(183 days)
This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:
- An inside diameter of 1 mm or larger and a length of 125 mm or shorter
- An inside diameter of 2 mm or larger and a length of 250 mm or shorter .
The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.
The STERRAD® 50 & 100S Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with radio frequency (RF) electrical energy.
The equipment (hardware and software) for the STERRAD® 50 & 100S Sterilizers is the same as that of the predicate devices. The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.
Here's a breakdown of the acceptance criteria and the studies conducted for the STERRAD® 50 and STERRAD® 100S Sterilization Systems, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Goal) | Reported Device Performance (STERRAD® 50 & 100S) |
|---|---|
| Sterilizing medical devices with titanium surfaces | Achieved a Sterility Assurance Level (SAL) of at least 10^-6 for medical device surface sterilization in the complete sterilization process. |
| Sterilizing stainless steel lumens: | |
| - 1 mm inside diameter (ID) or larger and 125 mm or shorter | Achieved an SAL of 10^-6 in a full sterilization cycle. SLRs for simulated use (unwashed/washed) were 6.1/6.0 (STERRAD 50) and 6.1/6.2 (STERRAD 100S). |
| - 2 mm inside diameter (ID) or larger and 250 mm or shorter | Achieved an SAL of 10^-6 in a full sterilization cycle. SLRs for simulated use (unwashed/washed) were 6.9/6.9 (STERRAD 50) and 7.0/6.9 (STERRAD 100S). |
| Sterilizing lumens in Tyvek-Mylar pouches | Achieved an SAL of 10^-6 in a full sterilization cycle for stainless steel lumens (1 mm ID x 125 mm long and 2 mm ID x 250 mm long) packaged in STERRAD Sterilization pouches, validating the use of these pouches. |
| Sterilization efficacy with organic/inorganic challenge (simulated use) | The process was not affected by the presence of an organic and inorganic challenge, as indicated by the achieved SALs and SLR (Sterility Log Reduction) values (e.g., SLR 6.1 to 7.0 across various lumen sizes and conditions, demonstrating effective sterilization even with soil). |
The In-Use testing demonstrated that the STERRAD® 50 and 100S Sterilization Systems were effective sterilizers of stainless steel lumen devices. |
| No cytotoxicity or toxic residuals on processed materials | Cytotoxicity test results indicated that titanium materials processed did not induce in vitro cytotoxicity. Residues testing showed no toxic sterilant residuals. |
Note: SAL of 10^-6 means there is a one in a million chance of a non-sterile unit. SLR values of 6.0 or higher indicate a 6-log reduction in microbial population, which is a common standard for sterilization.
2. Sample Size and Data Provenance
- Test Set Sample Sizes:
- Titanium Surface Sterilization: Not explicitly stated, but performed with "titanium materials representative of the materials commonly used in re-usable medical devices."
- Lumen Sterilization: Not explicitly stated, but for the validation loads, a "maximum of 10 lumens per load" was used for the 1mm x 125mm and 2mm x 250mm lumens. The half-cycle validation tests used sufficient materials to demonstrate the SAL.
- Tyvek-Mylar Pouched Device Sterilization: Not explicitly stated, but conducted with 1mm x 125mm and 2mm x 250mm stainless steel lumens in pouches.
- Simulated Use Testing: Not explicitly stated how many devices, but used "devices representative of lumen claims."
- In-Use Sterility Testing: Not explicitly stated how many devices, but used "Devices representative of lumen claims for the STERRAD® 50 Sterilization System" that were "used in routine surgeries at local hospitals."
- Data Provenance: Retrospective and prospective. The In-Use Sterility Testing involved devices "used in routine surgeries at local hospitals," suggesting data collected from real-world usage scenarios (retrospective element) which were then transported for prospective testing with the STERRAD systems. The other validation testing appears to be prospectively designed lab studies. No specific country of origin is mentioned beyond "local hospitals" for the in-use testing, implying a US-based context given the FDA submission.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the summary. The ground truth for sterilization is typically established through microbiological testing (e.g., demonstrating the death of a highly resistant test organism), rather than expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable as the studies are primarily microbiological challenge tests for sterilization efficacy, not human interpretation tasks requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was mentioned or performed. The device is a sterilizer, meaning its performance is assessed by its ability to render medical devices sterile, not by human interpretation or diagnosis. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.
6. Standalone Performance Study
- Yes, standalone performance studies were done. All the validation tests described (Surface Sterilization, Lumen Sterilization, Tyvek-Mylar Pouched Device Sterilization, Simulated Use Testing, In-Use Sterility Testing, Toxicity Testing) are assessing the algorithm/system-only performance of the STERRAD® 50 and 100S sterilizers without human intervention in the sterilization process itself. The "overkill" approach used in the validation testing directly assesses the system's ability to achieve a robust sterility assurance level.
7. Type of Ground Truth Used
- The primary ground truth used is microbiological evidence of sterility, specifically:
- Inactivation of B. stearothermophilus endospores: This is a highly resistant bacterial spore used as a biological indicator to challenge sterilization processes. Its inactivation to a specific Sterility Assurance Level (SAL) (e.g., 10^-6) or log reduction (e.g., 6-log reduction) serves as the ground truth for effective sterilization.
- Sterility Assessment: Direct assessment of the absence of viable microorganisms after processing.
- Toxicity testing: Used to establish ground truth that no cytotoxic effects or toxic residuals remain.
8. Sample Size for the Training Set
- This information is not applicable. The STERRAD® Sterilization System is a physical-chemical sterilization device, not an AI/ML algorithm that is "trained" on data in the traditional sense. Its operation is based on pre-defined scientific principles of hydrogen peroxide gas plasma sterilization, not on learning from a dataset.
9. How Ground Truth for the Training Set Was Established
- This information is not applicable for the reasons stated above. The system's "operating parameters" or "settings" are developed through scientific and engineering principles, not through a "training set" with established ground truth. The validation studies described in the summary are designed to prove the device meets performance criteria, not to train it.
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193290 0(k) Summary
APR - 3 2003
Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618
Contact Person
Kevin Corrigan, RAC Regulatory Affairs Director Tel: (949) 453-6410 Fax: (949) 789-3900
March 24, 2003
1.0 CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME Classification Name: Sterilizer, Class II Common/Usual Name: Hydrogen Peroxide Gas Plasma Sterilization System Product Classification: Sterilizer, Class II Proprietary Name: STERRAD® 50 Sterilization System and STERRAD® 100S Sterilization System
2.0 PREDICATE DEVICES
STERRAD® 50 Sterilization System (K981625) and STERRAD® 100S Sterilization System (K991999)
3.0 INDICATIONS FOR USE
This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:
- An inside diameter of 1 mm or larger and a length of 125 mm or shorter
- An inside diameter of 2 mm or larger and a length of 250 mm or shorter .
The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.
510(k) Summary Appendix 43 - Page 1
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4.0 DESCRIPTION OF DEVICES
The STERRAD® 50 & 100S Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with radio frequency (RF) electrical energy.
The equipment (hardware and software) for the STERRAD® 50 & 100S Sterilizers is the same as that of the predicate devices. The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.
5.0 SUMMARY OF NONCLINICAL TESTS
STERRAD® 50 & 100S Validation 5.1
- Testing was performed using the "overkill" approach. 5.1.1
- 5.1.2 Test Organism: B. stearothermophilus
- Titanium Surface Sterilization 5.1.3
5.1.3.1 STERRAD® 50
Surface sterilization efficacy studies were performed in the STERRAD® 50 Sterilizer with titanium materials representative of the materials commonly used in re-usable medical devices.
Results of this study demonstrated an SAL of at least 10° for medical device surface sterilization in the complete STERRAD® 50 sterilization process titanium material listed as recommended for use in the STERRAD® 50 Sterilizer.
5.1.3.2 STERRAD® 100S
Surface sterilization efficacy studies were performed in the STERRAD® 100S Sterilizer with titanium materials representative of the materials commonly used in re-usable medical devices.
Results of this study demonstrated an SAL of at least 10th for medical device surface sterilization in the complete STERRAD® 100S sterilization process titanium material listed as recommended for use in the STERRAD® 100S Sterilizer.
5.1.4 Lumen Sterilization 5.1.4.1 STERRAD® 50
Half-cycle validation tests were performed using B. stearothermophilus endospores (>106 spores) inside stainless steel
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lumens, 1 mm internal diameter (ID) x 125 mm long and 2 mm (ID) x 250 mm long, placed within the STERRAD® 50 Sterilizer expanded utility validation load.
The results of this study demonstrated that a sterility assurance level (SAL) of 10th is achieved in a full STERRAD 50 Sterilization cycle when processing stainless steel lumens of >1 mm (ID) x ≤125 mm long and >2 mm (ID) x <250 mm long.
5.1.4.2 STERRAD® 100S
Half-cycle validation tests were performed using B. stearothermophilus endospores (>106 spores) inside stainless steel lumens, 1 mm internal diameter (ID) x 125 mm long and 2 mm (ID) x 250 mm long, placed within the STERRAD® 100S Sterilizer expanded utility validation load.
The results of this study demonstrated that a sterility assurance level (SAL) of 10° is achieved in a full STERRAD 100S Sterilization cycle when processing stainless steel lumens of >1 mm (ID) x <125 mm long and >2 mm (ID) x <250 mm long.
5.1.5 Tyvek-Mylar Pouched Device Sterilization 5.1.5.1 STERRAD® 50
Half-cycle validation studies with 1 mm internal diameter (ID) x 125 mm long and 2 mm (ID) x 250 mm long stainless steel straight lumens in Tyvek-Mylar pouches were performed to demonstrate sterilization efficacy with the STERRAD® 50 Sterilization System.
The results of this study demonstrated that a sterility assurance level (SAL) of 10th was achieved in a full STERRAD 50 Sterilization cycle when processing stainless steel lumens. >1 mm (ID) x <125 mm long and >2 mm (ID) x <250 mm long, packaged in STERAD Sterilization pouches. This study validates the use of STERRAD Sterilization pouches in the STERRAD 50 Sterilization System.
5.1.5.2 STERRAD® 100S
Half-cycle validation studies with 1 mm internal diameter (ID) x 125 mm long and 2 mm (ID) x 250 mm long stainless steel straight lumens in Tyvek-Mylar pouches were performed to demonstrate sterilization efficacy with the STERRAD® 100S Sterilization System.
The results of this study demonstrated that a sterility assurance level (SAL) of 10th was achieved in a full STERRAD 100S Sterilization cycle when processing stainless steel lumens, ≥1 mm
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(ID) x <125 mm long and >2 mm (ID) x <250 mm long, packaged in STERRAD Sterilization pouches. This study validates the use of STERRAD Sterilization pouches in the STERRAD 100S Sterilization System.
5.2 Supporting Microbiological Testing
- 5.2.1 Simulated Use Testing
5.2.1.1 STERRAD 50
The devices were inoculated with spores of B. stearothermophilus suspended in 300 ppm hard water (AOAC preparation) supplemented with 5% fetal bovine serum. After drying, the devices were treated either by cleaning, then processing in the STERRAD® 50 sterilizer or by directly processing in the sterilizer, i.e., without cleaning.
The results show that the STERRAD® 50 process is not affected by the presence of an organic and inorganic challenge. The SLR for the unwashed, processed devices was 6.1 and for the washed, processed devices it was 6.0 (1 mm x 125 mm in length devices). The SLR for both the washed and unwashed, processed devices was 6.9 (2 mm ID x 250 mm in length devices).
5.2.1.2 STERRAD 100S
The devices were inoculated with spores of B. stearothermophilus suspended in 300 ppm hard water (AOAC preparation) supplemented with 5% fetal bovine serum. After drying, the devices were treated either by cleaning, then processing in the STERRAD® 100S sterilizer or by directly processing in the sterilizer, i.e., without cleaning.
The results show that the STERRAD® 100S process is not affected by the presence of an organic and inorganic challenge. The SLR for the unwashed, processed devices was 6.1 and for the washed, processed devices it was 6.2 (1 mm x 125 mm in length devices). The SLR for the unwashed, processed devices was 7.0 and for the washed, processed devices it was 6.9` (2 mm ID x 250 mm in length devices).
5.2.2 In-Use Sterility Testing
5.2.2.1 STERRAD 50
Devices representative of lumen claims for the STERRAD® 50 Sterilization System were selected for sterility testing. Devices tested were used in routine surgeries at local hospitals and included stainless steel lumen devices approximately 1 x 125mm and 2 x 250mm in length. The used devices were washed and dried
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according to hospital protocol at the hospital site and transported to ASP to be sterilized in a STERRAD® 50 Sterilization System.
The results of the In-Use testing demonstrated that the STERRAD® 50 Sterilization System was shown to be an effective sterilizer of stainless steel lumen devices approximately 1 x 125mm and 2 x 250mm in length.
5.2.2.2 STERRAD 100S
Devices representative of lumen claims for the STERRAD® 100S Sterilization System were selected for sterility testing. Devices tested were used in routine surgeries at local hospitals and included stainless steel lumen devices approximately 1 x 125mm and 2 x 250mm. The used devices were washed and dried according to hospital protocol at the hospital site and transported to ASP to be sterilized in a STERRAD® 100S Sterilization System.
The results of the In-Use testing demonstrated that the STERRAD® 100S Sterilization System was shown to be an effective sterilizer of stainless steel lumen devices approximately 1 x 125mm and 2 x 250mm in length.
5.3 Toxicity Testing of Processed Materials
The cytotoxicitv test results indicated that the titanium materials processed in the STERRAD® 50 & 100S Sterilizers did not induce in vitro cytotoxicity. The residues testing showed that the sterilization process leaves no toxic sterilant residuals on the materials processed.
6.0 OVERALL PERFORMANCE CONCLUSIONS
The nonclinical studies have demonstrated that medical devices with titanium surfaces and medical devices with only a single stainless steel lumen with:
- an inside diameter of 1 mm or larger and a length of 125 mm or shorter .
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter .
may be processed in the STERRAD 50 & 100S Sterilization Systems.
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 2003
Ms. Natalie Bennington Senior Affairs Specialist Advanced Sterilization Products 33 Technology Drive Irvine, California 92618
Re: K023290
Trade/Device Name: Expanded Indications for the STERRAD® 50 and STERRAD® 100S Sterilizers Regulation Number: 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: FLF Dated: February 4, 2003 Received: February 5, 2003
Dear Ms. Bennington:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Bennington
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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Susan Rosser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/0 description: The image shows a logo with the letters ASP inside of a rounded rectangle. The letters are white and the background is black. The letter A is a triangle shape.
ADVANCED STERILIZATION PRODUCTS® a Johnson a Johnson compan REGULATORY AFFAIRS DEPARTMENT
510(k) Number (if known): K023290
Device Name: Expanded Indications for the STERRAD® 50 and STERRAD® 100S Sterilizers
Indications-For-Use:
This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:
- An inside diameter of 1 mm or larger and a length of 125 mm or shorter .
- An inside diameter of 2 mm or larger and a length of 250 mm or shorter .
The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Olin S. Lin
Anesthesiology, General Hospital ontrol Den
510(k) Number: K023290
Prescription Use (PER 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
DIVISION OF ETHICON, INC. • 33 TECHNOLOGY DRIVE • IRVINE, CA 92618 • (949) 581-5799 • FAX (949) 789-3998
§ 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).