(200 days)
Not Found
No
The device description and performance studies focus on standard biological indicator technology and testing protocols, with no mention of AI or ML. The "Smart Read" likely refers to a reader device, not the biological indicator itself incorporating AI/ML.
No.
This device is a biological indicator used to monitor the efficacy of steam sterilization processes, not to treat a medical condition.
No
This device is a biological indicator used to monitor the efficacy of steam sterilization processes, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "self-contained biological indicator" consisting of physical components like bacterial spores, a paper filter carrier, a glass ampoule, and a plastic vial. This indicates a hardware device, 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 clearly stated as "monitoring the efficacy of steam sterilization processes." This is a quality control function for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains bacterial spores and a culture medium to assess the effectiveness of sterilization. It does not analyze human biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing patient samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Being used in a clinical laboratory setting for patient testing
This device falls under the category of a sterilization process indicator, which is a different type of medical device used to verify the effectiveness of sterilization cycles.
N/A
Intended Use / Indications for Use
"Mesa Smart Read EZTest - Steam is a self-contained Biological Indicator intended for monitoring the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles:
| Cycle Type | Cycle Temp | Cycle Exposure Time |
|---|---|---|
| Gravity | 121°C | 30 Minutes |
| Gravity | 132°C | 10 Minutes |
| Flash Gravity* | 132°C | 3 Minutes |
| Pre-Vac | 132°C | 4 Minutes |
| Pre-Vac | 135°C | 3 Minutes |
*Unwrapped nonporous devices only
Mesa Smart Read EZTest has a validated reduced incubation time of 10 hours."
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
"The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 incculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube."
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
Not Found
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
"Testing was performed in accordance with AAMI/ISO 11138-1:2006 and AAMI/ISO 11138-3:2006 to validate the labeled claims and performance characteristics of Smart Read EZTest - Steam.
Three separate lots of product manufactured from three different primary spore crops were tested for resistance, spore population, and effectiveness in gravity cycles. For all lots tested, the above parameters and overall effectiveness in monitoring routine steam sterilization cycles has been demonstrated."
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
510(k) Summary
JAN 3 0 2012
510(k) Notification Smart-Read EZTest - Steam Biological Indicator
Sponsor information
Mesa Laboratories, Inc. - 12100 W. 6th Ave Lakewood, CO 80228
Contact:
Prepared on:
Device:
Manufacturing Facility:
Classification name:
Classification:
Predicate Device:
Wendy Rovalty Sr. Director, BI Ops Quality & Regulatory Affairs 8607 Park Drive Omaha, NE 68127
Phone: (402) 593-0781 Fax: (402) 593-0921 Email: wroyalty@mesalabs.com
July 11, 2011
Trade name: Smart Read EZTest - Steam Biological Indicator Common name: Self-contained Biological Indicator for Steam
10 Evergreen Drive Bozeman, MT 59715 FDA facility registration #: 3026231
Indicator, Biological Sterilization Process (21 CFR 880.2800(a))
Class II
ProTest Steam (K041386 & K082756), Smart-Read EZTest Steam (K093794)
1
DESCRIPTION
The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 incculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. Smart Read EZTest - Steam is intended for use in monitoring the efficacy of steam sterilization processes with minimum exposure times of 20 minutes at 121 ℃ gravity displacement, 10 minutes at 132°C gravity displacement and 3 minutes at 132°C flash gravity displacement cycles.
INDICATIONS FOR USE
Mesa Smart Read EZTest - Steam is a self-contained Biological Indicator intended for monitoring the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles:
| Cycle Type | Cycle Temp | Cycle Exposure Time |
|---|---|---|
| Gravity | 121°C | 30 Minutes |
| Gravity | 132°C | 10 Minutes |
| Flash Gravity* | 132°C | 3 Minutes |
| Pre-Vac | 132°C | 4 Minutes |
| Pre-Vac | 135°C | 3 Minutes |
"Unwrapped nonporous devices only
Mesa Smart Read EZTest has a validated reduced incubation time of 10 hours.
OPERATIONAL PRINCIPALS
The Smart Read EZTest - Steam Biological Indicator is placed with a load in the sterilization chamber and subjected to a normal steam sterilization cycle. The unit is then removed and activated by crushing the glass media ampoule inside. The processed unit and an unprocessed (control) unit are incubated at 60 +/- 2°C for 10 hours.
During incubation, the available food supply (Tryptic Soy Broth) and temperature promote growth of any viable spores. As viable spores germinate and consume the provided nutrients waste products are released, increasing the acidity of the media which lowers the pH and causes a color change from purple to yellow.
Evidence of growth by color change and/or turbidity within 10 hours should be interpreted as a failure to meet the conditions necessary for sterilization, provided signs of growth are present in the control unit.
2
STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE
The subject device Smart Read EZTest - Steam is identical in composition and function to the legally marketed predicate device ProTest - Steam (K041386 & K082786) and Smart Read EZTezt Steam (K093794). This submission is to expand the label claims for the device #K093794 to include 121°C gravity and 132°C gravity/flash gravity cycles.
| ELEMENT | SMART READ EZTEST -
STEAM
(Subject Device) | PROTEST - STEAM
(K041386 and K082756)
(Predicate Device) | SMART READ EZTEST -
STEAM
(K-093794)
(Predicate Device) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Intended Use:
☐ Method of
sterilization | Steam | Steam | Steam |
| ☐ Process
Parameters | 121°C gravity - 30 minutes
132°C gravity - 10 minutes
132°C flash gravity - 3 minutes*
132°C prevacuum - 4 minutes
134°C prevacuum - 3 minutes | 121°C gravity;
121°C - 135°C prevacuum
10 minute 132°C gravity and 3
minute 132°C flash gravity | 121°C - 135°C prevacuum |
| Organism:. Spore
Species & Strain | Geobacillus stearothermophilus
ATCC#7953 | Geobacillus stearothermophilus
ATCC#7953 | Geobacillus
stearothermophilus
ATCC#7953 |
| Viable spore
population | Minimum
standard population 1.0 x 105 | $1.0-4.0 x 10^{(x)}$
standard population 105 | Minimum
standard population 1.0 x 105 |
| Resistance
characteristics: | | | |
| ☐ D-value | 1.5-3.0 minutes @ 121°C
NLT 10 sec. @ 132°C
NLT 8 sec. @ 134°C
NLT 8 sec @ 135°C | 1.5-3.0 minutes @ 121°C
NLT 10 sec. @ 132°C
NLT 8 sec. @ 134°C
NLT 8 sec @ 135°C | 1.5-3.0 minutes @ 121°C
NLT 10 sec. @ 132°C
NLT 8 sec. @ 134°C
NLT 8 sec @ 135°C |
| ☐ Z-value | Not Less than 10°C | Not Less than 10°C | Not Less than 10°C |
| ☐ Survival/Kill
Window | Calculated per USP
Survive time:
@ 121°C NLT 5 min.
@ 132°C NLT 1 min.
@ 134°C NLT 40 sec.
@ 135°C NLT 40 sec. | Calculated per USP
Survive time:
@ 121°C NLT 5 min.
@ 132°C NLT 1 min.
@ 134°C NLT 40 sec.
@ 135°C NLT 40 sec. | Calculated per USP
Survive time:
@ 121°C NLT 5 min.
@ 132°C NLT 1 min.
@ 134°C NLT 40 sec.
@ 135°C NLT 40 sec. |
| Culture Conditions | 60°C +/-2°C for 10 hours | 55-60°C for 24 hours | 60°C +/-2°C for 10 hours |
| Storage Conditions | Room temperature | 15-27°C, 30-70% RH | Room temperature |
| Shelf-life | 24 months | 18 months | 24 months |
*Unwrapped nonporous devices only
DESCRIPTION OF TESTING (NON-CLINICAL DATA)
Testing was performed in accordance with AAMI/ISO 11138-1:2006 and AAMI/ISO 11138-3:2006 to validate the labeled claims and performance characteristics of Smart Read EZTest - Steam.
Three separate lots of product manufactured from three different primary spore crops were tested for resistance, spore population, and effectiveness in gravity cycles. For all lots tested, the above parameters and overall effectiveness in monitoring routine steam sterilization cycles has been demonstrated.
STATEMENT OF SAFETY AND EFFECTIVENESS
Based on the similar claims, design and results from the above mentioned testing, the Smart Read EZTest - Steam Biological Indicator has been demonstrated to be substantially equivalent to and therefore, as safe and effect as, the legally marketed devices ProTest-Steam (K041386 and K082756) and Smart Read EZTest - Steam (K093794).
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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 3 0 2012
Mesa Laboratories Incorporated C/O Ms. Wendy Royalty Senior Director, BI Ops, Quality Assurance & Regulatory Affairs Bozeman Manufacturing Facility (SGM Biotech) 10 Evergreen Drive Bozeman, Montana 59715
Re: K112018
Trade/Device Name: Mesa Smart Read EZTest - Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 25, 2011 Received: January 26, 2011
Dear Ms. Royalty:
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.
4
Page 2 - Ms. Royalty
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.
G. for Andrew, D. Wilson.
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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K112018
Indications for Use Statement
510(k) Number
Device Name
Mesa Smart Read EZTest - Steam
Indications for Use
Mesa Smart Read EZTest - Steam is a self-contained Biological Indicator intended for monitoring the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles:
| Cycle Type | Cycle Temp | Cycle Exposure Time |
|---|---|---|
| Gravity | 121°C | 30 Minutes |
| Gravity | 132°C | 10 Minutes |
| Flash Gravity | 132°C | 3 Minutes* |
| Pre-Vac | 132°C | 4 Minutes |
| Pre-Vac | 135°C | 3 Minutes |
*Unwrapped nonporous devices only
Mesa Smart Read EZTest has a validated reduced incubation time of 10 hours.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
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)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112018
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