Getinge Assured MI Steam Migrating Integrator
Device Facts
| Record ID | K242795 |
|---|---|
| Device Name | Getinge Assured MI Steam Migrating Integrator |
| Applicant | Steritec Products Mfg. (A Getinge Group Company) |
| Product Code | JOJ · General Hospital |
| Decision Date | Oct 15, 2024 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
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, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal 273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal IUSS 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 IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS 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 2.4 minutes at 134°C 1.5 minutes at 135°C
Device Story
Internal pack integrating indicator; monitors steam sterilization cycle critical parameters. Consists of paper wick and steam-sensitive chemical pellet with blue dye inside aluminum foil tape base on film/paper label. During steam exposure, pellet melts and migrates into 'PASS' window if critical parameters met. Used in healthcare facilities within sterilization packs/trays. Provides visual pass/fail confirmation to clinicians/technicians; ensures sterilization cycle efficacy; aids in patient safety by verifying instrument sterility.
Clinical Evidence
Bench testing only. Performance verified per ANSI/AAMI/ISO 11140-1:2014 and FDA guidance. Testing included steam resistometer (BIER vessel) validation, hospital steam sterilizer testing, dry heat testing, side-by-side biological indicator comparison, and offset/transference testing. All samples passed pre-determined acceptance criteria for the claimed sterilization cycles.
Technological Characteristics
Type 5 Integrating Indicator per ANSI/AAMI/ISO 11140-1:2014. Materials: paper wick, steam-sensitive chemical pellet (blue dye), aluminum foil tape, film, paper label. Principle: chemical pellet melting and migration. Shelf life: 5 years. No software or electronics.
Indications for Use
Indicated for use as an internal pack integrating indicator to monitor critical process parameters of steam sterilization cycles (gravity and dynamic air removal) in healthcare facilities. Used in packs, pouches, trays, or containers.
Regulatory Classification
Identification
Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.
Predicate Devices
- Getinge Assured MI Steam Migrating Integrator (K200252)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2024
SteriTec Products Mfg. (a Getinge Group Company) % Barb Smith Principal Regulatory Affairs Specialist Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K242795
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: September 16, 2024 Received: September 16, 2024
Dear Barb Smith:
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.
{1}------------------------------------------------
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" (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 QS 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 Rule"). 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-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-regulatory
{2}------------------------------------------------
assistance/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,
Image /page/2/Picture/3 description: The image shows the text "Stephen A. Anisko -S" in a simple, sans-serif font. The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The text is black against a white background, and the letter "S" is slightly offset to the right.
Digitally signed by Stephen A. Anisko -S Date: 2024.10.15 15:28:23 -04'00'
for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control Devices 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
510(k) Number (if known) K242795
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, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal
273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal IUSS 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 IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS
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 2.4 minutes at 134°C 1.5 minutes at 135°C
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.
{4}------------------------------------------------
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."
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "SterTec" in a bold, sans-serif font. The letters are black, and the background is white. A horizontal line runs underneath the word, and a small triangle is located to the right of the word. The triangle is pointing to the left.
510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 1 of 6
# 510(k) Summary K242795
Date Prepared: October 15, 2024
Applicant Information
SteriTec Products Manufacturing CO INC (a Getinge Group company) 74 Inverness Drive East Englewood, CO 80112 U.S. Ph: 303-660-4201
Contact: Barb Smith Principal Regulatory Affairs Specialist Ph: 585-370-6101 e-mail: barb.smith@getinge.com
- 1. 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
Getinge Assured MI Steam Migrating Integrator (K200252). SteriTec Products, Manufacturing Co. Inc.
## 3. Description of Device
The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014.
It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dve. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "Steritec" in a bold, sans-serif font. The letters are black, and the word is underlined with a black line. The "T" in "Steritec" is larger than the other letters, and the "ec" is smaller than the other letters. There is a triangle shape to the right of the "ec".
510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 2 of 6
#### 4. 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, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal 273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity
#### Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS):
270°F/132°C, 4 minutes Dynamic Air Removal IUSS
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 IUSS
275°F/135°C, 3 minutes Gravity IUSS
275°F/135°C, 10 minutes Gravity IUSS
## 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 2.4 minutes at 134°C 1.5 minutes at 135°C
The intended use of the subject device has only been modified with the addition of sterilization cycles, from the referenced predicate device. The monitoring of the following cycles has been added:
- 10 minutes at 132°C Dynamic Air Removal .
- 3 minutes at 134°C Dynamic Air Removal .
- 4 minutes at 134°C Dynamic Air Removal. .
## 5. Technological Characteristics
The chart below compares the technological characteristics of the subject device, to that of the predicate device:
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "SterTec" in a bold, sans-serif font. The letters are black, and there is a horizontal line underneath the word. The "T" in "Tec" is slightly larger than the other letters, and there is a small triangle to the right of the "c".
#### 510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 3 of 6
| Feature | Predicate Device (K200252) | Modified/Subject Device (K242795) | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications<br>for Use | The Getinge Assured MI Steam<br>Migrating Integrator strip is an internal<br>pack integrating indicator designed to<br>react to critical process parameters of a<br>steam sterilization cycle within a stated<br>tolerance. The integrating indicator is<br>intended to be placed in each pack,<br>pouch, tray, or container to function as<br>an independent monitor of critical<br>parameters for the following<br>sterilization cycles:<br><br>Steam Sterilization Cycles:<br>250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic<br>Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic<br>Air Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic<br>Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity 275°F/135°C, 3 minutes Dynamic<br>Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity Stated values (as determined in a<br>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 | The Getinge Assured MI Steam Migrating<br>Integrator strip is an internal pack<br>integrating indicator designed to react to<br>critical process parameters of a steam<br>sterilization cycle within a stated tolerance.<br>The integrating indicator is intended to be<br>placed in each pack, pouch, tray, or<br>container to function as an independent<br>monitor of critical parameters for the<br>following sterilization cycles:<br><br>Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic Air<br>Removal 270°F/132°C, 4 minutes Dynamic Air<br>Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air<br>Removal 273°F/134°C, 4 minutes Dynamic Air<br>Removal 275°F/135°C, 3 minutes Dynamic Air<br>Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic Air<br>Removal IUSS 270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS 275°F/135°C, 3 minutes Dynamic Air<br>Removal IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS Stated values (as determined in a steam<br>resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C | The Intended Use of proposed<br>modified device is the same. This<br>submission proposes the<br>monitoring of additional exposure<br>temperatures and times: 10 minutes at 132°C<br>Dynamic Air Removal 3 minutes at 134°C Dynamic<br>Air Removal 4 minutes at 134°C Dynamic<br>Air Removal |
| Device Design | A paper wick and a steam sensitive<br>chemical pellet containing blue colored<br>dye. A pellet is held within a pocket<br>located at one end of an aluminum foil<br>tape base. The foil tape base is adhered<br>to a film material that has been bonded<br>with a paper label. During steam<br>sterilization, the integrating indicator<br>pellet will melt and migrate into the<br>PASS window when the specified<br>critical parameters of steam | A paper wick and a steam sensitive<br>chemical pellet containing blue colored dye.<br>A pellet is held within a pocket located at<br>one end of an aluminum foil tape base. The<br>foil tape base is adhered to a film material<br>that has been bonded with a paper label.<br>During steam sterilization, the integrating<br>indicator pellet will melt and migrate into<br>the PASS window when the specified<br>critical parameters of steam sterilization<br>have been met. | Same |
| | sterilization have been met. | | |
| Sterilization<br>methods and<br>cycles | Steam Sterilization Cycles:<br>• 250°F/121°C, 30 minutes Gravity<br>• 270°F/132°C, 4 minutes Dynamic<br>Air Removal<br>• 270°F/132°C, 15 minutes Gravity<br>• 275°F/135°C, 3 minutes Dynamic<br>Air Removal<br>• 275°F/135°C, 10<br>minutes Gravity<br>Steam Sterilization Cycles (IUSS):<br>• 270°F/132°C, 4 minutes Dynamic<br>Air Removal<br>• 270°F/132°C, 3 minutes Gravity<br>• 270°F/132°C, 10 minutes Gravity<br>• 275°F/135°C, 3 minutes Dynamic<br>Air Removal<br>• 275°F/135°C, 3 minutes Gravity<br>• 275°F/135°C, 10 minutes Gravity | Steam Sterilization Cycles:<br>• 250°F/121°C, 30 minutes Gravity<br>• 270°F/132°C, 10 minutes Dynamic Air<br>Removal<br>• 270°F/132°C, 4 minutes Dynamic Air<br>Removal<br>• 270°F/132°C, 15 minutes Gravity<br>• 273°F/134°C, 3 minutes Dynamic Air<br>Removal<br>• 273°F/134°C, 4 minutes Dynamic Air<br>Removal<br>• 275°F/135°C, 3 minutes Dynamic Air<br>Removal<br>• 275°F/135°C, 10 minutes Gravity<br>Steam Sterilization Cycles (IUSS):<br>• 270°F/132°C, 4 minutes Dynamic Air<br>Removal IUSS<br>• 270°F/132°C, 3 minutes Gravity IUSS<br>• 270°F/132°C, 10 minutes Gravity IUSS<br>• 275°F/135°C, 3 minutes Dynamic Air<br>Removal IUSS<br>• 275°F/135°C, 3 minutes Gravity IUSS<br>• 275°F/135°C, 10 minutes Gravity IUSS | Same with the addition of cycles:<br>• 10 minutes at 132°C<br>Dynamic Air Removal<br>• 3 minutes at 134°C Dynamic<br>Air Removal<br>• 4 minutes at 134°C Dynamic<br>Air Removal |
| Indicator Agent | Proprietary | Proprietary | Same |
| Endpoint<br>Specifications | The endpoint is determined by<br>migration of the steam sensitive pellet,<br>carrying the blue dye, to an area<br>marked PASS on the indicator.<br>Endpoint is reached at the stated value<br>(SV) for each claimed temperature.<br>Endpoint is not reached at the stated<br>value - 15% time and/or 1°C. | The endpoint is determined by migration of<br>the steam sensitive pellet, carrying the blue<br>dye, to an area marked PASS on the<br>indicator. Endpoint is reached at the stated<br>value (SV) for each claimed temperature.<br>Endpoint is not reached at the stated value -<br>15% time and/or 1°C. | Same |
| Shelf Life | 5 Years | 5 Years | Same |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "SterTec" in a bold, sans-serif font. The letters are black, and the word is underlined with a black line. The "T" in "Tec" is slightly larger than the other letters, and there is a small triangle to the right of the "c".
#### 510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 4 of 6
## 6. Non-Clinical Performance Testing
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 results to demonstrate that the Getinge Assured MI Steam Migrating Integrator met the requirements of its pre-determined acceptance criteria in its claimed intended steam sterilization cycles.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for SteriTec. The logo is black and white and features the word "SteriTec" in a bold, sans-serif font. The "T" in "Tec" is larger than the other letters and has a triangle shape cut out of the bottom right corner. A horizontal line is underneath the text.
#### 510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 5 of 6
| Performance Testing of 3<br>manufactured lots of<br>Integrator | Pre-Determined Acceptance Criteria | Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Steam Resistometer (BIER<br>vessel) Testing:<br>(According to ANSI/AAMI/ISO<br>11140-1:2014 Sterilization of health<br>care products - Chemical indicators<br>- Part 1: General requirements and<br>Premarket Notification [510(k)]<br>Submissions for Chemical<br>Indicators - Guidance for Industry<br>and FDA Staff.) | Pass result at the stated value for each<br>temperature claimed:<br>- 30 Minutes at 121°C<br>- 3.8 minutes at 132°C, 4.1 minutes at 132°C,<br>4.0 minutes at 132°C<br>- 2.1 minutes at 134°C, 2.2 minutes at 134°C,<br>2.4 minutes at 134°C<br>- 1.7 minutes at 135°C, 2.0 minutes at 135°C,<br>1.8 minutes at 135°C, | PASS |
| | Failing Result at 15% less time of SV for each<br>temperature claimed | PASS |
| | Failing Result at 1°C less for each temperature<br>claimed | PASS |
| Hospital Steam Sterilizer<br>Testing: | 100% samples passing under passing conditions<br>for each cycle | PASS |
| (To demonstrate pass/fail results<br>from an actual sterilization cycle<br>used in a health care facility<br>according to Premarket Notification<br>[510(k)] Submissions for Chemical<br>Indicators - Guidance for Industry<br>and FDA Staff) | 100% samples failing under failing conditions for<br>each cycle | PASS |
| Dry Heat Testing:<br>(According to ANSI/AAMI/ISO<br>11140-1:2014 Sterilization of health<br>care products - Chemical indicators<br>- Part 1: General requirements and<br>Premarket Notification [510(k)]<br>Submissions for Chemical<br>Indicators - Guidance for Industry<br>and FDA Staff) | Failing result when exposed to dry heat alone for<br>30 minutes (±1 minute) at 140°C (±2°C) | PASS |
| Side-by-side testing of the<br>biological indicator and<br>integrator in steam<br>resistometer:<br>(As specified in Premarket<br>Notification [510(k)] Submissions<br>for Chemical Indicators - Guidance<br>for Industry and FDA Staff) | The integrator does not reach its endpoint before<br>the biological indicator is inactivated | PASS |
| Offset/Transference:<br>(According to ANSI/AAMI/ISO<br>11140-1:2014 Sterilization of health<br>care products - Chemical indicators<br>- Part 1: General requirements.) | The indicator agent shall not offset or bleed,<br>penetrate the substrate to which it is applied, or<br>materials in which it is in contact before, during<br>or after the sterilization cycles for which it is<br>designed | PASS |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the word "Steritec" in a bold, sans-serif font. The word is written in black and is set against a white background. A horizontal line underlines the word, adding a sense of stability to the design. The overall design is simple and modern.
510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 6 of 6
#### 7. Conclusion:
Based on the results from the performance testing per 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 subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K200252), Class II Indicator, physical/chemical sterilization process (21 CFR 880.2800), JOJ.
