Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

K192001 · Sterilucent, Inc. · FRC · Oct 22, 2019 · General Hospital

Device Facts

• Record ID: K192001
• Device Name: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
• Applicant: Sterilucent, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Oct 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack. The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or malfunctions, or after sterilization process failures. Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

Device Story

Sterilucent SCBI and PCD test packs monitor Sterilucent HC 80TT hydrogen peroxide vapor sterilization cycles. SCBI contains Geobacillus stearothermophilus spores on quartz fiber disc in polypropylene vial. PCDs incorporate SCBI into test pack with diffusion restrictor (tube) to simulate worst-case sterilization load. Used in clinical settings to verify sterilization conditions; PCDs provide greater resistance than stand-alone SCBI. Healthcare staff place PCD in sterilizer; after cycle, SCBI is incubated to check for spore growth. Output indicates whether sterilization conditions were met. Benefits include ensuring effective sterilization of reusable medical devices, reducing risk of infection.

Clinical Evidence

No clinical data. Bench testing only. Testing performed per ANSI/AAMI/ISO 11138-1 and 11140-1. Validated SCBI resistance (D-value, survival/kill window), 24-hour holding time, 24-hour reduced incubation time, growth inhibition, population stability, and 12-month shelf life. PCD functionality confirmed via fractional kill at half-cycle and full kill at full-cycle.

Technological Characteristics

Biological indicator: G. stearothermophilus spores on quartz fiber carrier in polypropylene vial with Tyvek filter cap. PCD: Polymer vial with diffusion-restricting tube and external chemical indicator. Energy source: VHP. Sterilization monitoring via spore inactivation. Compliant with ANSI/AAMI/ISO 11138-1 and 11140-1.

Indications for Use

Indicated for routine monitoring and performance qualification of Sterilucent HC 80TT sterilizer Lumen and Flexible cycles. Used by healthcare personnel for sterilization process verification.

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

• STERRAD CYCLESURE 24 Plus BI (K140589)
• Sterilucent Process Challenge Device (K141312)

Submission Summary (Full Text)

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October 22, 2019

Sterilucent, Inc. Peter Kalkbrenner Director of Engineering 1400 Marshall St. NE Minneapolis, Minnesota 55413

Re: K192001

Trade/Device Name: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: July 25, 2019 Received: July 26, 2019

Dear Peter 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. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K192001

#### Device Name

Sterilucent Self-Contained Biological Indicator Sterilucent Lumen Cycle Process Challenge Device Sterilucent Flexible Cycle Process Challenge Device

Indications for Use (Describe)

The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack.

The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures.

Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

[X] Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary for the Sterilucent Self-Contained Biological Indicator and Test Pack (K192001)

| Submitted by: | Sterilucent, Inc.<br>1400 Marshall Street NE<br>Minneapolis, MN 55413<br>USA |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peter R. Kalkbrenner<br>Director of Engineering<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date of Summary: | 22 October 2019 |
| Device Trade Name: | Sterilucent Self-Contained Biological Indicator<br>Sterilucent Lumen Cycle Process Challenge Device<br>Sterilucent Flexible Cycle Process Challenge Device |
| Common or Usual<br>Name: | Biological Indicator (Test Pack) |
| Classification Name:<br>Classification: | Biological Sterilization Process Indicator<br>21 CFR 880.2800(a) |
| Class: | II |
| Product Code: | FRC |
| Predicate Device(s): | STERRAD® CYCLESURE® 24 Plus BI (K140589)<br>Sterilucent Process Challenge Device (K141312) |
| Device Description: | The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization<br>process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended<br>for use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The<br>HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization<br>cycles ("Lumen" and “Flexible") which both utilize vaporized hydrogen<br>peroxide (VHP) to rapidly sterilize a variety of reusable medical devices.<br><br>The Sterilucent SCBI is to be used in a test pack configuration, with a<br>different test pack (Process Challenge Device) used for each sterilization<br>cycle. Each Process Challenge Device (PCD) is designed to have greater<br>resistance than the worst-case sterilization load, allowing for survival beyond<br>the sterilization half-cycle, but complete inactivation upon exposure to the full<br>cycle.<br><br>The Sterilucent SCBI provides information on whether necessary conditions<br>were met to kill a specified number of microorganisms upon exposure to<br>either cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. |
| Indication for Use: | The Sterilucent SCBI is intended to be used as a standard method for frequent<br>monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated<br>into a test pack.<br><br>The Sterilucent Process Challenge Device (PCD) test pack is used for routine<br>monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles.<br>The Sterilucent PCD may also be used for performance qualification of the<br>Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial |

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installation, after relocation, major repairs or malfunctions, or after sterilization process failures.

Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

| | Proposed<br>Sterilucent SCBI<br>(K192001) | Predicate<br>STERRAD CYCLESURE 24 Plus<br>BI (K140589) | Comparison |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Single use sterilization process<br>indicator | Single use sterilization process<br>indicator | Same |
| Indications for Use | The STERRAD® CYCLESURE® 24<br>PLUS Biological Indicator is intended<br>to be used as a standard method for<br>frequent monitoring of STERRAD ®<br>Sterilizer Cycles. | The Sterilucent SCBI is intended to be<br>used as a standard method for frequent<br>monitoring of the Sterilucent HC<br>80TT Sterilizer Cycles, when<br>incorporated into a test pack. | Similar |
| Organism | Geobacillus stearothermophilus<br>ATCC 7953 | Geobacillus stearothermophilus<br>ATCC 7953 | Same |
| Viable Spore Population | Equal or greater than 1.0 x106 | Equal or greater than 1.0 x106 | Same |
| Sterilization Agent | Hydrogen Peroxide Vapor | Hydrogen Peroxide Vapor | Same |
| Culture Conditions | Crushable glass ampoule containing<br>modified Tryptic Soy Broth with a pH<br>indicator | Crushable glass ampoule containing<br>modified Tryptic Soy Broth with a pH<br>indicator | Same |
| Carrier Material | Quartz Fiber Disc | Quartz Fiber Disc | Same |
| Primary Packaging | Polypropylene vial with a white<br>polypropylene cap. The cap filter is<br>Tyvek non-woven polyethylene | Polypropylene vial with a white<br>polypropylene cap. The cap filter is<br>Tyvek non-woven polyethylene | Same |
| D-Value | 5.7 - 9.1 sec. | 1.93 - 2.28 sec. | Similar |
| Survival/Kill Window | 25.0 sec. (All survive)<br>140 sec. (All kill) | Not calculated or determined | Different |
| Shelf Life | 12 months from date of manufacture | 12 months from date of manufacture | Same |
| Storage Conditions | 2-25°C (35-77°F) under dry conditions | 2-25°C (35-77°F) under dry<br>conditions | Same |
| Manufacturer | MESA Laboratories, Inc. | MESA Laboratories, Inc. | Same |

## SCBI Technological Characteristics Table

## PCD Test Pack Technological Characteristics Table

| | Proposed<br>Sterilucent HC 80TT PCD<br>(K192001) | Predicate<br>Sterilucent PSD-85 PCD (K141312) | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Single use sterilization process<br>indicator | Single use sterilization process<br>indicator | Same |
| Indications for use | The Sterilucent Process Challenge<br>Device is used for performance<br>qualification of the Sterilucent PSD-85<br>sterilizer Lumen and Non-Lumen<br>Cycles during initial installation, after<br>relocation, major repairs or<br>malfunctions, or after sterilization<br>process failures. The Sterilucent | The Sterilucent Process Challenge<br>Device (PCD) test pack is used for<br>routine monitoring of the Sterilucent<br>HC 80TT Sterilizer Lumen and<br>Flexible Cycles.<br>The Sterilucent PCD may also be used<br>for performance qualification of the<br>Sterilucent HC 80TT sterilizer Lumen | Similar |

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| | Proposed<br>Sterilucent HC 80TT PCD<br>(K192001) | Predicate<br>Sterilucent PSD-85 PCD (K141312) | Comparison |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Process Challenge Device may also be<br>used for routine monitoring of the PSD-<br>85 sterilizer Lumen and Non-Lumen<br>Cycles. | and Flexible Cycles during initial<br>installation, after relocation, major<br>repairs or malfunctions, or after<br>sterilization process failures.<br>Both the Sterilucent Lumen Cycle<br>PCD and the Sterilucent Flexible<br>Cycle PCD are intended to have<br>greater resistance than the stand alone<br>SCBI. Both devices are designed to<br>have increased resistance beyond the<br>sterilization half-cycle, but complete<br>inactivation upon exposure to the full<br>cycle. | |
| SCBI | Sterilucent HC 80TT SCBI, quartz<br>fiber carrier inoculated with > 106<br>Geobacillus sterathermophilus spores<br>per disc, K192001 (current submission) | Sterilucent PSD-85 SCBI, stainless<br>steel carrier inoculated with > 106<br>Geobacillus sterathermophilus spores<br>per disc, K141238 | Similar |
| Packaging | Clear polymer vial with polymer caps<br>and a challenge tube on one end. | Clear polymer vial with polymer caps<br>and a challenge tube on one end. | Same |
| Diffusion Restrictor | Tube of various inner diameter and<br>lengths tailored to individual<br>sterilization cycle | Tube of various inner diameter and<br>lengths tailored to individual<br>sterilization cycle | Same |
| Integrated Process<br>Indicator | SPSmedical VH2O2 Chemical Indicator<br>placed on the outside of the vial | SPSmedical VH2O2 Chemical<br>Indicator placed on the outside of the<br>vial | Same |
| Relative Resistance | Greater than stand-alone SCBI; greater<br>than most difficult to sterilize device in<br>each respective cycle; all kill at full<br>cycle | Greater than stand-alone SCBI;<br>greater than most difficult to sterilize<br>device in each respective cycle; all kill<br>at half cycle | Similar |
| D-Value | 28.69 sec. (PCD-F) | 18.18 sec. (PCD-NL) | Different |
| Manufacturer | Sterilucent, Inc. | Sterilucent, Inc. | Same |

The Sterilucent SCBI is similar to the STERRAD CYCLESURE 24 Plus Biological Indicator (K140589), manufactured by MESA Laboratories (Bozeman. MT). The Sterilucent SCBI and predicate device are both single-use sterilization process indicators intended to monitor exposure to sterilization cycles utilizing VHP as a sterilant. Both devices have the same intended use, materials, specifications, and mode-of-action, and are manufactured using the exact same production methods.

The Sterilucent HC 80TT PCD (Lumen and Flexible) is similar to the Sterilucent PSD-85 PCD (Lumen and Non-Lumen), which is intended for use in routine monitoring of the Sterilycent PSD-85 sterilization cycles (K141312). Both devices are designed to increase resistance beyond that measured with a SCBI and to represent a challenge to the sterilization process that is equal to or greater than the routinely processed item that is most difficult to sterilize in each respective cycle (ref. AAMI TIR31:2008).

Performance testing was conducted to demonstrate the functionality of the Summary of Non-Clinical Testing (Bench): Sterilucent SCBI either alone or when incorporated into a PCD. Testing was completed in accordance with FDA Guidance ("Biological Indicator (BI) Premarket Notification [510(k)] Submissions" dated October 2007), ANSI/AAMI/ISO 11138-1, and/or ANSI/AAMI/ISO 11140-1. Resistance characterization of the SCBI was performed using a resistometer compliant with the requirements of ANSI/AAMI/ISO 18472. A summary of nonclinical

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tests performed to demonstrate the safety and effectiveness of both the Sterilucent SCBI and PCD are as follows:

| Test | Purpose | Acceptance Criteria | Result |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------|
| SCBI Resistance Evaluation<br>(D-Value & Survival/Kill<br>Window) | Determination of resistance<br>characteristics under conditions<br>representative of the subject<br>intended sterilizer | Meaningful value | Passed |
| SCBI Holding Time<br>Assessment (24 hours) | Determination of time period<br>exposed SCBI can be held<br>before incubation. | Meaningful value | Passed |
| SCBI Reduced Incubation<br>Time (24 hours) | Determination of reduced<br>incubation time | Value less than seven (7)<br>days based on FDA RIT<br>protocol | Passed |
| SCBI Growth Inhibition<br>(none allowed) | Demonstrate sterilant absorption<br>does not inhibit spore growth | Spore growth | Passed |
| SCBI Population Stability &<br>12-month Shelf Life | Demonstrate spore population is<br>maintained throughout the<br>labeled shelf life | Spore population remains<br>between 1.0-4.0 x 106<br>throughout | Passed |
| SCBI Integrated Chemical<br>Indicator Verification | Demonstrate compliance to ISO<br>11140-1 pass/fail criteria | ISO 11140-1 Section 8.7,<br>Table 6 | Passed |
| PCD Resistance<br>Characterization | Demonstrate test packs are more<br>difficult to sterilize than the<br>SCBI | Greater resistance as<br>demonstrated by fractional<br>kill | Passed |
| PCD Functionality | Demonstrate challenge to the<br>sterilization process is equal to<br>or greater than the most difficult<br>item routinely processed | Fractional kill at half-cycle;<br>all kill at full cycle | Passed |
| Summary of Clinical<br>Testing: | Clinical evaluations were not required and therefore are not submitted with<br>this 510(k). | | |
| Conclusions: | The conclusions drawn from the non-clinical tests demonstrate that the<br>subject device is as safe, as effective and performs as well as or better than<br>the legally marketed predicate device. | | |