SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS

K090650 · Spsmedical Supply Corp. · JOJ · Oct 9, 2009 · General Hospital

Device Facts

• Record ID: K090650
• Device Name: SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
• Applicant: Spsmedical Supply Corp.
• Product Code: JOJ · General Hospital
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators are process indicators used to verify exposure to the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro 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 strips, labels, tapes, and cards used to verify exposure to vaporized hydrogen peroxide (H2O2) during sterilization. Device changes color from original state to Blue upon exposure to H2O2. Used by healthcare providers in clinical settings to distinguish processed from unprocessed items (wraps, containers, cassettes, pouches). Provides visual confirmation of sterilization cycle exposure; does not indicate sterility of the item itself. Simple passive chemical reaction; no electronic or mechanical components.

Clinical Evidence

Bench testing only. Verification and validation performed per FMEA assessment. Testing conducted according to AAMI/ANSI/ISO 11140:2005 requirements for indicators in vaporized hydrogen peroxide sterilization. Simulated use testing performed in STERRAD 100S, 200, 100NX, NX and STERIS V-Pro processes using multiple lots with varying shelf life. All lots yielded acceptable results.

Technological Characteristics

Chemical indicator (strip, label, tape, card) for vaporized H2O2. Passive color-changing chemistry. Complies with AAMI/ANSI/ISO 11140:2005. No energy source, software, or electronic components.

Indications for Use

Indicated for use as process indicators for all vaporized hydrogen peroxide cycles in STERRAD 100S, 200, 100NX, NX and STERIS V-Pro sterilization processes. Used by healthcare providers 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

• SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators (K030680)

Submission Summary (Full Text)

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

# 510(k) Summary of Safety and Effectiveness

K090650 510k No.:

# Submitter:

OCT - 9 2009

- SPSmedical Supply Corp. . 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: [phone] Fax: [phone]
- Establishment FDA Registration No .: 1319130 .
- Date Summary was Prepared September 21, 2009 .
- . Gary J. Socola Printed name of person submitting for 510(k) വം . 70€

Signature of netson submitting for 510(k)

- . Vice President, Scientific Affairs Title of person submitting for 510(k)
## Device Name and Classification

Trade Name:

Classification Name:

Common Name:

Device Classification:

Product Code:

Predicate Device:

SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators

Sterilization Process Chemical Indicator

Vaporized Hydrogen Peroxide Chemical Indicators

General Hospital - Class II, Regulation Number 880.2800

80JOJ

SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators (K030680)

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

#### Device Description:

SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators are process indicators used to verify exposure to vapor hydrogen peroxide in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. Indicators will identify if an item has seen H2O2 during the sterilization process by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.

#### Intended Use:

The SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators are process indicators used to verify exposure to the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro 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.

Statement of Similarity to the Legally Marketed Predicate Device:

- Have the same intended use .
- Have the same device design .
- Incorporate the same technical characteristics ●
- Incorporate the same materials .
- Have the same endpoint color change .
- Have the same shelf life .
- Have the same storage conditions .
- Packaged using the same materials and processes .

#### Non-Clinical Testing:

Verification and validation tests were performed as a result of a Failure Mode and Effects Analysis (FMEA) assessment.

Various testing, including testing to AAMI/ANSI/ISO 11140:2005 requirements for indicators being run in vaporized hydrogen peroxide sterilization processes was performed. Testing also included simulated use in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro vaporized hydrogen peroxide sterilization processes. Multiple lots of indicators with various levels of shelf life were included in testing.

All lots of SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators gave acceptable results for all test performed.

### Conclusion:

For all the foregoing reasons, SPSmedical believes that the SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators are safe and effective when used for routine monitoring of STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro vaporized hydrogen peroxide sterilization processes and can be safely marketed in the United States.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Gary J. Socola Vice President, Scientific Affairs SPSmedical Supply Corporation 6789 West Henrietta Road Rush, New York 14543

OCT - 9 2009

Re: K090650

Trade/Device Name: SPSmedical H2O2 Chemical Indicator Regulation Number: 21CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 18, 2009 Received: June 22, 2009

Dear Mr. Socola:

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 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.

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

### Page 2- Mr. Socola

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony O., as attorn for
S. & R.S. M.

Susan Runner, D.D.S., M.A Acting Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

# INDICATIONS for USE STATEMENT

Applicant: ___________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SPSmedical H2O2 Chemical Indicator

Indications For Use:

The SPSmedical H2O2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro 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.

| Catalog Number | Product Name |
|----------------|-----------------|
| GPS-250R | Indicator Strip |
| GPS-250Y | Indicator Strip |
| GPL-2000R | Indicator Label |
| GPL-2000Y | Indicator Label |
| HT-048 | Indicator Tape |
| HT-036 | Indicator Tape |
| 5093 | Indicator Card |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use V (21 CFR 801 Subpart C)

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

oncurrence of CDRH, Office of Device Evaluation (ODE)

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

Page *_ of _*

510(k) Number: K090650