(37 days)
Not Found
No
The device description and performance studies focus on biological and chemical indicators for sterilization monitoring, with no mention of AI or ML.
No
This device, a biological indicator and challenge pack, is intended for routine monitoring and qualification testing of sterilization systems to ensure their effectiveness, not to provide therapeutic benefit to a patient.
No.
Explanation: This device is a biological indicator and challenge pack used to monitor and qualify the performance of sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly outlines physical components like a plastic vial containing spores and nutrient media, and the device relies on a separate hardware incubator for detection.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD). Here's why:
- Intended Use: The primary intended use of both the Biological Indicator and the Challenge Pack is to monitor and test the effectiveness of sterilization cycles for medical devices. They are used to confirm that the sterilization process has successfully killed microorganisms.
- Mechanism of Action: The Biological Indicator works by detecting the viability of Geobacillus stearothermophilus spores after exposure to a sterilization process. The Challenge Pack is a system for presenting the Biological Indicator and a Chemical Indicator to the sterilization process in a standardized way.
- No Diagnosis or Information for Diagnosis: The device does not provide information about a patient's health, disease state, or condition. It does not analyze biological samples from a human body for diagnostic purposes.
- Focus on Sterilization Process: The entire purpose of the device is to assess the performance of a sterilization process, which is a critical step in preventing the transmission of infections through medical devices.
In Vitro Diagnostics (IVDs) are defined as devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX2 and s2 Low Temperature Sterilization Systems.
- · STERRAD® 100S Sterilizer (Default Cycle)
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
- · Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear
When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
The CELERITY 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
Biological Indicator: The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
Challenge Pack: The CELERITY 20 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 20 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The BI is activated by sealing the vial and thus puncturing the cap to release the contained media. The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator* for a final determination of viability within 20 minutes of incubation.
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)
Biological Indicator:
Test: BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle
Acceptance Criteria: All BIs processed in full cycles will be negative for growth
Conclusion: PASS
Test: Recoverable Population after exposure to STERRAD ALLClear
Acceptance Criteria: Recoverable Population of 50 – 300% of the label claim
Conclusion: PASS
Challenge Pack:
Test: Simulated Use
Acceptance Criteria: Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions
Conclusion: PASS
Test: Cycle-Specific Testing
Acceptance Criteria: The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions.
Conclusion: PASS
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/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 3, 2019
STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K183294
Trade/Device Name: CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 26, 2018 Received: November 27, 2018
Dear Anthony Piotrkowski:
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 mav, 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 avare 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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Celerity 20 HP Biological Indicator
Indications for Use (Describe)
The Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX2 and s2 Low Temperature Sterilization Systems.
- · STERRAD® 100S Sterilizer (Default Cycle)
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
- · Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear
When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB number."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
51 0(k) Number (if known)
K183294
Device Name
CELERITY 20 HP Challenge Pack
Indications for Use (Describe)
The CELERITY 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.
Type of Use (Select one or both, as applicable)
□ Prescription Use(Part 21CFR801Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image contains the STERIS logo. The word "STERIS" is in a bold, serif typeface. Below the word is an image of several horizontal, curved lines that are stacked on top of each other. The lines are blue.
510(k) Summary For CELERITY 20 HP Biological Indicator And CELERITY 20 HP Challenge Pack
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Tony Piotrkowski Contact: Director Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 tony_piotrkowski@steris.com e-mail:
Submission Date: January 2, 2019
Premarket Notification Number: K183294
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack
Device Name 1.
| Trade Name: | CELERITY 20 HP Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process |
| [21 CFR 880.2800(a), FRC] |
2. Predicate Device Biological Indicator
CELERITY 20 HP Biological Indicator, K172752 (modified under K181429)
3. Description of Device - Biological Indicator
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
4. Intended Use/ Indications for Use - Biological Indicator
The Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
- · Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX2 and s2 Low Temperature Sterilization Systems.
- · STERRAD® 100S Sterilizer (Default Cycle)
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
- · Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear
When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack
Technical Characteristics Comparison Table – Biological Indicator 5.
| CELERITY 20 HP BI | CELERITY 20 HP BI | ||
|---|---|---|---|
| Feature | K183294 (proposed) | Predicate (K172752) | Comparison |
| Intended Use | The Celerity 20 HP | ||
| Biological Indicator is | |||
| intended for routine | |||
| monitoring of the following | |||
| sterilizer cycles: | |||
| Lumen, Non Lumen, | |||
| Fast Non Lumen, Fast | |||
| and Flexible Cycles of | |||
| the V-PRO: 1, 1 Plus, | |||
| maX, maX2 and s2 Low | |||
| Temperature | |||
| Sterilization Systems. STERRAD® 100S | |||
| Sterilizer (Default Cycle) Standard and Advanced | |||
| Cycles of the | |||
| STERRAD® NX | |||
| Sterilizer with or without | |||
| ALLClear Standard, Flex Scope, | |||
| Express and DUO | |||
| Cycles of the | |||
| STERRAD® 100NX | |||
| Sterilizer with or without | |||
| ALLClear When used in conjunction | |||
| with the Celerity HP | |||
| Incubator, the Celerity 20 HP | |||
| BI provides a fluorescent | |||
| result within 20 minutes. | The CELERITY Biological | ||
| Indicator is used for routine | |||
| monitoring, and | |||
| qualification of the Non | |||
| Lumen, Flexible, Lumen | |||
| and Fast Non Lumen Cycles | |||
| of the V-PRO 1, 1 Plus, | |||
| maX, 60 and maX 2 Low | |||
| Temperature Sterilizers in | |||
| healthcare facilities. | |||
| When used in conjunction | |||
| with the VERIFY | |||
| CELERITY 20 HP | |||
| Incubator, the CELERITY | |||
| 20 HP Biological Indicator | |||
| provides a fluorescent result | |||
| within 20 minutes. | The Fast Cycle is a new | ||
| cycle in the V-PRO s2 | |||
| Low Temperature | |||
| Sterilizer, which has | |||
| been submitted in a | |||
| separate premarket | |||
| notification. | |||
| Testing to support | |||
| claims in sterilizers with | |||
| ALLClear is included in | |||
| this submission. | |||
| Indications for | |||
| STERRAD sterilizers | |||
| were cleared under | |||
| K172474. | |||
| Indicator | |||
| organism | Geobacillus | ||
| stearothermophilus | Geobacillus | ||
| stearothermophilus | Same | ||
| Mechanism | |||
| of action | An enzyme, which is | ||
| produced by the organism, | |||
| reacts with a fluorogenic | |||
| substrate within the defined | |||
| nutrient media to produce a | |||
| fluorescent moiety. | An enzyme, which is | ||
| produced by the organism, | |||
| reacts with a fluorogenic | |||
| substrate within the defined | |||
| nutrient media to produce a | |||
| fluorescent moiety. | Same | ||
| Accessories | CELERITY HP Incubator* | ||
| (K171587) | CELERITY HP Incubator* | ||
| (K171587) | Same | ||
| Viable spore | |||
| population | 1.0 - 4.0 x 106 spore/BI | 1.0 – 4.0 x 106 spore/BI | Same |
| Resistance | |||
| characteristics | Resistance @ 9.1 mg/L | ||
| H2O2: | |||
| D-value > 6 sec Survival Time ≥ 4 sec Kill Time ≤ 7 min | Resistance @ 9.1 mg/L | ||
| H2O2: | |||
| D-value > 3 sec Survival Time ≥ 4 sec Kill Time ≤ 6 min | Increased minimum D- | ||
| value specification, | |||
| within the range of the | |||
| predicate device. | |||
| Feature | CELERITY 20 HP BI | ||
| K183294 (proposed) | CELERITY 20 HP BI | ||
| Predicate (K172752) | Comparison | ||
| Culture Conditions | 55- 59°C, media included in | ||
| BI, 20-minute incubation | |||
| time. | 55- 59°C, media included in | ||
| BI, 20-minute incubation | |||
| time. | Same | ||
| Primary Packaging | Direct inoculum on plastic | ||
| vial, cap with recovery | |||
| media. | Direct inoculum on plastic | ||
| vial, cap with recovery | |||
| media. | Same | ||
| Process indicator | VERIFY V-PRO Chemical | ||
| Indicator (K140515); | |||
| magenta to yellow color | |||
| change. | VERIFY V-PRO Chemical | ||
| Indicator (K140515); | |||
| magenta to yellow color | |||
| change. | Same | ||
| Shelf-life | Currently 10 months | ||
| Target of 13 months | Currently 10 months | ||
| Target of 13 months | Real-time testing | ||
| ongoing |
Table 5-1. BI Physical Description and Technological Properties vs the Predicate Device
7
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack
Summary of Nonclinical Performance Tests – Biological Indicator 6.
Performance testing demonstrated that the subject device met its acceptance criteria and the results are summarized in Table 5-2 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| BI Simulated Use in the V-PRO maX | ||
| 2 Sterilizer Fast Non Lumen Cycle | All BIs processed in full cycles will be | |
| negative for growth | PASS | |
| Recoverable Population after | ||
| exposure to STERRAD ALLClear | Recoverable Population of 50 – 300% | |
| of the label claim | PASS |
Table 5-2. Summary of Non-clinical Testing
Device Name – Challenge Pack 7.
| Trade Name: | CELERITY 20 HP Challenge Pack |
|---|---|
| Common/usual Name: | Biological Indicator Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Sterilization Process Indicator |
| (21 CFR 880.2800, FRC) |
8. Predicate Device - Challenge Pack
CELERITY 20 HP Challenge Pack K173488 (NOTE: The proposed and predicate devices are identical)
8
9. Description of Device - Challenge Pack
The CELERITY 20 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 20 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The BI is activated by sealing the vial and thus puncturing the cap to release the contained media.
The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator* for a final determination of viability within 20 minutes of incubation.
10. Intended Use/ Indications for Use - Challenge Pack
The CELERITY 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.
The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.
11. Technical Characteristics Comparison Table - Challenge Pack
9
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack
| Feature | CELERITY pack
K183294 (Proposed) | CELERITY pack
(K173488) Predicate | Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended
Use /
Indication
for Use | The CELERITY 20 HP
Challenge Pack is intended for
qualification testing of the V-
PRO Low
Temperature Sterilization
System following installation,
relocation, malfunctions or
major repairs and for routine
requalification testing.
The Challenge Pack is placed
in an otherwise empty
sterilizer chamber; a hospital-
defined challenge load is
not included.
The challenge pack is not
intended for routine
monitoring of the V-PRO
Sterilizers. It has been tested
and validated solely for use in
periodic testing of the
sterilizers. | The CELERITY 20 HP
Challenge Pack is intended
for qualification testing of the
V-PRO Low
Temperature Sterilization
System following installation,
relocation, malfunctions or
major repairs and for routine
requalification testing.
The Challenge Pack is placed
in an otherwise empty
sterilizer chamber; a hospital-
defined challenge load is
not included.
The challenge pack is not
intended for routine
monitoring of the V-PRO
Sterilizers. It has been tested
and validated solely for use in
periodic testing of the
sterilizers. | Same |
| General
Design | Sealed sterilization pouch
containing SCBI, CI and
barrier material. | Sealed sterilization pouch
containing SCBI, CI and
barrier material. | Same |
| Biological
Indicator | Celerity 20 HP Biological
Indicator | Celerity 20 HP Biological
Indicator | Same |
| Chemical
Indicator | VERIFY HPU Chemical
Indicator | VERIFY HPU Chemical
Indicator | Same |
| Means to
distinguish
processed
pack from
unprocessed | Proposed device's internal
indicator is visible through the
pack. | Proposed device's internal
indicator is visible through
the pack. | Same |
| Required
accessories | CELERITY HP Incubator*
(K171587) | CELERITY HP Incubator*
(K171587) | Same |
Table 5-3. Summary of Pack Physical Description and Technological Properties
12. Summary of Nonclinical Performance Tests – Challenge Pack
Performance testing demonstrated that the subject device met its acceptance criteria and the results are summarized in Table 5-4 below.
10
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indictor and CELERITY 20 HP Challenge Pack
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Simulated Use | Demonstrate the pack shows passing results in worst- | |
| case load under worst-case sterilization conditions | PASS | |
| Cycle-Specific Testing | The pack provides an equivalent or greater challenge | |
| to the claimed cycle than the biological model under | ||
| worst-case conditions. | PASS |
Table 5-4. Summary of Non-Clinical Testing
13. Conclusion
Based on the intended use, technological characteristics and the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, the CELERITY 20 HP Biological Indicator (cleared in K172752) Class II (21 CFR 880.2800, product code FRC).
The CELERITY 20 HP Challenge Pack has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device, K173488, Class II (21 CFR 880.2800, Product code FRC).
- The Celerity HP Incubator was cleared in K171587 under the name "VERIFY Incubator for Assert VH2O2 SCBI"