(28 days)
Not Found
No
The device is a challenge pack for sterilization system testing, relying on chemical and biological indicators with manual assessment and incubation, not AI/ML.
No
The device is used for qualification and requalification testing of sterilization systems, not for direct therapeutic treatment or diagnosis of patients.
No
Explanation: The device is used to test the functionality and effectiveness of a sterilization system (V-PRO Sterilizer), not to diagnose a medical condition in a patient. It assesses the performance of equipment, not the health status of an individual.
No
The device description clearly outlines physical components (pack, chemical indicator, biological indicator, incubator) and physical processes (placing in sterilizer, activating BI, incubating). It is a hardware-based sterilization challenge pack.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "qualification testing of the V-PRO Low Temperature Sterilization System." This is a quality control or performance monitoring function for a medical device (the sterilizer), not a diagnostic test performed on 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 diagnose a condition in a patient. The biological indicator involves incubating a spore sample to see if it was killed by the sterilization process.
- Lack of Patient Sample: The device is placed in the sterilizer chamber, not used to test a sample taken from a patient.
- No Diagnostic Claims: The description does not mention any claims related to diagnosing a disease, condition, or physiological state in a patient.
In summary, the CELERITY 20 HP Challenge Pack is a quality control tool for a sterilization system, not a device used for in vitro diagnostic testing of patient samples.
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 chad 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
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: Nonclinical Tests / Simulated Use
Sample Size: Not Specified
Key Results: Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions (Fast Non Lumen Cycle of V-PRO maX 2 Sterilizer). All CI complete change. All BI inactivated (PASS).
Key Metrics
Not Found
Predicate Device(s)
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 shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
March 18, 2022
Steris Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060
Re: K220473
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: February 17, 2022 Received: February 18, 2022
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. 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.
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
1
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 mediation-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,
Clarence W. Murray, III, Ph.D. Assistant Director 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) K220473
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 chad 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K220473 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 Director, Regulatory Affairs
Telephone: (440) 392-7437 (440) 357-9189 Fax No: e-mail: tony piotrkowski@steris.com
February 17, 2022 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION 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: | Indicator, Biological Sterilization Process |
| (21 CFR 880.2800, FRC) |
2. Predicate Device
CELERITY 20 HP Challenge Pack K173488 Note: K183294 is the most recent clearance for the CELERITY 20 HP Challenge pack but this submission specifically addresses the original clearance under K173488.
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.
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
5. Summary of Technological Characteristics
A comparison of technical characteristics are summarized in Table 5-1.
| Feature | CELERITY pack
(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 | CELERITY HP Incubator | Same |
Table 5-1 Summary of nack Physical Description and Technological Pronerties
6. Summarv of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
6
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION 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 (Fast Non | ||
| Lumen Cycle of V-PRO maX 2 Sterilizer) | PASS | |
| All CI complete change | ||
| All BI inactivated |
Tahle 5-2 Sr clinical Testi f N
7. Conclusion
The conclusion drawn from the non-clinical performance test demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device, K173488, Class II (21 CFR 880.2800, Product code FRC).