CelerityTM 10 STEAM Chemical Indicator

K182724 · STERIS Corporation · JOJ · Dec 10, 2018 · General Hospital

Device Facts

• Record ID: K182724
• Device Name: CelerityTM 10 STEAM Chemical Indicator
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Dec 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

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.

Device Story

Celerity 10 STEAM Chemical Indicator is a Type 6 emulating indicator used to verify sterilization cycle parameters. Device consists of a chemical indicator ink printed on white polypropylene with a polypropylene laminate (140 x 22 mm). Placed inside packs, trays, or rigid containers, the indicator undergoes a visual color change from yellow to blue/purple when exposed to 270°F/132°C for 10 minutes. Used by healthcare providers to confirm that critical sterilization variables have been met for specific cycles. The device is disposable and has a 3-year shelf life.

Clinical Evidence

Bench testing only. Performance verified against ANSI/AAMI/ISO 11140-1:2014 and ISO 18472 standards using a resistometer. Testing included simulated use (full vs. abbreviated cycles), 36-month shelf-life stability, and 12-month endpoint color stability. All tests passed.

Technological Characteristics

Type 6 emulating chemical indicator. Materials: white polypropylene substrate with polypropylene laminate. Dimensions: 140 x 22 mm. Sensing principle: pH-dependent chemical color change (yellow to blue/purple). Sterilization method: dynamic air removal steam. Shelf life: 3 years. Complies with ANSI/AAMI/ISO 11140-1:2014 and ISO 18472.

Indications for Use

Indicated for use in dynamic air removal steam sterilization cycles at 270°F/132°C for 10 minutes to verify sterilization parameters.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• STERIS VERIFY 270F 4 Indicator (K070461)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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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# STE

## 510(k) Summary For K182724 Celerity™ 10 STEAM Chemical Indicator

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact:

Eileen McCafferty Senior Regulatory Affairs Specialist Telephone: [phone] Fax No: [phone] Email: [e-mail]

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.

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## STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 10 STEAM CHEMICAL INDICATOR

| Feature | Proposed<br>Celerity 10 STEAM<br>Chemical Indicator | Predicate K070461<br>STERIS VERIFY 270F 4<br>Indicator | Comparison |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Celerity 10 STEAM<br>Chemical Indicator is intended<br>for use in dynamic air removal<br>steam sterilization cycles<br>operating at 270°F/132°C for<br>10 minutes. The Celerity 10<br>STEAM Chemical Indicator is<br>a Type 6 indicator that changes<br>colors from yellow to<br>blue/purple when exposed to<br>these cycle conditions. | The VERIFY® Steam<br>Indicators are chemical<br>indicators intended for use by<br>health care providers to<br>accompany products being<br>sterilized through a<br>sterilization procedure. The<br>indicators change color from<br>yellow to blue/purple whentemperature of the designated<br>steam sterilization cycle. The<br>performance of the VERIFY®<br>Steam Indicators exceeds that<br>of biological indicator kill and<br>meets the requirements of<br>ANSI/AAMI / ISO 11140-<br>1:2005 for Class 6 steam<br>indicators. | Both devices have<br>the same color<br>changes when<br>exposed to the<br>proper steam<br>sterilization cycle,<br>however the<br>proposed device<br>has a new<br>indication for use<br>in a dynamic air<br>removal steam<br>sterilization cycle<br>at 270°F/132°C<br>for 10 minutes.<br>Wording has been<br>updated for the<br>proposed device<br>from Class 6 to<br>Type 6 to match<br>the<br>ANSI/AAMI/ISO<br>11140-1:2014<br>revision. |
| Device design<br>-components | Printed indicator ink onto white<br>polypropylene with a<br>polypropylene laminate and<br>dimensions of 140 x 22 mm. | Printed indicator ink onto<br>white polypropylene with a<br>polypropylene laminate and<br>dimensions of 143 x 22 mm. | Identical except<br>for a minor<br>dimension<br>difference of 3<br>mm in length. |
| Indicator agent | Proprietary pH sensitive<br>indicator ink | Proprietary pH sensitive<br>indicator ink | Identical |
| Sterilization<br>method and<br>cycles | Dynamic air removal STEAM<br>sterilization | Dynamic air removal STEAM<br>sterilization | Identical |
| Mechanism of<br>action | Chemical pH dependent | Chemical pH dependent | Identical |
| Endpoint<br>Specifications<br>(Stated Value) | 270°F (132°C) / 10 minutes | 270°F / 4 minutes | The proposed<br>device is designed<br>for a 10 minute<br>cycle rather than 4<br>minutes. |
| Feature | Proposed<br>Celerity 10 STEAM<br>Chemical Indicator | Predicate K070461<br>STERIS VERIFY 270F 4<br>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<br>Testing | Meet requirements defined in<br>ANSI/AAMI/ISO 11140-1:2014 along with<br>additional FDA requirements for Type 6<br>emulating indicators | PASS |
| Simulated Use<br>Testing | Demonstrate color change when exposed to a<br>full cycle and no/incomplete color change<br>when exposed to an abbreviated cycle | PASS |
| Shelf Life for<br>36 months | Meet performance specifications at each time<br>point after storage in different environments | PASS |
| Endpoint Color<br>Stability for 12<br>months | Meet performance specifications at each time<br>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.