Search Results

The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. Use the Kem Medical Lead-free Chemical Indicators for Steam Sterilization in the validated steam sterilization processes described below:

*Gravity: 121 C/250 F - 30 minutes (wrapped/porous)
*Gravity: 132 C/270 F - 3 minutes (unwrapped/nonporous)
*Gravity: 132 C/270 F - 15 minutes (wrapped/porous)
*Gravity: 135 C/275 F - 3 minutes (unwrapped/nonporous)

• Gravity: 135 C/275 F - 10 minutes (wrapped/porous or unwrapped/nonporous, mixed load)
• Vacuum assisted (prevacuum): 132 C/270 F - 3 minutes (unwrapped/nonporous)
• Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes (wrapped/porous)
• Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes (wrapped/porous)
  *Vacuum assisted (prevacuum): 135 C/275 F - 3 minutes (wrapped/porous or unwrapped/nonporous, mixed load)

The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads.

They are Type 1 Process Indicators per ISO 11140-1:2014 Sterilization of healthcare products-Chemical Indicators - Part 1 General Requirements, consisting of chemical indicator ink and paper substrate with a visual color change from light color (white/off-white) to dark color (cocoa/black) when exposed to a steam sterilization process.

The Kem Medical Lead-free Chemical Indicators for Steam Sterilization consist of indicator ink printed on a paper substrate with or without adhesive. The indicator ink is lead free. An example of this indicator is the ink printed onto adhesive-coated paper for autoclave labels, or "dots", which are removed from a poly or paper backing for use.

Kem Medical manufactures in various shapes and sizes printed on paper substrates with and without adhesive on the underside, and with or without labeling on each individual indicator.

The provided text is a 510(k) summary for a medical device called "Kem Medical Lead-free Chemical Indicators for Steam Sterilization". It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text, while also noting what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Endpoints color not reached when exposed to failing conditions in autoclave cycles. | Pass |
  | Dry heat | Verify device requires the presence of saturated steam to turn to reach endpoint | - 30 min at 140 °C: No change | Pass |
  | Transference ISO 11140-1:2014 | Demonstrate the chemical indicators do not bleed or offset to substrate which it's applied according to ISO 11140-1:2014 | - The chemical indicators shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed | Pass |
  | Endpoint color stability | Endpoint color maintained | - Endpoint color remained unchanged for 8 months | Pass |
  | Shelf Life (Implicitly tied to test results) | Demonstrate long-term performance | Device performance meets ISO 11140-1:2014 requirements at 0, 1, 2, and 3 years real time. (This is an overall stated goal of the qualification, rather than a specific test with a single acceptance criterion in the table, but it's crucial for the 3-year shelf life claim.) | Met (supported by qualification testing at various time points) |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of indicators tested per condition). It mentions "All indicators exposed to..." for BIER vessel tests and implies multiple indicators were tested for autoclave cycles.
• Data Provenance: The testing was performed by "True Indicating LLC". The country of origin is not explicitly stated, but the submission is to the US FDA, implying testing relevant to US regulatory standards. The testing appears to be prospective as it's part of a formal qualification process for the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is not applicable to this type of device and study. Chemical indicators demonstrate a visible color change based on chemical reaction to sterilization conditions. The "ground truth" is the physical state of the indicator after exposure to specified conditions, which is objectively measurable (color change) against the predefined pass/fail criteria. Human expert interpretation of complex images or signals is not the primary mechanism of operation or evaluation here.

4. Adjudication Method for the Test Set:

• Not applicable. As above, the assessment is based on a measurable color change against a defined endpoint, not subjective interpretation requiring multi-expert adjudication. The document states "showed a dark color change" or "showed either no color change or a slight color change," which implies a direct observation against a known endpoint.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Reader Improvement:

• No. This is not an AI/Software as a Medical Device (SaMD) study. The device is a physical chemical indicator. Therefore, MRMC studies are not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

• Not applicable. This is not a software device. The "performance" is the chemical indicator's physical change.

7. The Type of Ground Truth Used:

• The ground truth is objective physical/chemical reaction to predefined sterilization parameters. The "pass" conditions are known levels of steam sterilization exposure, and the "fail" conditions are sub-optimal or non-sterilizing exposures (e.g., lower temperature, shorter time, or dry heat). The color change (or lack thereof) is then compared against the expected outcome for these conditions.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

Ask a specific question about this device