(73 days)
Not Found
No
The device is a chemical indicator that changes color based on physical parameters (temperature and time) and does not involve any computational analysis or learning.
No
This device is a chemical indicator used to verify sterilization cycles, not to treat, diagnose, or cure a disease or condition in a patient.
No
This device is a chemical indicator used to verify that specific sterilization cycle parameters have been met, not to diagnose a medical condition in a patient.
No
The device is a physical chemical indicator printed on polypropylene, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of a steam sterilization cycle for medical devices. It indicates whether the critical parameters of the sterilization process have been met.
- Device Description: It's a chemical indicator that changes color based on exposure to specific temperature and time conditions during sterilization.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not interact with human specimens or provide diagnostic information about a patient's health.
- Function: Its function is to verify the physical conditions of a sterilization process, not to diagnose or monitor a patient's condition.
Therefore, the Celerity 10 STEAM Chemical Indicator is a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Celerity 10 STEAM Chemical Indicator is intended for use in dynamic air removal steam sterilization cycles operating at 270°F/132°C for 10 minutes. The Celerity 10 STEAM Chemical Indicator that changes colors from yellow to blue/purple when exposed to these cycle conditions.
Product codes
JOJ
Device Description
The Celerity 10 STEAM Chemical Indicators are Type 6 emulating indicators. Type 6 indicators are cycle verification indicators which are designed to react to all critical variables for specific sterilization cycles.
They are designed to be placed in the center of each pack (e.g. tray, protective case, approved rigid sterilization container) to be sterilized and change color from yellow to blue/purple when the critical sterilization parameters have been met (270°F /132°C for 10 minutes).
They shall be printed onto white polypropylene with a polypropylene laminate and dimensions of 140 x 22 mm.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to verify that the proposed indicator meets the requirements for Type 6 emulating indicators as defined in ANSI/AAMI ISO 11140-1:2014 and additional FDA requirements using a resistometer conforming to ANSI/AAMI ISO 18472. Additional testing was completed to simulate typical in-use applications and to verify shelf life and the endpoint color stability.
Key Results:
- ISO 11140-1 Testing: Met requirements defined in ANSI/AAMI/ISO 11140-1:2014 along with additional FDA requirements for Type 6 emulating indicators. (PASS)
- Simulated Use Testing: Demonstrated color change when exposed to a full cycle and no/incomplete color change when exposed to an abbreviated cycle. (PASS)
- Shelf Life for 36 months: Met performance specifications at each time point after storage in different environments. (PASS)
- Endpoint Color Stability for 12 months: Met performance specifications at each time point after storage in typical conditions. (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
§ 880.2800 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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized caduceus. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 10, 2018
STERIS Corporation Eileen McCafferty Senior Regulatory Affairs Specialist 5960 Heisley Rd. Mentor, Ohio 44060
Re: K182724
Trade/Device Name: Celerity™ 10 STEAM Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 27, 2018 Received: September 28, 2018
Dear Eileen McCafferty:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182724
Device Name Celerity™ 10 STEAM Chemical Indicator
Indications for Use (Describe)
The Celerity 10 STEAM Chemical Indicator is intended for use in dynamic air removal steam sterilization cycles operating at 270°F/132°C for 10 minutes. The Celerity 10 STEAM Chemical Indicator that changes colors from yellow to blue/purple when exposed to these cycle conditions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
STE
510(k) Summary For K182724 Celerity™ 10 STEAM Chemical Indicator
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Eileen McCafferty Senior Regulatory Affairs Specialist Telephone: (440) 392-7189 Fax No: (440) 357-9198 Email: eileen.mccafferty@STERIS.com
Submission Date: September 27, 2018
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Celerity™ 10 | STEAM Chemical Indicator |
|---|---|---|
| Models: | PCC058 | |
| Common Name: | Chemical Indicator. | |
| Classification Name: | Physical/chemical sterilization process indicator | |
| Classification | 21 CFR 880.2800(b) | |
| Product Code | JOJ |
2. Predicate Device
STERIS VERIFY 270F 4 Indicator (K070461)
3. Device Description
The Celerity 10 |STEAM Chemical Indicators are Type 6 emulating indicators. Type 6 indicators are cycle verification indicators which are designed to react to all critical variables for specific sterilization cycles.
They are designed to be placed in the center of each pack (e.g. tray, protective case, approved rigid sterilization container) to be sterilized and change color from yellow to blue/purple when the critical sterilization parameters have been met (270°F /132°C for 10 minutes).
They shall be printed onto white polypropylene with a polypropylene laminate and dimensions of 140 x 22 mm.
4. Indications for Use:
The Celerity 10 STEAM Chemical Indicator is intended for use in dynamic air removal steam sterilization cycles operating at 270°F/132°C for 10 minutes. The Celerity 10 STEAM Chemical Indicator is a Type 6 indicator that changes colors from yellow to blue/purple when exposed to these cycle conditions.
5. Technological Characteristic Comparison Table
A comparison of technical characteristics is summarized in Table 5-1.
5
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 10 STEAM CHEMICAL INDICATOR
| Feature | Proposed
Celerity 10 STEAM
Chemical Indicator | Predicate K070461
STERIS VERIFY 270F 4
Indicator | Comparison |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Celerity 10 STEAM
Chemical Indicator is intended
for use in dynamic air removal
steam sterilization cycles
operating at 270°F/132°C for
10 minutes. The Celerity 10
STEAM Chemical Indicator is
a Type 6 indicator that changes
colors from yellow to
blue/purple when exposed to
these cycle conditions. | The VERIFY® Steam
Indicators are chemical
indicators intended for use by
health care providers to
accompany products being
sterilized through a
sterilization procedure. The
indicators change color from
yellow to blue/purple whentemperature of the designated
steam sterilization cycle. The
performance of the VERIFY®
Steam Indicators exceeds that
of biological indicator kill and
meets the requirements of
ANSI/AAMI / ISO 11140-
1:2005 for Class 6 steam
indicators. | Both devices have
the same color
changes when
exposed to the
proper steam
sterilization cycle,
however the
proposed device
has a new
indication for use
in a dynamic air
removal steam
sterilization cycle
at 270°F/132°C
for 10 minutes.
Wording has been
updated for the
proposed device
from Class 6 to
Type 6 to match
the
ANSI/AAMI/ISO
11140-1:2014
revision. |
| Device design
-components | Printed indicator ink onto white
polypropylene with a
polypropylene laminate and
dimensions of 140 x 22 mm. | Printed indicator ink onto
white polypropylene with a
polypropylene laminate and
dimensions of 143 x 22 mm. | Identical except
for a minor
dimension
difference of 3
mm in length. |
| Indicator agent | Proprietary pH sensitive
indicator ink | Proprietary pH sensitive
indicator ink | Identical |
| Sterilization
method and
cycles | Dynamic air removal STEAM
sterilization | Dynamic air removal STEAM
sterilization | Identical |
| Mechanism of
action | Chemical pH dependent | Chemical pH dependent | Identical |
| Endpoint
Specifications
(Stated Value) | 270°F (132°C) / 10 minutes | 270°F / 4 minutes | The proposed
device is designed
for a 10 minute
cycle rather than 4
minutes. |
| Feature | Proposed
Celerity 10 STEAM
Chemical Indicator | Predicate K070461
STERIS VERIFY 270F 4
Indicator | Comparison |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 3 years | 3 years | Identical |
Table 5-1. Device comparison table.
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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 10 STEAM CHEMICAL INDICATOR
Summary of Non-Clinical Performance Testing 6.
Performance testing was conducted to verify that the proposed indicator meets the requirements for Type 6 emulating indicators as defined in ANSI/AAMI ISO 11140-1:2014 and additional FDA requirements using a resistometer conforming to ANSI/AAMI ISO 18472. Additional testing was completed to simulate typical in-use applications and to verify shelf life and the endpoint color stability. Table 5-2 summarizes this non-clinical testing.
| Testing | Acceptance Criteria | Conclusion |
|---|---|---|
| ISO 11140-1 | ||
| Testing | Meet requirements defined in | |
| ANSI/AAMI/ISO 11140-1:2014 along with | ||
| additional FDA requirements for Type 6 | ||
| emulating indicators | PASS | |
| Simulated Use | ||
| Testing | Demonstrate color change when exposed to a | |
| full cycle and no/incomplete color change | ||
| when exposed to an abbreviated cycle | PASS | |
| Shelf Life for | ||
| 36 months | Meet performance specifications at each time | |
| point after storage in different environments | PASS | |
| Endpoint Color | ||
| Stability for 12 | ||
| months | Meet performance specifications at each time | |
| point after storage in typical conditions | PASS |
| Table 5-2. Performance Testing Summary Table | ||
|---|---|---|
7. Conclusion
The Celerity 10 STEAM Chemical Indicator has met the established performance criteria. Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K070461), Class II (CFR 880.2800), product code JOJ.