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.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sterilucent Process Challenge Device (PCD-L and PCD-NL), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Implied)	Reported Device Performance
Resistance to Sterilization Process	The PCDs must be "more resistant to the Sterilucent PSD-85 sterilization processes (Lumen and Non-Lumen Cycles) than is the biological model developed for validation of those sterilization cycles."	"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 used to validate the PSD-85 sterilizer."
PCD-L Suitability for Lumen Cycle	Suitable for performance qualification and routine monitoring of the Sterilucent PSD-85 sterilizer Lumen Cycle.	"The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification... and for routine monitoring of the PSD-85 Sterilizer Lumen Cycle."
PCD-NL Suitability for Non-Lumen Cycle	Suitable for performance qualification and routine monitoring of the Sterilucent PSD-85 sterilizer Non-Lumen Cycle.	"The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification... and for routine monitoring of the PSD-85 Sterilizer Non-Lumen Cycle."
Chemical Indicator Response (CI)	Chemical Indicator should demonstrate an "adequate" response (e.g., color change from pink to blue) during half-cycles with decreasing sterilant doses.	"The response of the PCDs chemical indicators during these exposures was also determined adequate."
Biological Indicator Organism	SCBI containing at least 10^6 spores of Geobacillus stearothermophilus.	"SCBI containing at least 10^6 spores of Geobacillus sterathermophilus" is a characteristic of the proposed device.
Chemical Indicator Class	Class 1 Chemical Indicator per ANSI/AAMI/ISO 11140-1.	"Class 1 Chemical Indicator per ANSI/AAMI/ISO 11140-1" is a characteristic of the proposed device.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set Sample Size: "PCDs from three separate manufacturing lots" were used for testing. The exact number of PCDs per lot is not specified.
Data Provenance: The data is retrospective, generated from testing conducted by Sterilucent, Inc. The country of origin is not explicitly stated but can be inferred to be USA, where Sterilucent, Inc. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" in the traditional sense. The ground truth for sterilization effectiveness is based on the biological indicator (absence or presence of bacterial growth) and the response of the chemical indicator, which are inherent properties of the device and the sterilization process being tested. This is a technical evaluation rather than an expert consensus interpretation.

4. Adjudication Method for the Test Set

Not applicable. The evaluation relies on objective measurements (biological indicator growth, chemical indicator color change) rather than subjective expert interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret output (e.g., images), and the goal is to assess reader performance with and without AI assistance. This device is a process challenge device for sterilizers, not a diagnostic tool requiring human interpretation comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the study described is a standalone performance evaluation of the device itself. The device is designed to provide an objective indication of sterilization effectiveness without human-in-the-loop interpretation of complex data. The performance evaluation focuses on the device's inherent characteristics (resistance, indicator response) against established biological models and half-cycle exposures.

7. Type of Ground Truth Used

The ground truth used is based on:

Biological Indicator Results: The presence or absence of Geobacillus stearothermophilus growth after incubation of the Self-Contained Biological Indicator (SCBI). A lack of growth indicates effective sterilization (passing result), while growth indicates a failure.
Chemical Indicator Response: The color change of the Chemical Indicator (from pink to blue). This provides an immediate visual indication of sterilant exposure.
Fraction-Negative Data: This method involves exposing biological indicators to varying sub-lethal sterilization doses and observing the proportion of indicators that fail to show growth. This helps establish the resistance characteristics.
Biological Model for Sterilizer Validation: The PCD's resistance is compared against a pre-established biological model for the PSD-85 sterilizer, which represents the worst-case challenge.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning model. The device itself is not an AI algorithm. The performance evaluation is based on direct testing with three manufacturing lots, as mentioned in point 2.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of an AI model. The ground truth used for evaluating the device's performance (resistance, indicator response) is established through standardized microbiological and chemical indicator testing protocols.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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 (612) 767.3260 | fx (612) 767.3261 | www.sterilucent.com

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1. Device Name and Classification

Trade Name:	Sterilucent Process Challenge Device PCD-L for Lumen CycleSterilucent Process Challenge Device PCD-NL for Non-LumenCycle
	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 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.

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.

TechnologicalCharacteristic	Proposed DeviceSterilucent Process Challenge Device	Predicate Device
SterilizationModality	Vaporized hydrogen peroxide	Same
BiologicalIndicator Organism	SCBI containing at least 106 spores ofGeobacillus sterathermophilus	Same
Process Indicator	Class 1 Chemical Indicator perANSI/AAMI/ISO 11140-1	Same
Packaging(Mechanism toIncrease theResistance of theBI)	The SCBI is packaged in a vial. The vial isplugged on one end, while the other endcontains a hole through which a diffusion-restricting challenge tube is inserted.	The SCBI is packaged with a sheet of foamand placed within a Tyvek pouch.
ResistanceCharacteristics	The Sterilucent Process Challenge Device ismore resistant to the Sterilucent PSD-85sterilization processes (Lumen and Non-Lumen Cycles) than is the biological modeldeveloped for validation of those sterilizationcycles.	The Verify Biological IndicatorChallenge Pack for Vaporized SterilizationProcesses is more resistant to the V-PRO 1and V-PRO 1 Plus (Lumen and Non-LumenCycles) sterilization processes than is thebiological model developed for validation ofthose 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.

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).