SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR

K030680 · Spsmedical Supply Corp. · JOJ · May 9, 2003 · General Hospital

Device Facts

• Record ID: K030680
• Device Name: SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
• Applicant: Spsmedical Supply Corp.
• Product Code: JOJ · General Hospital
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The SPSmedical Gas Plasma Chemical Indicators are indicated for use as process indicators to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 sterilization processes. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items.

Device Story

Chemical indicator strip/label/card used to verify exposure to vapor hydrogen peroxide in STERRAD sterilization processes. Device consists of synthetic paper substrate printed with indicator ink. Upon exposure to hydrogen peroxide, ink undergoes visual color change (Yellow/Red to Blue). Used by healthcare providers in clinical settings to distinguish processed from unprocessed sterilization items (wraps, containers, cassettes, pouches). Provides visual confirmation of sterilant introduction into chamber; does not indicate sterility, only exposure. Benefits patient by ensuring items have undergone intended sterilization cycle.

Clinical Evidence

Bench testing only. 3,000-4,000 indicators from 13 lots tested in STERRAD 100 GMP vessel. Compared against predicate ASP strips under incomplete (0.5 mg/L H2O2) and complete (3.0 mg/L H2O2) reaction cycles. Results showed consistent color change to blue in complete cycles and no change/different color in incomplete cycles, matching predicate performance. Stability testing verified 2-year shelf life and light stability.

Technological Characteristics

Synthetic paper substrate (21 CFR 177.1520) with indicator ink. Two types: Yellow-to-Blue or Red-to-Blue color change. Dimensions: strip, label, or card form factor. Shelf-life: 2 years. Storage: 15-30°C, away from acids/alkalis. Non-toxic inks/coatings.

Indications for Use

Indicated for use by healthcare providers to verify exposure to vapor hydrogen peroxide in STERRAD 100, 100S, and 50 sterilization processes. Used with sterilization wraps, containers, cassettes, or pouches to distinguish processed from unprocessed items.

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

• Advanced Sterilization Products (ASP) Gas Plasma Indicator Strip (K921910)

Submission Summary (Full Text)

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K030680

MAY - 9 2003

# 510(k) Summary of Safety and Effectiveness

Submitter:

- SPSmedical Supply Corp. . 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: [phone] Fax: [phone]
- Establishment FDA Registration No.: 1319130 s
- Date Summary was Prepared April 17, 2003 �
- Gary J. Socola � Printed name of person submitting for 510(k) ರಿ Docs W Aou � Signature of person submitting for 510(k)
- Director of Quality Assurance . Title of person submitting for 510(k)

Device Name and Classification

| Trade Name: | SPSmedical Gas Plasma Chemical Indicator |
|------------------------|-------------------------------------------------------------------------------|
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Common Name: | Chemical Indicator |
| Device Classification: | General Hospital - Class II, Regulation Number<br>880.2800 |
| Product Code: | 80JOJ |
| Predicate Device: | Advanced Sterilization Products (ASP) Gas Plasma<br>Indicator Strip (K921910) |

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# Device Description:

The SPSmedical Gas Plastua Chemical Indicators are process indicators used to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 sterilization processes. They provide a visual indication to belp distinguish between processed and unprocessed items

# Intended Use:

The SPSmedical Gas Plasma Chemical Indicators are indicated for use as process indicators to vetify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 sterilization processes. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items.

# Technical Characteristics:

The SPSmedical Gas Plasma Chemical Indicators are process indicators used to venify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 sterilization processes. The indicators provide a visual indication that hydrogen peroxide (H2O2), an essential ingredient in the STERRAD" sterilization process has been introduced into the sterilizer"s chamber. There are two indicators types. The first indicator changes from a YELLOW beginning color to a BLUE signal color and the second changes from a RED begiming color to a BLUE signal color. SPSmedical is claiming substantial equivalence for its SPSmedical gas plasma chemical indicators to the ASP chemical indicator strip based on test data taken during comparison studies. Testing has demonstrated that the SPSmedical gas plasma chemical indicators perform consistently with equivalent results to that of the predicate ASP indicator strip. Both indicate exposure to the STERRAD® sterilization process. The SPSmedical gas plasma chemical indicators are also comperable to other commercially available indicators currently cleared by the FDA

| ELEMENT | NEW DEVICE | PREDICATE |
|------------------------------|-------------------------|-------------------|
| Intended use | Process Indicator | Process Indicator |
| Device design | Strip, Label, Card | Strip |
| Indicator agent | Indicator Ink | Indicator Ink |
| Sterilization method | STERRAD® (H2O2) | STERRAD® (H2O2) |
| Initial Color/Endpoint Color | Yellow/Blue or Red/Blue | Red/Yellow |
| Substrate | Synthetic Paper | Synthetic Paper |
| Shelf-life | 2 years | 1 year |

Comparison of the SPSmedical Chemical Indicators to the Predicate

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#### Non-Clinical Testing:

During performance testing with the SPSmedical Gas Plasma Chemical Indicators between 3,000-4.000 indicators were tested from 13 separate lots of indicators containing multiple lots of substrates and indicator inks. Multiple lots of the predicate ASP indicator strips and tape were also included during the various testing.

Indicator samples were placed within an Advanced Sterilization Products (ASP) STERRAD® 100 GMP test vessel along with the predicate ASP indicator strip product. The indicators were then subjected to incomplete and complete reaction cycle conditions. In the incomplete cycle the H2O2 concentration was adjusted to 120 uL, resulting in 0.5 mg/L of H2O2. This level is significantly less than the normal concentration of 1440 uL of the 58% H2O2 solution which results in the typical concentration of 6,0 mg/L of H2O2. In the complete reaction cycle the H2O2 concentration was adjusted to be one half (720 uL) of the nominal concentration of 1440 uL of the 58% H2O2 solution resulting in 3.0 mg/L of H2O2. All incomplete and complete reaction cycles were allowed to run their normal processing parameters with the only exception being the reduced H2O2 concentrations which were injected into the STERRAD® 100 GMP test vessel. The incomplete and complete reaction cycles were repeated a total of 3 times, Indicators were observed for proper color change and results were recorded.

All SPSmedical gas plasma indicator samples processed for the incomplete reaction cycles showed "No change or a change that is markedly different from the change occurring after exposure" to the relevant full plasma sterilization process cycle (a color other than BLUE) and all indicator samples processed in the complete reaction cycles showed "A full signal color change to BLUE". Throughout the various testing the SPS medical indical indicators and the ASP chemical indicator strips reacted similarly in all test configurations.

#### Recommended Storage Conditions

Store in a cool, dry place (15-30°C), away from any alkaline chemicals and acids,

# Interfering Substances or Conditions

The SPSmedical gas plasma chemical indicators were tested for the effects of acid and base. Testing verified that the indicators in their unprocessed form are not sensitive to an acidic or basic environment. Testing verified that the indicators in their processed form are securitive to an acidic or basic environment. The instructions for use include a precaution to store the indicators away from any alkaline chemicals and acids.

#### Steam/EO Gas Exposure

Indicators printed on Tyvek and polypropylene were exposed to a steam sterilization cycle of 132°C for 4 minutes exposure time and in a 100% EO Gas sterilizer running at 600mg/l for 60 minutes exposure with 70%RH. The indicators were unaffected by the EO Gas process.

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The indicators printed on polypropylene shrunk slightly but were otherwise waffected in the steam process, The indicators printed on Tyvek were grossly deformed in the steam process, Stability

Light stability was verified over a 2 1/2 month period on indicators which actived a complete signal color change when processed in a STERRAD® Gas Plasms cycle with a H2O2 concentration of 6.0 mg/L and on unprocessed indicators. Both were subjected to natural and artificial light sources. Results verified the stability of the product to retain their inithal indicator color and their post processing signal color during this period. Furthermore, the indicators were not affected by, nor did they experience any substantial fading when subjected to natural or artificial light sources in either their unprocessed or processed form.

# Shelf life

The shelf life of the SPSmedical Plasma Chemical Indicators shall be 2 years from the date of manufacture, when stored in a cool, dry place (15-30°C). Indicators from unopened and opened packages were tested for proper color change results. Five and one-half month intening results verified that all indicators turned to their appropriate signal color when subjected to a STERRAD cycle with an infection volume of 720 µL of the 58% H2O2 solution giving a concentration 3.0 mg/L of H2O2. A two year stability testing study is ongoing.

# Biocompatibility

SPSmedical Gas Plasma Chemical Indicators are printed using nontoxic inks and coatings that will not alter the chemical composition of the products being sterilized and are safe for human contact. The synthetic paper used in the manufacturing of the SPSmedical gas plasma chemical indicator strip complies with 21 CFR 177.1520.

#### Conclusion

Supportive data has demonstrated that the SPSmedical gas plasms chemical indicators are equivalent to the predicate device. Throughout the various testing, the SPS pedical gas plasma chemical indicators and the ASP chemical indicator strips reacted similarly in ell test configurations. The SPSmedical gas plasma chemical indicators have the same intended use and characteristics as the ASP strip. The SPSmedical and ASP products are comprised of synthetic psper materials and are printed with indicator inks which provide a visual indication after being exposed to vapor hydrogen peroxide in the STERRAD® sterilization process. SPSmedical believes that the SPSmedical gas plasma chemical indicators are substantially equivalent to the predicate device because it has the same intended use, technical characteristics and performance. All SPS medical gas plasma chemical indicators are effective and reliable, single use devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing the body and wings.

Public Health Service

MAY - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SPS Medical Supply Company Mr. Ned Devine Responsible Third Party official ENTELA, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K030680

Trade/Device Name: SPSmedical Gas Plasma Chemical Indicator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: April 25, 2003 Received: April 28, 2003

Dear Mr. Devine:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Devine

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susa Punre

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS for USE STATEMENT

Applicant: ___________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: SPSmedical Gas Plasma Chemical Indicator

Indications For Use:

The SPSmedical Gas Plasma Chemical Indicators are indicated for use as process indicators to verify exposure to vapar hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 sterilization processes. They are intended to be used by health care providers with articles such as stenlization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of BLUE after exposure to vapor hydrogen peroxide in these sterilization processes.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE (F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K030680