Who is the manufacturer of Celerity HP Chemical Indicator (CI)?

Steris Corporations filed the 510(k) submission for Celerity HP Chemical Indicator (CI) (K183295).

What is the FDA product code for Celerity HP Chemical Indicator (CI)?

JOJ. It is classified under 21 CFR 880.2800 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Celerity HP Chemical Indicator (CI)?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for Celerity HP Chemical Indicator (CI)?

VERIFY V-PRO Chemical Indicator (K172746).

Who can help prepare an FDA 510(k) submission like Celerity HP Chemical Indicator (CI)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Celerity HP Chemical Indicator (CI)

K183295 · Steris Corporations · JOJ · Jan 4, 2019 · General Hospital

Device Facts

Record ID	K183295
Device Name	Celerity HP Chemical Indicator (CI)
Applicant	Steris Corporations
Product Code	JOJ · General Hospital
Decision Date	Jan 4, 2019
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.2800
Device Class	Class 2

Intended Use

The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the: . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP® STERRAD® System, including those systems with ALLClear Technology. A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the: . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

Device Story

Celerity HP Chemical Indicator is a Type 1 process indicator for vaporized hydrogen peroxide sterilization. It consists of a substrate (polypropylene or spun-bonded polyolefin) and a proprietary indicator ink. The device is placed inside packs or affixed to SCBI vials before sterilization. Upon exposure to specific sterilization cycles (V-PRO or ASP STERRAD systems), the ink undergoes a visible color change from red to orange/yellow. This provides a qualitative visual confirmation to healthcare personnel that the unit has been subjected to the sterilization process. It does not provide information on the efficacy of the sterilization cycle, only that exposure occurred. The device is intended for use in clinical settings where these sterilization systems are employed.

Clinical Evidence

No clinical data. Performance was established through bench testing, including Type 1 performance testing, simulated use, fluorescent light stability, temperature extremes (freeze/thaw), transference, adhesion stability, shelf life, and post-processing stability. All tests passed predefined acceptance criteria.

Technological Characteristics

Type 1 chemical indicator; single-use. Materials: polypropylene (Construction C) or spun-bonded polyolefin with adhesive/glassine backing (Construction B). Proprietary indicator ink (INK-PF2-RY). Mechanism: color change from red to orange/yellow upon VH2O2 exposure. Conforms to ANSI/AAMI/ISO 11140-1:2014. Standalone device; no software or electronics.

Indications for Use

Indicated for use as a Type 1 vaporized hydrogen peroxide sterilization process indicator to distinguish between processed and unprocessed units or SCBI vials in V-PRO or ASP STERRAD sterilization systems.

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

VERIFY V-PRO Chemical Indicator (K172746)

Related Devices

K233187 — Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) · Steris · Oct 27, 2023
K192020 — Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label · STERIS Corporation · Sep 5, 2019
K213262 — CELERITY HP Chemical Indicator · STERIS Corporation · Jan 7, 2022
K072510 — VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 · STERIS Corporation · Dec 11, 2007
K091174 — VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL · STERIS Corporation · Oct 27, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) Summary For CELERITY HP Chemical Indicator (CI) ## K183295 ## Sponsor Facility STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459 ## Manufacturing Facility Albert Browne Ltd., a subsidiary of STERIS Corporation Rayns Way Watermead Business Park Syston Leicester LE7 1PF UNITED KINGDOM Contact: Gregory Land Senior Regulatory Affairs Specialist Telephone: (440) 392-7424 Fax No: (440) 357-9198 Greg_land@steris.com December 21, 2018 Submission Date: STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {1}------------------------------------------------ ### 1. Predicate Device | Trade Name: | VERIFY V-PRO Chemical Indicator | |--------------------------|---------------------------------------------------| | Common/Usual Name: | Chemical Indicator | | Classification: | Class II | | Classification Name: | Physical/chemical sterilization process indicator | | 510(k) Submitter/Holder: | STERIS Corporation | | 510(k) Number: | K172746 | ### 2. Device Description The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the: - . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or - Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology. A version of the Celerity™ HP Chemical Indicator may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the: - Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle . of a V-PRO® Low Temperature Sterilization System, or - Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology ### 2.1 Physical Description - Design, Construction, Components The CI is composed of the following components: - Substrate ● - Indicator Ink The PI is composed of the following components - Substrate - Indicator Ink - Adhesive ● - Backing Paper {2}------------------------------------------------ The Substrate material for the CI is polypropylene (Construction C). The substrate for the PI (Construction B) is spun-bonded polyolefin with and adhesive back and a glassine backing paper. The glassine backing paper serves as a carrier for the label and is removed prior to use of the PI. The Indicator Ink is the same for both substrates of the CI (Construction C) and the PI (Construction B). The composition of the indicator ink is not known as it is a proprietary formulation, product code INK-PF2-RY, sold by Crosstex International, Inc. of Rush, NY. ### 3. Indications for Use: The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the: - . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or - Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP® STERRAD® System, including those systems with ALLClear Technology. A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the: - . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or - Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology. ### 4. Technological Characteristics The proposed and predicate devices are Type 1 single use process indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The ink, mechanism of action, and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to yellow. {3}------------------------------------------------ Table 1 contains a comparison of technological characteristics and specifications of the proposed Celerity™ HP Chemical Indicator Constructions B and C to the predicate Verify® V-PRO Chemical Indicator – Version 1C and 2C. | Feature | K183295 Proposed CelerityTM HP Chemical Indicator (CI) | K172746 VERIFY® V-PRO Chemical Indicator Versions 1C and 2C | Comparison | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The CelerityTM HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the: Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP® STERRAD® System, including those systems with ALLClear Technology. A version of the CelerityTM HP Chemical Indicator may be utilized on the V24 Self- Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the: Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast | The VERIFY® HPU Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to be sterilized to indicate, through visible change from magenta to yellow, when the device has been exposed to the Lumen, Non-Lumen, Flexible or Fast Non Lumen sterilization cycle of a V- PRO® Low Temperature Sterilization System. The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non Lumen, Flexible or Fast Non Lumen sterilization cycle of a V- PRO® Low Temperature Sterilization System. | The Intended Use has been modified in the proposed device in order to include the Fast Cycle of the V- Pro s 2 Device. Additional use in the Standard, Express, Flex Scope or Duo cycles of an ASP® STERRAD® System, including those systems with ALLClear Technology. Have been added. | | | K183295 | K172746 | Comparison | | Feature | Proposed Celerity™ HP Chemical Indicator (CI) | VERIFY® V-PRO Chemical Indicator Versions 1C and 2C | | | | sterilization cycle of a V- PRO® Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology. | | | | Device design - components | Indicator Ink printed onto spun-bonded polyolefin with an adhesive and a glassine backing (Construction B) and polypropylene (Construction C) | Indicator Ink printed onto spun-bonded polyolefin (Version 1C) and spun bonded polyolefin with an adhesive and a glassine backing (Version 2C) | The proposed device contains the same components as the predicate device for Construction B vs Version 2C. Construction C differs from Version 1C in the material for the substrate. The predicate is spun-bonded polyolefin and the proposed device is polypropylene. | | Indicator agent | Non-transferable indicator ink of proprietary formulation which changes color when exposed to VH2O2 | Non-transferable indicator ink of proprietary formulation which changes color when exposed to VH2O2 | Same | | Sterilization method and cycles | Vaporized Hydrogen Peroxide in the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, V-PRO maX 2, V-PRO s 2 Low Temperature Sterilizers and ASP STERRAD 110S, NX and 100NX System, including those systems with ALLClear Technology. | Vaporized Hydrogen Peroxide in the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60 and V-PRO max 2 Low Temperature Sterilizers | The sterilization cycles for the V- PRO s 2 and ASP STERRAD 110S, NX and 100NX Systems, including those systems with ALLClear Technology, are being added for the proposed device. | | Endpoint specifications | No Endpoint Specifications (Type 1 Process Indicator) | No Endpoint Specifications (Type 1 Process Indicator) | Same | | Feature | K183295 Proposed CelerityTM HP Chemical Indicator (CI) | K172746 VERIFY® V-PRO Chemical Indicator Versions 1C and 2C | Comparison | | Side by side testing with biological indicators? | No | No | Same | | Specification | Conforms to ANSI/AAMI/ISO 11140- 1:2014 requirements for a Type 1 Hydrogen Peroxide Chemical Indicator | Conforms to ANSI/AAMI/ISO 11140- 1:2005 requirements for a Class 1 Hydrogen Peroxide Chemical Indicator | Proposed device conforms to the most recent version of the standard. | Table 1. Device Comparison Table {4}------------------------------------------------ # STERIS Abbreviated 510(k) PREMARKET NOTIFICATION CELERITY HP Chemical Indicator (CI) {5}------------------------------------------------ ## STERIS Abbreviated 510(k) PREMARKET NOTIFICATION CELERITY HP Chemical Indicator (CI) ## Summarv The predicate and proposed devices are identical with regards to all features except for the indications for use and materials. The differences between the proposed Celerity™ HP Chemical Indicator and the predicate device are limited to a change in the indicator ink, material in construction C and the proposed claims to include the V-PRO s 2 Low Temperature Sterilization System and associated Lumen, Non Lumen, Flexible and Fast Cycles, and the ASP® STERRAD® 110S, NX and 100NX Systems and associated Standard, Advanced, Express, Flex Scope and Duo cycles with ALLClear technology. The differences between the proposed VERIFY V24 Self-Contained Biological Indicator Vial Label and the predicate device are limited to a change in the indicator ink and the proposed claims to include the V-PRO s 2 Low Temperature Sterilization System and associated Lumen, Non Lumen, Flexible and Fast Cycles, and the ASP® STERRAD® 110S, NX and 100NX Systems and associated Standard, Advanced, Express, Flex Scope and Duo cycles with ALLClear technology. ### ട. Performance Testing Performance testing was conducted to verify that the proposed VERIFY® V-PRO Chemical Indicator meets the requirements for Type 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2014. Additional testing was completed to simulate typical in-use applications. Table 2 summarizes the verification activities that were performed, with their respective Report Name, location in the submission and result to demonstrate that the proposed Celerity™ HP Chemical Indicator is safe and effective. These studies confirm that the proposed device's performance meets the requirements of its predefined acceptance criteria and intended uses, and qualify the proposed device for use in the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, V-PRO maX 2 and V-PRO s 2 Low Temperature Sterilization Systems and ASP STERRAD 110S, NX and 100NX Systems, including those systems with ALLClear Technology. {6}------------------------------------------------ | Testing | Report | Study Result | |-----------------------------------------------------------|-------------|-----------------| | Type 1 Performance Testing | RDP186-VER1 | Pass | | Simulated Use Testing | RDP186-VAL1 | Pass | | Fluorescent Light Stability Testing | RDP186-VER2 | Pass | | Temperature Extremes Exposure (Freeze/Thaw) Testing | RDP186-VER4 | Pass | | Transference Testing | RDP186-VER3 | Pass | | Adhesion Stability (Vials) Testing | RDP186-SSL3 | Pass | | Shelf Life Testing | E120-SSL1 | Pass | | Post-Processing Stability Testing | RDP186-SSL1 | Pass | Table 2. Verification Results Summary The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended. ### 6. Conclusion Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and perform at least as safely and effectively as the legally marketed predicate device (K172746, Class II (21 CFR 880.2800), product code JOJ. {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K183295 Device Name Celerity HP Chemical Indicator (CI) ### Indications for Use (Describe) The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterlized, through a visible change from red to orange/yellow, when the device has been exposed to the: · Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or · Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology. A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the: · Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or • Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. January 4, 2019 Steris Corporations Gregory Land Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060 Re: K183295 Trade/Device Name: Celerity HP Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 26, 2018 Received: November 27, 2018 Dear Gregory Land: 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 {9}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 mediation-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, ## Elizabeth F. Claverie -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

Celerity HP Chemical Indicator (CI)

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

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Related Devices

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Celerity HP Chemical Indicator (CI)

Device Facts

Intended Use

Device Story

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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