(189 days)
The STERRAD® 200 Sterilizer is 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® 200 Sterilizer can sterilize instruments which have diffusion-restricted spaces. such as the hinged portion of forceps and scissors.
Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer.
- 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* .
- An inside diameter of 3 mm or larger and a length of 400 mm or shorter .
Teflon® and polyethylene luments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer.
*The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs.).
The STERRAD® 200 Sterilizer is a self-contained stand-alone system 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 electrical energy.
The equipment (hardware) for the STERRAD® 200 Sterilizer is the same as that of the predicate device, the STERRAD® 100S Sterilizer. (Note: The STERRAD® 200 Sterilizer is available in either a one-door or two-door model, depending on customer preference). 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 a movable carriage for transport of the cart, disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.
The STERRAD® 200 Sterilizer is a medical device designed for the sterilization of both metal and non-metal medical devices at low temperatures. It uses a hydrogen peroxide gas plasma process.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Sterilization for 1x125mm Lumens | Passed Dose Response and Lumen Validation Studies |
| Sterilization for 2x250mm Lumens | Passed Dose Response and Lumen Validation Studies |
| Sterilization for 3x400mm Lumens | Passed Dose Response and Lumen Validation Studies |
| Sterilization for 6x310mm Teflon® and polyethylene lumens | Passed 6x310mm Lumen Validation Study |
| Surface Sterilization | Passed Surface Sterilization Study |
| Mated Surface Sterilization | Passed Mated Surface Sterilization Study |
| Sterilization for Pouched 1x125mm Lumens | Passed Pouched 1x125mm Lumen Validation Study |
| Sterilization for Pouched 2x250mm Lumens | Passed Pouched 2x250mm Lumen Validation Study |
| Sterilization for Pouched 3x400mm Lumens | Passed Pouched 3x400mm Lumen Validation Study |
| Prevention of Bacteriostasis in Carrier Materials | Passed Bacteriostasis Testing of Carrier Materials |
| Sporicidal Efficacy | Passed Sporicidal Testing |
| Efficacy in "In Use" conditions | Passed In Use Testing |
| Prevention of Bacteriostasis/Fungistasis | Passed Bacteriostasis/Fungistasis Testing |
| Efficacy in simulated use conditions | Passed Simulated Use Testing |
| Material Biocompatibility / Absence of Toxicity for Materials | Passed Toxicity Testing of Materials |
| Proper Functionality of Chemical Indicator | Passed Chemical Indicator Functionality |
| Prevention of Bacteriostasis of CycleSure Biological Indicator | Passed Bacteriostasis Testing of CycleSure Biological Indicator |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes (e.g., number of lumens, surfaces, or biological indicators) used for each validation study. However, it notes that for the lumen sizes, "The validation testing for this lumen size was conducted using a maximum of 12 lumens per load." This implies at least 12 lumens were used for these specific tests.
The data provenance is not explicitly stated in terms of country of origin. The studies are described as "nonclinical tests" and "validation studies," indicating they were conducted in a controlled environment, likely by the manufacturer or a contracted testing facility, to evaluate the device's performance. The nature of the tests (e.g., "Dose Response," "Lumen Validation") suggests a prospective design, where tests were specifically set up to challenge the sterilizer's capabilities under defined conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth. Sterilization validation often relies on established industrial and microbiological standards, rather than expert human interpretation in the same way a medical imaging AI might. The "ground truth" for sterilization is typically determined by the absence or presence of viable microbial spores after the sterilization process, which is a quantitative, laboratory-based assessment.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the context of human expert review. Given that the validation involves "overkill" approach utilizing B. stearothermophilus spores and subsequent laboratory analysis, the "adjudication" is inherent in the microbiological results (e.g., growth or no growth of spores). This is a objective, scientific measurement rather than a subjective human interpretation requiring consensus.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic devices where human interpretation is a key component, and the AI aims to assist human readers. The STERRAD® 200 Sterilizer is a standalone sterilization device, and its effectiveness is measured directly through its ability to kill microorganisms, not by how it influences human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The entire suite of "Validation Testing" listed in Table 1 represents the standalone performance of the STERRAD® 200 Sterilizer. The device's ability to sterilize was evaluated directly, independent of human intervention beyond loading and operating the machine.
7. The Type of Ground Truth Used
The primary type of ground truth used is microbiological outcome data/biological indicators. Specifically, the "overkill" approach utilizing B. stearothermophilus spores was employed. This method involves challenging the sterilization process with a high concentration of highly resistant microorganisms (biological indicators) within test devices. The "ground truth" for successful sterilization is the complete inactivation of these spores, indicated by no growth in subsequent laboratory incubation.
8. The Sample Size for the Training Set
The document does not mention a traditional "training set" in the context of machine learning or AI. This device is a physical sterilizer, not a software algorithm that learns from data. Its performance is based on its engineered design and process, which is validated through the nonclinical tests described.
9. How the Ground Truth for the Training Set Was Established
As there is no traditional "training set" for an AI or machine learning model, this question is not applicable. The device's design and operational parameters were established through engineering principles and prior research (implied by the predicate device), with the validation studies serving to confirm its efficacy.
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AUG 1 8 2003 510(k) Summary
K030429
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 Director of Regulatory Affairs Tel: (949) 453-6410 Fax: (949) 789-3900
August 12, 2003
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME 1.0
Classification Name: Sterilizer, Class II Common/Usual Name: Hydrogen Peroxide Gas Plasma Sterilization System Product Classification: Sterilizer, Class II Proprietary Name: STERRAD® 200 Sterilizer
2.0 PREDICATE DEVICES
STERRAD® 100S Sterilization System
INDICATIONS FOR USE 3.0
The STERRAD® 200 Sterilizer is designed for sterilization of both metal and nonnetal medical devices at low temperatures. Because the cvcle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture.
The STERRAD® 200 Sterilize can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer.
- 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* ●
- An inside diameter of 3 mm or larger and a length of 400 mm or shorter .
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Teflon® and polyethylene lumen instruments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer.
*The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs).
4.0 DESCRIPTION OF DEVICE
The STERRAD® 200 Sterilizer is a self-contained stand-alone system 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 electrical energy.
The equipment (hardware) for the STERRAD® 200 Sterilizer is the same as that of the predicate device, the STERRAD® 100S Sterilizer. (Note: The STERRAD® 200 Sterilizer is available in either a one-door or two-door model, depending on customer preference). 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 a movable carriage for transport of the cart, disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.
5.0 SUMMARY OF NONCLINICAL TESTS
Validation Testing 5.1
Testing was performed using the "overkill" approach utilizing B. stearothermophilus spores. Table one on the following page identifies the validation studies performed and the results obtained.
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| Table 1: Validation Studies | |||
|---|---|---|---|
| -- | -- | ----------------------------- | -- |
| Study | Results |
|---|---|
| Dose Response with 1 x 125mm Lumens | Passed |
| Dose Response with 2 x 250mm Lumens | Passed |
| Dose Response with 3 x 400mm Lumens | Passed |
| Surface Sterilization | Passed |
| Mated Surface Sterilization | Passed |
| 1 x 125mm Lumen Validation | Passed |
| 2 x 250mm Lumen Validation | Passed |
| 3 x 400mm Lumen Validation | Passed |
| 6 x 310mm Lumen Validation | Passed |
| Pouched 1 x 125mm Lumen Validation | Passed |
| Pouched 2 x 250mm Lumen Validation | Passed |
| Pouched 3 x 400mm Lumen Validation | Passed |
| Bacteriostasis Testing of Carrier Materials | Passed |
| Sporicidal Testing | Passed |
| In Use Testing | Passed |
| Bacteriostasis/Fungistasis Testing | Passed |
| Simulated Use Testing | Passed |
| Toxicity Testing of Materials | Passed |
| Chemical Indicator Functionality | Passed |
| Bacteriostasis Testing of CycleSure Biological Indicator | Passed |
6.0 OVERALL PERFORMANCE CONCLUSIONS
The nonclinical studies demonstrate that the STERRAD® 200 Sterilizer is safe and effective for sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® 200 Sterilizer to the predicate device, the STERRAD® 100S Sterilizer.
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Image /page/3/Picture/1 description: The image shows a black and white seal. The seal is circular and contains text around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and a wavy line representing its body. The text around the perimeter is not clearly legible.
Public Health Service
AUG 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Natalie Bennington Senior Regulatory Affairs Specialist Advanced Sterilization Products 33 Technology Drive Irvine, California 92618
Re: K030429
Trade/Device Name: STERRAD® 200 Sterilizer Regulation Number: 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: FLF, MRL Dated: May 21, 2003 Received: May 22, 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 your 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 (QS) 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 your 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 yours,
Patina Currente ffor
Susan Runner, DDS, 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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ADVANCED STERILIZATION PRODUCTS®
Johnson-Johnson company
REGULATORY AFFAIRS DEPARTMENT
510(k) Number (if known): K030429
STERRAD® 200 Sterilizer Device Name:
Indications-For-Use:
Chio S. Lim
n of Anesthesiology, General Hospital. on Control Dental Davices
510(k) Number: K030429
The STERRAD® 200 Sterilizer is 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® 200 Sterilizer can sterilize instruments which have diffusion-restricted spaces. such as the hinged portion of forceps and scissors.
Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer.
- 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* .
- An inside diameter of 3 mm or larger and a length of 400 mm or shorter .
Teflon® and polyethylene luments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer.
*The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs.).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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) 789-3988
§ 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).