(108 days)
Not Found
No
The device is a chemical indicator that relies on a physical process (pellet migration) to indicate sterilization, not computational analysis.
No
The device is an integrating indicator used to monitor steam sterilization cycles of other medical devices, ensuring they meet specified critical parameters for sterilization. It does not provide any therapeutic benefit to a patient.
No
Explanation: The device is an internal pack integrating indicator designed to monitor critical parameters of a steam sterilization cycle, not diagnose medical conditions in patients.
No
The device description clearly states it is a "single use device" with physical components like a paper wick, chemical pellet, aluminum foil base, and label material that undergo a physical change (pellet migration) to indicate sterilization. This is a hardware-based chemical indicator, not software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the critical process parameters of a steam sterilization cycle. This is a quality control measure for the sterilization process itself, not a test performed on a biological sample to diagnose a condition or provide information about a patient's health.
- Device Description: The device is a chemical indicator that reacts to steam, temperature, and time. It does not interact with biological samples or analyze biological markers.
- Lack of Biological Sample Interaction: The description clearly states the device is placed in packs, pouches, trays, or containers being sterilized. It does not involve the collection or analysis of blood, urine, tissue, or any other biological specimen.
- Performance Studies: The performance studies focus on the device's reaction to steam sterilization parameters and comparison to biological indicators used for sterilization validation. They do not involve clinical performance studies on patient samples.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that definition. It is a process indicator for sterilization.
N/A
Intended Use / Indications for Use
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity
Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Getinge Assured MI Steam Migrating Integrator is a single use device to monitor steam sterilization cycles. The integrating indicator is designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for sterilization cycles. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when sterilization conditions have been met.
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
Not Found
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)
Performance testing was conducted to verify that the proposed Getinge Assured MI Steam Migrating Integrator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014. The following table summarizes the performance testing that was completed, with acceptance criteria and the results demonstrate that the Getinge Assured MI Steam Migrating Integrator met the requirements of the pre-determined acceptance criteria in its claimed intended steam sterilization cycles.
-
Test Methodology: Steam Resistometer (BIER vessel) Testing
- Purpose: To test the pass/fail criteria for each critical cycle parameter and provide the pass/fail results to show how the chemical integrator reacts to all the critical parameters in the sterilization cycle for which it is intended according to ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators Part 1: General requirements and Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff.
- Pre-Determined Acceptance Criteria: Pass result at the stated value for each temperature claimed: - 30 Minutes at 121°C - 3.3 minutes at 132°C - 1.5 minutes at 135°C. Failing Result at 15% less time of SV for each temperature claimed.
- Results: PASS for both criteria.
-
Test Methodology: Steam Resistometer (BIER vessel) Testing
- Purpose: To evaluate one parameter at a time in a resistometer while holding the other parameters constant according to Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
- Pre-Determined Acceptance Criteria: Failing Result at 1°C less for each temperature claimed
- Results: PASS
-
Test Methodology: Hospital Steam Sterilizer Testing
- Purpose: To demonstrate pass/fail results from an actual sterilization cycle used in a health care facility according to Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
- Pre-Determined Acceptance Criteria: 100% samples passing under passing conditions for each cycle; 100% samples failing under failing conditions for each cycle
- Results: PASS
-
Test Methodology: Dry Heat Testing
- Purpose: To demonstrate that the integrator does not change color following a dry heat cycle according to ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements and Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
- Pre-Determined Acceptance Criteria: Failing result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C)
- Results: PASS
-
Test Methodology: Side-by-side testing of the biological indicator and integrator in steam resistometer
- Purpose: To demonstrate that the chemical integrator parallels the performance of an appropriate biological indicator. The results of this study should demonstrate that the integrator does not reach its endpoint before the biological indicator is inactivated, as specified in Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
- Pre-Determined Acceptance Criteria: The integrator does not reach its endpoint before the biological indicator is inactivated
- Results: PASS
-
Test Methodology: Offset/Transference
- Purpose: To demonstrate the indicator agent does not bleed or offset to substrate which it is applied according to ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements.
- Pre-Determined Acceptance Criteria: The indicator agent 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
- Results: PASS
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 21, 2020
SteriTec Products MFG Co Inc Jonathan Rutigliano Director, Regulatory Affairs 74 Inverness Drive East Englewood, Colorado 80112
Re: K200252
Trade/Device Name: Getinge Assured MI Steam Migrating Integrator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: February 21, 2020 Received: February 24, 2020
Dear Jonathan Rutigliano:
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
CAPT Elizabeth Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200252
Device Name Getinge Assured MI Steam Migrating Integrator
Indications for Use (Describe)
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity
Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
Manufacturing Facility SteriTec Products Manufacturing CO INC 74 Inverness Drive East Englewood, CO 80112 Ph: 303-660-4201
Contact: Jonathan Rutigliano Director, Regulatory Affairs Ph: 303-660-4201 e-mail: Jon.Rutigliano@Getinge.com
Submission Date: May 16, 2020
-
- Device Name
| Trade Name: | Getinge Assured MI Steam Migrating Integrator |
|---|---|
| Device Classification: | Class II |
| Common/Usual Name: | Indicator, physical/chemical sterilization process |
| Classification Name: | Indicator, physical/chemical sterilization process (21 CFR 880.2800, JOJ) |
2. Predicate Device
Steris Steam Integrating Indicator (K152630). Steris Corporation
3. Description of Device
The Getinge Assured MI Steam Migrating Integrator is a single use device to monitor steam sterilization cycles. The integrating indicator is designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for sterilization cycles. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when sterilization conditions have been met.
4. Indications For Use:
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to
5
be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
250°F/121°C, 30 minutes Gravity 270°F/132°C. 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity
275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity
Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C
5. Technological Characteristics
The chart below compares the technological characteristics to that of the predicate device:
| Feature | PREDICATE | 510(k) Filing | COMPARISON |
|---|---|---|---|
| --------- | ----------- | --------------- | ------------ |
6
| Intended Use | Similar | ||
|---|---|---|---|
| The integrating indicator is | |||
| designed to chemically react over | |||
| time with the critical parameters | |||
| of steam sterilization cycles | |||
| within a specified tolerance. The | |||
| integrating indicator strip is | |||
| intended to be placed in each | |||
| pack, pouch, container, tray or | |||
| other containment device to | |||
| function as an independent | |||
| monitor of critical parameters for | |||
| the following sterilization cycles: | Steam Sterilization Cycles: | ||
| • 250°F/121°C- 30 min | |||
| Gravity | |||
| • 270°F/132°C- 4 minutes | |||
| Dynamic Air Removal | |||
| • 270°F/132°C- 15 | |||
| minutes Gravity | |||
| • 275°F/135°C- 3 minutes | |||
| Dynamic Air Removal | |||
| • 275°F/135°C- 10 | |||
| minutes Gravity | The Getinge Assured MI Steam | ||
| Migrating Integrator strip is an | |||
| internal pack integrating indicator | |||
| designed to react to critical process | |||
| parameters of a steam sterilization | |||
| cycle within a stated tolerance. The | |||
| integrating indicator is intended to | |||
| be placed in each pack, pouch, tray | |||
| or container to function as an | |||
| independent monitor of critical | |||
| parameters for the following | |||
| sterilization cycles: | |||
| Steam Sterilization Cycles | |||
| (IUSS): | |||
| • 270°F/132°C- 4 minutes | |||
| Dynamic Air Removal | |||
| • 270°F/132°C- 3 minutes | |||
| Gravity | |||
| • 270°F/132°C- 10 | |||
| minutes Gravity | |||
| • 275°F/135°C- 3 minutes | |||
| dynamic air removal | |||
| • 275°F/135°C- 3 minutes | |||
| Gravity | |||
| • 275°F/135°C- 10 | |||
| minutes Gravity | Steam Sterilization Cycles: | ||
| • 250°F/121°C, 30 | |||
| minutes Gravity | |||
| • 270°F/132°C, 4 | |||
| minutes Dynamic | |||
| Air Removal | |||
| • 270°F/132°C, 15 | |||
| minutes Gravity | |||
| • 275°F/135°C, 3 minutes | |||
| Dynamic Air Removal | |||
| • 275°F/135°C, 10 | |||
| minutes Gravity | |||
| Steam Sterilization Cycles (IUSS): | |||
| • 270°F/132°C, 4 minutes | |||
| Dynamic Air Removal | |||
| • 270°F/132°C, 3 minutes | |||
| Gravity | |||
| • 270°F/132°C, 10 | |||
| minutes Gravity | |||
| • 275°F/135°C, 3 minutes | |||
| Dynamic Air Removal | |||
| • 275°F/135°C, 3 minutes | |||
| Gravity | |||
| • 275°F/135°C, 10 | |||
| minutes Gravity | |||
| Device | |||
| Design | Backing material with embossed | ||
| cavity containing temperature | |||
| sensitive chemical and coloring | |||
| dye, wicking strip, covered with | |||
| laminated paper containing | |||
| labeling and windows. | A paper wick and a steam | ||
| sensitive chemical pellet | |||
| containing blue colored dye. A | |||
| pellet is held within a pocket | |||
| located at one end of an aluminum | |||
| foil base. The foil base is adhered | |||
| to label material that has been | |||
| bonded with a film. During steam | |||
| sterilization, the integrating | |||
| indicator pellet will migrate into | |||
| the PASS zone when the specified | |||
| critical parameters of steam | |||
| sterilization have been met. | Similar | ||
| Sterilization | |||
| methods and | |||
| cycles | Steam Sterilization Cycles: | ||
| 250°F/121°C- 30 min | |||
| Gravity 270°F/132°C- 4 minutes | |||
| Dynamic Air Removal 270°F/132°C- 15 | |||
| minutes Gravity 275°F/135°C- 3 minutes | |||
| Dynamic Air Removal 275°F/135°C- 10 | |||
| minutes Gravity Steam Sterilization Cycles | |||
| (IUSS): 270°F/132°C- 4 minutes | |||
| Dynamic Air Removal 270°F/132°C- 3 minutes | |||
| Gravity 270°F/132°C- 10 | |||
| minutes Gravity 275°F/135°C- 3 minutes | |||
| dynamic air removal 275°F/135°C- 3 minutes | |||
| Gravity 275°F/135°C- 10 | |||
| minutes Gravity | Steam Sterilization Cycles: | ||
| 250°F/121°C, 30 | |||
| minutes Gravity 270°F/132°C, 4 | |||
| minutes Dynamic | |||
| Air Removal 270°F/132°C, 15 | |||
| minutes Gravity 275°F/135°C, 3 minutes | |||
| Dynamic Air Removal 275°F/135°C, 10 | |||
| minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes | |||
| Dynamic Air Removal 270°F/132°C, 3 minutes | |||
| Gravity IUSS 270°F/132°C, 10 | |||
| minutes Gravity IUSS 275°F/135°C, 3 minutes | |||
| Dynamic Air Removal 275°F/135°C, 3 minutes | |||
| Gravity 275°F/135°C, 10 | |||
| minutes Gravity | Same | ||
| Indicator | |||
| Agent | Proprietary | Proprietary | Same |
| Endpoint | |||
| Specifications | The endpoint is determined by | ||
| migration of the steam sensitive | |||
| dye to an area marked ACCEPT | |||
| (OK) on the indicator. Endpoint is | |||
| reached at the stated value (SV) | |||
| for each claimed temperature. | |||
| Endpoint is not reached at the | |||
| stated value – 15% time and/or | |||
| 1°C. | The endpoint is determined by | ||
| migration of the steam sensitive | |||
| dye to an area marked PASS on the | |||
| indicator. Endpoint is reached at | |||
| the stated value (SV) for each | |||
| claimed temperature. Endpoint is | |||
| not reached at the stated value – | |||
| 15% time and/or 1°C. | Same | ||
| Endpoint | |||
| Stability | 6 | ||
| months | 6 | ||
| months | Same | ||
| Shelf Life | 5 Years | 5 Years | Same |
7
8
6. Performance Testing
Performance testing was conducted to verity that the proposed Getinge Assured MI Steam Migrating Integrator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014. The following table summarizes the performance testing that was completed, with acceptance criteria and the results demonstrate that the Getinge Assured MI Steam Migrating Integrator met the requirements of the pre-determined acceptance criteria in its claimed intended steam sterilization cycles.
| Test Methodology | Purpose | Pre-Determined
Acceptance
Criteria | Results |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Steam Resistometer (BIER
vessel) Testing | To test the pass/fail criteria for
each critical cycle parameter
and provide the pass/fail results
to show how the chemical
integrator reacts to all the
critical parameters in the
sterilization cycle for which it is
intended according to
ANSI/AAMI/ISO 11140-1:2014
Sterilization of health care
products - Chemical indicators
Part 1: General requirements
and Premarket Notification
[510(k)] Submissions for
Chemical Indicators - Guidance
for Industry and FDA Staff. | Pass result at the stated
value for each temperature
claimed:
- 30 Minutes at 121°C
- 3.3 minutes at
132°C - 1.5 minutes at
135°C | PASS |
| | | Failing Result at 15% less
time of SV for each
temperature claimed | PASS |
| Steam Resistometer (BIER
vessel) Testing | To evaluate one parameter
at a time in a resistometer
while holding the other
parameters constant
according to Premarket
Notification [510(k)]
Submissions for Chemical
Indicators - Guidance for
Industry and FDA Staff | Failing Result at 1°C
less for each
temperature claimed | PASS |
| Hospital Steam
Sterilizer Testing | To demonstrate pass/fail
results from an actual
sterilization cycle used in a
health care facility according to
Premarket Notification [510(k)]
Submissions for Chemical
Indicators - Guidance for
Industry and FDA Staff | 100% samples passing
under passing conditions
for each cycle
100% samples failing
under failing conditions
for each
cycle | PASS |
| Dry Heat Testing | To demonstrate that the
integrator does not change
color following a dry heat cycle
according to ANSI/AAMI/ISO
11140-1:2014 Sterilization of
health care products - Chemical
indicators - Part 1: General
requirements and Premarket
Notification [510(k)]
Submissions for Chemical
Indicators - Guidance for
Industry and FDA Staff | Failing result when
exposed to dry heat alone
for
30 minutes (±1 minute) at
140°C (±2°C) | PASS |
| Side-by-side testing of
the biological indicator
and integrator in steam
resistometer | To demonstrate that the
chemical integrator parallels
the performance of an
appropriate biological
indicator. The results of this
study should demonstrate
that the integrator does not
reach its endpoint before the
biological indicator is
inactivated, as specified in
Premarket Notification
[510(k)] Submissions for
Chemical Indicators -
Guidance for Industry and
FDA Staff | The integrator does not
reach its endpoint before
the biological indicator is
inactivated | PASS |
| Offset/Transference | To demonstrate the indicator
agent does not bleed or offset to
substrate which it is applied
according to ANSI/AAMI/ISO
11140-1:2014 Sterilization of
health care products - Chemical
indicators - Part 1: General
requirements. | The indicator agent 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 |
9
7. Conclusion
Based on the results from the performance testing as required in Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140- 1:2014, the proposed device is as safe, as effective and performs as well as or better than the legally marketed device (K152630), Class II Indicator, physical/chemical sterilization process (21 CFR 880.2800), JOJ.