(67 days)
No
The document describes a sterilization system with pre-programmed cycles and software validation, but there is no mention of AI or ML capabilities.
No.
The device is a sterilizer intended for processing medical devices, not for diagnosing, treating, or preventing disease in patients.
No
The device is a sterilizer, used for processing reusable medical devices, not for diagnosing medical conditions.
No
The device description explicitly states it is a "selfcontained stand-alone device using vaporized hydrogen peroxide," indicating it is a physical hardware system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities." This is a process for making medical devices sterile for reuse, not for performing diagnostic tests on biological samples.
- Device Description: The description reinforces its function as a sterilizer using vaporized hydrogen peroxide.
- 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.)
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
- Reagents or assays for detecting specific substances.
The device's purpose is to prepare medical devices for use in patient care, not to perform diagnostic testing.
N/A
Intended Use / 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 pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The Amsco 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.
Product codes
MLR
Device Description
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.
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
healthcare facilities
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
| Device Modification | Testing | Acceptance Criteria | Results |
|---|---|---|---|
| Odor Filter | Filters were tested running continuous Non-Lumen cycles. | Oil smell shall not be present in devices using the proposed filter before that observed for devices using the current filter. | PASS |
| Vacuum pump oil | Testing was performed concurrently with the ARS Filter testing. | For devices using the proposed oil, oil smell shall not be detected before or at higher levels that that observed for devices using the current oil. No alarms or failures shall be observed during testing. | PASS |
| ARS Filter | Nine filters of each variety of were run either until an oil smell was detected or 750 cycles were reached. | The proposed ARS filters perform equally to or better than the current ARS filters. | PASS |
| Gas Ballast Filter | The proposed filters (a total of 5) was tested by running until a failure was detected. | The proposed filters perform equally to or better than the current filters. | PASS |
| Software Modifications | Software Validation | Software shall be appropriately verified and validated. | PASS |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
STERIS®
KIII810
, "
SEP - 2 2011
510(k) Summary For Amsco® V-PRO™ 1 and V-PRO™ 1 Plus Low Temperature 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:
June 24, 2011
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
| 出
1
SEP - 2 2011
1. Device Name
| Trade Name: | Amsco V-PRO 1 Low Temperature Sterilization
System and Amsco V-PRO 1 Plus Low
Temperature 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 |
Predicate Device 2.
Amsco® V-PROTM 1 Low Temperature Sterilization System (K062297)
Amsco® V-PROTM 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
2
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification of K062297 and K083097 V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems
- 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 K083097 and can sterilize: **
Non-lumened instruments including non-lumened instruments 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.
5. 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). Minor modifications are proposed to the device software and hardware that collectively address customer requests and enhance device usability. The following performance testing has been completed to ensure substantial equivalence.
| Device
Modification | Testing | Acceptance
Criteria | Results |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Odor Filter | Filters were tested
running continuous
Non-Lumen cycles. | Oil smell shall not be present in devices
using the proposed filter before that observed
for devices using the current filter. | PASS |
| Vacuum pump oil | Testing was performed
concurrently with the
ARS Filter testing. | For devices using the proposed oil, oil smell
shall not be detected before or at higher
levels that that observed for devices using the
current oil. No alarms or failures shall be
observed during testing. | PASS |
| ARS Filter | Nine filters of each
variety of were run
either until an oil smell
was detected or 750
cycles were reached. | The proposed ARS filters perform equally to
or better than the current ARS filters. | PASS |
| Gas Ballast Filter | The proposed filters (a
total of 5) was tested by
running until a failure
was detected. | The proposed filters perform equally to or
better than the current filters. | PASS |
| Software
Modifications | Software Validation | Software shall be appropriately verified and
validated. | PASS |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Mr. Robert Sullivan Senior Director, FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
SEP - 2 2011
Re: K111810
Trade/Device Name: Amsco® V-PRO™ I Low Temperature Sterilization System 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: August 5, 2011
Received: August 8, 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.
ff 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.
4
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.
ff 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/ReportaProblem/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,
Cintron V. O'Brien
Anthony B. 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
5
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 pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The Amsco 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 ____________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K111 810 |
|---|---|
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| June 24, 2011 | Page 7-1 |