(88 days)
Not Found
No
The device description and performance studies focus on the biological and chemical properties of a sterilization indicator and test pack, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is intended for monitoring sterilizer cycles and determining whether conditions were met to kill microorganisms, not for treating a disease or condition in a patient.
No
The device is a sterilization process indicator used for monitoring sterilizer cycles, not for diagnosing medical conditions in patients. It assesses whether equipment sterilization conditions were met.
No
The device description clearly states it is a "Self-Contained Biological Indicator (SCBI)" and a "Process Challenge Device (PCD)", which are physical components used in sterilization monitoring. The performance studies also describe testing of these physical devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of a sterilization process for medical devices. It assesses whether the sterilizer is killing microorganisms, not diagnosing a condition in a patient or providing information about a patient's health.
- Device Description: The device is a biological indicator containing spores, used to challenge a sterilization process. It provides information about the sterilization cycle's ability to kill microorganisms.
- Lack of IVD Characteristics: The description does not mention analyzing human specimens (blood, urine, tissue, etc.), providing diagnostic information about a disease or condition, or being used in a laboratory setting for patient testing.
The device falls under the category of a sterilization process indicator, which is a different type of medical device than an IVD.
N/A
Intended Use / 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 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.
Product codes
FRC
Device Description
The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended for use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and “Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices.
The Sterilucent SCBI is to be used in a test pack configuration, with a different test pack (Process Challenge Device) used for each sterilization cycle. Each Process Challenge Device (PCD) is designed to have greater resistance than the worst-case sterilization load, allowing for survival beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.
The Sterilucent SCBI provides information on whether necessary conditions were met to kill a specified number of microorganisms upon exposure to either cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.
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 demonstrate the functionality of the 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.
Summary of Non-Clinical Testing (Bench):
- Test: SCBI Resistance Evaluation (D-Value & Survival/Kill Window)
- Purpose: Determination of resistance characteristics under conditions representative of the subject intended sterilizer
- Acceptance Criteria: Meaningful value
- Result: Passed
- Test: SCBI Holding Time Assessment (24 hours)
- Purpose: Determination of time period exposed SCBI can be held before incubation.
- Acceptance Criteria: Meaningful value
- Result: Passed
- Test: SCBI Reduced Incubation Time (24 hours)
- Purpose: Determination of reduced incubation time
- Acceptance Criteria: Value less than seven (7) days based on FDA RIT protocol
- Result: Passed
- Test: SCBI Growth Inhibition (none allowed)
- Purpose: Demonstrate sterilant absorption does not inhibit spore growth
- Acceptance Criteria: Spore growth
- Result: Passed
- Test: SCBI Population Stability & 12-month Shelf Life
- Purpose: Demonstrate spore population is maintained throughout the labeled shelf life
- Acceptance Criteria: Spore population remains between 1.0-4.0 x 10^6 throughout
- Result: Passed
- Test: SCBI Integrated Chemical Indicator Verification
- Purpose: Demonstrate compliance to ISO 11140-1 pass/fail criteria
- Acceptance Criteria: ISO 11140-1 Section 8.7, Table 6
- Result: Passed
- Test: PCD Resistance Characterization
- Purpose: Demonstrate test packs are more difficult to sterilize than the SCBI
- Acceptance Criteria: Greater resistance as demonstrated by fractional kill
- Result: Passed
- Test: PCD Functionality
- Purpose: Demonstrate challenge to the sterilization process is equal to or greater than the most difficult item routinely processed
- Acceptance Criteria: Fractional kill at half-cycle; all kill at full cycle
- Result: Passed
Summary of Clinical Testing: Clinical evaluations were not required and therefore are not submitted with this 510(k).
Conclusions: The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SCBI D-Value: 5.7 - 9.1 sec.
SCBI Survival/Kill Window: 25.0 sec. (All survive), 140 sec. (All kill)
PCD D-Value: 28.69 sec. (PCD-F)
Predicate Device(s)
STERRAD® CYCLESURE® 24 Plus BI (K140589), Sterilucent Process Challenge Device (K141312)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary for the Sterilucent Self-Contained Biological Indicator and Test Pack (K192001)
| Submitted by: | Sterilucent, Inc.
1400 Marshall Street NE
Minneapolis, MN 55413
USA |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peter R. Kalkbrenner
Director of Engineering
peter.kalkbrenner@sterilucent.com
Phone: 612-767-3253
Fax: 612-767-3261 |
| Date of Summary: | 22 October 2019 |
| Device Trade Name: | Sterilucent Self-Contained Biological Indicator
Sterilucent Lumen Cycle Process Challenge Device
Sterilucent Flexible Cycle Process Challenge Device |
| Common or Usual
Name: | Biological Indicator (Test Pack) |
| Classification Name:
Classification: | Biological Sterilization Process Indicator
21 CFR 880.2800(a) |
| Class: | II |
| Product Code: | FRC |
| Predicate Device(s): | STERRAD® CYCLESURE® 24 Plus BI (K140589)
Sterilucent Process Challenge Device (K141312) |
| Device Description: | The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization
process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended
for use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The
HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization
cycles ("Lumen" and “Flexible") which both utilize vaporized hydrogen
peroxide (VHP) to rapidly sterilize a variety of reusable medical devices.
The Sterilucent SCBI is to be used in a test pack configuration, with a
different test pack (Process Challenge Device) used for each sterilization
cycle. Each Process Challenge Device (PCD) is designed to have greater
resistance than the worst-case sterilization load, allowing for survival beyond
the sterilization half-cycle, but complete inactivation upon exposure to the full
cycle.
The Sterilucent SCBI provides information on whether necessary conditions
were met to kill a specified number of microorganisms upon exposure to
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
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 |
4
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
Sterilucent SCBI
(K192001) | Predicate
STERRAD CYCLESURE 24 Plus
BI (K140589) | Comparison |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Single use sterilization process
indicator | Single use sterilization process
indicator | Same |
| Indications for Use | The STERRAD® CYCLESURE® 24
PLUS Biological Indicator is intended
to be used as a standard method for
frequent monitoring of STERRAD ®
Sterilizer Cycles. | 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. | Similar |
| Organism | Geobacillus stearothermophilus
ATCC 7953 | Geobacillus stearothermophilus
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
modified Tryptic Soy Broth with a pH
indicator | Crushable glass ampoule containing
modified Tryptic Soy Broth with a pH
indicator | Same |
| Carrier Material | Quartz Fiber Disc | Quartz Fiber Disc | Same |
| Primary Packaging | Polypropylene vial with a white
polypropylene cap. The cap filter is
Tyvek non-woven polyethylene | Polypropylene vial with a white
polypropylene cap. The cap filter is
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)
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
conditions | Same |
| Manufacturer | MESA Laboratories, Inc. | MESA Laboratories, Inc. | Same |
SCBI Technological Characteristics Table
PCD Test Pack Technological Characteristics Table
| | Proposed
Sterilucent HC 80TT PCD
(K192001) | Predicate
Sterilucent PSD-85 PCD (K141312) | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Single use sterilization process
indicator | Single use sterilization process
indicator | Same |
| Indications for use | The Sterilucent Process Challenge
Device is used for performance
qualification of the Sterilucent PSD-85
sterilizer Lumen and Non-Lumen
Cycles during initial installation, after
relocation, major repairs or
malfunctions, or after sterilization
process failures. The Sterilucent | 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 | Similar |
5
| | Proposed
Sterilucent HC 80TT PCD
(K192001) | Predicate
Sterilucent PSD-85 PCD (K141312) | Comparison |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Process Challenge Device may also be
used for routine monitoring of the PSD-
85 sterilizer Lumen and Non-Lumen
Cycles. | 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. | |
| SCBI | Sterilucent HC 80TT SCBI, quartz
fiber carrier inoculated with > 106
Geobacillus sterathermophilus spores
per disc, K192001 (current submission) | Sterilucent PSD-85 SCBI, stainless
steel carrier inoculated with > 106
Geobacillus sterathermophilus spores
per disc, K141238 | Similar |
| Packaging | Clear polymer vial with polymer caps
and a challenge tube on one end. | Clear polymer vial with polymer caps
and a challenge tube on one end. | Same |
| Diffusion Restrictor | Tube of various inner diameter and
lengths tailored to individual
sterilization cycle | Tube of various inner diameter and
lengths tailored to individual
sterilization cycle | Same |
| Integrated Process
Indicator | SPSmedical VH2O2 Chemical Indicator
placed on the outside of the vial | SPSmedical VH2O2 Chemical
Indicator placed on the outside of the
vial | Same |
| Relative Resistance | Greater than stand-alone SCBI; greater
than most difficult to sterilize device in
each respective cycle; all kill at full
cycle | Greater than stand-alone SCBI;
greater than most difficult to sterilize
device in each respective cycle; all kill
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
6
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 | |||
| (D-Value & Survival/Kill | |||
| Window) | Determination of resistance | ||
| characteristics under conditions | |||
| representative of the subject | |||
| intended sterilizer | Meaningful value | Passed | |
| SCBI Holding Time | |||
| Assessment (24 hours) | Determination of time period | ||
| exposed SCBI can be held | |||
| before incubation. | Meaningful value | Passed | |
| SCBI Reduced Incubation | |||
| Time (24 hours) | Determination of reduced | ||
| incubation time | Value less than seven (7) | ||
| days based on FDA RIT | |||
| protocol | Passed | ||
| SCBI Growth Inhibition | |||
| (none allowed) | Demonstrate sterilant absorption | ||
| does not inhibit spore growth | Spore growth | Passed | |
| SCBI Population Stability & | |||
| 12-month Shelf Life | Demonstrate spore population is | ||
| maintained throughout the | |||
| labeled shelf life | Spore population remains | ||
| between 1.0-4.0 x 106 | |||
| throughout | Passed | ||
| SCBI Integrated Chemical | |||
| Indicator Verification | Demonstrate compliance to ISO | ||
| 11140-1 pass/fail criteria | ISO 11140-1 Section 8.7, | ||
| Table 6 | Passed | ||
| PCD Resistance | |||
| Characterization | Demonstrate test packs are more | ||
| difficult to sterilize than the | |||
| SCBI | Greater resistance as | ||
| demonstrated by fractional | |||
| kill | Passed | ||
| PCD Functionality | Demonstrate challenge to the | ||
| sterilization process is equal to | |||
| or greater than the most difficult | |||
| item routinely processed | Fractional kill at half-cycle; | ||
| all kill at full cycle | Passed | ||
| Summary of Clinical | |||
| Testing: | Clinical evaluations were not required and therefore are not submitted with | ||
| this 510(k). | |||
| Conclusions: | The conclusions drawn from the non-clinical tests demonstrate that the | ||
| subject device is as safe, as effective and performs as well as or better than | |||
| the legally marketed predicate device. |