STERRAD 50 & STERRAD 100S STERILIZERS

K023290 · Advanced Sterilization Products · FLF · Apr 3, 2003 · General Hospital

Device Facts

• Record ID: K023290
• Device Name: STERRAD 50 & STERRAD 100S STERILIZERS
• Applicant: Advanced Sterilization Products
• Product Code: FLF · General Hospital
• Decision Date: Apr 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations: - 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 . The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.

Device Story

STERRAD 50 and 100S are stand-alone hydrogen peroxide gas plasma sterilization systems; used in hospital settings to process reusable medical instruments. System hardware/software injects aqueous hydrogen peroxide into a vaporizer bowl; vapor enters a negative-pressure chamber; radio frequency (RF) energy transforms vapor into gas plasma. Process eliminates microbial contaminants on device surfaces and within lumens. Healthcare providers load instruments into the chamber; system operates automatically; output is a sterilized device ready for clinical use. Benefits include effective sterilization of titanium and specific stainless steel lumen configurations without toxic residuals.

Clinical Evidence

Bench testing only. Validation used B. stearothermophilus endospores (>10^6) in half-cycle tests. Results confirmed SAL of 10^-6 for titanium surfaces and specified stainless steel lumens (1mm x 125mm and 2mm x 250mm). Simulated use testing with organic/inorganic challenge (fetal bovine serum/hard water) showed spore log reduction (SLR) of 6.0–7.0. In-use testing on hospital-processed devices confirmed efficacy.

Technological Characteristics

Hydrogen peroxide gas plasma sterilization system. Hardware includes sterilization chamber, vaporizer, and RF energy source. Compatible with titanium and stainless steel. Operates under negative pressure. Software-controlled cycle. No specific ASTM material standards cited.

Indications for Use

Indicated for sterilization of medical devices composed of titanium or single stainless steel lumens (ID ≥1 mm, length ≤125 mm; or ID ≥2 mm, length ≤250 mm) in STERRAD 50 and 100S systems.

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® 50 Sterilization System (K981625)
• STERRAD® 100S Sterilization System (K991999)

Submission Summary (Full Text)

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# 193290 0(k) Summary

APR - 3 2003

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, RAC Regulatory Affairs Director Tel: [phone] Fax: [phone]

March 24, 2003

1.0 CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME Classification Name: Sterilizer, Class II Common/Usual Name: Hydrogen Peroxide Gas Plasma Sterilization System Product Classification: Sterilizer, Class II Proprietary Name: STERRAD® 50 Sterilization System and STERRAD® 100S Sterilization System

#### 2.0 PREDICATE DEVICES

STERRAD® 50 Sterilization System (K981625) and STERRAD® 100S Sterilization System (K991999)

#### 3.0 INDICATIONS FOR USE

This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:

- 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 .

The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.

> 510(k) Summary Appendix 43 - Page 1

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#### 4.0 DESCRIPTION OF DEVICES

The STERRAD® 50 & 100S Sterilizers are self-contained stand-alone systems 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 radio frequency (RF) electrical energy.

The equipment (hardware and software) for the STERRAD® 50 & 100S Sterilizers is the same as that of the predicate devices. 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 disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.

#### 5.0 SUMMARY OF NONCLINICAL TESTS

#### STERRAD® 50 & 100S Validation 5.1

- Testing was performed using the "overkill" approach. 5.1.1
- 5.1.2 Test Organism: B. stearothermophilus
- Titanium Surface Sterilization 5.1.3

### 5.1.3.1 STERRAD® 50

Surface sterilization efficacy studies were performed in the STERRAD® 50 Sterilizer with titanium materials representative of the materials commonly used in re-usable medical devices.

Results of this study demonstrated an SAL of at least 10° for medical device surface sterilization in the complete STERRAD® 50 sterilization process titanium material listed as recommended for use in the STERRAD® 50 Sterilizer.

### 5.1.3.2 STERRAD® 100S

Surface sterilization efficacy studies were performed in the STERRAD® 100S Sterilizer with titanium materials representative of the materials commonly used in re-usable medical devices.

Results of this study demonstrated an SAL of at least 10th for medical device surface sterilization in the complete STERRAD® 100S sterilization process titanium material listed as recommended for use in the STERRAD® 100S Sterilizer.

### 5.1.4 Lumen Sterilization 5.1.4.1 STERRAD® 50

Half-cycle validation tests were performed using B. stearothermophilus endospores (>106 spores) inside stainless steel

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lumens, 1 mm internal diameter (ID) x 125 mm long and 2 mm (ID) x 250 mm long, placed within the STERRAD® 50 Sterilizer expanded utility validation load.

The results of this study demonstrated that a sterility assurance level (SAL) of 10th is achieved in a full STERRAD 50 Sterilization cycle when processing stainless steel lumens of >1 mm (ID) x ≤125 mm long and >2 mm (ID) x <250 mm long.

### 5.1.4.2 STERRAD® 100S

Half-cycle validation tests were performed using B. stearothermophilus endospores (>106 spores) inside stainless steel lumens, 1 mm internal diameter (ID) x 125 mm long and 2 mm (ID) x 250 mm long, placed within the STERRAD® 100S Sterilizer expanded utility validation load.

The results of this study demonstrated that a sterility assurance level (SAL) of 10° is achieved in a full STERRAD 100S Sterilization cycle when processing stainless steel lumens of >1 mm (ID) x <125 mm long and >2 mm (ID) x <250 mm long.

### 5.1.5 Tyvek-Mylar Pouched Device Sterilization 5.1.5.1 STERRAD® 50

Half-cycle validation studies with 1 mm internal diameter (ID) x 125 mm long and 2 mm (ID) x 250 mm long stainless steel straight lumens in Tyvek-Mylar pouches were performed to demonstrate sterilization efficacy with the STERRAD® 50 Sterilization System.

The results of this study demonstrated that a sterility assurance level (SAL) of 10th was achieved in a full STERRAD 50 Sterilization cycle when processing stainless steel lumens. >1 mm (ID) x <125 mm long and >2 mm (ID) x <250 mm long, packaged in STERAD Sterilization pouches. This study validates the use of STERRAD Sterilization pouches in the STERRAD 50 Sterilization System.

## 5.1.5.2 STERRAD® 100S

Half-cycle validation studies with 1 mm internal diameter (ID) x 125 mm long and 2 mm (ID) x 250 mm long stainless steel straight lumens in Tyvek-Mylar pouches were performed to demonstrate sterilization efficacy with the STERRAD® 100S Sterilization System.

The results of this study demonstrated that a sterility assurance level (SAL) of 10th was achieved in a full STERRAD 100S Sterilization cycle when processing stainless steel lumens, ≥1 mm

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(ID) x <125 mm long and >2 mm (ID) x <250 mm long, packaged in STERRAD Sterilization pouches. This study validates the use of STERRAD Sterilization pouches in the STERRAD 100S Sterilization System.

#### 5.2 Supporting Microbiological Testing

- 5.2.1 Simulated Use Testing
## 5.2.1.1 STERRAD 50

The devices were inoculated with spores of B. stearothermophilus suspended in 300 ppm hard water (AOAC preparation) supplemented with 5% fetal bovine serum. After drying, the devices were treated either by cleaning, then processing in the STERRAD® 50 sterilizer or by directly processing in the sterilizer, i.e., without cleaning.

The results show that the STERRAD® 50 process is not affected by the presence of an organic and inorganic challenge. The SLR for the unwashed, processed devices was 6.1 and for the washed, processed devices it was 6.0 (1 mm x 125 mm in length devices). The SLR for both the washed and unwashed, processed devices was 6.9 (2 mm ID x 250 mm in length devices).

### 5.2.1.2 STERRAD 100S

The devices were inoculated with spores of B. stearothermophilus suspended in 300 ppm hard water (AOAC preparation) supplemented with 5% fetal bovine serum. After drying, the devices were treated either by cleaning, then processing in the STERRAD® 100S sterilizer or by directly processing in the sterilizer, i.e., without cleaning.

The results show that the STERRAD® 100S process is not affected by the presence of an organic and inorganic challenge. The SLR for the unwashed, processed devices was 6.1 and for the washed, processed devices it was 6.2 (1 mm x 125 mm in length devices). The SLR for the unwashed, processed devices was 7.0 and for the washed, processed devices it was 6.9` (2 mm ID x 250 mm in length devices).

### 5.2.2 In-Use Sterility Testing

### 5.2.2.1 STERRAD 50

Devices representative of lumen claims for the STERRAD® 50 Sterilization System were selected for sterility testing. Devices tested were used in routine surgeries at local hospitals and included stainless steel lumen devices approximately 1 x 125mm and 2 x 250mm in length. The used devices were washed and dried

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according to hospital protocol at the hospital site and transported to ASP to be sterilized in a STERRAD® 50 Sterilization System.

The results of the In-Use testing demonstrated that the STERRAD® 50 Sterilization System was shown to be an effective sterilizer of stainless steel lumen devices approximately 1 x 125mm and 2 x 250mm in length.

### 5.2.2.2 STERRAD 100S

Devices representative of lumen claims for the STERRAD® 100S Sterilization System were selected for sterility testing. Devices tested were used in routine surgeries at local hospitals and included stainless steel lumen devices approximately 1 x 125mm and 2 x 250mm. The used devices were washed and dried according to hospital protocol at the hospital site and transported to ASP to be sterilized in a STERRAD® 100S Sterilization System.

The results of the In-Use testing demonstrated that the STERRAD® 100S Sterilization System was shown to be an effective sterilizer of stainless steel lumen devices approximately 1 x 125mm and 2 x 250mm in length.

#### 5.3 Toxicity Testing of Processed Materials

The cytotoxicitv test results indicated that the titanium materials processed in the STERRAD® 50 & 100S Sterilizers did not induce in vitro cytotoxicity. The residues testing showed that the sterilization process leaves no toxic sterilant residuals on the materials processed.

#### 6.0 OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies have demonstrated that medical devices with titanium surfaces and medical devices with only a single stainless steel lumen with:

- 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 .

may be processed in the STERRAD 50 & 100S Sterilization Systems.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2003

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

Re: K023290

Trade/Device Name: Expanded Indications for the STERRAD® 50 and STERRAD® 100S Sterilizers Regulation Number: 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: FLF Dated: February 4, 2003 Received: February 5, 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 vour 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 - 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 (OS) 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 vours,

Susan Rosser

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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Image /page/7/Picture/0 description: The image shows a logo with the letters ASP inside of a rounded rectangle. The letters are white and the background is black. The letter A is a triangle shape.

ADVANCED STERILIZATION PRODUCTS® a Johnson a Johnson compan REGULATORY AFFAIRS DEPARTMENT

## 510(k) Number (if known): K023290

### Device Name: Expanded Indications for the STERRAD® 50 and STERRAD® 100S Sterilizers

## Indications-For-Use:

This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:

- 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 .

The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Olin S. Lin

Anesthesiology, General Hospital ontrol Den

510(k) Number: K023290

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]