(83 days)
Not Found
No
The device is a chemical indicator that changes color based on physical parameters (time, temperature, steam). There is no mention of software, algorithms, or data processing that would involve AI/ML.
No
This device is a process indicator used for monitoring steam sterilization cycles, not for treating any condition or disease.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition in a patient. The Steam-Dot Process Indicator, as described, is used to confirm exposure of units or loads to a steam sterilization process, not to diagnose a medical condition in a patient.
No
The device is a physical chemical indicator (ink on paper with adhesive) that changes color based on exposure to steam sterilization parameters. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to demonstrate that a unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed items. This is a quality control function for sterilization equipment and processes, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is a chemical indicator that reacts to the physical parameters of a steam sterilization cycle (time, temperature, steam). It does not analyze biological samples or provide information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Diagnosing, monitoring, or predicting disease
- Providing information about a patient's physiological state
The device is a sterilization process indicator, which falls under a different regulatory category than IVDs. The predicate device (K140940) is also described as a "Process indicator tape for steam sterilization," further supporting this classification.
N/A
Intended Use / Indications for Use
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 units or loads. The indicator dots turn from white to dark brown/black when 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 minutes
-
- Vacuum assisted (pre-vacuum): 132 C/270 F 3 minutes
-
- Vacuum assisted (pre-vacuum): 132 C/270 F 4 minutes
-
- Vacuum assisted (pre-vacuum): 134 C/273 F 3 minutes
-
- Vacuum assisted (pre-vacuum): 134 C/273 F 4 minutes
-
- Vacuum assisted (pre-vacuum): 135 C/275 F 3 minutes
Product codes
JOJ
Device Description
The Steam-Dot Process Indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam indicator ink printed on a substrate paper circle, 3/4" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only.
The indicator responds to the critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from white to black/dark brown. If the parameters do not achieve the required level, the indicator color will be light brown or crème.
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)
-
ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 indicator.
- Purpose: To demonstrate conformance of Steam-Dot indicator to the requirements specified in ISO 11140-1:2014 for process indicators.
- Acceptance Criteria: 121°C-10 min: dark brown or black color; 121°C-2 min: no color change or color markedly different compared to dark brown or black; 134°C-2 min: dark brown or black color; 134°C-0.3 min: no color change or color markedly different compared to dark brown or black; 140°C-30 min Dry heat: no color change
- Result: Passed
-
FDA Guidance for industry for chemical indicators. Steam process indicator performance test.
- Purpose: To demonstrate conformance of Steam-Dot indicator to the requirements specified in the FDA Guidance for industry for process indicators.
- Acceptance Criteria: 121°C-10 min: dark brown or black color; 121°C-2 min: no color change or color markedly different compared to dark brown or black; 132-135°C-2 min: dark brown or black color; 132-135°C-20sec: no color change or color markedly different compared to dark brown or black; 140°C-30 min Dry heat: no color change
- Result: Passed
-
Testing in hospital type sterilizers in gravity and pre-vacuum 510k cleared cycles.
- Purpose: To demonstrate that Steam-Dot Process indicator achieves specified end color in typical cycles in hospital sterilizers.
- Acceptance Criteria: Color change from white to dark brown or black
- Result: Passed
-
Biocompatibility study 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.
- Result: Passed
-
End point stability and shelf-life study
- Purpose: To confirm that Steam-Dot process indicator has acceptable stability after processing when achieved and not achieved end point color ("Pass" and "Fail" conditions). To demonstrate that Steam-Dot indicator meets the performance parameters when tested using real-time shelf-life exposure method
- Acceptance Criteria: Steam-Dot indicators processed in Pass and Fail cycles at various time points after production and at the end of shelf life should demonstrate stable color for 110 days. Meet specifications after real-time 48 months shelf-life exposure.
- Result: Passed
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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
May 19, 2021
Propper Manufacturing Co., Inc. Andrew Sharavara Chief Technical Officer 36-04 Skillman Avenue Long Island City, New York 11101
Re: K210553
Trade/Device Name: Steam-Dot Process Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: February 19, 2021 Received: February 25, 2021
Dear Andrew Sharavara:
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.
1
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) 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 medical devices and radiation-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.
for Clarence W. Murray, III, PhD Acting 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
4. Indications for Use Statement
3
Indications for Use
510(k) Number (if known)
Device Name Steam-Dot Process Indicator
Indications for Use (Describe)
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 units or loads. The indicator dots turn from white to dark brown/black when 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 minutes
-
- Vacuum assisted (pre-vacuum): 132 C/270 F 3 minutes
-
- Vacuum assisted (pre-vacuum): 132 C/270 F 4 minutes
-
- Vacuum assisted (pre-vacuum): 134 C/273 F 3 minutes
-
- Vacuum assisted (pre-vacuum): 134 C/273 F 4 minutes
-
- Vacuum assisted (pre-vacuum): 135 C/275 F 3 minutes
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 K210533
5
510(k) Summary
| Submitted by: | Propper Manufacturing Company, Inc. |
|---|---|
| Address: | 36-04 Skillman Avenue, |
| Long Island City, New York 11101 | |
| Contact Name: | Andrew Sharavara, Ph.D., Chief Technical Officer |
| Telephone: | (800) 832-4300 x149 |
| Fax: | (718) 482-8909 |
| E-mail: | as@proppermfg.com |
| Date Submitted: | February 19, 2021 |
Device information:
| Device Trade Name: | Steam-Dot™ Process Indicator |
|---|---|
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Common Name: | Steam Sterilization Indicator |
| Product Code: | JOJ |
| Classification: | Class II (21 C.F.R. 880.2800) |
Description of the Device
The Steam-Dot Process Indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam indicator ink printed on a substrate paper circle, 3/4" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only.
The indicator responds to the critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from white to black/dark brown. If the parameters do not achieve the required level, the indicator color will be light brown or crème.
Indications for Use
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.
6
The Steam-Dot process indicators can be used in the following steam sterilization cycles:
*Gravity: 121°C/250°F - 30 minutes * Vacuum assisted (pre-vacuum): 132°C/270°F - 3 minutes * Vacuum assisted (pre-vacuum): 132°C/270°F - 4 minutes * Vacuum assisted (pre-vacuum): 134°C/273°F - 3 minutes * Vacuum assisted (pre-vacuum): 134°C/273°F - 4 minutes *Vacuum assisted (pre-vacuum): 135°C/275°F - 3 minutes
Performance
The performance of the Steam-Dot process indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators and the requirements of FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003.
Technological Characteristics Comparison Table
Comparison of the subject device (Steam-Dot process indicator, Propper Manufacturing Co., Inc) to Predicate device (Process indicator tape for steam sterilization, Canadian Technical Tape, Ltd).
| Subject device (K210553) | Predicate device (K140940) | Comparison | |
|---|---|---|---|
| Product name | Steam-Dot TM Process Indicator | Process indicator tape for steam sterilization | Similar. Both use “Process indicator” according to Intended use |
| Product generic name | A physical/chemical sterilization process indicator | A physical/chemical sterilization process indicator | Identical |
| Product code | JOJ | JOJ | Identical |
| Sterilization method | Steam sterilization | Steam sterilization | Identical |
| Intended use | Sterilization process indicator | Sterilization process indicator | Identical |
| Sterilization method | The Steam-Dot indicator is intended for use as a steam sterilization cycle process indicator in gravity and pre- vacuum steam sterilizers. | The tape is intended for use as a steam sterilization cycle process indicator in gravity and pre- vacuum steam sterilizers. | Identical |
| Sterilization cycles | 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 | 121°C-30 min gravity | ||
| 132°C-4 min pre-vacuum | |||
| 135°C-3 min pre-vacuum | Similar. Steam-Dot Process Indicator can be used in additional cycles: 132°C-3 min pre-vacuum, 134°C-3 min pre- vacuum 134°C-4 min pre-vacuum. | ||
| End-point | |||
| specification | 121°C-10 min | ||
| 132°C-135°C-2 min | 121°C-10 min | ||
| 132°C-135°C-2 min | Identical | ||
| Device | |||
| design | Paper dots printed with indicator ink | Crepe paper printed with | |
| indicator ink lines | Similar | ||
| Back side of | |||
| indicators | Adhesive | Adhesive | Identical |
| Indicator | |||
| agent | Sulfur, lead carbonate hydroxide | ||
| and magnesium oxide | Sulfur, lead carbonate hydroxide | ||
| and magnesium oxide | Identical | ||
| Initial color | White | White | Identical |
| End point | |||
| color | Black, Dark brown | Black, Dark brown | Identical |
| Performance | ANSI/AAMI/ISO 11140-1:2014 | ANSI/AAMI/ISO 11140-1:2005 | |
| (R)2010 | Identical | ||
| requirements | |||
| for Process | |||
| indicator. | |||
| ISO Indicator | |||
| type | Type 1 | Type 1 | Identical |
| Single use | Yes | Yes | Identical |
| Shelf life | 4 years | 3 years | Similar |
| Indications | |||
| for use | 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 | The Process Indicator Tape for
Steam Sterilization is indicated
for use in holding sterilization
packs together and can be used in
gravity sterilizers operating at
121°C for 30 minutes or pre-
vacuum sterilizers operating at
132°C for 4 minutes and 135°C
for 3 minutes. The indicator
stripes turn dark brown/black
when exposed to steam
sterilization conditions, thus
providing an indication of
processed items. | Similar
Steam-Dot
Process Indicator
can be used in
additional cycles:
132°C-3 min pre-
vacuum, 134°C-3
min pre-vacuum
134°C-4 min pre-
vacuum.
The predicate
device is a
process indicator
tape that changes
color in the
presence of the
sterilant at
Gravity: 121°C
for 30 minutes
and Pre-Vacuum:
132°C for 4
minutes and
135°C for 3
minutes |
| Test | Purpose | Acceptance Criteria | Result |
| ANSI/AAMI/
ISO 11140-
1:2014 testing
for Type 1
indicator. | To demonstrate conformance
of Steam-Dot indicator to the
requirements specified in
ISO 11140-1:2014 for
process indicators. | 121°C-10 min: dark brown or black color
121°C-2 min: no color change or color
markedly different compared to dark brown or
black
134°C-2 min: dark brown or black color
134°C-0.3 min: no color change or color
markedly different compared to dark brown or
black
140°C-30 min Dry heat: no color change | Passed |
| FDA Guidance
for industry for
chemical
indicators.
Steam process
indicator
performance
test. | To demonstrate conformance
of Steam-Dot indicator to the
requirements specified in the
FDA Guidance for industry
for process indicators. | 121°C-10 min: dark brown or black color
121°C-2 min: no color change or color
markedly different compared to dark brown or
black
132-135°C-2 min: dark brown or black color
132-135°C-20sec: no color change or color
markedly different compared to dark brown or
black
140°C-30 min Dry heat: no color change | Passed |
| Testing in
hospital type
sterilizers in
gravity and pre-
vacuum 510k
cleared cycles. | To demonstrate that Steam-
Dot Process indicator
achieves specified end color
in typical cycles in hospital
sterilizers. | Color change from white to dark brown or
black | Passed |
| Biocompatibilit
y study 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. | Passed |
| End point
stability and
shelf- life study | To confirm that Steam-Dot
process indicator has
acceptable stability after
processing when achieved
and not achieved end point
color ("Pass" and "Fail"
conditions).
To demonstrate that Steam-
Dot indicator meets the
performance parameters
when tested using real-time
shelf-life exposure method | Steam-Dot indicators processed in Pass and
Fail cycles at various time points after
production and at the end of shelf life should
demonstrate stable color for 110 days.
Meet specifications after real-time 48 months
shelf-life exposure. | Passed |
7
8
Summary of Non-Clinical Testing
9
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Steam-Dot process indicator is as safe, as effective, and performs as well as or better than the legally marketed device K140940.