(21 days)
Not Found
No
The device is a chemical indicator tape that changes color based on exposure to vaporized hydrogen peroxide. There is no mention of AI or ML in the description, intended use, or performance studies.
No
The device is an indicator tape used to distinguish between processed and unprocessed sterilization units and to secure items. It does not provide any therapeutic benefit to a patient.
No
Explanation: The device is described as an "Indicator Tape" intended to distinguish between processed and unprocessed units through a color change and to be used as an external process indicator for sterilization cycles. It does not provide any information about a patient's health or disease state, which is the primary function of a diagnostic device.
No
The device is a physical tape with a reactive ink, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure items and indicate whether they have undergone a sterilization process using a color change. This is a process indicator for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The device is a tape with a chemical indicator that reacts to vaporized hydrogen peroxide. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing, monitoring, or predicting disease
- Providing information about a patient's health status
The device is clearly intended for use in the sterilization process of medical devices, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:
· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX 2, 60, and s2 Low Temperature Sterilization Systems.
· 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.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The CELERITY HP Indicator Tape (Indicator Tape) is a ¾' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.
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 completed using well established methods such as those described in ISO 11140-1 and those used to verify the predicate design.
Testing performed:
- Simulated Use Testing:
- Acceptance Criteria: Complete color change in full cycle; Incomplete color change in partial cycle; Remain adhered after worst-case cycle
- Study Result: Complete color change in full cycle; Incomplete color change in partial cycle; Remains adhered after worst-case cycle
- ISO 11140-1 Testing:
- Acceptance Criteria: Meets requirement of Type 1 VHP Indicator
- Study Result: Meets requirement of Type 1 VHP Indicator
- Light Stability:
- Acceptance Criteria: Ink performs as intended when exposed to light for labeled period
- Study Result: Ink performs as intended when exposed to light for labeled period
- Endpoint Stability:
- Acceptance Criteria: Endpoint color remains stable for labeled period
- Study Result: Endpoint color remains stable for labeled period
- Shelf Life:
- Acceptance Criteria: Meets all performance requirements at labeled shelf-life
- Study Result: Meets all performance requirements at labeled shelf-life
The results of the performed testing demonstrate that the CELERITY HP Indicator Tape performs as intended.
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 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 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.
April 10, 2024
Steris Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K240760
Trade/Device Name: CELERITY HP Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: March 20, 2024 Received: March 20, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Stephen A. Digitally signed by Stephen A. Anisko -S Date: 2024.04.10 Anisko -S 11:42:33 -04'00'
For: Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240760
Device Name CELERITY HP Indicator Tape
Indications for Use (Describe)
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:
· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX 2, 60, and s2 Low Temperature Sterilization Systems.
· 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.
| 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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4
K240760 510(k) Summary for CELERITY HP Indicator Tape
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 Tony piotrkowski@steris.com
Anthony Piotrkowski
Submission Date: April 10, 2024
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
1. Predicate Device
Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:
VERIFY VH2O2 Indicator Tape Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K231488
2. Device Description
The CELERITY HP Indicator Tape (Indicator Tape) is a ¾' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.
3. Indications for Use:
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:
- . Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
- . 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.
4. Technological Characteristics
The proposed and predicate devices are chemical indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change.
6
| Feature | Proposed: CELERITY HP Indicator Tape | Predicate: VERIFY VH2O2 Indicator
Tape (K231488) | Comparison |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
/ Indications
for Use | The Indicator Tape is intended to secure items
wrapped in synthetic wrap materials until used
and to distinguish between processed and
unprocessed units through a color change
from the start color (pink/magenta) to orange,
yellow or lighter. The Indicator Tape is also
intended to be used as an external process
indicator when applied to synthetic wrap
materials and/or Tyvek pouches. | The Indicator Tape is intended to secure items
wrapped in synthetic wrap materials until used
and to distinguish between processed and
unprocessed units through a color change
from the start color (pink) to peach, yellow or
lighter. The Indicator Tape is also intended to
be used as an external process indicator when
applied to synthetic wrap materials and/or
Tyvek pouches. | Similar, a slight
change to the
start and end
color descriptor
to match color
description of
other Celerity
chemical
indicators and |
| | The tape may be used in the following
sterilization cycles:
• Lumen, Non Lumen, Fast Non Lumen,
Fast, Flexible, and Specialty Cycles of the
V-PRO: 1, 1 Plus, maX, maX 2, 60, and
s2 Low Temperature Sterilization
Systems.
• 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 | The tape may be used in the following
sterilization cycles:
• Lumen, Non Lumen, Fast Non Lumen,
Fast, Flexible, and Specialty Cycles of the
V-PRO: 1, 1 Plus, maX, maX 2, 60, 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 | removal of the
STERRAD
100S Default
Cycle |
| Chemical
Indicator
Agent and
Performance
Specification | The indicator agent is a vaporized hydrogen
peroxide reactive ink that meets the
requirement specified in ANSI/AAMI/ISO
11140-1:2014 for a Type 1 Process Indicator
for a vaporized hydrogen peroxide process | The indicator agent is a vaporized hydrogen
peroxide reactive ink that meets the
requirement specified in ANSI/AAMI/ISO
11140-1:2014 for a Type 1 Process Indicator
for a vaporized hydrogen peroxide process | Identical |
| Device
Design | Tape: 3/4" wide by 60 yards long crepe
(masking) tape which is wound around a 3"
core. A hydrogen peroxide reactive ink is laid
down on the non-adhesive surface. The ink is
protected from transfer to the adhesive via a
coating. | Tape: 3/4" wide by 60 yards long crepe
(masking) tape which is wound around a 3"
core. A hydrogen peroxide reactive ink is laid
down on the non-adhesive surface. The ink is
protected from transfer to the adhesive via a
coating. | Identical |
| Shelf Life | 5 months - real-time testing is ongoing | Tape 24 months | real-time
testing is
ongoing |
| Performance
Limitations
(taken from
instructions
for use) | Do not overlap the tape onto itself as this may
prevent the underlying layer from being
appropriately exposed to hydrogen peroxide
resulting in a failed indicator response. | Do not overlap the tape onto itself as this may
prevent the underlying layer from being
appropriately exposed to hydrogen peroxide
resulting in a failed indicator response. | Identical |
Table 1 Comparison of CI Physical Description and Technological Properties
7
STERIS Traditional 510(k) PREMARKET NOTIFICATION K240760 CELERITY HP Indicator Tape
5. Performance Testing
Performance testing was completed using well established methods such as those described in ISO 11140-1 and those used to verify the predicate design.
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use | ||
| Testing | • Complete color change in full cycle | |
| • Incomplete color change in partial cycle | ||
| • Remain adhered after worst-case cycle | • Complete color change in full cycle | |
| • Incomplete color change in partial cycle | ||
| • Remains adhered after worst-case cycle | ||
| ISO 11140-1 Testing | Meets requirement of Type 1 VHP Indicator | Meets requirement of Type 1 VHP Indicator |
| Light Stability | Ink performs as intended when exposed to | |
| light for labeled period | Ink performs as intended when exposed to | |
| light for labeled period | ||
| Endpoint Stability | Endpoint color remains stable for labeled | |
| period | Endpoint color remains stable for labeled | |
| period | ||
| Shelf Life | Meets all performance requirements at | |
| labeled shelf-life | Meets all performance requirements at labeled | |
| shelf-life |
| Table 2. Verification Results Summary | |
|---|---|
| --------------------------------------- | -- |
The results of the performed testing demonstrate that the CELERITY HP Indicator Tape performs as intended.
6. Conclusion
The conclusion drawn from the non-clinical testing demonstrates that the subject device, CELERITY HP Indicator Tape, submitted under K240760, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K231488.