(61 days)
No
The document describes a sterilization system with pre-programmed cycles based on device type and load configuration. There is no mention of adaptive learning, pattern recognition, or any other characteristics typically associated with AI/ML. The software validation mentioned is standard for medical devices and does not imply AI/ML.
No.
The device is a sterilizer for medical devices, not a therapeutic device. It is used to prepare instruments for medical procedures, but does not directly treat a patient's condition.
No
The device is a sterilizer, intended for use in the terminal sterilization of medical devices, not for diagnosing medical conditions.
No
The device description clearly describes a physical sterilization system that uses vaporized hydrogen peroxide and includes hardware components like a sterilizer model, trays, and pouches. While software is mentioned as being validated, the core device is a hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities." Sterilization of medical devices is not an in vitro diagnostic activity.
- Device Description: The description reinforces its function as a sterilizer that uses vaporized hydrogen peroxide to sterilize surgical instruments and endoscopes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on those analyses.
- Reagents, calibrators, or controls used in laboratory testing.
The device's purpose is to render medical devices sterile for reuse, which is a critical function in healthcare but falls outside the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Amsco® V-PRO™ maX Low Temperature Sterilization System, with VAPROXTM HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The Amsco V-PRO maX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:4
- . Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Medical devices, including rigid endoscopes, with a single stainless . steel lumen with:
- an inside diameter of 1 mm or larger and a length of 125 mm or o shorter
- an insider diameter of 2 mm or larger and a length of 250 mm or 0 shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or o shorter
- a 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 maX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize: 9
Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
- b 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 maX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations: - Two flexible endoscopes with a light cord (if not integral to 1. endoscope) and mat with no additional load. 6.
The flexible endoscopes may contain either: - a single lumen with an inside diameter of 1 mm or larger and a . length of 1050 mm or shorter
- or two lumens with: .
- one lumen having an inside diameter of 1 mm or larger and a . length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
- C The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
- One flexible endoscope with a light cord (if not integral to endoscope) 2. and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors."
The flexible endoscope can contain either: - a single lumen with an inside diameter of 1 mm or larger and a . length of 1050 mm or shorter
- or two lumens with: . •
- one lumen having an inside diameter of 1 mm or larger and a . length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
- d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.
Product codes (comma separated list FDA assigned to the subject device)
MLR
Device Description
The Amsco V-PRO maX Low Temperature Sterilization System is a new sterilizer model to be added to the Amsco V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1 and Amsco V-PRO 1 Plus Sterilizers.
The V-PRO maX Sterilizer has three pre-programmed cycles: the Lumen Cycle (K062297), the Non Lumen Cycle (K083097) and the Flexible Cycle (K102330). The V-PRO maX Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.
The V-PRO maX Sterilizer uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize a conditioning phase, a sterilization phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required.
The Flexible Cycle has been designed to sterilize surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes. The flexible endoscopes can be single or dual channeled and they may be processed in a flexible endoscope-only load or in combination with non-lumened medical instruments. The cycle is approximately 35 minutes long.
The Verify V24 SCBI (K073244 and K09051), Verify VH2O2 Process Indicator (K091174), V-PRO Sterilization Trays (K070769), and Vis-U-All Tyvek pouches (K070765, K071087, and K090371) have been validated for use in the V-PRO maX Sterilizer.
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: Software Modifications
Testing: Software Validation
Acceptance Criteria: Software shall be appropriately verified and validated.
Results: 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.
K062297, K083097, K073244, K09051, K091174, K070769, K070765, K071087, K090371
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
STERIS®
NOV 222 2011
510(k) Summary For Amsco® V-PRO™ maX Plus Low Temperature Sterilization Systems
t
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:
September 21, 2011
STERIS Corporation = 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
1. Device Name
| Trade Name: | Amsco V-PRO maX 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 maX Low Temperature Sterilization System (K102330)
3. Description of Device
The Amsco V-PRO maX Low Temperature Sterilization System is a new sterilizer model to be added to the Amsco V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1 and Amsco V-PRO 1 Plus Sterilizers.
The V-PRO maX Sterilizer has three pre-programmed cycles: the Lumen Cycle (K062297), the Non Lumen Cycle (K083097) and the Flexible Cycle (K102330). The V-PRO maX Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.
The V-PRO maX Sterilizer uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize a conditioning phase, a sterilization phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required.
The Flexible Cycle has been designed to sterilize surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes. The flexible endoscopes can be single or dual channeled and they may be processed in a flexible endoscope-only load or in combination with non-lumened medical instruments. The cycle is approximately 35 minutes long.
The Verify V24 SCBI (K073244 and K09051), Verify VH2O2 Process Indicator (K091174), V-PRO Sterilization Trays (K070769), and Vis-U-All Tyvek pouches (K070765, K071087, and K090371) have been validated for use in the V-PRO maX Sterilizer.
2
4. Intended Use
The Amsco V-PRO maX Low Temperature Sterilization System, with VAPROXTM HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The Amsco V-PRO maX Low Temperature Sterilizer System's Lumen Cycle, cleared under K062297, can sterilize:4
- . Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- . Medical devices, including rigid endoscopes, with a single stainless steel lumen with:
- an inside diameter of 1 mm or larger and a length of 125 mm or o shorter
- an insider diameter of 2 mm or larger and a length of 250 mm or o shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or o shorter
- a 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 maX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize: 0
Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
-
b 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 maX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes in either of two load configurations: -
- Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.6
The flexible endoscopes may contain either:
- Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.6
3
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification of K102330 V-PRO maX Low Temperature Sterilization System
- · a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
- · or two lumens with:
- · one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
- c The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
-
- One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. "
The flexible endoscope can contain either:
- · a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
- or two lumens with:
- · one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- . and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
- ರ್ The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.
Description of Safety and Substantial Equivalence ક.
The Amsco V-PRO maX Low Temperature Sterilization System is the same as the predicate devices (K102330). Minor modifications are proposed to the device software that addresses customer requests and enhance device usability. The following performance testing has been completed to ensure substantial equivalence.
| Device
Modification | Testing | Acceptance
Criteria | Results |
|---------------------------|---------------------|------------------------------------------------------------|---------|
| Software
Modifications | Software Validation | Software shall be appropriately verified and
validated. | PASS |
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is written in a bold, sans-serif font. The words are arranged on a single line and centered horizontally. The text is black against a white background.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 222 2011
Mr. Robert Sullivan Senior Director, FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
Re: K112760
Trade/Device Name: Amsco® V-PRO™ maX Low Temperature Sterilization System . Regulation Number: 21 CFR 880.6860 Regulation Name: Etylene Oxide Gas Sterilzer Regulatory Class: II Product Code: MLR Dated: October 24, 2011 Received: October 25, 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/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 O. waton
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-PROTM maX Low Temperature Sterilization System
Indications For Use:
The Amsco® V-PRO™ maX Low Temperature Sterilization System, with VAPROXTM HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The Amsco V-PRO maX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:4
- . Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Medical devices, including rigid endoscopes, with a single stainless . steel lumen with:
- an inside diameter of 1 mm or larger and a length of 125 mm or o shorter
- an insider diameter of 2 mm or larger and a length of 250 mm or 0 shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or o shorter
- a 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 maX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize: 9
Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
Page 1 of 3
7
-
b 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 maX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations: -
Two flexible endoscopes with a light cord (if not integral to 1. endoscope) and mat with no additional load. 6.
The flexible endoscopes may contain either: -
a single lumen with an inside diameter of 1 mm or larger and a . length of 1050 mm or shorter
-
or two lumens with: .
- one lumen having an inside diameter of 1 mm or larger and a . length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
-
C The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
-
One flexible endoscope with a light cord (if not integral to endoscope) 2. and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors."
The flexible endoscope can contain either:
- a single lumen with an inside diameter of 1 mm or larger and a . length of 1050 mm or shorter
- or two lumens with: . •
- one lumen having an inside diameter of 1 mm or larger and a . length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
- d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.
Page 2 of 3
8
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification of K102330 V-PRO maX Low Temperature Sterilization System
| Sterilization
Cycle | Sterilant
injection
(g) | # of
Injections | Sterilant
Exposure
Time (min) | Chamber
Pressure
Prior to
Injection
(Torr) | Chamber/
Vaporizer
Temperature
(°C) |
|------------------------|-------------------------------|--------------------|-------------------------------------|--------------------------------------------------------|----------------------------------------------|
| Lumen | 2.1 | 4 | 32 | 0.4 | 50/60 |
| Non Lumen | 2.1 | 4 | 12 | 1 | 50/60 |
| Flexible | 2.1 | 4 | 12 | 0.4 | 50/60 |
The parameters for the three V-PRO Cycles are as follows:
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of 3
Elizabeth F. Clavie-Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112760