(423 days)
Sterrad 100S Sterilization System
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No
The document describes a low-temperature sterilization system using vaporized hydrogen peroxide. The description focuses on the physical components, sterilization process, and validation studies related to microbial efficacy and material compatibility. There is no mention of AI, ML, or any computational analysis of data for decision-making or process optimization beyond standard control systems.
No.
This device is a sterilizer, intended to sterilize medical instruments and devices, not to provide therapy or treatment to a patient.
No
This device is a sterilizer, meaning its function is to sterilize medical devices. It does not diagnose any condition or disease.
No
The device description explicitly states it is a "self contained standalone device" with "equipment (hardware)" including a "welded frame," "sterilization chamber," "instruments and components," "controls," "piping," and "vacuum pump." While it mentions software validation, the core device is a physical sterilizer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities." This describes a process for making medical devices sterile for use in procedures, not for performing diagnostic tests on biological samples.
- Device Description: The device is a "self contained standalone device, using vaporized hydrogen peroxide as the sterilant." This further confirms its function as a sterilizer.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Therefore, the V-PRO 1 Low Temperature Sterilization System and Vaprox® HC Hydrogen Peroxide Sterilant are sterilization devices, not IVDs.
N/A
Intended Use / Indications for Use
The V-PRO 1 Low Temperature Sterilization System and Vaprox® HC Hydrogen Peroxide Sterilant (59%) are intended for use in terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities.
The V-PRO 1 Low Temperature Sterilization System can sterilize*:
- Instruments with diffusion-restricted spaces such as the hinged portion of . forceps and scissors.
- Medical devices with a single stainless steel lumen with: .
- an inside diameter of 1 mm or larger and a length of 125 mm or shorter o
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter o
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter o
- The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs,
Product codes (comma separated list FDA assigned to the subject device)
MLR
Device Description
The STERIS Amsco V-PRO Low Temperature Sterilizer is a self contained standalone device, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusshle metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suits ator processing medical devices sensitive to heat and moisture. The hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into a vaporization chamber where the solution is heated and converted to a vapor, and then introduced into the sterilizer chamber under negative pressure.
The equipment (hardware) for the V-PRO 1 Sterilizer is similar to that of the predicate device (Sterrad 100S Sterilizer System). The hardware consists of a welded frame onto which is mounted the sterilization chamber along with a variety of instruments and components, controls, piping, vacuum pump, housed in a covered frame of stainless steel panels. The V-PRO 1 Sterilizer also uses accessories such as disposable multiple use sterilant cartridge, reusable instrument trays, printer paper and ink cartridges.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Validation Testing: "overkill" method was used.
Pre-validation Testing:
- Test Organism: Geobacillus stearothermophilus
- Process Variables and Parameters: "The four critical process parameters that may affect process lethality are chamber wall temperature, vaporizer temperature, injection pressure and injection weight." The study showed that process lethality was unaffected over the range of process parameters tested.
V-PRO 1 Sterilization System Process Validation:
- Surface Sterilization of Medical Device Materials: Coupons made from a wide variety of medical device materials were inoculated with >10^6 Geobacillus stearothermophilus spores and dried. "All of the coupons tested in the V-PRO 1 Sterilizer 1/2 cvcles were sterile indicating sterile efficacy of all representative device materials using End of Shelf Life (EOSL) sterilant dose at 1/2 cycle conditions."
- Mated Surfaces: Metallic and polymer (stainless steel, Ultem, Radel, Delrin, and Noryl) carriers with mated surfaces were tested under half-cycle conditions using EOSL sterilant. "All of the coupons tested in the V-PRO 1 Sterilizer 1/2 cycles were sterile indicating sterile efficacy of all representative device materials using EOSL sterilant dose."
- Lumen Sterilization - Worst Case Lumen Size: Lumen sizes of 1 x 125 mm, 2 x 250 mm, and 3 x 400 mm stainless steel were tested. "Results indicate that the 3 x 400 mm is the worst case, i.e. most difficult to sterilize, of the lumens size claims for the V-PRO 1 Sterilizer."
- Half Cycle Verification at Multiple Peroxide Injection Weights Worse Case . Lumen Size: Five injection weights (0.121, 0.607, 1.214, 1.457, and 2.1g) were used to test the 3 x 400 mm lumen at 1/2 cycle parameters and EOSL sterilant. "At the standard hydrogen peroxide injection weight of 2.1g and the reduced injection weight of 1.457g, all lumens were sterile."
- Half Cycle Verification of Lumen Claims: 1 x 125 mm, 2 x 250, and 3 x 400 mm stainless steel lumens were tested under ½ cycle parameters and EOSL sterilant. "All lumens of each size were sterile after the V-PRO 1 ½ cycle using EOSL sterilant."
- Tyvek/Mylar Pouched Device Sterilization: Test articles of lumen sizes of 1 x 125 mm, 2 x 250 mm, and 3 x 400 mm stainless steel in Tyvek/Mylar pouches were tested with EOSL sterilant at ½ cycle parameters. "All lumens of each size were sterile after the V-PRO 1 ½ cycle using EOSL sterilant."
- Supporting Microbiological Testing: AOAC Sporicidal carrier testing was performed. "None of the carriers demonstrated growth."
- Modified Total Kill Endpoint Bracket Testing: The V-PRO 1 Sterilizer was modified to perform cycles consisting of 1, 3, and 4 pulses to evaluate the total kill endpoint. "An all kill endpoint was demonstrated with sterile results at the 2, 3 and 4 pulse cycles in the V-PRO 1 Sterilizer. These results demonstrate a SAL of 10-6 for the complete V-PRO 1 sterilization process."
- Toxicity Testing of Processed Materials: Cytotoxicity and in vivo biocompatibility testing was performed. "The sterilization process leaves no toxic sterilant residuals on the materials."
- Simulated Use Testing: 16 devices with 19 inoculated sites were tested in each cycle, with three replicate cycles performed with and without cleaning conditions, equating to a total of 114 device sites. "All sites sterile for a full cycle in the V-PRO 1 Low Temperature Sterilization System."
- In-Use Sterility Testing: 12 devices with 14 inoculated sites were tested in this study, equating to a total of 42 device sites. "All sites for all three trials were sterile after processing the pre-cleaned devices together in the V-PRO 1 Low Temperature Sterilization System."
- Software Validation: Performed according to FDA's moderate level of concern recommendations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sterrad 100S Sterilization System
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.
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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).
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§ 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
510(k) Summary For Amsco® V-PRO™ 1 Low Temperature Sterilization System
1. Submitter Information
2007 OCT 4
| Contact: | Patrick J. McCullagh, Ph.D.
Vice President
Global Quality Systems Engineering & Regulatory Affairs |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Address: | STERIS Corporation
5960 Heisley Rd.
Mentor, Ohio 44060 |
| Telephone:
Fax No: | (440) 392-7601
(440) 392-8963 |
| Submission Date: | August 4, 2006 |
2. Device Name
| Trade Name: | Amsco® V-PRO™ Low Temperature Sterilization
System |
|----------------------|-------------------------------------------------------|
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas |
3. Predicate Device
Sterrad 100S Sterilization System
4. Description of Device
The STERIS Amsco V-PRO Low Temperature Sterilizer is a self contained standalone device, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusshle metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suits ator processing medical devices sensitive to heat and moisture. The hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into a vaporization chamber where the solution is heated and converted to a vapor, and then introduced into the sterilizer chamber under negative pressure.
1
The equipment (hardware) for the V-PRO 1 Sterilizer is similar to that of the predicate device (Sterrad 100S Sterilizer System). The hardware consists of a welded frame onto which is mounted the sterilization chamber along with a variety of instruments and components, controls, piping, vacuum pump, housed in a covered frame of stainless steel panels. The V-PRO 1 Sterilizer also uses accessories such as disposable multiple use sterilant cartridge, reusable instrument trays, printer paper and ink cartridges.
5. Statement of Intended Use
The V-PRO 1 Low Temperature Sterilization System and Vaprox® HC Hydrogen Peroxide Sterilant (59%) are intended for use in terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities.
The V-PRO 1 Low Temperature Sterilization System can sterilize*:
- Instruments with diffusion-restricted spaces such as the hinged portion of . forceps and scissors.
- . Medical devices with a single stainless steel lumen with:
- an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter o
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter o
- The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 Ibs.
6. Effectiveness
Validation Testing
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 the process parameters on lethality. The four critical process parameters that may affect process lethality are chamber wall temperature, vaporizer temperature, injection pressure and injection weight. 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 process parameters tested.
2
V-PRO 1 Sterilization System Process Validation
- . Surface Sterilization of Medical Device Materials:
The purpose of this study was to demonstrate the effectiveness of the V-PRO 1 Sterilizer using EOSL sterilant under ½ cycle parameters with Geobacillus stearothermophilus spores inoculated on a wide variety of medical device materials. Coupons made from these materials were cleaned, then inoculated with >10° Geobacillus stearothermophilus spores. the Most Resistant Organism (MRO), and dried for 1 hour.
All of the coupons tested in the V-PRO 1 Sterilizer 1/2 cvcles were sterile indicating sterile efficacy of all representative device materials using End of Shelf Life (EOSL) sterilant dose at 1/2 cycle conditions.
Mated Surfaces: .
This study was designed to demonstrate the ability of the V-PRO 1 Sterilizer using EOSL sterilant to effectively sterilize mated or closelyopposed surfaces, a study was performed with metallic and polymer carriers and tested under half cycle conditions in the V-PRO 1 sterilization process. The materials used were stainless steel, Ultem, Radel, Delrin, and Noryl. These polymers were chosen because they are the most commonly used in nonmetallic reusable devices with mated surfaces.
All of the coupons tested in the V-PRO 1 Sterilizer 1/2 cycles were sterile indicating sterile efficacy of all representative device materials using EOSL sterilant dose.
Lumen Sterilization - Worst Case Lumen Size: .
Microbial efficacy testing was performed to determine the most difficult of the V-PRO 1 System's lumen claims to sterilize. The iumen sizes tested were 1 x 125 mm, 2 x 250 mm, and 3 x 400 mm stainless steel.
Worst case lumen testing was performed in the V-PRO 1 Sterilizer at ½ cycle operation parameters using a reduced hydrogen peroxide injection weight of the EOSL sterilant; that is at