Who is the manufacturer of Getinge Assured MI Steam Migrating Integrator?

Steritec Products Mfg Co, Inc. filed the 510(k) submission for Getinge Assured MI Steam Migrating Integrator (K200252).

What is the FDA product code for Getinge Assured MI Steam Migrating Integrator?

JOJ. It is classified under 21 CFR 880.2800 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Getinge Assured MI Steam Migrating Integrator?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Getinge Assured MI Steam Migrating Integrator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Getinge Assured MI Steam Migrating Integrator

K200252 · Steritec Products Mfg Co, Inc. · JOJ · May 21, 2020 · General Hospital

Device Facts

Record ID	K200252
Device Name	Getinge Assured MI Steam Migrating Integrator
Applicant	Steritec Products Mfg Co, Inc.
Product Code	JOJ · General Hospital
Decision Date	May 21, 2020
Decision	SESE
Submission Type	Traditional
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, 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 Story

Single-use chemical indicator for steam sterilization monitoring; consists of paper wick and steam-sensitive blue dye pellet housed in aluminum foil pocket on laminated film/paper base. Placed inside sterilization packs/trays; during steam exposure, chemical pellet melts and migrates along wick. Reaches 'PASS' zone when critical sterilization parameters (time/temperature) are met. Used by sterile processing staff in clinical settings to verify sterilization cycle efficacy. Provides visual confirmation of cycle completion; aids in clinical decision-making regarding sterility of processed instruments.

Clinical Evidence

Bench testing only. Performance verified via steam resistometer (BIER vessel) and hospital steam sterilizer testing. Evaluated against ANSI/AAMI/ISO 11140-1:2014 requirements. Results confirmed 100% pass rate under specified sterilization conditions and 100% fail rate under sub-lethal conditions. Demonstrated parallel performance to biological indicators.

Technological Characteristics

Single-use chemical indicator; aluminum foil base with embossed cavity; paper wicking strip; steam-sensitive blue dye pellet; laminated film/paper cover. Operates via chemical migration principle. Complies with ANSI/AAMI/ISO 11140-1:2014. Shelf life: 5 years.

Indications for Use

Indicated for use as an internal pack chemical integrating indicator to monitor critical parameters of steam sterilization cycles (gravity and dynamic air removal) in healthcare facilities. Suitable for use 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

Steris Steam Integrating Indicator (K152630)

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). 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}------------------------------------------------ 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 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 - 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 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.

Getinge Assured MI Steam Migrating Integrator

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Getinge Assured MI Steam Migrating Integrator

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

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