specifying the number of samples.
- Data Provenance: The studies were conducted as "Non-Clinical testing" and "In-Vitro testing." The location of these tests is not specified beyond "an independent government recognized laboratory" for the In-Vitro study. It is implied these were prospective tests specifically conducted for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of clinical evaluation by human readers. The performance assessment relies on objective measurements of bacterial count reduction.
4. Adjudication Method for the Test Set
Not applicable. The performance assessment is based on quantitative microbial reduction, not subjective human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a UV water purifier, and its effectiveness is measured by its ability to reduce bacterial counts, not by improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies conducted were standalone performance tests of the device itself.
- "Non-Clinical testing was completed on the Remedy® system taking water samples from bacterial contaminated water..."
- "In-Vitro testing was conducted by an independent government recognized laboratory."
These tests evaluate the device's ability to disinfect water autonomously.
7. The Type of Ground Truth Used
The ground truth used was microbial count reduction. This was established by measuring the initial bacterial load in contaminated water samples and comparing it to the bacterial load after treatment with the Remedy® device.
8. The Sample Size for the Training Set
The document does not describe a training set in the context of an AI or machine learning model. The device is a physical UV water purifier, not a software algorithm that requires a "training set." The effectiveness is based on scientific principles of UV light and experimental validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical device. The scientific principles and effectiveness of UV light in killing microorganisms have been "well established in numerous studies since the early 1900's," and these established principles (referred to as "referenced and relied upon in this submission") could be considered the foundational "ground truth" for the device's design, but not a specific training set with ground truth labels.
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