(254 days)
The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycle and the Flexible Cycle, operate at low temperature and are thus suitable for processing medical devices that are sensitive to heat and moisture.
The HC 80TT Lumen Cycle can sterilize:
o Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hinged portion of forceps and scissors;
O Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are:
- · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or
- · ≥ 1.33 mm ID and ≤ 430 mm long; and,
o Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are: - ≥ 1.00 mm ID and ≤ 310 mm long.
The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using two (2) separate validation loads as described in the following table.
The HC 80TT Flexible Cycle can sterilize:
- · Rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;
- · Single channel flexible endoscopes with flexible lumens that are:
- · ≥ 1.00 mm ID and ≤ 1280 mm long; and,
- · Dual channel flexible endoscopes with flexible lumens that are:
- · ≥ 0.80 mm ID and ≤ 1000 mm long.
The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (HC 80TT) is a self-contained standalone device, using vaporized hydrogen peroxide as the sterilant. The HC 80TT is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and non-metal medical device used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures and is therefore suitable for processing medical devices that are sensitive to heat and moisture. The hydrogen peroxide vapor is generated by heating aqueous hydrogen peroxide and injecting into a chamber.
This document is a 510(k) summary for the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. It details the device's technical characteristics, indications for use, and a comparison to a predicate device (Sterilucent PSD-85 Hydrogen Peroxide Sterilizer). It extensively describes the performance testing conducted to demonstrate the device's safety and efficacy.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a discrete table of "acceptance criteria" with quantitative targets alongside the "reported device performance." Instead, it describes various performance tests and the positive outcomes, implying that successful completion of these tests serves as the acceptance criteria. The overarching acceptance criterion for a sterilizer is achieving a Sterility Assurance Level (SAL) of 10^-6.
Below is a table summarizing the performance claim and the evidence provided:
| Performance Claim / Acceptance Criteria (Implicit) | Reported Device Performance (Evidence) |
|---|---|
| Overall Sterilization Efficacy | Achieved an SAL of at least 10^-6 for medical device surface sterilization. |
| Material Compatibility & Sterilization | No spore survivors on any material tested (various representative materials) at concentrations lower than the standard exposure concentration for half-cycle conditions. |
| Dose-Response Relationship (Hydrogen Peroxide) | Demonstrated >6 Spore Log Reduction (SLR) for a half cycle exposure across various material coupons. |
| Mated Surface Sterilization | Achieved an SAL of at least 10^-6 for mated material sterilization. |
| Lumen Sterilization (Rigid Stainless Steel) | No spore survivors after multiple ½ cycle exposure tests for lumens meeting specified dimensions (e.g., ≥ 0.77 mm ID and ≤ 410 mm long). |
| Lumen Sterilization (Flexible) | No spore survivors after multiple ½ cycle exposure tests for flexible lumens meeting specified dimensions (e.g., ≥ 1.00 mm ID and ≤ 1280 mm long). |
| Simulated Use Sterilization | Results showed sterility of all tested devices (representative lumen and non-lumen devices inoculated with spores and organic challenge soil, then exposed to a full sterilization cycle). |
| In-Use Sterilization (Clinical Settings) | Successfully sterilizes surgical instruments used in clinical settings (devices soiled with clinical soils, manually cleaned/washed, packaged, and processed in applicable cycles). |
| Sporicidal Activity | None of the carriers demonstrated growth in accordance with AOAC Official Method 966.04. |
| Software Validation | Performed according to FDA's moderate level of concern recommendations. |
| Process Lethality Stability | Process lethality was unaffected over the range of tested process parameters (chamber wall temperature, vaporizer temperature, injection pressure, vaporized hydrogen peroxide concentration). |
2. Sample sizes used for the test set and the data provenance
- Sample Size: The document provides some detail on sample sizes indirectly through load descriptions.
- Lumen Cycle Validation Loads: Two separate validation loads were used. Load #1 contained 15 total lumens. Load #2 contained 10 lumens. The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) lumens per load.
- Flexible Cycle Validation Loads: Four separate validation loads were used. No specific lumen counts are given for these, but Load #1 included one single-channel flexible angioscope and one single-channel flexible ureteroscope. Load #3 included one dual-channel flexible ureteroscope and one single-channel flexible angioscope.
- Surface Sterilization, Mated Surface Sterilization, Lumen Sterilization: Tests involved "a wide variety of material coupons" or "a variety of medical device materials" or placing "at least 10⁶ Geobacillus stearothermophilus spores in the center of the lumens." The exact number of samples (coupons, devices) used in each of these tests is not explicitly stated numerically, beyond the load descriptions for the overall cycle validation.
- Simulated Use Testing: "Representative lumen and non-lumen devices" were inoculated. The exact number is not quantified.
- In-Use Testing: "Devices representative of surface features and lumen claims for the HC 80TT were selected." The exact number is not quantified.
- Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission for a US-based company (Minneapolis, Minnesota), it's highly probable the testing was conducted in the United States, likely in a laboratory setting. The studies described are prospective in nature, as they involve actively setting up and running sterilization cycles under controlled conditions to observe outcomes, rather than analyzing existing, previously collected data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable in the context of this device. The "ground truth" for sterilization devices is established by objective microbiological methods, specifically the inactivation of highly resistant bacterial spores (Geobacillus stearothermophilus) to a statistically defined Sterility Assurance Level (SAL). It does not involve human expert interpretation of images or clinical data in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The "ground truth" (i.e., whether sterilization was achieved) is determined by the absence or presence of viable spores after exposure to the sterilization process, which is an objective laboratory measure (incubation of biological indicators) and does not require adjudication by multiple human experts.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images. The Sterilucent HC 80TT is a sterilizer, not an AI diagnostic device, and its performance is evaluated through its ability to inactivate microorganisms, not through human interpretation of results.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the device's performance as a sterilizer without human intervention in the sterilization process itself. The entire battery of tests described (Dose-Response, Surface, Mated Surface, Lumen, Simulated Use, In-Use, Sporicidal Activity) are essentially "standalone" performance evaluations of the device's ability to sterilize. The human role is in setting up the device, loading items, initiating cycles, and performing post-sterilization analysis (e.g., biological indicator incubation), not in assisting the sterilization process itself in real-time. The device operates automatically once a cycle is initiated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used is microbiological proof of sterility, specifically the inactivation of a highly resistant biological indicator organism, Geobacillus stearothermophilus, to a demonstrated Sterility Assurance Level (SAL) of 10^-6. This is an objective and quantitative measure, not subjective like expert consensus or pathology in a diagnostic context. This is also supported by the AOAC Official Method 966.04 for Sporicidal Activity.
8. The sample size for the training set
The concept of a "training set" is not applicable here. This device is a traditional medical device (a sterilizer), not an AI/ML-based device that learns from data. Therefore, there is no training set in the machine learning sense. The testing described is verification and validation.
9. How the ground truth for the training set was established
As there is no training set for this traditional sterilizer, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
September 13, 2019
Sterilucent, Inc. Peter Kalkbrenner Director of Engineering 1400 Marshall St. NE Minneapolis, Minnesota 55413
Re: K190005
Trade/Device Name: Sterilucent HC 80TT Hydrogen Peroxide Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: August 8, 2019 Received: August 13, 2019
Dear Peter Kalkbrenner:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 (OS) 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,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190005
Device Name
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
Indications for Use (Describe)
Indications for Use:
The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterlization of cleaned, rinsed and dried reusable metal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycle and the Flexible Cycle, operate at low temperature and are thus suitable for processing medical devices that are sensitive to heat and moisture.
The HC 80TT Lumen Cycle can sterilize:
o Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hinged portion of forceps and scissors;
O Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are:
- · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or
- · ≥ 1.33 mm ID and ≤ 430 mm long; and,
o Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are:
- ≥ 1.00 mm ID and ≤ 310 mm long.
The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) Jumens per load. Hospital loads should not exceed the maximum number offumens validated by this testing. The validation studies were performed using two(2) separate validation loads as described in the following table.
| HC-80TT-Lumen-Cycle-Validation-Load-Descriptions | ||
|---|---|---|
| Load# | Description | Load-Weight |
| 1 | Two-wrapped-trays-with-silicone-mats, one-(1)-triple-channel-hysteroscope, three-(3)-dual-channel-rigid-ureteroscopes, -six-(6)-suction-tubes-(15-total-lumens), -and-general-medical-instruments-such-as-clamps, forceps, shears, mallets, scissors-and-retractors. | 20.2-lb. |
| 2 | Wrapped-heavy-drill-set-with-ten-(10)-lumens-and-pouched-batteries. | 28.1-lb. |
Excluding the weight of the wrap.
-
1 Excluding the weight of the wrap.
The HC 80TT Flexible Cycle can sterilize: -
· Rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;
-
· Single channel flexible endoscopes with flexible Iumens that are:
- · ≥ 1.00 mm ID and ≤ 1280 mm long; and,
-
· Dual channel flexible endoscopes with flexible Iumens that are:
- · 2: 0.80 mm ID and :S 1000 mm long.
The validation studies were performed using four (4) separate validation loads as described in the following table.
FORM FDA 3881 (7/17) Page 1 of 2 psc Publishing Services (30)) 433-6740 EF
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| HC-80TT-Flexible-Cycle-Validation-Load-Descriptionsα | ||
|---|---|---|
| Load#α | Descriptionα | Load-Weight¹α |
| 1α | Two-wrapped-trays-with-silicone mats, one-(1)-single-channel-flexible-angioscope (1.0mm-ID-x-1280mm-L), -one-(1)-single-channel-flexible-ureteroscope-(1.2mm-ID-x-800mm-L), -and-general-medical-instruments-such-as-clamps, forceps, shears, rongeurs, mallets, scissors, retractors-and-spreaders.α | 31.9-lb.α |
| 2α | Two-wrapped-trays with silicone-mats-and-general-medical-instruments-such-as-clamps, forceps, shears, rongeurs, mallets, scissors, retractors-and-spreaders.α | 30.6-lb.α |
| 3α | Two-wrapped-trays with silicone mats, one-with-one-(1)-dual-channel-flexible-ureteroscope-(1.2/0.8-mm-ID-x-850/1000-mm-L)-with-light-cord-and-accessories, the other with one-(1)-single-channel-flexible-angioscope (1.0mm-ID-x-1280mm-L)-with-light-cord.α | 14.4-lb.α |
| • 4α | Two-wrapped-trays, one-with-a-silicone-mat-and-general-medical-instruments-such as forceps, shears, mallets, and retractors, the other-with eight-(8)-batteries.α | 17.6-lb.α |
· 1 Excluding the weight of the wrap. T
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.
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FORM FDA 3881 (7/17)
Page 2 of 2
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510(K) SUMMARY
| Submitted by: | Sterilucent, Inc.1400 Marshall Street NEMinneapolis, MN 55413Phone: 612-767-3260Fax: 612-767-3261 |
|---|---|
| Contact Person: | Peter R. KalkbrennerDirector of Engineeringpeter.kalkbrenner@sterilucent.comPhone: 612-767-3253Fax: 612-767-3261 |
| Date of Summary: | September 11, 2019 |
| Device Trade Name: | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer |
| Common or Usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification: | 21 CFR 880.6860 |
| Class: | II |
| Product Code: | MLR |
| Predicate Device(s): | Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (K140464) |
| Device Description: | The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (HC 80TT)is a self-contained standalone device, using vaporized hydrogenperoxide as the sterilant. The HC 80TT is intended for use in theterminal sterilization of cleaned, rinsed, and dried, reusable metal andnon-metal medical device used in healthcare facilities. Thesterilization cycle operates at low pressure and temperatures and istherefore suitable for processing medical devices that are sensitive toheat and moisture. The hydrogen peroxide vapor is generated byheating aqueous hydrogen peroxide and injecting into a chamber. |
| Indications for Use: | The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is avaporized hydrogen peroxide sterilizer intended for use in theterminal sterilization of cleaned, rinsed and dried reusable metal andnonmetal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycle and the FlexibleCycle, operate at low pressure and low temperature and are thussuitable for processing medical devices that are sensitive to heat andmoisture.The HC 80TT Lumen Cycle can sterilize:• Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hingedportion of forceps and scissors; |
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| ●● | Single or dual channeled rigid and semi-rigid endoscopes,with stainless steel lumens that are:≥ 0.77 mm internal diameter (ID) and ≤ 410 mmOlong, or≥ 1.33 mm ID and ≤ 430 mm long; and,OTriple channeled rigid and semi-rigid endoscopes, withstainless steel lumens that are:≥ 1.00 mm ID and ≤ 310 mm long.O | ||
|---|---|---|---|
| table. | The validation testing for all lumen sizes was conducted usinga maximum of fifteen (15) lumens per load. Hospital loadsshould not exceed the maximum number of lumens validatedby this testing. The validation studies were performed usingtwo (2) separate validation loads as described in the following | ||
| HC 80TT Lumen Cycle Validation Load Descriptions | |||
| Load# | Description | LoadWeight1 | |
| 1 | Two wrapped trays with silicone mats, one(1) triple channel hysteroscope, three (3) dualchannel rigid ureteroscopes, six (6) suctiontubes (15 total lumens), and general medicalinstruments such as clamps, forceps, shears,mallets, scissors and retractors. | 20.2 lb. | |
| 2 | Wrapped heavy drill set with ten (10) lumensand pouched batteries. | 28.1 lb. | |
| ●● | 1 Excluding the weight of the wrap.The HC 80TT Flexible Cycle can sterilize:Rigid or semi-rigid non-lumen medical devices including non-lumendevices with metallic diffusion-restricted spaces such or matedsurfaces such as the hinged portion of forceps or scissors;Single channel flexible endoscopes with flexible lumens thatare:≥ 1.00 mm ID and ≤ 1280 mm long; and,ODual channel flexible endoscopes with flexible lumens thatare:≥ 0.80 mm ID and ≤ 1000 mm long.OThe validation studies were performed using four (4) separatevalidation loads as described in the following table. | ||
| HC 80TT Flexible Cycle Validation Load Descriptions | |||
| Load# | Description | LoadWeight1 | |
| 1 | Two wrapped trays with silicone mats, one (1) single channel flexible angioscope (1.0mm ID x 1280mm L), one (1) single channel flexible ureteroscope (1.2mm ID x 800mm L), and general medical instruments such as clamps, forceps, shears, rongeurs, mallets, scissors, retractors and spreaders. | 31.9 lb. | |
| 2 | Two wrapped trays with silicone mats and general medical instruments such as clamps, forceps, shears, rongeurs, mallets, scissors, retractors and spreaders. | 30.6 lb. | |
| 3 | Two wrapped trays with silicone mats, one with one (1) dual channel flexible ureteroscope (1.2/0.8 mm ID x 850/1000 mm L) with light cord and accessories, the other with one (1) single channel flexible angioscope (1.0mm ID x 1280mm L) with light cord. | 14.4 lb. | |
| 4 | Two wrapped trays, one with a silicone mat and general medical instruments such as forceps, shears, mallets, and retractors, the other with eight (8) batteries. | 27.7 lb. | |
| 1 Excluding the weight of the wrap. | |||
| TechnologicalCharacteristics | The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (HC 80TT) is compared to the predicate device Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (K140464) using the information supplied below. |
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| Subject Device:Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (HC80TT) | Predicate Device (K140464):Sterilucent PSD-85 Hydrogen Peroxide Sterilizer(PSD-85) | |
|---|---|---|
| Classification | 21 CFR 880.6860 | 21 CFR 880.6860 |
| Product Code | MLR | MLR |
| Indications for Use | The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is avaporized hydrogen peroxide sterilizer intended for use in theterminal sterilization of cleaned, rinsed and dried reusablemetal and nonmetal medical devices used in healthcarefacilities. The two pre-programmed sterilization cycles, theLumen Cycle and the Flexible Cycle, operate at low pressureand low temperature and are thus suitable for processingmedical devices that are sensitive to heat and moisture.The HC 80TT Lumen Cycle can sterilize:Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hingedportion of forceps and scissors; Single or dual channeled rigid and semi-rigidendoscopes, with stainless steel lumens that are:$\geq$ 0.77 mm internal diameter (ID) and $\leq$ 410 mm long, or $\geq$ 1.33 mm ID and $\leq$ 430 mm long; and, Triple channeled rigid and semi-rigid endoscopes, withstainless steel lumens that are:$\geq$ 1.00 mm ID and $\leq$ 310 mm long. The validation testing for all lumen sizes was conducted usinga maximum of fifteen (15) lumens per load. Hospital loads | The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer(PSD-85) is a vaporized hydrogen peroxide sterilizerintended for use in the terminal sterilization ofcleaned, rinsed and dried reusable metal and nonmetalmedical devices used in healthcare facilities. The twopre-programmed sterilization cycles, the Lumen andthe Non-Lumen Cycles, operate at lowpressure and low temperature and are thus suitable forprocessing medical devices sensitive to heat andmoisture.The PSD-85 Lumen Cycle can sterilize*:Instruments with diffusion-restricted spacessuch as the hinged portion of forceps andscissors Medical devices with a single stainless steellumen with: An inside diameter of 1 mm or largerand a length of 60 mm or shorter An inside diameter of 2 mm or largerand a length of 250 mm or shorter An inside diameter of 3 mm or largerand a length of 350 mm or shorter |
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| Load # | Description | Load Weight1 |
|---|---|---|
| 1 | Two wrapped trays with silicone mats, one (1) triple channel hysteroscope, three (3) dual channel rigid ureteroscopes, six (6) suction tubes (15 total lumens), and general medical instruments such as clamps, forceps, shears, mallets, scissors and retractors. | 20.2 lb. |
| 2 | Wrapped heavy drill set with ten (10) lumens and pouched batteries. | 28.1 lb. |
| 1Excluding the weight of the wrap.The HC 80TT Flexible Cycle can sterilize:Rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion- restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors; Single channel flexible endoscopes with flexible lumens that are: $\geq$ 1.00 mm ID and $\leq$ 1280 mm long; and, Dual channel flexible endoscopes with flexible lumens that are: $\geq$ 0.80 mm ID and $\leq$ 1000 mm long. |
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| The validation studies were performed using four (4) separatevalidation loads as described in the following table. | ||
|---|---|---|
| HC 80TT Flexible Cycle Validation Load Descriptions | ||
| Load # | Description | Load Weight1 |
| 1 | Two wrapped trays with silicone mats, one (1) single channel flexible angioscope (1.0mm ID x 1280mm L), one (1) single channel flexible ureteroscope (1.2mm ID x 800mm L), and general medical instruments such as clamps, forceps, shears, rongeurs, mallets, scissors, retractors and spreaders. | 31.9 lb. |
| 2 | Two wrapped trays with silicone mats and general medical instruments such as clamps, forceps, shears, rongeurs, mallets, scissors, retractors and spreaders. | 30.6 lb. |
| 3 | Two wrapped trays with silicone mats, one with one (1) dual channel flexible ureteroscope (1.2/0.8 mm ID x 850/1000 mm L) with light cord and accessories, the other with one (1) single channel flexible angioscope (1.0mm ID x 1280mm L) with light cord. | 14.4 lb. |
| 4 | Two wrapped trays, one with a silicone mat and general medical | 27.7 lb. |
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| instruments such as forceps, shears,mallets, and retractors, the other witheight (8) batteries.1 Excluding the weight of the wrap. | ||
|---|---|---|
| Single Use/Reusable | Reusable | Reusable |
| Type of Process | Terminal Sterilization | Terminal Sterilization |
| Sterility Assurance Level | $10^{-6}$ | $10^{-6}$ |
| Sterilant | 59% aqueous solution of hydrogen peroxide (H2O2) | 59% aqueous solution of hydrogen peroxide (H2O2) |
| Sterilization Cycles | Two pre-programmed cycles:Lumen (approximately 65 min) andFlexible (approximately 35 min) | Two pre-programmed cycles:Lumen (approximately 72 min) andNon-Lumen (approximately 40 min) |
| Physical Characteristics | Self-contained, stand-alone device | Self-contained, stand-alone device |
| Design and Construction | Welded frame onto which is mounted the sterilization chamberalong with a variety of instruments and components, controls,piping, and vacuum pump, all of which is housed in anenclosed frame | Welded frame onto which is mounted the sterilizationchamber along with a variety of instruments andcomponents, controls, piping, and vacuum pump, allof which is housed in an enclosed frame |
| • Chamber Volume | 80 L | 85 L |
| • Weight | 306 lbs (139 kg) | 440 lbs (200 kg) |
| • Maximum Power | 2400 Watts | 1650 Watts |
| Overall design | Deep vacuum sterilizerFirmware controlled, non-programmableSingle doorTwo shelves | Deep vacuum sterilizerFirmware controlled, non-programmableSingle doorOne shelf |
| Chamber Materials | Aluminum | Stainless steel |
| Chamber Heating system | Electric silicone-rubber resistive heaters | Electric silicone-rubber resistive heaters |
| Internal Process Monitors | ||
| • Temperature | Chamber and vaporizer thermistors | Chamber and vaporizer thermistors |
| • Pressure | Chamber pressure transducers | Chamber pressure transducers |
| • Sterilant Concentration | Real-time hydrogen peroxide vapor monitor | Real-time hydrogen peroxide vapor monitor |
| User Interface | 7 inch capacitive touch thin-film-transistor (TFT) liquid-crystaldisplay (LCD) graphical user interface (GUI) | 40 character x 4 line dot matrix liquid crystal display(LCD) |
| External Process Monitors | • Electronic controls• USB port for communicating with separate computer• Printer | • Electronic controls• USB port for communicating with separatecomputer |
| Operational Principle | Sterilization of the intended devices by exposure undercontrolled conditions of pressure, temperature, and time | Sterilization of the intended devices by exposureunder controlled conditions of pressure, temperature,and time |
| Operational Parameters | Low pressure and temperature | Low pressure and temperature |
| Pre-processing requirements | Cleaned, rinsed and dried medical devices | Cleaned, rinsed and dried medical devices |
| Amount of sterilant per injection | Variable, based on actual measured vapor concentration | Variable, based on actual measured vaporconcentration |
| Monitoring – biological and chemical indicators | ||
| • Biological Indicator | Self-contained biological indicator, Geobacillusstearothermophilus | Self-contained biological indicator, Geobacillusstearothermophilus |
| • Process ChallengeDevice/Routine Test Pack | Self-contained biological indicator, Geobacillusstearothermophilus | Self-contained biological indicator, Geobacillusstearothermophilus |
| • Chemical Indicator | Sterilucent CI Strips, Labels | Sterilucent CI Strips, Labels and Tape |
| Miscellaneous | ||
| Materials Sterilized | Reusable metal and non-metal medical devices that are used inhealthcare facilities, including those that are sensitive to heatand moisture | Reusable metal and non-metal medical devices thatare used in healthcare facilities, including those thatare sensitive to heat and moisture |
Sterilucent, Inc.
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Comparison to the Both the HC 80TT and the predicate device have the same: Predicate device: . Intended use Processes validated to a Sterility assurance level (10-6) ● . Sterilant The HC 80TT design differs slightly from the predicate; the HC 80TT is slightly smaller and lighter that the PSD-85. Using the Lumen Cycle, the HC 80TT can sterilize single-, dual-, or triplechanneled rigid and semi-rigid endoscopes with stainless steel lumens as specified in the Indications for Use, while the PSD-85 is indicated to sterilize medical devices with only a single stainless-steel lumen of larger diameter and shorter length. The HC 80TT's "Flexible Cycle" and the PSD-85's "Non-Lumen Cycle'' both sterilize non-lumen instruments with diffusion-restricted spaces, but the HC 80TT is also indicated to sterilize single- and dual-channel flexible endoscopes. Performance Testing The HC 80TT sterilization cycle parameters have been shown to provide a (Bench): level of safety and efficacy at least equivalent to that of the predicate device. Testing was performed using the "overkill" method. Pre-Validation Testing Test Organism: Geobacillus stearothermophilus Process Variables and Parameters Testing was conducted to characterize the effect of process parameters on lethality. The four critical process parameters are chamber wall temperature, vaporizer temperature, injection pressure and vaporized hydrogen peroxide concentration. The level tested for each parameter was selected to provide a worst-case situation for the test series and to be outside the abort levels or settings for the sterilizer. The study showed that process lethality was unaffected over the range of tested process parameters. HC 80TT Sterilization Process Validation Demonstration of Dose-Response Relationship to Increasing Hydrogen Peroxide Concentration Dose response testing was performed using various materials (representative of materials used in medical devices) as spore carriers. Geobacillus stearothermophilus death kinetics data obtained for each material tested demonstrate a positive "dose response" to increasing concentration of hydrogen peroxide injected under half cycle conditions in the HC 80TT. There were no spore survivors on any material at concentrations lower than the standard exposure concentration for the Lumen and Flexible Cycles. The result
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demonstrates that the dose response observed is not limited to a single substrate and in each case >6 Spore Log Reduction (SLR) was observed for a half cycle exposure.
Surface Sterilization
The purpose of the study was to demonstrate sterilization of medical device surfaces. Geobacillus stearothermophilus spores were inoculated on a wide variety of material coupons that were representative of materials used in reusable medical devices. The coupons were inoculated with at least 106 Geobacillus stearothermophilus spores and then exposed to ½ cycle sterilization parameters.
Results from this testing demonstrate a Sterility Assurance Level (SAL) of at least 10-6 for medical device surface sterilization in the HC 80TT for all materials listed as recommended for use in the HC 80TT.
Mated Surface Sterilization
The purpose of the study was to demonstrate sterilization of mated medical device surfaces using the HC 80TT. Geobacillus stearothermophilus spores were inoculated on a variety of medical device materials. The materials were than mated to the same material and exposed to ½ cycle sterilization parameters. An SAL of least 10° was demonstrated for mated material sterilization.
Lumen Sterilization
The purpose of this validation test was to demonstrate that the HC 80TT could effectively sterilize specific dimensions of rigid stainless steel and flexible lumened medical devices. Testing was completed by placing at least 10° Geobacillus stearothermophilus spores in the center of the lumens and exposing them to ½ cycle sterilization parameters. There were no spore survivors after multiple ½ cycle exposure tests.
Results from this testing demonstrate an SAL of at least 10-6 for lumen sterilization in the HC 80TT for the lumen dimensions listed as indicated for use in the HC 80TT.
Simulated Use Testing
Simulated use testing was performed to confirm sterilization of medical device surfaces and lumens after processing in the HC 80TT. Representative lumen and non-lumen devices were inoculated with at least 10-6 Geobacillus stearothermophilus spores, suspended in an inorganic and organic challenge soil and exposed to a full sterilization cycle. The results showed sterility of all tested devices.
In-Use Testing
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Devices representative of surface features and lumen claims for the HC 80TT were selected for sterility testing. Devices including stainless steel devices with open surfaces, mated or hinged surfaces, representative stainless steel lumen devices, and representative flexible scopes were soiled with clinical soils. The soiled devices were manually cleaned and/or washed per the Manufacturer's Instructions for Use, dried, packaged and processed in the applicable HC 80TT cycle (Lumen or Flexible). The results of the in-use testing demonstrated that the HC 80TT successfully sterilizes surgical instruments used in clinical settings.
Supporting Microbiological Testing
Sterilizing agent efficacy (Sporicidal Activity of a Disinfectant) testing was performed in the HC 80TT in accordance with the guidelines provided in AOAC Official Method 966.04, Sporicidal Activity of Disinfectants. None of the carriers demonstrated growth.
Software Validation
Software validation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices".
Conclusion:
The nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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).