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. Indicators change to a signal color of BLUE after exposure to vapor hydrogen peroxide in these sterilization processes.

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. 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.

AI/ML Overview

This premarket notification describes the SPSmedical Gas Plasma Chemical Indicator. The study conducted aimed to demonstrate substantial equivalence to the predicate device, the Advanced Sterilization Products (ASP) Gas Plasma Indicator Strip (K921910).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Adequate Color Change for Incomplete Cycle (Clearly distinguish unprocessed or incompletely processed items)	All SPSmedical gas plasma indicator samples processed for 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). This indicates successful differentiation of incomplete cycles. The H2O2 concentration was adjusted to 120 uL, resulting in 0.5 mg/L of H2O2, which is significantly less than normal (1440 uL for 6.0 mg/L).
Adequate Color Change for Complete Cycle (Clearly indicate successful processing)	All SPSmedical gas plasma indicator samples processed in complete reaction cycles showed "A full signal color change to BLUE." This confirms successful indication of complete sterilization. The H2O2 concentration was adjusted to one half (720 uL) of the nominal (1440 uL), resulting in 3.0 mg/L of H2O2.
Consistency with Predicate Device	Throughout the various testing, the SPSmedical indicators and the ASP chemical indicator strips reacted similarly in all test configurations. This supports the claim of substantial equivalence.
Stability (Light)	Results verified the stability of the product to retain their initial indicator color and their post-processing signal color over a 2 ½ month period when subjected to natural and artificial light sources. Indicators were not affected by, nor did they experience any substantial fading.
Stability (Shelf Life - Intermediate)	Five and one-half month interim results verified that all indicators turned to their appropriate signal color when subjected to a STERRAD® cycle with an injection volume of 720 µL of the 58% H2O2 solution (3.0 mg/L H2O2). A two-year stability study is ongoing, but initial results support the 2-year shelf life claim.
Resistance to Interfering Substances	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 sensitive to an acidic or basic environment, leading to a precaution in the instructions for use. This indicates awareness and mitigation of potential interference.
Inertness to Other Sterilization Methods (Steam/EO Gas)	Indicators were unaffected by the EO Gas process. Indicators printed on polypropylene shrunk slightly but were otherwise unaffected in the steam process. Indicators printed on Tyvek were grossly deformed in the steam process (this does not hinder the intended H2O2 use).
Biocompatibility	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 complies with 21 CFR 177.1520.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "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.
Data Provenance: The testing was conducted in-house by SPSmedical Supply Corp. The data is retrospective, as it was generated to support the 510(k) submission. No specific country of origin for the data is mentioned other than the submitter's location (Rush, NY, U.S.A.). It is expected that the testing was performed in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The ground truth in this context is the actual state of sterilization (incomplete or complete). This was established by controlling the H2O2 concentration within defined parameters (e.g., 0.5 mg/L for incomplete, 3.0 mg/L for complete, 6.0 mg/L for nominal). The "ground truth" was therefore determined by the controlled experimental conditions rather than human expert opinion. There were no human experts used to establish a subjective "ground truth" for the test set; the ground truth was inherently objective based on the physical process parameters.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was established by controlled experimental conditions (H2O2 concentration), subjective adjudication by experts was not required. The results were objectively recorded as "No change or a change that is markedly different from the change occurring after exposure" or "A full signal color change to BLUE."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where human readers interpret medical images. This device is a chemical indicator with an objective color change.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is a chemical indicator, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance is its inherent color change in response to H2O2 exposure. The testing described demonstrates the direct performance of the chemical indicator itself.

7. The Type of Ground Truth Used

The ground truth used was controlled physical parameters (specifically, varying concentrations of vapor hydrogen peroxide within a STERRAD® 100 GMP test vessel). The "correct" outcome (color change or no color change) was determined by whether the H2O2 concentration represented an incomplete or complete sterilization cycle.

8. The Sample Size for the Training Set

There is no explicit "training set" as this is a physical chemical indicator, not an AI/ML algorithm that requires training data. The device's performance is based on its chemical properties.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

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: (585)-359-0130 Fax: (585)-359-0167
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 Number880.2800
Product Code:	80JOJ
Predicate Device:	Advanced Sterilization Products (ASP) Gas PlasmaIndicator Strip (K921910)

{1}------------------------------------------------

Device Description:

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

{2}------------------------------------------------

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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

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.

{5}------------------------------------------------

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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

{6}------------------------------------------------

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

Regulation Number and Section

§ 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).