Search Results
Found 2 results
510(k) Data Aggregation
(268 days)
RGS; RGS Mini
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.
The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
This device is not intended for use in areas with a sterile field or controlled air flow.
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The device uses a MERV 13 filter for particle filtration. Down upstream of the pre-filter is a PCO component. The PCO consists of a TiO2 coated mesh and UV lights. When the UV lights (UV-C) provide sufficient energy, the TiO2 coated photo catalyst is activated. This component will deactivate microorganisms and viruses through a chemical reaction.
The RGS / RGS mini model numbers RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
The RGS / RGS mini is a medical ultraviolet air purifier intended to destroy bacteria in the air by exposure to ultraviolet radiation. The device was tested for its ability to eliminate specific bacteria and viruses.
Here's the detailed breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria and Source | Reported Device Performance |
|---|---|---|
| Electrical Safety and Electromagnetic Compatibility | UL 507 Standard for Electrical Fans, IEC 60601-1-2 EMC for medical devices | Compliant / Pass |
| Bacteria Reduction Test (Gram-Negative - E. Coli) | Log 4 reduction of Gram-Negative Bacteria (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of E. Coli |
| Bacteria Reduction Test (Gram-Positive - Staph. Epidermidis) | Log 4 reduction of Gram-Positive Bacteria (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of Staphylococcus Epidermidis |
| Virus Inactivation Test (MS-2 Bacteriophage) | Log 4 reduction of representative virus (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of MS-2 Bacteriophage |
| Filtration Efficiency Testing (Gram-Negative - E. Coli) | Log 4 reduction of Gram-Negative Bacteria (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of E. Coli |
| Filtration Efficiency Testing (Gram-Positive - Staph. Epidermidis) | Log 4 reduction of Gram-Positive Bacteria (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of Staphylococcus Epidermidis |
| UV Lamp Shelf Life | 12,000 hrs. of continuous operation | Compliant / Pass: 12,000 hrs. of continuous operation |
| Pre-filter Shelf Life | 3 months of continuous operation | Compliant / Pass: 3 months of continuous operation |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes (number of tests) for each microbial reduction, filtration efficiency, or shelf-life test. However, the tests against bacteria and viruses were conducted by "LMS Technologies" to assess reduction capabilities in the air of a test chamber. The origin of the data is not specified beyond being generated by "LMS Technologies," implying a laboratory setting. These tests are inherently retrospective as they are conducted on a completed device to assess its performance against predefined criteria.
Specifically, for the RGS model:
- Staphylococcus Epidermidis: Log reduction of 4.0 PFU/ft^3
- Bacteriophage MS2: Log reduction of 4.02 PFU/ft^3
- Escherichia Coli: Log reduction of 4.24 PFU/ft^3
For the RGS mini model:
- Staphylococcus Epidermidis: Log reduction of 4.04 PFU/ft^3
- Bacteriophage MS2: Log reduction of 4 PFU/ft^3
- Escherichia Coli: Log reduction of 4.0 PFU/ft^3
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "ground truth" for the performance tests relies on the results obtained by "LMS Technologies," which are standard microbiological and engineering testing methods. Expert consensus for determining the "ground truth" for microbial reduction or filtration efficiency is typically not applicable in this context; instead, it is based on quantitative laboratory measurements compared against defined log reduction targets.
4. Adjudication method for the test set:
Not applicable. The tests involve objective quantitative measurements (e.g., log reduction, hours of operation). There is no mention of an adjudication process for these test results, as they are typically direct measurements against predetermined performance targets.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that involve human interpretation, which is not the case for an air purifier.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is an air purifier and does not involve an algorithm or human-in-the-loop performance in the conventional sense of a medical diagnostic or AI device. The performance tests are for the device's physical and functional capabilities in reducing airborne microbes and filtering particles.
7. The type of ground truth used:
The ground truth for the performance tests is derived from quantitative laboratory measurements of microbial reduction and filtration efficiency, and direct functional testing for electrical safety and shelf life. For example, for bacteria and virus reduction, the "ground truth" is the measured log reduction achieved in a controlled test chamber, compared against the acceptance criterion of a "Log 4 reduction."
8. The sample size for the training set:
Not applicable. This device is a physical air purifier, not an AI/ML-based device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
Ask a specific question about this device
(28 days)
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
HSG Catheter Set (5F & 7F) is indicated for use to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus.
The device is to be used by physicians in hospitals. The HSG catheter set consists of two parts: a double lumen catheter and a semi-rigid introducing sheath. The catheter is available in two different sizes 5 and 7 French diameter with a length of 30 cm. The distal end has a side port and a non-latex Kraton balloon whose capacity is 1.5 cc for 5F and 3cc for 7F. The proximal end that ends in side port is fitted with a halkey clamp and female luer lock hub. The other channel is fitted with one way stop cock and a 3cc syringe.
The provided text is a 510(k) summary for the HSG Catheter Set (5F and 7F). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed clinical study data showing primary safety and effectiveness.
Therefore, the document does not contain a traditional study with acceptance criteria and reported device performance in the way a clinical trial for a new drug or a novel, high-risk device would. Instead, it relies on demonstrating that its technological characteristics are equivalent to a predicate device that has already been deemed safe and effective.
Here's an analysis based on the provided text, addressing your points where possible:
Acceptance Criteria and Device Performance
The acceptance criteria here are implicitly met by demonstrating "substantial equivalence" to the predicate device. The performance is deemed "Identical" to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Indications for Use | Identical |
| Target Population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Similar (Ethylene Oxide instead of Gamma) |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |
Study Proving Acceptance Criteria:
The "study" in this context is the 510(k) submission itself, where the manufacturer provides a detailed comparison of their device to a legally marketed predicate device (K943494 from Lyco Enterprises. Inc.). The FDA reviewed this descriptive information and concluded that the device is substantially equivalent, thereby accepting the manufacturer's claim of identical performance and safety, with a minor difference in sterilization method.
2. Sample Size Used for the Test Set and the Data Provenance
This document does not mention a test set with a specific sample size for evaluating the new device's performance in a clinical or user-based study. The determination of substantial equivalence is primarily based on a comparison of technological characteristics with the predicate device, not on new clinical performance data from a test set.
The data provenance for the comparison itself is the manufacturer's internally generated comparison table and potentially existing data/information from the predicate device within FDA files or literature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable or not provided in the context of this 510(k) summary. "Ground truth" for a test set, typically established by experts, is relevant for performance studies (e.g., diagnostic accuracy for AI devices). This submission focuses on demonstrating equivalence through comparison of design, materials, and intended use, not through a new performance study requiring expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Without a specific test set or performance study, there's no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess the impact of AI assistance on human reader performance. This device is a catheter for hysterisalpingography, and the submission's focus is substantial equivalence based on design and materials, not diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study was not done. This concept is primarily relevant for AI algorithms. The HSG Catheter Set is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used here is a comparison to the established characteristics of the predicate device (Lyco Enterprises. Inc.'s HSG Catheter Set, K943494). The predicate device serves as the benchmark against which the new device's technological characteristics, safety, and performance are evaluated for equivalence. This is not "expert consensus," "pathology," or "outcomes data" for the new device, but rather a reference to an already cleared device's known attributes.
8. The Sample Size for the Training Set
This information is not applicable or not provided. There is no "training set" in the context of this 510(k) submission. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided. As there is no training set mentioned, there is no method for establishing its ground truth.
Ask a specific question about this device
Page 1 of 1