(216 days)
The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of:
- ID of 1.0 mm or larger and a length of 3580 mm or shorter and .
- ID of 1.2 mm or larger and a length of 4095 mm or shorter .
The SteroScope® Sterilization Technology System is a vaporized hydrogen peroxide based (VHP) sterilizer for the terminal sterilization of flexible endoscopes with the following characteristics: Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of: · ID of 1.0 mm or larger and a length of 3580 mm or shorter and · ID of 1.2 mm or larger and a length of 4095 mm or shorter. The SteroScope® Sterilization Technology System is a Gas Plasma VHP sterilization system designed specifically for flexible endoscope terminal sterilization, not for general surgical instrument loads. It is a self-contained stand-alone system of hardware and software system that uses technology to rapidly diffuse VHP into all the channels of the flexible endoscope to facilitate the sterilization of inner device surfaces, while being occupationally and environmentally safe to use. To enable the terminal sterilization of long multi-lumen endoscopes, while minimizing oxidation damage, the SteroScope® Sterilization Technology System incorporates a proprietary gas diffusion technology which creates a pressure differential in each internal endoscope lumen channel to actively pull hydrogen peroxide vapor from the chamber of the VHP sterilizer through the distal end of each endoscope channel, while the endoscope is in a sterile container. Utilizing a separate mechanism for the rapid diffusion of VHP from the chamber into the individual SteroScope® Sterilization Technology System allows the entire endoscope to be sterilized with less overall peroxide dose exposure.
The provided document is a 510(k) summary for the SteroScope® Sterilization Technology System. It outlines the non-clinical performance testing conducted to establish the device's safety and efficacy. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table (Table 3) listing various testing methods, their purpose, acceptance criteria, and results. All tests listed show a "Pass" result, indicating the device met the specified acceptance criteria.
| Testing Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| System Environmental Testing | System environmental testing under extreme conditions operating conditions | Internal Specification | Pass |
| SteroScope H2O2 Emissions Test | H2O2 emissions compliance to required OSHA safety levels | OSHA H2O2 SEL/PEL | Pass |
| System H2O2 Concentration Mapping | Peroxide concentration mapping during operation | Internal Specification | Pass |
| System Temperature Mapping | Temperature mapping during operation | Internal Specification | Pass |
| System Functional Test | Testing of system functional requirements to ensure conformance to system specifications | Internal Specification | Pass |
| SteroScope System Shipping | System shipping test for vibration, shock & drop to ensure system and packaging integrity | ISTA 2B | Pass |
| SteroScope Consumable Shipping | Consumable shipping test for vibration, shock & drop to ensure consumable and packaging integrity | ISTA 2A | Pass |
| EMC & Electrical Safety | The sterilizer was tested in accordance with IEC 60601-1-2 and IEC 61010-1 standards | IEC 60601-1-2 and IEC 61010-1 | Pass |
| Qualification of Pressure Limits | Validation of sterilizer operational pressure limits | Internal Specification | Pass |
| Human Factors | Validation of system ergonomics and human factors with clinical users | Internal Specification | Pass |
| Software Validation | Software verification and validation of software requirements | Internal Specification | Pass |
| Subsystem Design Verifications | Testing of each subsystem to ensure functional performance met design requirements | Internal Specification | Pass |
| H2O2 Consumable Shelf-life | Long term stability study of H2O2 consumable to establish shelf life | Internal Specification | Pass |
| H2O2 Consumable Storage | Stability testing of H2O2 consumable in extreme conditions | Internal Specification | Pass |
| Endoscope Temperature Mapping | Mapping of endoscope temperatures during cycle to verify the internal and external temperatures of a flexible endoscope | Internal Specification | Pass |
| Final Process Qualification | Operational process qualification with multiple systems | Internal Specification | Pass |
| Mated Surface Connector-Port | Half cycle connector efficacy test | No growth of Geobacillus stearothermophilus | Pass |
| BI & CI Functionality | BI & CI functionality under worst case conditions | No Growth in BI & color change in CI | Pass |
| AOAC Sporicidal Test | Process and sterilant efficacy for multiple organisms | AOAC Official Method 966.04 | Pass |
| Mated Surface Sterilization | Half cycle mated material efficacy using material coupons | No growth of Geobacillus stearothermophilus | Pass |
| Material Surface Sterilization | Half cycle surface efficacy using material coupons | No growth of Geobacillus stearothermophilus | Pass |
| Uniformity Microbial Inactivation | Dosing study to assess uniformity of microbial inactivation | Uniformity in inactivation kinetics based on SLR | Pass |
| Endoscope Dose Response Curves | Dosing study with various flexible endoscopes | Internal Specification | Pass |
| Material Bacteriostasis Validation | Confirmation that there are no bacteriostatic effects that inhibit growth for material coupons | No bacteriostatic effect after sterilization with growth of defined micro-organisms | Pass |
| Bacteriostasis & Fungistasis Validation | Confirmation that there are no bacteriostatic effects that inhibit growth for flexible endoscopes | No bacteriostatic effect after sterilization with growth of defined micro-organisms | Pass |
| Simulated Use Testing | Worst-case testing with unwashed flexible endoscopes inoculated with test culture challenge | 6-log reduction in Geobacillus stearothermophilus | Pass |
| In-Use Testing | Worst-case testing with clinically used flexible endoscopes. | No growth upon recovery after sterilization | Pass |
| Functionality & Material Compatibility | Worst-case material compatibility testing of multiple flexible endoscopes with back to back cycles | Internal Specification | Pass |
| Biocompatibility Coupons | Worst-case residual and cytotoxicity (MTT) testing with material coupons | ISO 10993-5 | Pass |
| Biocompatibility Flexible Endoscopes | Worst-case residual and cytotoxicity (MTT) testing with flexible endoscopes | ISO 10993-5 | Pass |
2. Sample sized used for the test set and the data provenance:
The document describes non-clinical performance testing. It doesn't explicitly state sample sizes for each test in a numerical format that would typically be used for a clinical study (e.g., N=X patients). However, it mentions "multiple systems" for "Final Process Qualification," "multiple organisms" for "AOAC Sporicidal Test," "various flexible endoscopes" for "Endoscope Dose Response Curves," and "multiple flexible endoscopes" for "Functionality & Material Compatibility."
The data provenance is from non-clinical laboratory testing of the device, not from human subjects. The country of origin for the data is not specified, nor is whether the data is retrospective or prospective. Given it's non-clinical testing for a new device, it is inherently prospective data generation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are primarily performance-based tests against established standards and internal specifications, not expert-driven diagnostic interpretations. For example, for sterilization efficacy, the ground truth is "no growth" of specified microorganisms or a "6-log reduction," which are objective laboratory measurements, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the tests are non-clinical performance evaluations, not human reader-based assessments requiring adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable as this is a non-clinical 510(k) submission for a sterilization system, not a diagnostic imaging device utilizing AI that would involve human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a physical sterilization system, not an algorithm or AI. Therefore, standalone algorithm performance is not applicable. The tests performed are essentially "standalone" device performance evaluations in a controlled environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical performance testing is based on established scientific and engineering principles, industry standards (e.g., ISO, IEC, AAMI, ASTM, AOAC, USP-NF, ISTA, OSHA), and internal specifications. For sterilization efficacy tests, the ground truth is a specific microbial reduction (e.g., 6-log reduction) or absence of microbial growth, which is a definitively measurable biological outcome. For other tests, it's adherence to specified physical, electrical, or chemical parameters.
8. The sample size for the training set:
This information is not applicable. The device is a physical sterilization system, not a machine learning model that requires a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
{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.
June 27, 2024
IDEATE Medical, Inc. % Kevin Corrigan Regulaory Consultant Corrigan Regulatory Consulting P.O. Box 6284 Anaheim, California 92816
Re: K233762
Trade/Device Name: SteroScope® Sterilization Technology System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: November 22, 2023 Received: November 24, 2023
Dear Kevin Corrigan:
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 and Part 809); 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-safetyreporting-combination-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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher K. Dugard -2
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control
{2}------------------------------------------------
and Plastic and Reconstructive Surgery 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) K233762
Device Name
SteroScope® Sterilization Technology System
Indications for Use (Describe)
The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable
- Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of:
- ID of 1.0 mm or larger and a length of 3580 mm or shorter and ●
- . ID of 1.2 mm or larger and a length of 4095 mm or shorter
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) SUMMARY K233762
26 June 2024
I. SUBMITTER
IDEATE Medical, Inc. 2821 N. Ballas Road C55 St. Louis, MO 63131
Phone: 760-402-8322
Contact Person: William Wong, CEO bill.wong@ideatemedical.com
II. DEVICE
| Name of Device: | SteroScope® Sterilization Technology System |
|---|---|
| Common Name: | Vaporized Hydrogen Peroxide Sterilizer |
| Classification Name: | Ethylene oxide gas sterilizer (21 CFR 888.6860) |
| Regulatory: | Class II |
| Product Code: | MLR, Sterilizer, Chemical |
III. PREDICATE DEVICE
STERRAD 100NX DUO Cycle (K111377)
Reference Device: STERRAD 100NX EXPRESS Cycle (K092622)
IV. DEVICE DESCRIPTION
The SteroScope® Sterilization Technology System is a vaporized hydrogen peroxide based (VHP) sterilizer for the terminal sterilization of flexible endoscopes with the following characteristics:
Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of:
- · ID of 1.0 mm or larger and a length of 3580 mm or shorter and
- · ID of 1.2 mm or larger and a length of 4095 mm or shorter.
The SteroScope® Sterilization Technology System is a Gas Plasma VHP sterilization system designed specifically for flexible endoscope terminal sterilization, not for general surgical instrument loads. It is a self-contained stand-alone system of hardware and software system that uses technology to rapidly diffuse VHP into all the channels of the flexible endoscope to facilitate the sterilization of inner device surfaces, while being occupationally and environmentally safe to use. To enable the terminal sterilization of long multi-lumen endoscopes, while minimizing oxidation damage, the SteroScope® Sterilization Technology System incorporates a proprietary gas diffusion technology which creates a pressure differential
{5}------------------------------------------------
in each internal endoscope lumen channel to actively pull hydrogen peroxide vapor from the chamber of the VHP sterilizer through the distal end of each endoscope channel, while the endoscope is in a sterile container. Utilizing a separate mechanism for the rapid diffusion of VHP from the chamber into the individual SteroScope® Sterilization Technology System allows the entire endoscope to be sterilized with less overall peroxide dose exposure.
V. INDICATIONS FOR USE
The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of:
- ID of 1.0 mm or larger and a length of 3580 mm or shorter and .
- ID of 1.2 mm or larger and a length of 4095 mm or shorter .
VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON
Table 1 (below) provides a summary of the device's technological characteristics comparing the subject device and the predicate device and reference device(s).
| Characteristic | Subject Device | Predicate Device | Reference Device | Comments |
|---|---|---|---|---|
| STEROSCOPESYSTEM (K233762) | STERRAD100NX DUO(K111377) | STERRAD 100NXEXPRESS (K092622) | ||
| Intend Use | SteroScope Sterilizer isintended for the terminalsterilization of properlyprepared (cleaned,rinsed, and dried) flexibleendoscopes in HealthcareFacilities. Thepreprogrammedsterilization cycleoperates at low pressureand temperature, suitablefor processingendoscopes withoutleaving toxic residues. | The STERRAD Sterilizersare designed forsterilization of both metaland nonmetal medicaldevices at lowtemperatures. Because thecycle operates within a dryenvironment and at lowtemperatures, it isespecially suitable forinstruments sensitive toheat and moisture. | The STERRAD Sterilizersare designed for sterilizationof both metal and nonmetalmedical devices at lowtemperatures. Because thecycle operates within a dryenvironment and at lowtemperatures, it is especiallysuitable for instrumentssensitive to heat andmoisture. | SIMILARSubject topredicate &reference |
| Indications forUse | The SteroScopeSterilization System isindicated for the terminalsterilization of cleanedreusable flexibleendoscopes with up to 8internal lumens withlumen dimensions of: | The STERRAD®100NXTM DUOCycle is an additionaloptional cycle designed forsterilization of medicaldevices including mostflexible endoscopes, withup to 1 internal lumen withlumen dimension of:1.0 mm or larger and alength of 875mm or shorter | The STERRAD® 100NXTMEXPRESS Cycle is anadditional optional cycledesigned for surfacesterilization of both metaland nonmetal medicaldevices at low temperatures.It can sterilize instrumentsurfaces and it can sterilizerigid and semi-rigidendoscopes without lumens | SIMILARSubject topredicate &reference |
Table 2: TECHNOLOGY Comparison
{6}------------------------------------------------
| Characteristic | Subject DeviceSTEROSCOPESYSTEM (K233762)ID of 1.0 mm or largerand a length of 3580 mmor shorter andID of 1.2 mm or largerand a length of 4095 mmor shorter | Predicate DeviceSTERRAD100NX(K111377) | Reference DeviceSTERRAD 100NXEXPRESS (K092622) | Comments |
|---|---|---|---|---|
| SterilizationTechnology | VHP Gas Plasma | VHP Gas Plasma | VHP Gas Plasma | SAME |
| Sterilant | 59% H2O2 | 59% H2O2 | 59% H2O2 | SAME |
| H2O2/cycle | 5.8 mL | 3.1 mL | 10.8 mL | SIMILARSubject topredicate &reference |
| ChamberTemperature | 57° C | 57° C | 57° C | SAME |
| ChamberVolume | 91.0 Liters | 93.4 Liters | 93.4 Liters | SIMILARSubject topredicate &reference |
| Load Type | (1) flexible endoscope(8) internal lumens(1.0mm ID x 3585mm) | (2) flexible endoscopes(1) internal lumen(1.0mm ID x 850mm) | (2) Semi-rigid/rigidendoscopes(no lumens up to 500mm) | SIMILARSubject topredicate |
| Load Weight | 17.8 lbs. | 13.2 lbs. | 10.7 lbs. | SIMILARSubject topredicate |
| H2O2 Delivery | Extracted from H2O2consumable and metered | Extracted from H2O2consumable and metered | Extracted from H2O2consumable with no metering | SAME |
| Cycle Time | 43 mins. | 51 mins. | 26 mins | SIMILARSubject topredicate |
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
Table 3 (below) provides a summary of the non-clinical performance testing conducted on the subject device, SteroScope Sterilization System, to establish safety and efficacy. Table 4 below provides a list of standards used in the testing of the SteroScope Sterilization System
| Table 3: | |||
|---|---|---|---|
| Testing Method | Purpose | Acceptance Criteria | Results |
| System EnvironmentalTesting | System environmental testing underextreme conditions operatingconditions | InternalSpecification | Pass |
| SteroScope H2O2Emissions Test | H2O2 emissions compliance torequired OSHA safety levels | OSHA H2O2SEL/PEL | Pass |
| Testing Method | Purpose | Acceptance Criteria | Results |
| System H2O2Concentration Mapping | Peroxide concentration mapping during operation | InternalSpecification | Pass |
| System TemperatureMapping | Temperature mapping during operation | InternalSpecification | Pass |
| System Functional Test | Testing of system functional requirements to ensure conformance to system specifications | InternalSpecification | Pass |
| SteroScope SystemShipping | System shipping test for vibration, shock & drop to ensure system and packaging integrity | ISTA 2B | Pass |
| SteroScope ConsumableShipping | Consumable shipping test for vibration, shock & drop to ensure consumable and packaging integrity | ISTA 2A | Pass |
| EMC & Electrical Safety | The sterilizer was tested in accordance with IEC 60601-1-2 and IEC 61010-1 standards | IEC 60601-1-2 andIEC 61010-1 | Pass |
| Qualification of PressureLimits | Validation of sterilizer operational pressure limits | InternalSpecification | Pass |
| Human Factors | Validation of system ergonomics and human factors with clinical users | InternalSpecification | Pass |
| Software Validation | Software verification and validation of software requirements | InternalSpecification | Pass |
| Subsystem DesignVerifications | Testing of each subsystem to ensure functional performance met design requirements | InternalSpecification | Pass |
| H2O2 Consumable Shelf-life | Long term stability study of H2O2 consumable to establish shelf life | InternalSpecification | Pass |
| H2O2 ConsumableStorage | Stability testing of H2O2 consumable in extreme conditions | InternalSpecification | Pass |
| Endoscope TemperatureMapping | Mapping of endoscope temperatures during cycle to verify the internal and external temperatures of a flexible endoscope | InternalSpecification | Pass |
| Final ProcessQualification | Operational process qualification with multiple systems | InternalSpecification | Pass |
| Mated Surface Connector-Port | Half cycle connector efficacy test | No growth ofGeobacillusstearothermophilus | Pass |
| BI & CI Functionality | BI & CI functionality under worst case conditions | No Growth in BI &color change in CI | Pass |
| AOAC Sporicidal Test | Process and sterilant efficacy for multiple organisms | AOAC OfficialMethod 966.04 | Pass |
| Mated SurfaceSterilization | Half cycle mated material efficacy using material coupons | No growth ofGeobacillusstearothermophilus | Pass |
| Testing Method | Purpose | Acceptance Criteria | Results |
| Material SurfaceSterilization | Half cycle surface efficacy usingmaterial coupons | No growth ofGeobacillusstearothermophilus | Pass |
| Uniformity MicrobialInactivation | Dosing study to assess uniformity ofmicrobial inactivation | Uniformity ininactivation kineticsbased on SLR | Pass |
| Endoscope DoseResponse Curves | Dosing study with various flexibleendoscopes | InternalSpecification | Pass |
| Material BacteriostasisValidation | Confirmation that there are nobacteriostatic effects that inhibitgrowth for material coupons | No bacteriostaticeffect aftersterilization withgrowth of definedmicro-organisms | Pass |
| Bacteriostasis &Fungistasis Validation | Confirmation that there are nobacteriostatic effects that inhibitgrowth for flexible endoscopes | No bacteriostaticeffect aftersterilization withgrowth of definedmicro-organisms | Pass |
| Simulated Use Testing | Worst-case testing with unwashedflexible endoscopes inoculated withtest culture challenge | 6-log reduction inGeobacillusstearothermophilus | Pass |
| In-Use Testing | Worst-case testing with clinically usedflexible endoscopes. | No growth uponrecovery aftersterilization | Pass |
| Functionality & MaterialCompatibility | Worst-case material compatibilitytesting of multiple flexible endoscopeswith back to back cycles | InternalSpecification | Pass |
| Biocompatibility Coupons | Worst-case residual and cytotoxicity(MTT) testing with material coupons | ISO 10993-5 | Pass |
| Biocompatibility FlexibleEndoscopes | Worst-case residual and cytotoxicity(MTT) testing with flexibleendoscopes | ISO 10993-5 | Pass |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
Table 4 Standards Used:
| Organization | Designation | Title |
|---|---|---|
| IEC | 60601-1-2 Edition 4.0 2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC | 61010-1 Edition 3.1 2017-01CONSOLIDATED VERSION | Safety requirements for electrical equipment for measurement control and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] |
| AAMI | TIR 12:2020 | Design, Testing and Labeling of Reusable Medical Devices |
| ANSI AAMIISO | 11737-1:2018 | Microbial Methods Determination of the population of microorganisms |
| ASTM | E1837-96 (2014) | Simulated Use Test |
| AAMI ANSI | ST77:2013(R)2018 | Containment Devices |
| ANSI AAMIISO | 17664:2017 | Info To Be Provided for the processing of medical devices |
| AAMI | TIR39:2009(R)2017 | Selecting a Microbial Challenge and Inoculation sites |
| ANSI AAMIISO | 11138-1:2017 | BIs part 1 |
| ISO | 10993-5 Third edition 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO | 10993-12 Fourth edition 2012-07-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| USP-NF | 1035 | BIs for Sterilization |
| AOAC | 966.04 | Sporicidal Activity of Disinfectants |
| AAMI ANSI | ST14:2008 | EtO Sterilization in Health Care Facilities |
| IEC | 61000 | Electromagnetic Compatibility |
| ISTA | 2A and 2B | International Safe Transit Association |
| OSHA | CAS 7722-84-1 | H2O2 Handling Guidance |
| AOAC | Official Method 966.04 | Sporicidal Activity of Disinfectants. Official Methods of Analysis of the AOAC, 2013 Edition |
Conclusion
The conclusion drawn from the non-clinical testing demonstrates that the subject device, SteroScope® Sterilization Technology System submitted under K233762, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K131407, the STERRAD 100NX DUO Cycle, and the legally marketed reference device cleared under K092622, the STERRAD 100NX EXPRESS Cycle.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).