(108 days)
No
The device description and performance studies focus on the physical components and biological/chemical indicators used for sterilization qualification testing. There is no mention of AI or ML in the text.
No
The device is intended for qualification and requalification testing of sterilization systems, not for treating any medical condition or patient.
No
Explanation: The device is used for qualification testing of sterilization systems to ensure they are working properly, not for diagnosing a medical condition in a patient.
No
The device description clearly outlines physical components (pack, chemical indicator, biological indicator, vial, media) and a required hardware component for incubation (CELERITY HP Incubator). It is not solely software.
Based on the provided text, the CELERITY 20 HP Challenge Pack is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for qualification and requalification testing of a sterilization system (V-PRO Low Temperature Sterilization System). It's a quality control tool for the sterilizer itself, not for diagnosing a condition in a patient or analyzing a biological sample from a patient.
- Device Description: The device contains a chemical indicator and a biological indicator. These are used to assess the effectiveness of the sterilization process, not to perform a diagnostic test on a patient sample. The biological indicator is incubated to see if the sterilization process killed the microorganisms, which is a measure of the sterilizer's performance.
- Lack of IVD Characteristics: The description does not mention analyzing human biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, treatment, or prevention of disease in a patient.
In summary, the CELERITY 20 HP Challenge Pack is a sterilization process indicator used to verify the performance of a medical device sterilizer. This falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
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
healthcare providers
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)
Summary of Nonclinical Tests
| 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 |
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.
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 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.
March 1, 2018
STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060
Re: K173488
Trade/Device Name: CELERITY 20 HP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 31, 2018 Received: February 1, 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 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Michael J. Ryan -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173488
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 21 CFR 801 Subpart D)
[X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
STERIS®
510(k) Summary For 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
Contact: Anthony Piotrkowski Senior Manager, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9189 e-mail: tony_piotrkowski@steris.com
Submission Date: January 31, 2018
Premarket Notification Number: K173488
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173488 CELERITY 20 HP Challenge Pack
Device Name 1.
| 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) |
2. Predicate Device
VERIFY V24 Biological Indicator Challenge Pack K140499
3. Description of Device
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.
4. Intended Use/ Indications 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 hospitaldefined challenge load is not included.
5
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173488 CELERITY 20 HP Challenge Pack
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.
5. Summary of Technical Characteristics
A comparison of technical characteristics is summarized in Table 5-1.
| Feature | CELERITY pack | VERIFY Pack | Comparison |
|---|---|---|---|
| Intended | |||
| Use / | |||
| Indication | |||
| for Use | (K173488) Proposed | ||
| 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. | (K140499) Predicate | ||
| The VERIFY V24 | |||
| Biological Indicator | |||
| Challenge Pack is | |||
| intended for | |||
| qualification testing of | |||
| the Lumen, Non Lumen | |||
| and Flexible Cycles in | |||
| V-PRO Low | |||
| Temperature | |||
| Sterilization Systems | |||
| following installation, | |||
| relocation, malfunctions | |||
| or major repairs. | |||
| 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 V-PRO | |||
| Sterilizers. It has been | |||
| tested and validated | |||
| solely for use in periodic | |||
| testing of the Sterilizers. | An additional cycle, Fast | ||
| Non Lumen, has been | |||
| added to indications. The | |||
| BI and CI in the pack as | |||
| well the predicate | |||
| challenge pack are | |||
| currently under review to | |||
| add this claim. Testing is | |||
| provided in this | |||
| submission to | |||
| demonstrate suitable | |||
| performance in the | |||
| additional cycle. | |||
| Proposed device has | |||
| additional wording to | |||
| clarify that the pack can | |||
| be used for routine | |||
| requalification. | |||
| General | |||
| Design | Sealed sterilization | ||
| pouch containing SCBI, | |||
| CI and barrier material. | Sealed sterilization | ||
| pouch containing SCBI, | |||
| CI and barrier material. | Same configuration | ||
| Biological | |||
| Indicator | Celerity 20 HP | ||
| Biological Indicator* | |||
| (K171504) | Verify V24 SCBI | ||
| (K140708) | Both have 510(k)- | ||
| cleared BI with reduced | |||
| incubation time. | |||
| Chemical | |||
| Indicator | VERIFY HPU Chemical | ||
| Indicator | VERIFY HPU Chemical | ||
| Indicator | Same | ||
| Means to | |||
| distinguish | Proposed device's | ||
| internal indicator is | |||
| visible through the pack. | Proposed device's | ||
| internal indicator is | |||
| visible through the pack. | Same |
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173488 CELERITY 20 HP Challenge Pack
| Feature | CELERITY pack
(K173488) Proposed | VERIFY Pack
(K140499) Predicate | Comparison |
|---------------------------------------|--------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| processed
pack from
unprocessed | | | |
| Required
accessories | CELERITY HP
Incubator** (K171587) | VERIFY Activator | Proposed device requires
the incubator to read and
report final result but
does not require a
separate activator. Use of
the incubator with the
SCBI contained within
the pack was part of
K171587. |
6. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
| 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 5-2. Summary of Non-Clinical Testing
7. Conclusion
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, K140499, Class II (21 CFR 880.2800, Product code FRC).
- The Celerity 20 HP Biological Indicator was cleared in K171504 under the name "VERIFY Assert VH2O2 Self Contained Biological Indicator"
** The Celerity HP Incubator was cleared in K171587 under the name "VERIFY Incubator for Assert VH2O2 SCBI"