(216 days)
STERRAD 100NX DUO Cycle (K111377)
No
The description focuses on the hardware and chemical process (vaporized hydrogen peroxide) for sterilization, with no mention of AI or ML in the device description, performance studies, or key metrics.
No
The device is a sterilizer for flexible endoscopes, not a medical device intended to treat or diagnose a disease or condition in a patient.
No.
The document explicitly states that the device is a "vaporized hydrogen peroxide based (VHP) sterilizer for the terminal sterilization of flexible endoscopes." Its function is to sterilize medical instruments, not to diagnose diseases or conditions.
No
The device description explicitly states it is a "self-contained stand-alone system of hardware and software system" and describes physical components and processes like vaporized hydrogen peroxide diffusion and pressure differentials. The performance studies also include extensive hardware-related testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the terminal sterilization of reusable flexible endoscopes. This is a process performed on medical devices to render them free of viable microorganisms, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is a sterilization system using vaporized hydrogen peroxide. It is designed to sterilize the internal and external surfaces of endoscopes. This is a physical/chemical process applied to a medical device, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly intended for the reprocessing of medical devices (endoscopes) to ensure their safety for subsequent use, which falls under the category of medical device sterilization, not in vitro diagnostics.
N/A
Intended Use / 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 .
Product codes (comma separated list FDA assigned to the subject device)
MLR
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare Facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted to establish safety and efficacy. Key tests included:
- System Environmental Testing: Verified operation under extreme conditions.
- SteroScope H2O2 Emissions Test: Confirmed compliance with OSHA H2O2 safety levels.
- System H2O2 Concentration Mapping: Mapped peroxide concentration during operation.
- System Temperature Mapping: Mapped temperature during operation.
- System Functional Test: Ensured conformance to system specifications.
- SteroScope System Shipping: Tested vibration, shock, and drop for system integrity.
- SteroScope Consumable Shipping: Tested vibration, shock, and drop for consumable integrity.
- EMC & Electrical Safety: Tested in accordance with IEC 60601-1-2 and IEC 61010-1.
- Qualification of Pressure Limits: Validated operational pressure limits.
- Human Factors: Validated system ergonomics and human factors with clinical users.
- Software Validation: Verified and validated software requirements.
- Subsystem Design Verifications: Tested functional performance of each subsystem.
- H2O2 Consumable Shelf-life: Long term stability study to establish shelf life.
- H2O2 Consumable Storage: Stability testing in extreme conditions.
- Endoscope Temperature Mapping: Mapped endoscope temperatures during cycle.
- Final Process Qualification: Operational process qualification with multiple systems.
- Mated Surface Connector-Port: Half cycle connector efficacy test.
- BI & CI Functionality: Tested under worst case conditions.
- AOAC Sporicidal Test: Evaluated process and sterilant efficacy for multiple organisms.
- Mated Surface Sterilization: Half cycle mated material efficacy using material coupons.
- Material Surface Sterilization: Half cycle surface efficacy using material coupons.
- Uniformity Microbial Inactivation: Assessed uniformity of microbial inactivation.
- Endoscope Dose Response Curves: Dosing study with various flexible endoscopes.
- Material Bacteriostasis Validation: Confirmed no bacteriostatic effects for material coupons.
- Bacteriostasis & Fungistasis Validation: Confirmed no bacteriostatic effects for flexible endoscopes.
- Simulated Use Testing: Worst-case testing with unwashed flexible endoscopes inoculated with test culture challenge, achieving 6-log reduction in Geobacillus stearothermophilus.
- In-Use Testing: Worst-case testing with clinically used flexible endoscopes, showing no growth upon recovery after sterilization.
- Functionality & Material Compatibility: Worst-case material compatibility testing of multiple flexible endoscopes with back to back cycles.
- Biocompatibility Coupons: Worst-case residual and cytotoxicity (MTT) testing with material coupons (ISO 10993-5).
- Biocompatibility Flexible Endoscopes: Worst-case residual and cytotoxicity (MTT) testing with flexible endoscopes (ISO 10993-5).
Results: All tests passed their respective acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
6-log reduction in Geobacillus stearothermophilus for simulated use testing.
No growth upon recovery after sterilization for in-use testing.
No growth of Geobacillus stearothermophilus for mated surface connector-port and mated surface/material surface sterilization.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
STERRAD 100NX DUO Cycle (K111377)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
STERRAD 100NX EXPRESS Cycle (K092622)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6860 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).
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) |
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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 |
|---|---|---|---|---|
| STEROSCOPE | ||||
| SYSTEM (K233762) | STERRAD100NX DUO | |||
| (K111377) | STERRAD 100NX | |||
| EXPRESS (K092622) | ||||
| Intend Use | SteroScope Sterilizer is | |||
| intended for the terminal | ||||
| sterilization of properly | ||||
| prepared (cleaned, | ||||
| rinsed, and dried) flexible | ||||
| endoscopes in Healthcare | ||||
| Facilities. The | ||||
| preprogrammed | ||||
| sterilization cycle | ||||
| operates at low pressure | ||||
| and temperature, suitable | ||||
| for processing | ||||
| endoscopes without | ||||
| leaving toxic residues. | The STERRAD Sterilizers | |||
| are designed for | ||||
| sterilization of both metal | ||||
| and nonmetal medical | ||||
| devices at low | ||||
| temperatures. Because the | ||||
| cycle operates within a dry | ||||
| environment and at low | ||||
| temperatures, it is | ||||
| especially suitable for | ||||
| instruments sensitive to | ||||
| heat and moisture. | The STERRAD Sterilizers | |||
| are designed for sterilization | ||||
| of both metal and nonmetal | ||||
| medical devices at low | ||||
| temperatures. Because the | ||||
| cycle operates within a dry | ||||
| environment and at low | ||||
| temperatures, it is especially | ||||
| suitable for instruments | ||||
| sensitive to heat and | ||||
| moisture. | SIMILAR | |||
| Subject to | ||||
| predicate & | ||||
| reference | ||||
| Indications for | ||||
| Use | The SteroScope | |||
| Sterilization System is | ||||
| indicated for the terminal | ||||
| sterilization of cleaned | ||||
| reusable flexible | ||||
| endoscopes with up to 8 | ||||
| internal lumens with | ||||
| lumen dimensions of: | The STERRAD® | |||
| 100NXTM DUO | ||||
| Cycle is an additional | ||||
| optional cycle designed for | ||||
| sterilization of medical | ||||
| devices including most | ||||
| flexible endoscopes, with | ||||
| up to 1 internal lumen with | ||||
| lumen dimension of: | ||||
| 1.0 mm or larger and a | ||||
| length of 875mm or shorter | The STERRAD® 100NXTM | |||
| EXPRESS Cycle is an | ||||
| additional optional cycle | ||||
| designed for surface | ||||
| sterilization of both metal | ||||
| and nonmetal medical | ||||
| devices at low temperatures. | ||||
| It can sterilize instrument | ||||
| surfaces and it can sterilize | ||||
| rigid and semi-rigid | ||||
| endoscopes without lumens | SIMILAR | |||
| Subject to | ||||
| predicate & | ||||
| reference |
Table 2: TECHNOLOGY Comparison
6
| Characteristic | Subject Device
STEROSCOPE
SYSTEM (K233762)
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 | Predicate Device
STERRAD100NX
(K111377) | Reference Device
STERRAD 100NX
EXPRESS (K092622) | Comments |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------|
| Sterilization
Technology | 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 | SIMILAR
Subject to
predicate &
reference |
| Chamber
Temperature | 57° C | 57° C | 57° C | SAME |
| Chamber
Volume | 91.0 Liters | 93.4 Liters | 93.4 Liters | SIMILAR
Subject to
predicate &
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/rigid
endoscopes
(no lumens up to 500mm) | SIMILAR
Subject to
predicate |
| Load Weight | 17.8 lbs. | 13.2 lbs. | 10.7 lbs. | SIMILAR
Subject to
predicate |
| H2O2 Delivery | Extracted from H2O2
consumable and metered | Extracted from H2O2
consumable and metered | Extracted from H2O2
consumable with no metering | SAME |
| Cycle Time | 43 mins. | 51 mins. | 26 mins | SIMILAR
Subject to
predicate |
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 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 | ||
| Testing Method | Purpose | Acceptance Criteria | Results |
| 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 | ||
| Testing Method | Purpose | Acceptance Criteria | Results |
| 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 |
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 2017-01 | |
| CONSOLIDATED 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 AAMI | ||
| ISO | 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 AAMI | ||
| ISO | 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 AAMI | ||
| ISO | 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.