(147 days)
No
The summary describes a low-temperature sterilization system with pre-programmed cycles based on physical parameters (pressure, temperature, time, sterilant concentration). There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on sterilization efficacy and material compatibility, not on algorithmic performance.
No
This device is a sterilizer intended for cleaning medical instruments, not for providing therapy to patients.
No
Explanation: The device is a sterilizer intended for the terminal sterilization of reusable medical devices, not for diagnosing medical conditions.
No
The device is a physical sterilization system that uses vaporized hydrogen peroxide and includes hardware components like a chamber, controls, and mechanisms for generating and circulating the sterilant. The description focuses on the physical process and validation of sterilization efficacy on various medical devices.
Based on the provided information, 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." This describes a process for making medical devices safe for reuse, not for performing diagnostic tests on biological samples.
- Device Description: The description reinforces that it's a sterilizer using vaporized hydrogen peroxide to sterilize surgical instruments.
- 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 compatibility testing.
Therefore, the V-PRO 60 Low Temperature Sterilization System is a medical device used for sterilization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The V-PRO 60 Low Temperature Sterilization System, with VAPROX® 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 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 V-PRO 60 Sterilizer's Lumen Cycle can sterilize: 4
- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: 4
- single or dual lumen devices with stainless steel lumens that are o ■ = > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length
- triple lumen devices with stainless steel lumens that are o
- = 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") in length .
- = 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length 1 or
- = 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length 사
- a The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg).
The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize °
- · Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: 6
- · One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
- single or dual lumen device with lumens that are = 1 mm (~3/64") ID and ≤ 990 o mm (38-63/64") in length
Product codes
MLR
Device Description
The V-PRO 60 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1, Amsco V-PRO 1 Plus and Amsco V-PRO maX Sterilizers.
As with the predicate device (K102330), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle. The V-PRO 60 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 60 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 sterilize 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 following completion of the cvcle.
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)
AOAC Sporicidal Test: All 720 carriers processed using 3 lots of EOSL sterilant were sterile. (PASS)
Determination of D-value and Total Kill Endpoint: Greater than a 12 log reduction of the most resistant organism is achieved within all cycle (Lumen Cycle, Non Lumen Cycle and Flexible Cycle) of the V-PRO 60 Sterilizer. (PASS)
½ Cycle Modified Total Kill Endpoint Verification: Modified total kill end point analysis was demonstrated for all three V-PRO 60 Sterilizer cycles. The standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. Partial positives or all survive results were seen at lower injection weights. (PASS)
½ Cycle Sterilization Verification of Cycle Claims:
The Lumen Cycle reproducibly sterilizes single, dual and triple lumen devices under worst case conditions in ½ Cycle
The Flexible Cycle reproducibly sterilizes 1 x 990 mm flexible endoscope lumens under worst case conditions in ½ Cycle
The Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in ½ Cycle (PASS)
½ Cycle Verification of Mated Surfaces: Sterile efficacy was demonstrated for mated surfaces under worst case conditions. (PASS)
Simulated Use Test: Simulated use testing verified the ability of the V-PRO 60 Sterilizer cycles to sterilize medical devices under worst case processing conditions. (PASS)
In Use Test: The in use investigation demonstrated the ability of the V-PRO 60 Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. (PASS)
Biocompatibility: Cytotoxicity and residue analysis of 23 materials have demonstrated biocompatibility after processing in the V-PRO 60 Sterilizer. (PASS)
Medical Device Material Compatibility: Evaluation of medical devices after multiple cycles in the V-PRO 60 Sterilizer has demonstrated compatibility with 23 materials of construction. (PASS)
Final Process Qualification: The V-PRO 60 Sterilizer final process qualification was successful for all three (3) sterilizer cycles. All three lots of CI exhibited complete color change. All three SCBI PIs exhibited a passing color change and all SCBIs were negative for growth. Manual inspection of the process parameter data confirmed that all cycle specifications were met. (PASS)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K102330, K083097, K102394, K111810, K112760
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
Image /page/0/Picture/0 description: The image shows the word "STERIS" in a large, bold font, with the registered trademark symbol next to it. Above the word "STERIS" is the code "K140498". Below the word "STERIS" is a graphic of several horizontal wavy lines stacked on top of each other.
JUL 2 4 2014
510(k) Summary For V-PRO® 60 Low Temperature Sterilization System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Bill Brodbeck Contact: Director, Regulatory Affairs
Telephone: (440) 392-7690 Fax No: (440) 357-9198
July 24, 2014 Summary Date:
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
1
1. Device Name
| Trade Name: | V-PRO® 60 Low Temperature Sterilization System |
|---|---|
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas |
| 21 CFR 880.6860 | |
| Product Code MLR | |
| Device Class: | Class II |
Predicate Devices 2.
Amsco V-PRO maX Low Temperature Stetilization System (K131120). Please note that the predicate device was originally cleared under K102330.
A comparison between the proposed V-PRO 60 Low Temperature Sterilization System to the predicate device is summarized in the table below.
| Feature | V-PRO 60 Low Temperature
Sterilization System
(Proposed Device) | V-PRO maX Low Temperature Sterilization System
(Predicate Device/K131120) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The V-PRO 60 Low Temperature
Sterilization System, with VAPROX® 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 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 1, V-PRO 1 Plus and V-
PRO maX 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 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 V-PRO 60 Sterilizer's Lumen Cycle
can sterilize:a Instruments with diffusion-restricted
spaces such as the hinged portion of
forceps and scissors Non-lumened devices including non-
lumened rigid and semi-rigid
endoscopes Medical devices, including single,
dual and triple channeled rigid and
semi-rigid endoscopes, with the
following configurations: a | The Amsco V-PRO 1, V-PRO 1 Plus and V-
PRO maX Low Temperature Sterilization
System's Lumen Cycle, can sterilize:a Lumened and non-lumened instruments
with diffusion-restricted spaces such as
the hinged portion of forceps and
scissors Medical devices, including single, dual
and triple channeled rigid and semi-rigid
endoscopes, with the following
configurations: a single channeled devices with a
stainless steel lumen that is ≥ 0.77
mm internal diameter (ID) and 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length triple lumen devices with stainless steel lumens that are
- . ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length = or
- . ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
4 The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 1bs (5.0 kg).
The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize °
- · Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusionrestricted spaces such as the hinged portion of forceps and scissors.
6
-
b The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg).
The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: 6 -
One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
-
single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 . O mm (38-63/64") in length
- C The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load.
5. Summary of Nonclinical Tests
The V-PRO 60 Low Temperature Sterilization System has the same or similar intended use and the same technological characteristics as compared to the predicate device. Performance testing to assess and demonstrate substantial equivalence to the predicate is summarized below.
| Test | Result | Conclusion |
|---|---|---|
| AOAC Sporicidal | ||
| Test | All 720 carriers processed using 3 lots of EOSL | |
| sterilant were sterile. | PASS | |
| Determination of D- | ||
| value and Total Kill | ||
| Endpoint | Greater than a 12 log reduction of the most resistant | |
| organism is achieved within all cycle (Lumen | ||
| Cycle, Non Lumen Cycle and Flexible Cycle) of | ||
| the V-PRO 60 Sterilizer. | PASS | |
| ½ Cycle Modified | ||
| Total Kill Endpoint | ||
| Verification | Modified total kill end point analysis was | |
| demonstrated for all three V-PRO 60 Sterilizer | ||
| cycles. The standard injection weight of 1.1 g and | ||
| at least one lower injection weight resulted in all | ||
| sterile results within the validation load used to | ||
| qualify each sterilizer cycle. Partial positives or all | ||
| survive results were seen at lower injection | ||
| weights. | PASS | |
| ½ Cycle Sterilization | ||
| Verification of Cycle | ||
| Claims | • The Lumen Cycle reproducibly sterilizes single, | |
| dual and triple lumen devices under worst case | ||
| conditions in ½ Cycle | ||
| • The Flexible Cycle reproducibly sterilizes 1 x | ||
| 990 mm flexible endoscope lumens under worst | ||
| case conditions in ½ Cycle | ||
| • The Non Lumen Cycle reproducibly sterilizes | ||
| non-lumened devices under worst case | ||
| conditions in ½ Cycle | PASS |
7
| Test | Result | Conclusion |
|---|---|---|
| ½ Cycle Verification | ||
| of Mated Surfaces | Sterile efficacy was demonstrated for mated | |
| surfaces under worst case conditions | PASS | |
| Simulated Use Test | Simulated use testing verified the ability of the | |
| V-PRO 60 Sterilizer cycles to sterilize medical | ||
| devices under worst case processing conditions. | PASS | |
| In Use Test | The in use investigation demonstrated the ability of | |
| the V-PRO 60 Sterilizer cycles to sterilize patient- | ||
| soiled, clinically-cleaned, medical instruments. | PASS | |
| Biocompatibility | Cytotoxicity and residue analysis of 23 materials | |
| have demonstrated biocompatibility after | ||
| processing in the V-PRO 60 Sterilizer. | PASS | |
| Medical Device | ||
| Material | ||
| Compatibility | Evaluation of medical devices after multiple cycles | |
| in the V-PRO 60 Sterilizer has demonstrated | ||
| compatibility with 23 materials of construction. | PASS | |
| Final Process | ||
| Qualification | The V-PRO 60 Sterilizer final process qualification | |
| was successful for all three (3) sterilizer cycles. All | ||
| three lots of CI exhibited complete color change. | ||
| All three SCBI PIs exhibited a passing color change | ||
| and all SCBIs were negative for growth. Manual | ||
| inspection of the process parameter data confirmed | ||
| that all cycle specifications were met. | PASS |
The V-PRO 60 Low Temperature Sterilization System has been tested for conformity and is certified to the following standards:
- . EN 61010-1:2001 Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements; Part 1: General Requirements
- . EN61326-1:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
ર્. Conclusion
The V-PRO 60 Low Temperature Sterilization System's Lumen, Non Lumen and Flexible Cycles have been validated to meet the established performance criteria. The results of the V-PRO 60 Low Temperature Sterilization System verification studies demonstrate that the sterilizer performs as intended and the proposed device is substantially equivalent to the predicate device.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
July 24, 2014
STERIS Corporation Dr. William Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060
Re: K140498
Trade/Device Name: V-Pro 60 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: II Product Code: MLR Dated: June 24, 2014 Received: June 25, 2014
Dear Dr. Brodbeck
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.
9
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
・・
Teiashri Purohi FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K140498
Device Name:
V-PRO® 60 Low Temperature Sterilization System
Indications For Use:
The V-PRO 60 Low Temperature Sterilization System, with VAPROX® 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 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 V-PRO 60 Sterilizer's Lumen Cycle can sterilize: 4
- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: 4
- single or dual lumen devices with stainless steel lumens that are o ■ ≥ 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length
- triple lumen devices with stainless steel lumens that are o
- ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") in length .
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length 1 or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length 사
- a The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg).
The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize °
- · Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.
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11
-
b The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg).
The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: 6 -
· One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
- single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 o mm (38-63/64") in length
- E The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
× 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)
Image /page/11/Picture/11 description: The image shows a digital signature of Sreekanth Gutala. The signature includes the name "Sreekanth Gutala -S" in a large font on the left side of the image. On the right side, there is information about the digital signature, including the date and time: 2014:07:24 12:48:52 -04'00'.
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