Steam-Dot Process Indicator

K210553 · Propper Manufacturing Co., Inc. · JOJ · May 19, 2021 · General Hospital

Device Facts

• Record ID: K210553
• Device Name: Steam-Dot Process Indicator
• Applicant: Propper Manufacturing Co., Inc.
• Product Code: JOJ · General Hospital
• Decision Date: May 19, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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

Device Story

Single-use chemical indicator; 3/4" diameter paper circle with adhesive backing; printed with reactive steam indicator ink (sulfur, lead carbonate hydroxide, magnesium oxide). Used by healthcare providers in steam sterilizers to monitor exposure to critical parameters: time, temperature, saturated steam. Ink changes color from white to dark brown/black upon successful exposure; light brown/crème if parameters not met. Provides visual confirmation of processed items; aids in distinguishing processed from unprocessed loads. Bench testing confirms performance per ANSI/AAMI/ISO 11140-1:2014.

Clinical Evidence

Bench testing only. Conformance to ANSI/AAMI/ISO 11140-1:2014 and FDA guidance for chemical indicators demonstrated. Testing included performance in hospital-type sterilizers across cleared cycles, biocompatibility, ink transfer, end-point stability, and real-time shelf-life (48 months) studies. All tests passed.

Technological Characteristics

Single-use chemical indicator; 3/4" diameter paper substrate with adhesive. Reactive ink contains sulfur, lead carbonate hydroxide, and magnesium oxide. Type 1 process indicator per ANSI/AAMI/ISO 11140-1:2014. Color change: white to dark brown/black. Shelf life: 4 years.

Indications for Use

Indicated for use by healthcare providers to verify exposure of units or loads to steam sterilization and distinguish between processed and unprocessed items. Compatible with gravity (121°C/30 min) and pre-vacuum (132°C/3-4 min, 134°C/3-4 min, 135°C/3 min) steam sterilization cycles.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Process indicator tape for steam sterilization (K140940)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 4. Indications for Use Statement

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## Indications for Use

510(k) Number (if known)

K210553

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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510(k) Summary K210533

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# 510(k) Summary

| Submitted by: | Propper Manufacturing Company, Inc. |
|-----------------|------------------------------------------------------------|
| Address: | 36-04 Skillman Avenue,<br>Long Island City, New York 11101 |
| Contact Name: | Andrew Sharavara, Ph.D., Chief Technical Officer |
| Telephone: | [phone] x149 |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| 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.

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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<br>132°C-3 min pre-vacuum<br>132°C-4 min pre-vacuum<br>134°C-3 min pre-vacuum<br>134°C-4 min pre-vacuum<br>135°C-3 min pre-vacuum | 121°C-30 min gravity<br>132°C-4 min pre-vacuum<br>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<br>specification | 121°C-10 min<br>132°C-135°C-2 min | 121°C-10 min<br>132°C-135°C-2 min | Identical |
| Device<br>design | Paper dots printed with indicator ink | Crepe paper printed with<br>indicator ink lines | Similar |
| Back side of<br>indicators | Adhesive | Adhesive | Identical |
| Indicator<br>agent | Sulfur, lead carbonate hydroxide<br>and magnesium oxide | Sulfur, lead carbonate hydroxide<br>and magnesium oxide | Identical |
| Initial color | White | White | Identical |
| End point<br>color | Black, Dark brown | Black, Dark brown | Identical |
| Performance | ANSI/AAMI/ISO 11140-1:2014 | ANSI/AAMI/ISO 11140-1:2005<br>(R)2010 | Identical<br>requirements<br>for Process<br>indicator. |
| ISO Indicator<br>type | Type 1 | Type 1 | Identical |
| Single use | Yes | Yes | Identical |
| Shelf life | 4 years | 3 years | Similar |
| Indications<br>for use | The Steam-Dot process indicator<br>for steam sterilization is designed<br>for use by a health care provider<br>to demonstrate that the unit or<br>load has been exposed to a steam<br>sterilization process, and to<br>distinguish between processed and<br>unprocessed units or loads.<br>The indicator dots turn from<br>white to dark brown/black when<br>exposed to steam sterilization<br>conditions, thus providing an<br>indication of processed items.<br><br>The Steam-Dot process indicator<br>can be used in the following<br>steam sterilization cycles:<br>Gravity: 121°C/250°F - 30 min<br>Pre-vacuum: 132°C/270°F -3min<br>Pre-vacuum: 132°C/270°F -4min<br>Pre-vacuum: 134°C/273°F -3 min<br>Pre-vacuum: 134°C/273°F -4 min<br>Pre-vacuum: 135°C/275°F -3 min | The Process Indicator Tape for<br>Steam Sterilization is indicated<br>for use in holding sterilization<br>packs together and can be used in<br>gravity sterilizers operating at<br>121°C for 30 minutes or pre-<br>vacuum sterilizers operating at<br>132°C for 4 minutes and 135°C<br>for 3 minutes. The indicator<br>stripes turn dark brown/black<br>when exposed to steam<br>sterilization conditions, thus<br>providing an indication of<br>processed items. | Similar<br><br>Steam-Dot<br>Process Indicator<br>can be used in<br>additional cycles:<br>132°C-3 min pre-<br>vacuum, 134°C-3<br>min pre-vacuum<br>134°C-4 min pre-<br>vacuum.<br><br>The predicate<br>device is a<br>process indicator<br>tape that changes<br>color in the<br>presence of the<br>sterilant at<br>Gravity: 121°C<br>for 30 minutes<br>and Pre-Vacuum:<br>132°C for 4<br>minutes and<br>135°C for 3<br>minutes |
| Test | Purpose | Acceptance Criteria | Result |
| ANSI/AAMI/<br>ISO 11140-<br>1:2014 testing<br>for Type 1<br>indicator. | To demonstrate conformance<br>of Steam-Dot indicator to the<br>requirements specified in<br>ISO 11140-1:2014 for<br>process indicators. | 121°C-10 min: dark brown or black color<br>121°C-2 min: no color change or color<br>markedly different compared to dark brown or<br>black<br>134°C-2 min: dark brown or black color<br>134°C-0.3 min: no color change or color<br>markedly different compared to dark brown or<br>black<br>140°C-30 min Dry heat: no color change | Passed |
| FDA Guidance<br>for industry for<br>chemical<br>indicators.<br>Steam process<br>indicator<br>performance<br>test. | To demonstrate conformance<br>of Steam-Dot indicator to the<br>requirements specified in the<br>FDA Guidance for industry<br>for process indicators. | 121°C-10 min: dark brown or black color<br>121°C-2 min: no color change or color<br>markedly different compared to dark brown or<br>black<br>132-135°C-2 min: dark brown or black color<br>132-135°C-20sec: no color change or color<br>markedly different compared to dark brown or<br>black<br>140°C-30 min Dry heat: no color change | Passed |
| Testing in<br>hospital type<br>sterilizers in<br>gravity and pre-<br>vacuum 510k<br>cleared cycles. | To demonstrate that Steam-<br>Dot Process indicator<br>achieves specified end color<br>in typical cycles in hospital<br>sterilizers. | Color change from white to dark brown or<br>black | Passed |
| Biocompatibilit<br>y study and ink<br>transfer test | To demonstrate that the<br>indicator does not create<br>biocompatibility issues to<br>health care professionals and<br>patients. | Individual components should not create<br>biocompatibility issues.<br>Testing according to ISO 11140-1:2014.<br>Requirement: 6.2.2. No ink transfer should be<br>observed on unprocessed and steam processed<br>indicators. | Passed |
| End point<br>stability and<br>shelf- life study | To confirm that Steam-Dot<br>process indicator has<br>acceptable stability after<br>processing when achieved<br>and not achieved end point<br>color ("Pass" and "Fail"<br>conditions).<br>To demonstrate that Steam-<br>Dot indicator meets the<br>performance parameters<br>when tested using real-time<br>shelf-life exposure method | Steam-Dot indicators processed in Pass and<br>Fail cycles at various time points after<br>production and at the end of shelf life should<br>demonstrate stable color for 110 days.<br>Meet specifications after real-time 48 months<br>shelf-life exposure. | Passed |

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# Summary of Non-Clinical Testing

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## 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.