(183 days)
No
The summary describes a sterilization system and its validation for new materials and lumen sizes. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is designed to sterilize medical instruments and devices, not to directly treat a patient or disease.
No
Explanation: The device described is a sterilizer (STERRAD 50 & 100S Sterilizers) which sterilizes medical instruments and devices. It does not perform any diagnostic function.
No
The device description explicitly states that the STERRAD® 50 & 100S Sterilizers are "self-contained stand-alone systems of hardware and software" and details the hardware components involved in the sterilization process.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sterilize medical instruments and devices. This is a process applied to medical devices before they are used on or in a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device is a sterilizer that uses a hydrogen peroxide gas plasma process. This is a method of disinfection/sterilization, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device's function is to render medical devices sterile for safe use, which falls under the category of medical device processing, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLF
Device Description
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.
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
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
STERRAD® 50 & 100S Validation:
- Testing was performed using the "overkill" approach.
- Test Organism: B. stearothermophilus
Surface Sterilization:
- STERRAD® 50: Surface sterilization efficacy studies were performed with titanium materials. Results demonstrated an SAL of at least 10⁻⁶ for medical device surface sterilization in the complete STERRAD® 50 sterilization process titanium material listed as recommended for use.
- STERRAD® 100S: Surface sterilization efficacy studies were performed with titanium materials. Results demonstrated an SAL of at least 10⁻⁶ for medical device surface sterilization in the complete STERRAD® 100S sterilization process titanium material listed as recommended for use.
Lumen Sterilization:
- STERRAD® 50: 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. The results demonstrated that a sterility assurance level (SAL) of 10⁻⁶ is achieved in a full STERRAD 50 Sterilization cycle.
- 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. The results demonstrated that a sterility assurance level (SAL) of 10⁻⁶ is achieved in a full STERRAD 100S Sterilization cycle.
Tyvek-Mylar Pouched Device Sterilization:
- STERRAD® 50: Half-cycle validation studies with 1 mm ID x 125 mm long and 2 mm ID x 250 mm long stainless steel straight lumens in Tyvek-Mylar pouches were performed. Results demonstrated an SAL of 10⁻⁶ in a full STERRAD 50 Sterilization cycle, validating the use of STERRAD Sterilization pouches.
- STERRAD® 100S: Half-cycle validation studies with 1 mm ID x 125 mm long and 2 mm ID x 250 mm long stainless steel straight lumens in Tyvek-Mylar pouches were performed. Results demonstrated an SAL of 10⁻⁶ in a full STERRAD 100S Sterilization cycle, validating the use of STERRAD Sterilization pouches.
Supporting Microbiological Testing:
Simulated Use Testing:
- STERRAD 50: Devices inoculated with B. stearothermophilus spores in hard water supplemented with 5% fetal bovine serum were processed with and without cleaning. Results show the process is not affected by organic and inorganic challenge. SLR for unwashed, processed devices was 6.1 and for washed, processed devices was 6.0 (1 mm x 125 mm); SLR for both was 6.9 (2 mm ID x 250 mm).
- STERRAD 100S: Devices inoculated with B. stearothermophilus spores in hard water supplemented with 5% fetal bovine serum were processed with and without cleaning. Results show the process is not affected by organic and inorganic challenge. SLR for unwashed, processed devices was 6.1 and for washed, processed devices was 6.2 (1 mm x 125 mm); SLR for unwashed was 7.0 and for washed was 6.9 (2 mm ID x 250 mm).
In-Use Sterility Testing:
- STERRAD 50: Used stainless steel lumen devices (1 x 125mm and 2 x 250mm) from hospitals, washed and dried per protocol, were sterilized. Results demonstrated effectiveness as a sterilizer for these devices.
- STERRAD 100S: Used stainless steel lumen devices (1 x 125mm and 2 x 250mm) from hospitals, washed and dried per protocol, were sterilized. Results demonstrated effectiveness as a sterilizer for these devices.
Toxicity Testing of Processed Materials:
The cytotoxicity test results indicated that titanium materials processed in the STERRAD® 50 & 100S Sterilizers did not induce in vitro cytotoxicity. Residues testing showed no toxic sterilant residuals.
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, and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sterility Assurance Level (SAL): At least 10⁻⁶ (for surface and lumen sterilization studies)
- Sterility Log Reduction (SLR): 6.1, 6.0, 6.9 (STERRAD 50 simulated use); 6.1, 6.2, 7.0, 6.9 (STERRAD 100S simulated use)
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.
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.
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
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
1
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
2
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 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 2 mm (ID) x 1 mm (ID) x 2 mm (ID) x 2 mm (ID) x