(97 days)
Not Found
No
The device is a simple chemical indicator that changes color based on exposure to steam sterilization parameters. There is no mention of any computational or analytical components that would utilize AI/ML.
No.
This device is a chemical indicator used to confirm exposure to a steam sterilization process, not to treat or cure a disease or condition.
No
This device is a chemical indicator used to demonstrate exposure to a steam sterilization process, not to diagnose a medical condition in a patient.
No
The device is a physical chemical indicator consisting of ink printed on paper, designed to change color when exposed to steam sterilization. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to demonstrate that a unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed items. This is a quality control measure for sterilization equipment and processes, not a diagnostic test performed on biological samples to diagnose a disease or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to steam sterilization conditions. It does not interact with biological samples or provide information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Measuring analytes in biological samples
- Being used in a laboratory setting for patient testing
The device is clearly intended for monitoring the effectiveness of a sterilization process, which falls under the category of sterilization process indicators, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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)
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Qualification of the Kem Medical Products Type 1 Chemical Indicators for Steam Sterilization was performed by True Indicating LLC for 0-, 1-, 2- and 3-years real time. Testing was done to demonstrate that the CI's (Chemical Indicator's) performance meets the requirements defined in ISO 11140-1: 2014 Sterilization of Healthcare Products- Chemical Indicators- General Requirements for a Type 1 Chemical Indicator, and to determine substantial equivalence to the 3M Comply Lead Free Indicator Tape for Steam Sterilization. The CIs are for use as an external or internal chemical indicator in monitoring exposure to conditions of steam sterilization for 121°C - 135°C gravity and pre-vacuum sterilizer cycles.
Cycles for validation testing included BIER Vessel runs, with "pass/fail" criteria, of Saturated Steam 121°C for 2 minutes "fail" and 10 minutes "pass", Saturated Steam 132°C, 134°C and 135°C for 0.3 minutes "fail" and for 2 minutes "pass". Autoclave cycles were also used to test for reaction to Dry Heat 140°C for 30 minutes, and performance in the following standard autoclave cycles: Autoclave Pre- vac cycle 132°C for 3 minutes, Pre-vac cycle 132°C for 4 minutes, Pre-vac cycle 134°C for 3 minutes, Pre-vac cycle 135°C for 3 minutes; and Autoclave Gravity cycle 121°C for 30 minutes, Autoclave Gravity cycle 132°C for 15 minutes, Autoclave Gravity cycle 135°C for 10 minutes. Failure cycles were run for Pre-vac 132°C for 0 minutes and Pre-vac 135°C for 0 minutes.
Chemical indicator results for all testing performed under the acceptance criteria listed and as required in ISO 11140-1:2014 for Type 1 chemical indicators to achieve the target 3-year shelf life. All indicators exposed to either BIER sterilization parameters at "pass" test criteria (121°C for 10 minutes and at 132°C, 134°C and 135°C for 2 minutes) showed a dark color change. All indicators exposed to either BIER sterilization parameters at "fail" test criteria (121°C for 2 minutes and at 132°C, 134°C for .3 minutes) and dry heat (140°C for 30 minutes) showed either no color change or a slight color change. All samples also met the endpoint/color change requirements per the ISO standard.
Clinical Testing: Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 30, 2024
Kem Medical Products Corporation Lisa Kruger Vice President 400 Oser Avenue Suite 2400 Hauppauge, New York 11788
Re: K241836
Trade/Device Name: Kem Medical Lead-free Chemical Indicators for Steam Sterilization Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: June 25, 2024 Received: June 25, 2024
Dear Lisa Kruger:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Digitally signed by Stephen A. Stephen A. Anisko -S Anisko -S Date: 2024.09.30 16:22:13 -04'00'
for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Kem Medical Lead-free Chemical Indicators for Steam Sterilization
Indications for Use (Describe)
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) |
Type of Use (Select one or both, as applicable)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
Prepared on: 2024-09-25
| Contact Details | 21 CFR 807.92(a)(1) | ||
|---|---|---|---|
| Applicant Name | Kem Medical Products Corporation | ||
| Applicant Address | 400 Oser Avenue Suite 2400 Hauppauge NY 11788 United States | ||
| Applicant Contact Telephone | 631-454-6565 | ||
| Applicant Contact | Lisa Kruger | ||
| Applicant Contact Email | lisa@kemmed.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | ||
| Common Name | Sterilization process indicator | ||
| Classification Name | Indicator, Physical/Chemical Sterilization Process | ||
| Regulation Number | 880.2800 | ||
| Product Code(s) | JOJ | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K101528 | 3M Comply Process Indicators for Steam | JOJ |
Device Description Summary
21 CFR 807.92(a)(4)
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.
5
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)
Indications for Use Comparison
Indications for Use for the Kem Medical Lead-free Chemical Indicators for Steam Sterilization are the same as the Predicate Device, the 3M Comply Lead-free Indicator Tape for Steam Sterilization. They are both designed for use by a healthcare provider to accompany individual units or loads (wrapped or unwrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units or loads. For use in validated 121 - 135 degrees Celsius (250 - 275 degrees Fahrenheit) steam sterilization processes.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
| Element | Subject Device (K241836) | Predicate Device (K101528) | Comparison |
|---|---|---|---|
| Intended Use | Process indicator for steam | ||
| sterilization | Process Indicator for steam | ||
| sterilization | Same | ||
| Product Code | JOJ | JOJ | Same |
| Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications for Use | The Kem Medical Lead-free | ||
| Chemical Indicator 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: | The 3M Comply™ Lead Free | ||
| Process Indicators for Steam are | |||
| designed 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. | |||
| 3M Comply Lead Free Process | |||
| Indicators for Steam include: * | |||
| Comply 68200 Lead Free Record | |||
| Card * Comply 1 322 Lead Free | |||
| Indicator Tape * Lead Free Test | |||
| Pack Labels to be used on test | |||
| packs including the following - | |||
| Comply 4 13 80 Steam-Plus Test | |||
| Pack - Comply 4 1360 Steam Test | |||
| Pack -3M Attest™ 1276 Steam | Same | ||
| *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) | Test Pack - 3M AttestTM 1296 | ||
| Steam Test Pack - 3M AttestTM 4 | |||
| 1382 Steam-Plus Test Pack - | |||
| Comply 1233LF, 001 32LF, 0013 | |||
| 5LF Bowie Dick Test Packs | |||
| Intended Use | Process indicator for steam | ||
| sterilization | Process indicator for steam | ||
| sterilization | Same | ||
| Indicator Agent | Lead-free Steam Indicator | ||
| Ink | Lead Free Steam Indicator Ink | Same | |
| Endpoint | |||
| Specification | Cocoa/Black color change | Dark brown/black color change | Different ink chemical |
| composition | |||
| Endpoint Stability | 8 months | 6 months | Different |
| Shelf Life | 3 years from date of | ||
| manufacture, validated real | |||
| time at 0, 1, 2, 3 years | 18 months from date of | ||
| manufacture | Different | ||
| validation | |||
| testing schedule |
Technological Characteristics Comparison Table
6
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non-Clinical Testing
Qualification of the Kem Medical Products Type 1 Chemical Indicators for Steam Sterilization was performed by True Indicating LLC for 0-, 1-, 2- and 3-years real time. Testing was done to demonstrate that the CI's (Chemical Indicator's) performance meets the requirements defined in ISO 11140-1: 2014 Sterilization of Healthcare Products- Chemical Indicators- General Requirements for a Type 1 Chemical Indicator, and to determine substantial equivalence to the 3M Comply Lead Free Indicator Tape for Steam Sterilization. The Cls are for use as an external or internal chemical indicator in monitoring exposure to conditions of steam sterilization for 121°C - 135°C gravity and pre-vacuum sterilizer cycles.
Cycles for validation testing included BIER Vessel runs, with "pass/fail" criteria, of Saturated Steam 121°C for 2 minutes "fail" and 10 minutes "pass", Saturated Steam 132°C, 134°C and 135°C for 0.3 minutes "fail" and for 2 minutes "pass". Autoclave cycles were also used to test for reaction to Dry Heat 140°C for 30 minutes, and
7
performance in the following standard autoclave cycles:
Autoclave Pre- vac cycle 132°C for 3 minutes, Pre-vac cycle 132°C for 4 minutes, Pre-vac cycle 134°C for 3 minutes, Pre-vac cycle 135°C for 3 minutes; and Autoclave Gravity cycle 121°C for 30 minutes, Autoclave Gravity cycle 132°C for 15 minutes, Autoclave Gravity cycle 135°C for 10 minutes. Failure cycles were run for Pre-vac 132°C for 0 minutes and Pre-vac 135°C for 0 minutes.
Chemical indicator results for all testing performed under the acceptance criterialisted and as required in ISO 11140-1:2014 for Type 1 chemical indicators to achieve the target 3-year shelf life. All indicators exposed to either BIER sterilization parameters at "pass" test criteria (121°C for 10 minutes and at 132°C, 134°C and 135°C for 2 minutes) showed a dark color change. All indicators exposed to either BIER sterlization parameters at "fail" test criteria (121°C for 2 minutes and at 132°C, 134°C for .3 minutes) and dry heat (1400 C for 30 minutes) showed either no color change or a slight color change. All samples also met the endpoint/color change requirements per the ISO standard.
| Test | Purpose | Acceptance Criteria | Result | |
|---|---|---|---|---|
| Saturated | ||||
| Steam Testing; | ||||
| ISO 11140- | ||||
| 1:2014 | Meets the | |||
| requirements for | ||||
| Type I process | ||||
| indicator for steam. | 2 min at 121 °C | No change or change | ||
| that is markedly | ||||
| different from the | ||||
| visible color change | Pass | |||
| 10 min at 121 °C | Visible color change | |||
| 0.3 min at 132 °C / | ||||
| 134 °C /135 °C | No change or change | |||
| that is markedly | ||||
| different from the | ||||
| visible color change | ||||
| 2 min at 132 °C / | ||||
| 134 °C /135 °C | Visible color change | |||
| Standard | ||||
| Autoclave | ||||
| cycles | Meets performance | |||
| criteria in standard | ||||
| autoclave cycles | Endpoint color reached when exposed to | |||
| standard autoclave cycles. | ||||
| 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 | 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 |
Summary of Non-Clinical Testing
8
Clinical Testing
Not Applicable
Conclusion
The conclusions drawn from the nonclinical testing demonstrate that the subject device, Kem Medical Lead-Free Chemical Indicators for Steam Sterilization, are as safe, as effective and performs as well as or better than the legally marketed predicate, 3M Comply Process Indicators for Steam, K101528.