(360 days)
The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and 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 insider 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.
The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle was cleared under K.083097 and can sterilize: **
Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
- ** The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilizers are selfcontained stand-alone devices using vaporized hydrogen peroxide. These devices are intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizers operate at low pressure and low temperature and are therefore suitable for processing medical devices sensitive to heat and moisture.
The provided text describes the acceptance criteria and the study conducted for the STERIS Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems. The changes to the device described in this submission are an update to the device Operator Manual to include polyether ether ketone (PEEK) as a compatible material for the V-PRO 1 Cycle and V-PRO 1 Plus Lumen and Non Lumen Cycles; and polyurethane as a compatible material for the V-PRO 1 Plus Non Lumen Cycle.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity and residue analysis have demonstrated biocompatibility after processing in the V-PRO sterilizer | Pass |
| Material Compatibility | Device maintains functionality following sterilization | Pass |
| ½ Cycle Sterilization Efficacy | No survivors at ½ cycle condition with End Of Shelf Life (EOSL) Sterilant | Pass |
| Simulated Use Evaluation | No survivors on device surface after processing with the V-PRO Non Lumen Cycle using EOSL sterilant | Pass |
| In Use Evaluation | Sterile results on all polyurethane and PEEK containing devices | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a separate "test set" sample size in the context of typical AI/ML studies (i.e., a dataset used for final model evaluation). Instead, the listed "tests" appear to be validation activities for the material compatibility claims.
- Sample Size: The document mentions that the Biocompatibility, Material Compatibility, ½ Cycle Sterilization Efficacy, Simulated Use Evaluation, and In Use Evaluation tests were completed for both polyurethane and PEEK.
- For the V-PRO 1 Cycle / V-PRO 1 Plus Lumen Cycle, validation testing for lumen sizes used a maximum of twenty (20) lumens per load. 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. This was for the original K062297 clearance.
- For the V-PRO 1 Plus Non Lumen Cycle, validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. This was for the original K083097 clearance.
- The current submission adds PEEK and polyurethane, and these materials were subjected to the tests mentioned in the table. The exact number of PEEK/polyurethane items tested for each specific test is not detailed beyond "all polyurethane and PEEK containing devices" for the In Use evaluation.
- Data Provenance: The document does not specify the country of origin. Given it's a STERIS Corporation submission (located in Mentor, OH, USA) to the FDA, it is highly likely the studies were conducted in the USA or under US regulatory guidelines. The studies appear to be prospective validation studies rather than retrospective data analysis, as they involve performing specific tests to demonstrate safety and effectiveness for the new material claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not directly applicable in the context of this device and study. The "ground truth" for a sterilizer device typically involves established scientific and regulatory standards for sterility (e.g., no microbial survivors). The validation studies involve laboratory testing and biological indicator challenges, not expert interpretation of outputs in the same way an AI diagnostic imaging system would. Therefore, there's no mention of "experts" establishing ground truth in terms of clinical image interpretation or similar tasks.
4. Adjudication Method for the Test Set
Not applicable. The study is based on laboratory and performance testing of a physical device and its sterilization efficacy, not on human interpretation or adjudication of data.
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
Not applicable. This is not an AI-assisted diagnostic device, but a sterilization system. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used in these studies is based on established sterilization principles and methods, primarily:
- Absence of Microbial Survivors: Demonstrated through biological indicators (e.g., spore strips) or direct microbial culture methods, particularly for "½ Cycle sterilization efficacy" and "Simulated Use evaluation."
- Biocompatibility Standards: Referring to established methods (e.g., ISO standards for cytotoxicity and residue analysis).
- Material Functionality: Assessed through engineering and functional tests to ensure the device maintains its intended performance after sterilization.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system, so there is no "training set." The studies are validation efforts for material compatibility of a physical sterilization system.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model.
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pl of
STERIS
AUG 18 2011
510(k) Summary For 1 and V-PRO™ 1 Plus Low Temperature Amsco® V-PR Sterilization Systems
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Robert Sullivan Senior Director, FDA Regulatory Affairs Tel: 440-392-7695 Fax: 440-357-9198
Submission Date: July 27, 2011
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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$\overline{K102394}$
p2d4
1. Device Name
Trade Name:
| System and Amsco V-PRO 1 Plus LowTemperature Sterilization System | |
|---|---|
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas |
| Classification Number: | 21 CFR 880.6860 |
| Product Code: | MLR |
Amsco V-PRO 1 Low Temperature Sterilization
2. Predicate Device
Amsco® V-PROTM 1 Low Temperature Sterilization System (K062297)
Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System (K083097)
3. Description of Device
The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilizers are selfcontained stand-alone devices using vaporized hydrogen peroxide. These devices are intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizers operate at low pressure and low temperature and are therefore suitable for processing medical devices sensitive to heat and moisture.
4. Intended Use
The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and 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
{2}------------------------------------------------
- p 3d 4 an insider 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.
The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle was cleared under K.083097 and can sterilize: **
Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
- ** The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
ഗ് Description of Safety and Substantial Equivalence
The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems are the same as the predicate devices (K062297 and K083097) except for a proposed change to the device Operator Manual to include polyether ether ketone (PEEK) as a compatible material for the V-PRO 1 Cycle and V-PRO 1 Plus Lumen and Non Lumen Cycles; and polyurethane as a compatible material for the V-PRO 1 Plus Non Lumen Cycle. These proposed labeling changes to add these materials as compatible with VAPROX HC Sterilant do not affect the design or performance specifications of the devices and no new concerns arise regarding the safety and effectiveness when compared to the predicate devices.
The following table summarizes the verification activities that were performed with their respective acceptance criteria to ensure the safety and effectiveness of processing PEEK-containing materials in the V-PRO 1 Cycle and V-PRO 1 Plus Lumen and Non Lumen Cycles and polyurethane-containing materials in the V-PRO 1 Plus Non Lumen Cycle. Each test listed was completed for both polyurethane and PEEK.
The differences between the proposed and predicate device are limited to the described modifications of the device and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device. The proposed Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems are substantially equivalent to the predicate.
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K102394/S002 STERIS Response to 03/14/11 Request for Additional Information
Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems
| Test | Acceptance Criteria | Result |
|---|---|---|
| Biocompatibility | Cytotoxicity and residue analysis havedemonstrated biocompatibility afterprocessing in the V-PRO sterilizer | Pass |
| Materialcompatibility | Device maintains functionality followingsterilization | Pass |
| ½ Cycle sterilizationefficacy | No survivors at ½ cycle condition withEnd Of Shelf Life Sterilant | Pass |
| Simulated Useevaluation | No survivors on device surface afterprocessing with the V-PRO Non LumenCycle using EOSL sterilant | Pass |
| In Use evaluation | Sterile results on all polyurethane andPEEK containing devices | Pass |
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Image /page/4/Picture/2 description: The image shows a logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Sullivan Senior Director. FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
1 8 2011 ୟାତି
Re: K102394
Trade/Device Name: Amsco® V-PRO™ 1 Low Temperature Sterilization System and Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: July 27, 2011 Received: July 28, 2011
Dear Mr. Sullivan:
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. 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.
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Page 2 - Mr. Sullivan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anton van
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known):
Device Name:
Amsco® V-PRO™ 1 Low Temperature Sterilization System Amsco V-PROTM 1 Plus Low Temperature Sterilization System
Indications For Use:
The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles operate at low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and 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: . o an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o an insider 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
-
- 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.
The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle was cleared under K083097 and can sterilize. **
Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
- ** The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR |
|---|---|
| ------------------------------------------------- | -------- |
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
rrence of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K102294 510(k) Number:
Page 1 of 1
§ 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).