Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a chemical indicator that changes color based on exposure to sterilization processes, which is a purely chemical reaction and does not involve AI/ML.

Therapeutic

No.
This device is a chemical indicator used to verify the sterilization process, not to treat or directly affect a patient's health condition.

Diagnostic

No

This device is a chemical indicator designed to distinguish between processed and unprocessed units in sterilization cycles by changing color. It does not diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is composed of physical components: Substrate and Indicator Ink (and Adhesive and Backing Paper for the PI version). This indicates it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, 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 sterilization process indicator." Its purpose is to indicate whether a sterilization process has occurred by changing color. It is used within packs or affixed to biological indicator vials that are being sterilized.
Mechanism: The device works through a visible color change in response to exposure to vaporized hydrogen peroxide during a sterilization cycle. This is a chemical reaction, not a diagnostic test performed on a biological sample.
Lack of Biological Sample Analysis: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions. This device does not interact with or analyze any biological samples.
Regulatory Standard: The performance testing references ANSI/AAMI/ISO 11140-1:2014, which is a standard for sterilization indicators, not IVD devices.

In summary, the Celerity™ HP Chemical Indicator is a sterilization process indicator, not a device used for in vitro diagnostic testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JOJ

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

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 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.

Testing:
Type 1 Performance Testing - Result: Pass
Simulated Use Testing - Result: Pass
Fluorescent Light Stability Testing - Result: Pass
Temperature Extremes Exposure (Freeze/Thaw) Testing - Result: Pass
Transference Testing - Result: Pass
Adhesion Stability (Vials) Testing - Result: Pass
Shelf Life Testing - Result: Pass
Post-Processing Stability Testing - Result: Pass

The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.

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.

K172746

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

Regulation Number and Section

§ 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).

Summary

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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8

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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