(164 days)
Not Found
No
The device description and performance studies focus on biological and chemical indicators for sterilization efficacy, with no mention of AI or ML.
No.
The device is used to monitor and qualify the performance of a sterilizer, not to provide therapy or treatment to a patient.
No
This device is used to monitor the performance of a sterilizer, not to diagnose a patient's condition or disease. It assesses the efficacy of a sterilization process.
No
The device description clearly outlines physical components (vial, cap, challenge tube, biological indicator, chemical indicator label) and a physical process (placing in sterilizer, retrieving, incubating). It is a hardware-based device used in conjunction with a sterilizer.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used for "performance qualification" and "routine monitoring" of a sterilizer. This involves assessing the effectiveness of the sterilization process.
- Device Description: The device contains a "Self-Contained Biological Indicator (SCBI)" which includes a "growth media." The user incubates the SCBI and monitors for a "color change" in the media. A color change indicates "bacterial growth (a failing result)," while no color change indicates "adequate sterilization (a passing result)."
- Mechanism: The core function of the device is to detect the presence or absence of viable microorganisms (bacterial spores) after a sterilization cycle. This detection is done in vitro (outside the body) using a biological indicator and growth media. The result provides information about the effectiveness of the sterilization process, which is a critical step in preventing the transmission of infectious agents.
While the device itself isn't directly diagnosing a disease in a patient, it is performing a diagnostic test in vitro to assess the performance of a medical device (the sterilizer) that is crucial for patient safety. The detection of microbial growth in the biological indicator is a diagnostic test for the failure of the sterilization process.
The predicate device listed (K092906; Steris Verify Biological Indicator Challenge Pack for Vaporized H2O2 Sterilization Processes) is also a biological indicator used for sterilization monitoring, which further supports the classification of this type of device as an IVD.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FRC
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).
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)
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. 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.
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.
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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.
1
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)
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)
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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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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 Cycle
Sterilucent Process Challenge Device PCD-NL for Non-Lumen
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,
5
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
Characteristic | Proposed Device
Sterilucent Process Challenge Device | Predicate Device |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
Modality | Vaporized hydrogen peroxide | Same |
| Biological
Indicator Organism | SCBI containing at least 106 spores of
Geobacillus sterathermophilus | Same |
| Process Indicator | Class 1 Chemical Indicator per
ANSI/AAMI/ISO 11140-1 | Same |
| Packaging
(Mechanism to
Increase the
Resistance of the
BI) | The SCBI is packaged in a vial. The vial is
plugged on one end, while the other end
contains a hole through which a diffusion-
restricting challenge tube is inserted. | The SCBI is packaged with a sheet of foam
and placed within a Tyvek pouch. |
| Resistance
Characteristics | The Sterilucent Process Challenge Device is
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 Verify Biological Indicator
Challenge Pack for Vaporized Sterilization
Processes is more resistant to the V-PRO 1
and V-PRO 1 Plus (Lumen and Non-Lumen
Cycles) sterilization processes than is the
biological model developed for validation of
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
6
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.