(360 days)
K062297, K.083097
Not Found
No
The document describes a standard sterilization system with pre-programmed cycles and does not mention any AI or ML components in its operation or description.
No.
Explanation: The device is a sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable medical devices, not for diagnosing, curing, mitigating, treating, or preventing disease in humans or animals.
No
This device is a sterilizer, intended for use in the terminal sterilization of reusable medical devices, not for diagnosing medical conditions.
No
The device description clearly 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 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 safe for reuse, not for diagnosing a condition or analyzing a sample from the human body.
- Device Description: The description reinforces the intended use as a sterilizer for reusable medical devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to sterilize medical instruments, which is a different category of medical device.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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)
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.
| Test | Acceptance Criteria | Result |
|---|---|---|
| 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 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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
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
1
$\overline{K102394}$
p2d4
1. Device Name
Trade Name:
| | 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 |
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.
3
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 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 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 |
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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.
5
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
6
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:
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