STERILUCENT PROCESS CHALLENGE DEVICE

K141312 · Sterilucent, Inc. · FRC · Oct 31, 2014 · General Hospital

Device Facts

• Record ID: K141312
• Device Name: STERILUCENT PROCESS CHALLENGE DEVICE
• Applicant: Sterilucent, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Oct 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation, after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle. The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 Sterilizer during initial installation, after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-NL may also be used for routine monitoring of the PSD-85 Sterlizer Non-Lumen Cycle.

Device Story

Pre-assembled process challenge devices (PCD-L and PCD-NL) used for monitoring vaporized hydrogen peroxide sterilization; contain self-contained biological indicator (SCBI) with Geobacillus stearothermophilus spores and Class 1 chemical indicator (CI). User places PCD in sterilizer with load; post-cycle, CI checked for color change (pink to blue). If pass, SCBI activated by breaking internal glass ampoule containing growth media; incubated at 60°C for 18 hours. Yellow color indicates bacterial growth (fail); no color change indicates sterilization (pass). Used by healthcare providers for installation qualification, post-repair verification, and routine cycle monitoring. Provides assurance of sterilization efficacy for PSD-85 sterilizer cycles.

Clinical Evidence

Bench testing only. Evaluated resistance to Sterilucent PSD-85 Lumen and Non-Lumen cycles using fraction-negative data from biological indicators across three manufacturing lots. PCDs demonstrated resistance at least equal to the biological model used for sterilizer validation. Chemical indicator response was confirmed adequate.

Technological Characteristics

Consists of SCBI with >=10^6 Geobacillus stearothermophilus spores, Class 1 CI (ANSI/AAMI/ISO 11140-1), and diffusion-restricting challenge tube in a vial. Modality: Vaporized hydrogen peroxide. Designed for PSD-85 sterilizer. No electronic components or software.

Indications for Use

Indicated for performance qualification and routine monitoring of the Sterilucent PSD-85 sterilizer (Lumen and Non-Lumen cycles) in healthcare settings.

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 Biological Indicator Challenge Pack for Vaporized H2O2 Sterilization Processes (K092906)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2014

Sterilucent, Inc. Mr. Peter Kalkbrenner Director of Engineering 1400 Marshall Street NE Minneapolis, MN 55413

Re: K141312

Trade/Device Name: Sterilucent Process Challenge Device PCD-L for Lumen Cycle Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: September 25, 2014 Received: October 3, 2014

Dear Mr. Kalkbrenner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Kalkbrenner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K141312

Device Name Sterilucent Process Challenge Device PCD-L for Lumen Cycle Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle

Indications for Use (Describe)

The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation, after relocation, major repairs or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle.

The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 Sterilizer during initial installation, after relocation, major repairs or after sterilization process failures. The Sterilucent PCD-NL may also be used for routine monitoring of the PSD-85 Sterlizer Non-Lumen Cycle.

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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Image /page/3/Picture/0 description: The image shows the logo for Sterilucent. The logo consists of a blue icon resembling interconnected circles, followed by the word "sterilucent" in blue, block letters. Below the company name is the text "scientific sterilization solutions" in a smaller font, also in blue.

# 510(k) Summary for the Sterilucent Process Challenge Device K141312

Owner: Address:

Telephone: Fax:

Sterilucent, Inc. 1400 Marshall Street NE Minneapolis, MN 55413 612-767-3260 612-767-3261

Contact:

Peter R. Kalkbrenner Director of Engineering

Telephone: Fax:

612-767-3253 612-767-3261

Summary Date:

25 September, 2014

sterilucent 1400 Marshall Street NE Minneapolis, MN 55432 [phone] | fx [phone] | www.sterilucent.com

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#### 1. Device Name and Classification

| Trade Name: | Sterilucent Process Challenge Device PCD-L for Lumen Cycle<br>Sterilucent Process Challenge Device PCD-NL for Non-Lumen<br>Cycle | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|--|
| | Common/Usual Name: Biological Indicator (BI) Process Challenge Device | |
| Classification Name: | Sterilization Process Indicator | |
| Device Class: | Class II | |
| Product Code: | FRC (21 CFR 880,2800) | |

#### 2. Predicate Device

Steris Verify Biological Indicator Challenge Pack for Vaporized H2O2 Sterilization Processes (K092906)

#### 3. Device Description

The Sterilucent PCD-L and PCD-NL are pre-assembled devices that consist of a Sterilucent Self-Contained Biological Indicator (SCBI), a vial, a vial cap containing a challenge tube, and a Chemical Indicator (CI) Label. The design of the PCD is such that it creates a challenge at least as challenging as the most difficult to sterilize item routinely processed in the PSD-85 sterilizer.

The PCDs are used by healthcare providers for qualification testing of the Sterilucent PSD-85 sterilizer and for routine monitoring of the PSD-85 sterilizer Lumen and Non-Lumen Cycles.

The user places the Sterilucent PCD into the Sterilucent PSD-85 along with a load and initiates a sterilization cycle. After cycle completion, the PCD is retrieved. The Cl is immediately accessed for a passing color change from pink to blue. If the CI is blue, the SCBI is removed from the PCD vial and activated by breaking the glass ampoule which contains a growth media. The SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates adequate sterilization (a passing result).

#### 4. Statement of Intended Use

The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation,

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after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle.

The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 Sterilizer during initial installation. after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-NL may also be used for routine monitoring of the PSD-85 Sterilizer Non-Lumen Cycle.

### 5. Technological Characteristics Summary Comparison

The Sterilucent PCD technological characteristics are substantially equivalent to the predicate device as summarized in the table below. Each include an SCBI containing at least 10° spores of Geobacillus sterathermophilus (the most resistant organism for vaporized hydrogen peroxide sterilization). an ANSI/AAMI/ISO 11140-1 Class 1 Chemical Indicator appropriate for vaporized hydrogen peroxide sterilization, and device specific packaging which increases the resistance of the packaged BI to represent a challenge greater than or equal to the worst-case biological model used to validate the respective sterilizer in which the challenge device is to be used.

| Technological<br>Characteristic | Proposed Device<br>Sterilucent Process Challenge Device | Predicate Device |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization<br>Modality | Vaporized hydrogen peroxide | Same |
| Biological<br>Indicator Organism | SCBI containing at least 106 spores of<br>Geobacillus sterathermophilus | Same |
| Process Indicator | Class 1 Chemical Indicator per<br>ANSI/AAMI/ISO 11140-1 | Same |
| Packaging<br>(Mechanism to<br>Increase the<br>Resistance of the<br>BI) | The SCBI is packaged in a vial. The vial is<br>plugged on one end, while the other end<br>contains a hole through which a diffusion-<br>restricting challenge tube is inserted. | The SCBI is packaged with a sheet of foam<br>and placed within a Tyvek pouch. |
| Resistance<br>Characteristics | The Sterilucent Process Challenge Device is<br>more resistant to the Sterilucent PSD-85<br>sterilization processes (Lumen and Non-<br>Lumen Cycles) than is the biological model<br>developed for validation of those sterilization<br>cycles. | The Verify Biological Indicator<br>Challenge Pack for Vaporized Sterilization<br>Processes is more resistant to the V-PRO 1<br>and V-PRO 1 Plus (Lumen and Non-Lumen<br>Cycles) sterilization processes than is the<br>biological model developed for validation of<br>those sterilization cycles. |

## 6. Summary of Non-Clinical Performance Data

The Sterilucent Process Challenge Device, PCD-L and PCD-NL, have been evaluated for resistance to the Sterilucent PSD-85 Lumen and Non-Lumen cycles respectively. These PCDs are at least as resistant to the sterilization process as the biological model

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used to validate the PSD-85 sterilizer. This determination is based on fraction-negative data from the PCDs biological indicator as a function of sterilant dose. PCDs from three separate manufacturing lots were exposed to PSD-85 Lumen and Non-Lumen half-cycles with decreasing doses of sterilant. The response of the PCDs chemical indicators during these exposures was also determined adequate.

#### 7. Overall Performance Conclusion Statement

The Sterilucent Process Challenge Devices have the necessary resistance relative to the biological model to be an appropriate challenge to qualify the PSD-85 Lumen and Non-Lumen Cycles. The Sterilucent PCDs are substantially equivalent to the predicate device.