STERRAD 200 STERILIZER

K030429 · Advanced Sterilization Products · MLR · Aug 18, 2003 · General Hospital

Device Facts

• Record ID: K030429
• Device Name: STERRAD 200 STERILIZER
• Applicant: Advanced Sterilization Products
• Product Code: MLR · General Hospital
• Decision Date: Aug 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The STERRAD® 200 Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cvcle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture. The STERRAD® 200 Sterilize can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer. - An inside diameter of 1 mm or larger and a length of 125 mm or shorter* ● - An inside diameter of 2 mm or larger and a length of 250 mm or shorter* ● - An inside diameter of 3 mm or larger and a length of 400 mm or shorter . Teflon® and polyethylene lumen instruments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer. *The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs).

Device Story

STERRAD 200 Sterilizer is a stand-alone system for low-temperature sterilization of heat/moisture-sensitive medical instruments. Process: aqueous hydrogen peroxide injected into vaporizer; transformed into vapor; introduced into process chamber under negative pressure; converted to gas plasma via electrical energy. System includes sterilization chamber, carriage, disposable sterilant cassettes, and reusable trays. Operated in clinical settings to ensure instrument sterility. Hardware is identical to predicate STERRAD 100S. Benefits include effective sterilization of complex, diffusion-restricted devices without heat damage.

Clinical Evidence

Bench testing only. Validation studies utilized the "overkill" approach with B. stearothermophilus spores. Testing confirmed efficacy for various lumen sizes (1x125mm, 2x250mm, 3x400mm, 6x310mm), surface sterilization, mated surfaces, and pouched configurations. Additional testing included bacteriostasis/fungistasis, simulated use, toxicity, and chemical indicator functionality. All tests passed.

Technological Characteristics

Hydrogen peroxide gas plasma sterilization system. Operates under negative pressure with electrical energy for plasma generation. Hardware includes sterilization chamber, carriage, and disposable cassettes. Compatible with stainless steel, Teflon, and polyethylene materials. Stand-alone system.

Indications for Use

Indicated for sterilization of heat- and moisture-sensitive metal and nonmetal medical devices, including those with diffusion-restricted spaces (e.g., hinged instruments) and specific stainless steel, Teflon, or polyethylene lumens.

Regulatory Classification

Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Predicate Devices

• STERRAD® 100S Sterilization System

Submission Summary (Full Text)

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

# AUG 1 8 2003 510(k) Summary

## K030429

## Applicant's Name, Address, Telephone, FAX, Contact Person

Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

## Contact Person

Kevin Corrigan Director of Regulatory Affairs Tel: [phone] Fax: [phone]

August 12, 2003

#### CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME 1.0

Classification Name: Sterilizer, Class II Common/Usual Name: Hydrogen Peroxide Gas Plasma Sterilization System Product Classification: Sterilizer, Class II Proprietary Name: STERRAD® 200 Sterilizer

#### 2.0 PREDICATE DEVICES

STERRAD® 100S Sterilization System

#### INDICATIONS FOR USE 3.0

The STERRAD® 200 Sterilizer is designed for sterilization of both metal and nonnetal medical devices at low temperatures. Because the cvcle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture.

The STERRAD® 200 Sterilize can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer.

- An inside diameter of 1 mm or larger and a length of 125 mm or shorter* ●
- An inside diameter of 2 mm or larger and a length of 250 mm or shorter* ●
- An inside diameter of 3 mm or larger and a length of 400 mm or shorter .

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

Teflon® and polyethylene lumen instruments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer.

*The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs).

#### 4.0 DESCRIPTION OF DEVICE

The STERRAD® 200 Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices, using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with electrical energy.

The equipment (hardware) for the STERRAD® 200 Sterilizer is the same as that of the predicate device, the STERRAD® 100S Sterilizer. (Note: The STERRAD® 200 Sterilizer is available in either a one-door or two-door model, depending on customer preference). The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as a movable carriage for transport of the cart, disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.

#### 5.0 SUMMARY OF NONCLINICAL TESTS

#### Validation Testing 5.1

Testing was performed using the "overkill" approach utilizing B. stearothermophilus spores. Table one on the following page identifies the validation studies performed and the results obtained.

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

| | | Table 1: Validation Studies | |
|--|--|-----------------------------|--|
|--|--|-----------------------------|--|

| Study | Results |
|----------------------------------------------------------|---------|
| Dose Response with 1 x 125mm Lumens | Passed |
| Dose Response with 2 x 250mm Lumens | Passed |
| Dose Response with 3 x 400mm Lumens | Passed |
| Surface Sterilization | Passed |
| Mated Surface Sterilization | Passed |
| 1 x 125mm Lumen Validation | Passed |
| 2 x 250mm Lumen Validation | Passed |
| 3 x 400mm Lumen Validation | Passed |
| 6 x 310mm Lumen Validation | Passed |
| Pouched 1 x 125mm Lumen Validation | Passed |
| Pouched 2 x 250mm Lumen Validation | Passed |
| Pouched 3 x 400mm Lumen Validation | Passed |
| Bacteriostasis Testing of Carrier Materials | Passed |
| Sporicidal Testing | Passed |
| In Use Testing | Passed |
| Bacteriostasis/Fungistasis Testing | Passed |
| Simulated Use Testing | Passed |
| Toxicity Testing of Materials | Passed |
| Chemical Indicator Functionality | Passed |
| Bacteriostasis Testing of CycleSure Biological Indicator | Passed |

#### 6.0 OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the STERRAD® 200 Sterilizer is safe and effective for sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® 200 Sterilizer to the predicate device, the STERRAD® 100S Sterilizer.

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

Image /page/3/Picture/1 description: The image shows a black and white seal. The seal is circular and contains text around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and a wavy line representing its body. The text around the perimeter is not clearly legible.

Public Health Service

AUG 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Natalie Bennington Senior Regulatory Affairs Specialist Advanced Sterilization Products 33 Technology Drive Irvine, California 92618

Re: K030429

Trade/Device Name: STERRAD® 200 Sterilizer Regulation Number: 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: FLF, MRL Dated: May 21, 2003 Received: May 22, 2003

Dear Ms. Bennington:

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.

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

### Page 2 - Ms. Bennington

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 your 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,

Patina Currente ffor

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

Enclosure

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

ADVANCED STERILIZATION PRODUCTS®

*Johnson-Johnson company*
REGULATORY AFFAIRS DEPARTMENT

## 510(k) Number (if known): K030429

STERRAD® 200 Sterilizer Device Name:

## Indications-For-Use:

Chio S. Lim

n of Anesthesiology, General Hospital. on Control Dental Davices

510(k) Number: K030429

The STERRAD® 200 Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture.

The STERRAD® 200 Sterilizer can sterilize instruments which have diffusion-restricted spaces. such as the hinged portion of forceps and scissors.

Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer.

- An inside diameter of 1 mm or larger and a length of 125 mm or shorter* .
- An inside diameter of 2 mm or larger and a length of 250 mm or shorter* .
- An inside diameter of 3 mm or larger and a length of 400 mm or shorter .

Teflon® and polyethylene luments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer.

*The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs.).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (PER 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

DIVISION OF ETHICON, INC. . 33 TECHNOLOGY DRIVE . IRVINE, CA 92618 . [phone] FAX [phone]