(149 days)
The qke Steam SCBI 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 nominal 100,000 spores of Geobacillus stearothermophilus on a carier and enclosed in a protective plastic vial. The spores have a known resistance to certain steam sterilization cycles. The device can be used for gravity and pre-vacuum cycles according to the following conditions: 121 °C, 30 minutes / 132, 134 and 135°C, 3 minutes.
Subsequent growth or failure of the microorqanisms after an incubation time of 24 hours at 55-60 °C indicates the adequacy of sterilization.
The gke Steri-Record Steam Mini-Bio-Plus SCBI uses a plastic vial with a minimized internal volume containing a biological indicator spore disc and a glass ampoule with a growth medium and pH-indicator inside. The growth medium is optimized to support growth.
Here's a breakdown of the acceptance criteria and study information for the Gke Steri-Record Steam Mini-Bio-Plus Self-Contained Biological Indicator (SCBI) based on the provided text:
Gke Steri-Record Steam Mini-Bio-Plus SCBI Acceptance Criteria and Performance Study
The Gke Steri-Record Steam Mini-Bio-Plus SCBI is intended to monitor the adequacy of steam sterilization procedures. Its performance was evaluated against recognized standards for biological indicators.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Total Viable Spore Count | ≥10^5^/unit per ISO 11138-3 | Passed |
| D value (at 121°C) | ≥1.5 min. at 121°C per ISO 11138-3 | Passed |
| z-value | ≥6°C per ISO 11138-3 | Passed |
| Survival time (at 121°C) | ≥4.5 min. per ISO 11138-3 | Passed |
| Kill time (at 121°C) | ≥13.5 min. per ISO 11138-3 | Passed |
| Carrier & Primary Packaging Evaluation | No inhibitory properties on the growth of gke Steam SCBI after exposure to steam sterilization processes (ISO 11138-1:2006, 5.2 and Annex B) | Passed |
| Holding Time Assessment | No negative impact on the growth of SCBIs after ≤ 72 h holding time. | Passed |
| Reduced Incubation Time Studies | 30 – 80% of BIs survived in all tested partial cycles. No further growth of BIs after 24 hours of incubation is observed. | Passed |
| Medium Suitability | USP medium suitability for Self-Contained Biological Indicators (SCBIs) | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for each test in the "test set" (i.e., the BIs used for performance evaluation). However, it mentions that testing was performed “using multiple lots of gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicators over the range of the shelf life.” This implies a statistically significant number of BIs were used to ensure representativeness.
Data Provenance: The studies were conducted by GKE-GMBH, a German company (Waldems, Germany), indicating the country of origin of the data. The studies are described as internal performance testing to support a 510(k) submission, making them prospective in nature for the purpose of demonstrating device performance against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the device is a biological indicator, and its performance is measured against objective, quantifiable parameters (spore count, D-value, z-value, survival/kill times, growth/no growth). The determination of "ground truth" (i.e., whether sterilization was successful or not) is based on the biological response of the indicator itself, not on human expert interpretation of images or other data that require subjective assessment. The "experts" in this context would be the microbiologists and engineers conducting the tests according to the specified standards (USP, ISO 11138).
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where human interpretation can vary (e.g., medical image diagnosis). For this device, the outcomes of the tests (e.g., positive or negative growth, numerical values for D-value) are objective and determined by laboratory measurement and observation. Therefore, an adjudication method in the traditional sense is not applicable. The results are either within the acceptance criteria (Passed) or not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often comparing human performance with and without AI assistance. The Gke Steri-Record Steam Mini-Bio-Plus SCBI is a biological indicator that provides a direct biological response (growth or no growth) as an indication of sterilization effectiveness. It does not involve human readers interpreting complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance study results essentially demonstrate the standalone performance of the biological indicator itself. The device is designed to function and provide a clear, objective output (color change indicating growth or no growth) without human interpretation affecting the core measurement of sterilization efficacy. The tests (D-value, z-value, survival/kill windows, etc.) directly assess the indicator's intrinsic biological properties and response to sterilization conditions.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Gke Steri-Record Steam Mini-Bio-Plus SCBI's performance can be categorized as a combination of:
- Biological/Microbiological Measurement: The core of the ground truth is the presence or absence of viable Geobacillus stearothermophilus spores and their defined resistance characteristics (D-value, z-value, survival/kill times) when subjected to known, controlled sterilization conditions.
- Reference Standards: The "ground truth" is defined by adherence to internationally recognized and FDA-accepted consensus standards such as USP Biological Indicator for Steam Sterilization, ANSI/AAMI/ISO 11138-1, and ISO 11138-3. These standards rigorously define how D-values, z-values, and survival/kill windows should be measured and what constitutes an effective biological indicator. The "truth" is established by these standardized methodologies.
8. The Sample Size for the Training Set
This concept is not applicable to the Gke Steri-Record Steam Mini-Bio-Plus SCBI. This is not an AI/ML device that requires a "training set" of data to learn patterns or make predictions. It is a biological device with inherent physical and biological properties. Its performance is demonstrated through empirical testing against established standards, not through "training" an algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" is not applicable. The device's performance is verified directly through laboratory testing against predefined, objective biological and physical parameters outlined in international standards for biological indicators.
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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized representation of a human figure embracing a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
GKE-GMBH Ulrich Kaiser, Ph.D. General Manager Auf Der Lind 10 Waldems, 65529 DE
Re: K163144
Trade/Device Name: Gke Steri-Record Steam Mini-Bio-Plus Self-Contained Biological Indicator (SCBI) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: March 1, 2017 Received: March 6, 2017
Dear Dr. Kaiser:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
Indications for Use (Describe)
The qke Steam SCBI 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 nominal 100,000 spores of Geobacillus stearothermophilus on a carier and enclosed in a protective plastic vial. The spores have a known resistance to certain steam sterilization cycles. The device can be used for gravity and pre-vacuum cycles according to the following conditions: 121 °C, 30 minutes / 132, 134 and 135°C, 3 minutes.
Subsequent growth or failure of the microorqanisms after an incubation time of 24 hours at 55-60 °C indicates the adequacy of sterilization.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
x Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Submission Page 37 of 157
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Image /page/3/Picture/0 description: The image shows the logo for GKE Cleaning and Sterilization Monitoring. The logo is in blue and features the letters "gke" in a stylized font. Below the letters is the text "Cleaning and Sterilization Monitoring" in a smaller font, underlined by a blue line.
510(k) Summary for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
K163144
- Submitter: gke-GmbH Auf der Lind 10 65529 Waldems Germany P: +49 6126 9432-0 F: +49 6126 9432-10 E: info@gke.eu
- Contacts: Dr. Ulrich Kaiser General Manager P: +49 6126 9432-0 office@ake.eu
Dr. Claus-Jürgen Kaiser Regulatory Affairs Manager P: +49 6126 9432-32 org@gke.eu
Prepared on: April 05, 2017
Device qke Steri-Record Steam Mini-Bio-Plus self-contained biological Name: indicator (SCBI)
-
Classification: Class II Medical Device, FDA Product Code FRC, General Hospital 3MTM Attest™ 1262/1262P Predicate (pre-amendment)
Devices: Legally Marketed) -
The gke Steam SCBI is a device intended for use by a health Intended Use: care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of nominal 100.000 spores of Geobacillus stearothermophilus on a carrier and enclosed in a protective plastic vial. The spores have a known resistance to certain steam sterilization cycles. The device can be used for gravity and pre-vacuum cycles according to the following conditions:
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Image /page/4/Picture/0 description: The image shows the logo for GKE Cleaning and Sterilization Monitoring. The logo is in blue and features the letters "gke" in a stylized font. Below the letters is the text "Cleaning and Sterilization Monitoring" in a smaller font, underlined by a blue line.
121 °C, 30 minutes / 132, 134 and 135°C, 3 minutes. Subsequent growth or failure of the microorganisms after an incubation time of 24 hours at 55-60 °C indicates the adequacy of sterilization.
- The gke Steri-Record Steam Mini-Bio-Plus SCBI uses a plastic Description of Device: vial with a minimized internal volume containing a biological indicator spore disc and a glass ampoule with a growth medium and pH-indicator inside. The growth medium is optimized to support growth.
- Operational The gke Steri-Record Steam Mini-Bio-Plus SCBI is Principles: placed in the most difficult to sterilize area of a load. Upon cycle completion, the SCBI is removed and activated by crushing the growth medium ampoule to immerse the disc in the growth medium. The activated SCBI should be incubated at 55-60 °C. The SCBI should be monitored for visible signs of growth. Growth will be indicated by a color shift from purple to yellow. The absence of growth indicates the exposure was effective.
Statement of The gke Steri-Record Steam Mini-Bio-Plus Self-Contained Similarity Biological Indicators have the following similarities to the legally to Legally marketed predicate device:
-
Marketed Predicate
Device: -
Incorporation of the same or similar materials
-
Similar intended use
-
Have the same or similar shelf life, and ●
-
The same or similar materials for packaging ●
In summary, the data provided demonstrates substantial equivalence to the predicate device.
| Element | New Device | Predicate Device |
|---|---|---|
| gke Steam SCBI | 3MTM AttestTM | |
| product type | Self-contained biological indicator | Self-contained biological indicator |
| Intended use | Steam at 121°C, 132°C,134°, 135°C | Steam at 121°C and132°C |
| Construction | Vial, cap, paper cap liner,paper spore disc, glassampoule of growth media | Vial, cap, paper cap liner,paper spore disc, glassampoule of growth media |
A device comparison table is provided below.
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Image /page/5/Picture/0 description: The image shows the logo for GKE Cleaning and Sterilization Monitoring. The logo is in blue and features the letters "gke" in a stylized font. Below the letters is the text "Cleaning and Sterilization Monitoring" in a smaller font, underlined by a blue line.
| modified with pH indicator | modified with pH indicator | |
|---|---|---|
| Activation | Squeeze to break ampoule | Squeeze to break ampoule |
| Organism | Geobacillus stearothermophilus ATCC® 7953 or other micro-organism of demonstrated equivalent performance as required by ISO 11138-3 | Geobacillus stearothermophilus ATCC® 7953 |
| Viable spore population | $>10^5$ /unit per ISO 11138 | $10^5$ /unit |
| Certified resistance D-value at 121°C | 1.5-3.0 min | 1.5-3.0 min |
| z-value | ≥6°C per ISO 11138 | ≥6°C per ISO 11138Per USP and ISO 11138 |
| Survival/kill window | Survival time: ≥4.5 minKill time: ≥13.5 min.both at 121 °C per ISO 11138-3 | |
| Incubation temperature | 55°C-60°C | 56°±2°C |
| Readout time | 24 h | 12 hours-48h final detection |
| Media color (Initial)) | Purple | Purple |
| Media color(Growth) | Yellow | Yellow |
| Shelf Life | 24 Month | 18 Month |
There are no relevant deviations between the gke Steam SCBI and the predicate device.
Non relevant deviations:
The incubation temperature of the gke Steam SCBI is 55 to 60 ℃. the predicate device requests 54 to 58 °C (56°±2°C). It is a nonrelevant deviation to the incubation temperature of the predicate device.
The predicate device has a readout time of 12 hours to 48 hours for final detection. gke Steam SCBI has a readout time of 24 hours as seen in the reduced incubation time report. The readout times of both products are in a similar range. Therefore, it is a non-relevant deviation.
Additionally, to the shelf life of the whole complete device gke describes the shelf life of the components of gke Steam SCBI, too. In summary, the gke Steam SCBI and the predicate device
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Image /page/6/Picture/0 description: The image shows the logo for "gke Cleaning and Sterilization Monitoring". The logo is in blue and features the letters "gke" in a stylized font. The words "Cleaning and Sterilization Monitoring" are written in a smaller font below the letters "gke". A blue line underlines the words "Cleaning and Sterilization Monitoring".
have the same shelf of 18 months. No relevant deviation.
Description of Per FDA recognized consensus standards and guidance Testing: documents (Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions, issued on October 4, 2007) testing was performed for steam sterilization processes using multiple lots of gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicators over the range of the shelf life:
All population and performance parameters were measured in conformity with FDA recognized consensus standards:
- USP Biological Indicator for Steam Sterilization, Selfo Contained
- ANSI/AAMI/ISO 11138-1: 2006 Sterilization of health ● care products - Biological indicators - Part 1: General Requirements
- . Guidance for Industry and FDA Stuff (BI) Premarket Notification [510(k)] Submissions, issued on October 4, 2007)
Summary of testing
| Test | Description | Acceptance Criteria | Result |
|---|---|---|---|
| Total ViableSpore Count | According USP (55)and ISO 11138 | ≥105/unit per ISO11138-3 | Passed |
| D value | ISO 11138-1 | ≥1.5 min. at 121°Cper ISO 11138-3 | Passed |
| z-value | ISO 11138-1 | ≥6°C per ISO 11138-3 | Passed |
| Survival/KillWindows | ISO 11138-1:2006 | Survival time: ≥4.5minKill time: ≥13.5 min.both at 121°C perISO 11138-3 | Passed |
| Carrier andPrimaryPackagingMaterialsEvaluation | ISO 11138-1:2006,5.2 and Annex B andISO 11138-3:2006 | No inhibitoryproperties on thegrowth of gke SteamSCBI after exposureto steam sterilizationprocessesISO 11138-1:2006,5.2 and Annex B | Passed |
| Holding TimeAssessment | FDA Guidance"Biological Indicator(BI) PremarketNotification (510(k))Submissions" | No negative impacton the growth ofSCBIs after ≤ 72 hholding time. | Passed |
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Image /page/7/Picture/0 description: The image shows the logo for GKE Cleaning and Sterilization Monitoring. The logo is in blue and consists of the letters "gke" in a stylized font. Underneath the letters is the text "Cleaning and Sterilization Monitoring" in a smaller font. The text is underlined with a blue line.
| Attachment II) | |||
|---|---|---|---|
| ReducedIncubation TimeStudies | FDA Guidance"Biological Indicator(BI) PremarketNotification [510(k)]Submissions"Attachment II | 30 – 80% of BIssurvived in all testedpartial cycles. Nofurther growth of BIsafter 24 hours ofincubation isobserved. | Passed |
| MediumSuitability | USP mediumsuitability for Self-Contained BiologicalIndicators (SCBIs) | USP mediumsuitability for Self-Contained BiologicalIndicators (SCBIs) | Passed |
Conclusion of performance testing - bench
Based on the results of the performance testing study the gke Steam SCBI correspond to the following standards, which are also our acceptance criteria:
- USP Biological Indicator for Steam Sterilization, Self-. Contained
- ANSI/AAMI/ISO 11138-1: 2006 Sterilization of health ● care products – Biological indicators – Part 1: General Requirements
- Guidance for Industry and FDA Stuff (BI) Premarket . Notification [510(k)] Submissions, issued on October 4, 2007)
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.
§ 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).