(245 days)
Not Found
No
The device description and intended use clearly indicate a simple chemical indicator tape that changes color based on exposure to sterilization conditions. There is no mention of any computational processing, learning, or adaptive capabilities.
No
The device is an indicator tape used to confirm that sterilization processes have occurred, not to treat a medical condition or disease.
No
The device is an indicator tape used to confirm that a sterilization process has occurred, not to diagnose a medical condition in a patient. It assesses the functioning of a sterilization unit.
No
The device is described as physical indicator tape with chemical ink that changes color, indicating exposure to sterilization processes. There is no mention of software components.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Autoclave Indicator Tape and EO Indicator Tape described are used to monitor the effectiveness of sterilization processes for medical devices or other items. They indicate whether the items have been exposed to the required sterilization conditions (steam or EO gas).
- Lack of Biological Specimen Interaction: The devices do not interact with or analyze any biological specimens from the human body. Their function is solely related to the sterilization process itself.
- Intended Use: The intended use is to demonstrate exposure to a sterilization process and distinguish between processed and unprocessed units/loads, not to diagnose or provide information about a patient's health.
Therefore, these devices fall under the category of sterilization process indicators, which are distinct from In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.
The Autoclave Indicator Tape can be used in the following steam sterilization cycles:
-
Gravity: 121°C, 30 minutes
-
Vacuum assisted (pre-vacuum): 134°C, 4 minutes
EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile.
The EO Indicator Tape can be used in the following EO sterilization cycle:
55°C, 762mg/l EO, 40~80%RH, 4 hours exposure
Product codes
JOJ
Device Description
Autoclave Indicator Tape is a single chemical indicator designed for steam sterilizing monitoring. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial yellow color of the indicator ink on the autoclave indicator tape changes to Black. If no color change occurs, it may indicate that the autoclave indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.
EO Indicator Tape is single chemical indicator designed for use in ethylene oxide sterilizing processes. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial orange color of the indicator ink on the EO indicator tape changes to green. If no color change occurs, it may indicate that the EO indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.
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
health care provider
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)
Autoclave Indicator Tape
Steam process indicator performance test according to ISO 11140-1:2014 testing for Type 1 indicator and FDA guidance
Purpose: To demonstrate conformance of Autoclave indicator tape to the requirements specified in ISO 11140-1:2014 and FDA guidance for industry and FDA staff, "Premarket Notification [510(k)] Submissions for Chemical Indicators".
Acceptance Criteria: 121°C for 10 minutes: black; 121°C for 2 minutes: no color change or color markedly different compared to black; 134°C for 2 minutes: black; 134°C for 0.3 minutes: no color change or color markedly different compared to black; 140°C for 30 minutes Dry heat: no color change
Result: PASS
Hospital steam sterilizer testing
Purpose: To demonstrate that Autoclave indicator tape achieves specified end color in typical cycles in hospital sterilizers.
Acceptance Criteria: Color change from yellow to black
Result: PASS
Biocompatibility and ink transfer test
Purpose: To demonstrate that the indicator does not create biocompatibility issues to health care professionals and patients.
Acceptance Criteria: Individual components should not create biocompatibility issues. Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and steam processed indicators. Testing according to ISO 10993-5, ISO 10993-10 and ISO 10993-23. The subject device is non-toxic, non-irritant or non-sensitizing.
Result: PASS
End point stability and shelf life study
Purpose: Determine the length of time that an exposed Autoclave Indicator Tape retains its postexposure signal color. To demonstrate that Autoclave Indicator Tape meets the performance parameters when tested using real-time shelf-life exposure method.
Acceptance Criteria: 9 month Meet specifications after real-time 24 months shelf-life exposure.
Result: PASS
Offset/transference
Purpose: Demonstrate the Autoclave indicator tape do not bleed or offset to substrate which it's applied according to ISO 11140-1: 2014.
Acceptance Criteria: The Autoclave indicator tapes shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the steam sterilization cycles for which it is designed.
Result: PASS
Adhesion test
Purpose: To evaluate if the peel adhesion of the autoclave indicator tape.
Acceptance Criteria: ≥3.8 N/19mm
Result: PASS
EO Indicator Tape
ISO 11140-1:2014 testing for Type 1 indicator
Purpose: To demonstrate conformance of EO indicator tape to the requirements specified in ISO 11140-1:2014 for process indicators and the FDA guidance for industry and FDA staff, "Premarket Notification [510(k)] Submissions for Chemical Indicators".
Acceptance Criteria: 54°C, RH 60%, EO 600mg/l, 2 min: no color change or color markedly different compared to green; 54°C, RH 60%, EO 600mg/l, 20 min: green color; 60°C, RH ≥85%, EO - none, 90 min: no change
Result: PASS
Hospital EO sterilizer testing
Purpose: To demonstrate that EO indicator tape achieves specified end color in typical cycles in hospital sterilizers.
Acceptance Criteria: Color change from orange to green.
Result: PASS
Biocompatibility and ink transfer test
Purpose: To demonstrate that the indicator does not create biocompatibility issues to health care professionals and patients.
Acceptance Criteria: Individual components should not create biocompatibility issues. Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and EO processed indicators. Testing according to ISO 10993-5, ISO 10993-10 and ISO 1099-23. The subject device is non-toxic, non-irritant or non-sensitizing.
Result: PASS
End point stability and shelf-life study
Purpose: Determine the length of time that an exposed EO Indicator Tape retains its postexposure signal color. To demonstrate that Autoclave Indicator Tape meets the performance parameters when tested using real-time shelf-life exposure method.
Acceptance Criteria: 9 month Meet specifications after real-time 18 months shelf-life exposure.
Result: PASS
Offset/transference
Purpose: Demonstrate the EO indicator tape do not bleed or offset to substrate which it's applied according to ISO 11140-1: 2014.
Acceptance Criteria: The EO indicator tapes shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the EO sterilization cycles for which it is designed.
Result: PASS
Adhesion test
Purpose: To evaluate if the peel adhesion of the EO indicator tape.
Acceptance Criteria: ≥3.8 N/19mm
Result: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2024
Jiangmen New Era External Use Drug Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K241036
Trade/Device Name: Autoclave Indicator Tape; EO Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: JOJ Dated: November 15, 2024 Received: November 15, 2024
Dear Ivy Wang:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
Stephen A. Anisko -S
Digitally signed by Stephen A. Anisko -S Date: 2024.12.17 08:16:57 -05'00'
for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control Devices 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) K241036
Device Name Autoclave Indicator Tape EO Indicator Tape
Indications for Use (Describe)
Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.
The Autoclave Indicator Tape can be used in the following steam sterilization cycles:
-
Gravity: 121°C, 30 minutes
-
Vacuum assisted (pre-vacuum): 134°C, 4 minutes
EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile.
The EO Indicator Tape can be used in the following EO sterilization cycle:
55°C, 762mg/l EO, 40~80%RH, 4 hours exposure
| 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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4
510(K) Summary
K241036
Prepared date: 2024-12-10 A. Applicant: Jiangmen New Era External Use Drug Co., Ltd Address: No 8 Beiyuan RD., Jianghai Dist., Jiangmen City Guangdong China Contact: Mr. Yingxuan Mu Tel: +86 13119640020 Email: myxuan@kenai-tape.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
| B. Device: | |
|---|---|
| Device Name | Model |
| Autoclave Indicator Tape | 19mm x 50m, 25mm x 50m, 18mm x 50m, 24mm x 50m, 12mm x 50m, 12.5mm x 50m, 19mm x 30m, 25mm x 30m, 12mm x 30m, 19mm x 55m, 25mm x 55m, 18mm x 55m, 24mm x 55m, 12mm x 55m, 12.5mm x 55m, 19mm x 45yards, 25mm x 45yards, 12mm x 45yards, 20mm x 45yards |
| EO Indicator Tape | 19mm x 50m, 25mm x 50m, 18mm x 50m, 24mm x 50m, 12mm x 50m, 12.5mm x 50m, 19mm x 30m, 25mm x 30m, 12mm x 30m, 19mm x 55m, 25mm x 55m, 18mm x 55m, 24mm x 55m, 12mm x 55m, 12.5mm x 55m, 19mm x 45yards, 25mm x 45yards, 12mm x 45yards, 20mm x 45yards |
R Device:
Common name: Sterilization Indicator
Classification Name: Physical/Chemical Sterilization Process Indicator
Regulation Number: 880.2800
Product Code: JOJ
Device Class: Class II
5
C. Predicate device:
| 510(k) Number | Trade Name | Manufacturer |
|---|---|---|
| K210553 | Steam-Dot Process Indicator | Propper Manufacturing Company, Inc. |
| K210866 | Steri-Dot® Process Indicator | Propper Manufacturing Company, Inc. |
D. Indications for use of the device:
Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.
The Autoclave Indicator Tape can be used in the following steam sterilization cycles:
-
- Gravity: 121℃, 30 minutes
-
- Vacuum assisted (pre-vacuum):
134℃, 4 minutes
EO Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed and unprocessed units or loads. The chemical indicator lines turn from orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile. The EO Indicator Tape can be used in the following EO sterilization cycle: 55°C, 762mg/l EO, 40~80%RH, 4 hours exposure
E. Device Description:
Autoclave Indicator Tape is a single chemical indicator designed for steam sterilizing monitoring. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial yellow color of the indicator ink on the autoclave indicator tape changes to Black. If no color change occurs, it may indicate that the autoclave indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.
EO Indicator Tape is single chemical indicator designed for use in ethylene oxide sterilizing processes. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial orange color of the indicator ink on the EO indicator tape changes to green. If no color change occurs, it may indicate that the EO indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.
F. Technological Characteristics Comparison Table
| Device | Subject Device | Predicate Device | Result |
|---|---|---|---|
| 510K number | K241036 | K210553 | - |
6
| Product name | Autoclave Indicator Tape | Steam-Dot™ Process Indicator | - |
|---|---|---|---|
| Classification | Class II | Class II | Same |
| Regulation | 880.2800 | 880.2800 | Same |
| Product code | JOJ | JOJ | Same |
| Indications | |||
| for | |||
| use | Autoclave Indicator Tape is | ||
| designed for use by a health care | |||
| provider to demonstrate that the | |||
| unit or load has been exposed to a | |||
| steam sterilization process and to | |||
| distinguish between processed and | |||
| unprocessed units or loads. After | |||
| steam sterilization, the chemical | |||
| indicator lines will show a visual | |||
| color change from yellow to | |||
| Black. This is a single use, | |||
| disposable device(s), and provided | |||
| non-sterile. | |||
| The Autoclave Indicator Tape can | |||
| be used in the following steam | |||
| sterilization cycles: |
- Gravity: 121°C, 30 minutes
- Vacuum assisted (pre-vacuum):
134°C, 4 minutes | The Steam-Dot process indicator
for steam sterilization is designed
for use by a health care provider
to demonstrate that the unit or
load has been exposed to a steam
sterilization process, and to
distinguish between processed
and unprocessed units or loads.
The indicator dots turn from
white to dark brown/black when
exposed to steam sterilization
conditions, thus providing an
indication of processed items.
The Steam-Dot process indicator
can be used in the following
steam sterilization cycles:
Gravity: 121°C/250°F - 30 min
Pre-vacuum: 132°C/270°F -3min
Pre-vacuum: 132°C/270°F -4min
Pre-vacuum: 134°C/273°F -3 min
Pre-vacuum: 134°C/273°F -4 min
Pre-vacuum: 135°C/275°F -3 min | Similar
The subject
device has
less steam
sterilization
cycle than
predicate
device. |
| Intended use | sterilization process indicator | sterilization process indicator | Same |
| Sterilization
method | Steam sterilization | Steam sterilization | Same |
| Type of
sterilization
cycles | Gravity and pre-vacuum | Gravity and pre-vacuum | Same |
| Sterilization
cycles | Gravity: 121°C, 30 minutes
Vacuum assisted (pre-vacuum):
134°C, 4 minutes | 121°C-30 min gravity
132°C-3 min pre-vacuum
132°C-4 min pre-vacuum
134°C-3 min pre-vacuum
134°C-4 min pre-vacuum
135°C-3 min pre-vacuum | Similar
The subject
device has
less steam
sterilization
cycle than
predicate
device. |
| Endpoint
specification | Change to Black color | Change to Black, dark brown
color | Similar |
| Initial color | Yellow | White | Similar |
| Device design | Crepe paper printed with
indicator ink lines | Paper dots printed with indicator
ink | Similar |
| Back
side
of
indicators | Adhesive | Adhesive | Same |
| Performance | ISO 11140-1:2014 | ANSI/AAMI/ISO 11140-1:2014 | Same |
| ISO
Indicator
type | Type 1 | Type 1 | Same |
| Single use | Yes | Yes | Same |
| Shelf life | 2 years | 4 years | Similar |
7
| Device | Subject Device | Predicate Device | Result |
|---|---|---|---|
| 510K number | K241036 | K210866 | - |
| Product name | EO Indicator Tape | Steri-Dot Process Indicator | - |
| Classification | Class II | Class II | Same |
| Regulation | 880.2800 | 880.2800 | Same |
| Product code | JOJ | JOJ | Same |
| Indications | |||
| for | |||
| use | EO Indicator Tape is designed for | ||
| use by a health care provider to | |||
| demonstrate that the unit or load | |||
| has been exposed to an EO gas | |||
| sterilization process and | |||
| to | |||
| distinguish between processed and | |||
| unprocessed units or loads. The | |||
| chemical indicator lines turn from | |||
| orange to Green when exposed to | |||
| EO gas sterilization conditions. | |||
| This is a single use, disposable | |||
| device(s), and provided | |||
| non-sterile. | |||
| The EO Indicator Tape can be | |||
| used in the following EO | |||
| sterilization cycle: | The Steri-Dot® process indicator | ||
| for EO gas sterilization is | |||
| designed for use by a health care | |||
| provider to demonstrate that the | |||
| unit or load has been exposed to | |||
| an EO gas sterilization process, | |||
| and to distinguish between | |||
| processed and unprocessed units | |||
| or loads. The indicator dots turn | |||
| from purple-red to green when | |||
| exposed to EO gas sterilization | |||
| conditions, thus providing an | |||
| indication of processed items. | |||
| The Steri-Dot process indicator | |||
| can be used in the following EO | Similar | ||
| The subject | |||
| device has | |||
| less | |||
| sterilization | |||
| cycle than | |||
| predicate | |||
| device. | |||
| 55°C, 762mg/l EO, 40~80%RH, 4 | sterilization cycles: |
- 37° C, 736 mg/l EO, ≥35% | |
| | hours exposure | RH, 3 hours exposure - 37° C, 759 mg/l EO, ≥35%
RH, 3 hours exposure - 54°C, 600 mg/l EO, 40-60%
RH, 45 min or longer - 54° C, 736 mg/l EO, ≥35%
RH, 1 hour exposure - 55° C, 759 mg/l EO, ≥35%
RH, 1 hour exposure - 55°C, 600 mg/l EO, 40-60%
RH, 4 hours exposure | |
| Intended use | sterilization process indicator | sterilization process indicator | Same |
| Sterilization
method | Ethylene Oxide gas sterilization | Ethylene Oxide gas sterilization | Same |
| Sterilization
cycles | 55°C, 762mg/1 EO, 40~80%RH, 4
hours exposure | 37° C, 736 mg/l EO, ≥35% RH, 3
hrs
37° C, 759 mg/l EO, ≥35% RH, 3
hrs
54°C, 600 mg/1 EO, 40-60% RH, 45
min or longer
54° C, 736 mg/l EO, ≥35% RH, 1
hour
55° C, 759 mg/l EO, ≥35% RH, 1
hour
55°C, 600 mg/l EO, 40-60% RH, 4
hrs | Similar.
The subject
device has
less
sterilization
cycle than
predicate
device. |
| Endpoint
specification | Change to Green color | Change to green color | Similar |
| Initial color | Orange | Purple-red | Similar |
| Device design | Crepe paper printed with
indicator ink lines. | Paper dots printed with adhesive
backing printed with indicator
ink | Similar |
| Back side of
indicators | Adhesive | Adhesive | Same |
| ISO Indicator
type | Type 1 | Type 1 | Same |
| Single use | Yes | Yes | Same |
| Shelf life | 18 months | 42 months | Similar |
8
9
G. Summary of Non-Clinical Testing
Provided below is the non-clinical testing that was performed to demonstrate that the subject device met the acceptance criteria for each standard or test method.
| Autoclave Indicator Tape | |||
|---|---|---|---|
| Test | Purpose | Acceptance Criteria | Result |
| Steam process | |||
| indicator | |||
| performance test | |||
| according to | |||
| ISO 11140- | |||
| 1:2014 testing | |||
| for Type 1 | |||
| indicator and | |||
| FDA guidance | To demonstrate conformance | ||
| of Autoclave indicator tape | |||
| to the requirements specified | |||
| in ISO 11140-1:2014 and | |||
| FDA guidance for industry | |||
| and FDA staff, "Premarket | |||
| Notification [510(k)] | |||
| Submissions for Chemical | |||
| Indicators". | 121°C for 10 minutes: black | ||
| 121°C for 2 minutes: no color | |||
| change or color markedly | |||
| different compared to black | |||
| 134°C for 2 minutes: black | |||
| 134°C for 0.3 minutes: no color | |||
| change or color markedly | |||
| different compared to black | |||
| 140°C for 30 minutes Dry heat: | |||
| no color change | PASS | ||
| Hospital steam | |||
| sterilizer testing | To demonstrate that | ||
| Autoclave indicator tape | |||
| achieves specified end color | |||
| in typical cycles in hospital | |||
| sterilizers. | Color change from yellow to | ||
| black | PASS | ||
| Biocompatibility | |||
| and ink transfer | |||
| test | To demonstrate that the | ||
| indicator does not create | |||
| biocompatibility issues to | |||
| health care professionals and | |||
| patients. | Individual components should not | ||
| create biocompatibility issues. | |||
| Testing according to ISO | |||
| 11140-1:2014. | |||
| Requirement: 6.2.2. No ink | |||
| transfer should be observed on | |||
| unprocessed and steam processed | |||
| indicators. | |||
| Testing according to ISO | |||
| 10993-5, ISO 10993-10 and ISO | |||
| 10993-23. The subject device is | |||
| non-toxic, non-irritant or | |||
| non-sensitizing. | PASS | ||
| End point | |||
| stability and | |||
| shelf life study | Determine the length of time | ||
| that an exposed Autoclave | |||
| Indicator Tape retains its | 9 month | PASS |
10
| | postexposure signal color.
To demonstrate that
Autoclave Indicator Tape
meets the performance
parameters when tested using
real-time shelf-life exposure
method. | Meet specifications after
real-time 24 months shelf-life
exposure. | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Offset/
transference | Demonstrate the Autoclave
indicator tape do not bleed or
offset to substrate which it's
applied according to ISO
11140-1: 2014. | The Autoclave indicator tapes
shall not offset or bleed, penetrate
the substrate to which it is
applied, or materials in which it is
in contact before, during or after
the steam sterilization cycles for
which it is designed. | PASS |
| Adhesion test | To evaluate if the peel
adhesion of the autoclave
indicator tape. | ≥3.8 N/19mm | PASS |
EO Indicator Tape
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ISO 11140- | |||
| 1:2014 testing | |||
| for Type 1 | |||
| indicator | To demonstrate conformance | ||
| of EO indicator tape to the | |||
| requirements specified in | |||
| ISO 11140-1:2014 for | |||
| process indicators and the | |||
| FDA guidance for industry | |||
| and FDA staff, "Premarket | |||
| Notification [510(k)] | |||
| Submissions for Chemical | |||
| Indicators". | 54°C, RH 60%, EO 600mg/l, 2 | ||
| min: no color change or color | |||
| markedly different compared to | |||
| green | |||
| 54°C, RH 60%, EO 600mg/l, 20 | |||
| min: green color | |||
| 60°C, RH ≥85%, EO - none, 90 | |||
| min: no change | PASS | ||
| Hospital EO | |||
| sterilizer | |||
| testing | To demonstrate that EO | ||
| indicator tape achieves | |||
| specified end color in typical | |||
| cycles in hospital sterilizers. | Color change from orange to | ||
| green. | PASS | ||
| Biocompatibility | |||
| and ink transfer | |||
| test | To demonstrate that the | ||
| indicator does not create | |||
| biocompatibility issues to | |||
| health care professionals and | |||
| patients. | Individual components should not | ||
| create biocompatibility issues. | |||
| Testing according to ISO | |||
| 11140-1:2014. | |||
| Requirement: 6.2.2. No ink | |||
| transfer should be observed on | |||
| unprocessed and EO processed | |||
| indicators. | PASS |
11
| Testing according to ISO 10993-5, ISO 10993-10 and ISO 1099-23. The subject device is non-toxic, non-irritant or non-sensitizing. | |||
|---|---|---|---|
| End point stability and shelf-life study | Determine the length of time that an exposed EO Indicator Tape retains its postexposure signal color. | ||
| To demonstrate that Autoclave Indicator Tape meets the performance parameters when tested using real-time shelf-life exposure method. | 9 month | ||
| Meet specifications after real-time 18 months shelf-life exposure. | PASS | ||
| Offset/transference | Demonstrate the EO indicator tape do not bleed or offset to substrate which it's applied according to ISO 11140-1: 2014. | The EO indicator tapes shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the EO sterilization cycles for which it is designed. | PASS |
| Adhesion test | To evaluate if the peel adhesion of the EO indicator tape. | ≥3.8 N/19mm | PASS |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K210553 and K210866.