The STERRAD® 100S Sterilizer is designed for sterilization of both metal and mommetal 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. (See list of recommended Materials in Section 3 of the Operator's Manual.)

The STERRAD® 100S Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Metal and nonmetal lumened instruments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 100S Sterilizer. (See list of recommended Materials in Section 3 of the Operator's Manual)

Medical devices with only a single stainless steel lumen which has an inside diameter equal to or greater than 3 mm and a length less than or equal to 400 mm can be processed in the STERRAD® 100S Sterilizer.

Device Description

The STERRAD® 100S 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 radio frequency (RF) electrical energy.

The equipment (hardware) for the STERRAD® 100S Sterilizer is the same as that of the predicate device, the STERRAD® 100 Sterilizer. (Note that the STERRAD® 100S Sterilizer does contain two additional hardware features, an oil return valve, added for customer convenience; and a door position sensor and control.) 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.

AI/ML Overview

Acceptance Criteria and Device Performance for STERRAD® 100S Sterilizer

The STERRAD® 100S Sterilizer is a hydrogen peroxide gas plasma sterilization system designed to sterilize medical instruments and devices at low temperatures. The validation testing followed an "overkill" approach, demonstrating efficacy under challenging conditions.

1. Acceptance Criteria and Reported Device Performance

The acceptance criterion for sterilization is a Sterility Assurance Level (SAL) of at least 10⁻⁶, meaning there is no more than a one in a million chance of a single viable microorganism remaining after sterilization.

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance
Dose-Response Relationship	Positive "dose response" to increasing hydrogen peroxide injection volume. No spore survivors with 720 µL or greater injection volume under half-cycle conditions. A 10⁻⁶ SAL for a full-cycle.	B. stearothermophilus spore death kinetics data on various materials demonstrated a positive "dose response." No spore survivors on any material with an injection volume of 720 µL or greater under half-cycle conditions (nominal half-cycle volume is 1440 µL). This validates a 10⁻⁶ SAL for a STERRAD® 100S Sterilizer full-cycle. (>6 SLR in a half-cycle exposure).
Surface Sterilization	10⁻⁶ SAL for medical device surface sterilization for all materials listed as recommended for use.	Results demonstrate an SAL of at least 10⁻⁶ for medical device surface sterilization in the complete STERRAD® 100S sterilization process for all recommended materials.
Mated Surfaces Sterilization	10⁻⁶ SAL for mated surface sterilization.	An SAL of 10⁻⁶ was demonstrated for mated surface sterilization in the complete STERRAD® 100S Sterilization process (half-cycle studies with mated biological indicator carriers).
Lumen Sterilization (Metal)	10⁻⁶ SAL for stainless steel lumens (3 x 400 mm).	No spore survivors after multiple half-cycles for stainless steel lumens (3 x 400 mm). These results demonstrate an SAL of 10⁻⁶ for the complete STERRAD® 100S Sterilization process.
Lumen Sterilization (Non-metal)	10⁻⁶ SAL for plastic lumens with inner diameters of 6 mm or larger and lengths of 310 mm or shorter.	All test samples were sterile after processing polyethylene lumens (6 x 310 mm) with B. stearothermophilus spores under half-cycle conditions (3 cycles, 10 test samples each). This demonstrates an SAL of 10⁻⁶.
Tyvek-Mylar Pouched Device Sterilization	No spore survivors with half-cycle conditions for 3 x 400 mm stainless steel straight lumens in Tyvek-Mylar pouches.	No spore survivors were observed with the half-cycle conditions for Tyvek pouched stainless steel lumens (with BIs) in a validation tray.
Bacteriostasis Testing	No bacteriostatic effect from processed carriers on microorganisms.	All test carriers/materials demonstrated the desired outgrowth within the 14-day incubation period when inoculated with B. stearothermophilus spores. This indicates no bacteriostatic effect, though neoprene required catalase.
Sporicidal Microbiological Testing	No growth on carriers (silk suture loops and penicylinders) contaminated with B. subtilis and Cl. sporogenes.	None of the carriers demonstrated growth after AOAC Sporicidal Activity of Disinfectants tests.
Simulated Use Testing	Efficacy minimally affected by organic and inorganic soil challenge. A 6.1 log reduction for properly washed devices.	The process is minimally affected by the presence of an organic and inorganic soil challenge. For properly washed devices, a 6.1 log reduction was shown. The process demonstrated effective sterilization of highly resistant spores in diffusion-restricted environments (e.g., scissors hinges).
In-Use Sterility Testing	Successful sterilization of actual surgical instruments with open, mated/hinged, and lumened surfaces (3 x 400 mm).	The results demonstrated that the STERRAD® 100S Sterilizer successfully sterilizes actual surgical instruments (stainless steel, open, mated/hinged, and 3x400mm lumened) used in clinical cases.
In Use Bacteriostasis/Fungistasis	No bacteriostatic or fungistatic effects seen with processed stainless steel open surfaces, mated/hinged surfaces, and 3 x 400 mm lumened surgical instruments.	The study demonstrated no bacteriostatic or fungistatic effects when processed instruments (stainless steel open, mated/hinged, and 3x400mm lumened) were exposed to Cl. sporogenes, C. albicans, or B. subtilis.
Toxicity Testing	No toxic sterilant residuals on processed materials.	Cytotoxicity and in vivo biocompatibility testing of materials processed showed that the sterilization process leaves no toxic sterilant residuals.

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

The document does not explicitly state a singular "test set" sample size in terms of number of devices or total runs, as the testing was multifaceted. However, specific sample sizes are mentioned for certain tests:

Dose-Response Relationship: "various materials (representative of materials used in medical devices) as spore carriers" were used. The results state "no spore survivors on any material" with sufficient injection volume, but the exact number of material types or replicates is not specified.
Surface Sterilization: "various substrate materials representative of the material commonly used in re-usable medical devices" were used. "Inoculated spore carriers (with at least 1 x 10⁶ B. stearothermophilus endospores)" were processed, but the precise number of carriers is not given.
Mated Surfaces Sterilization: "Mated BIs with at least 1 x 10⁶ B. stearothermophilus spores" were used, but the number of mated BIs is not specified.
Lumen Sterilization (Metal): B. stearothermophilus endospores (>10⁶ spores) were inside stainless steel lumens (3 x 400 mm). There were "no spore survivors after multiple half-cycles," implying multiple lumens and cycles were run, but specific numbers are not provided.
Lumen Sterilization (Non-metal): "Three cycles were performed with ten test samples in each cycle" for 6 x 310 mm polyethylene lumens. This means a total of 30 test samples.
Tyvek-Mylar Pouched Device Sterilization: "Ten Tyvek pouched stainless steel lumens, with BIs (>10⁵ B. stearothermophilus spores)," were processed in one half-cycle run.
Bacteriostasis Testing: "carriers of various materials" were used, but the number is not specified.
AOAC Sporicidal Activity: "carriers (silk suture loops and penicylinders)" were used, but the number is not specified.
Simulated Use Testing: "The devices were inoculated with spores...". No specific sample size is given.
In-Use Sterility Testing: "Devices representative of surface-feature and lumen claims" were "used in routine surgeries at a local hospital." The report states "actual surgical instruments" but does not give a quantity of instruments or tests. Given the context (submission date 1999), this data is retrospective in nature (using previously used instruments).
In Use Bacteriostasis and Fungistasis Test: "Devices representative of surface features and lumen claims" were selected, but the number is not specified.

Data Provenance: The studies were conducted by Advanced Sterilization Products (ASP), a division of Ethicon, Inc. in Irvine, CA. The "In-Use Sterility Testing" mentions "routine surgeries at a local hospital" and "transported to ASP," suggesting the clinical data originated from a US hospital and was then tested at ASP's facilities. The other studies appear to be laboratory-based validation tests conducted by ASP. All data can be considered retrospective in the context of the device's development and submission.

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 microbial inactivation, specifically the absence of viable spores to demonstrate a sterility assurance level (SAL) of 10⁻⁶. This is established through standard microbiological methods involving culture and detection of microbial growth (or lack thereof).

Number of Experts: The document does not specify the number of individual experts (e.g., microbiologists) who established the ground truth. It refers to the testing being performed by the applicant (ASP). It's reasonable to assume that qualified microbiologists or biotechnicians within ASP's R&D or Quality Assurance departments conducted these studies.
Qualifications of Experts: The specific qualifications of the individuals performing the microbiological analysis are not explicitly stated (e.g., "radiologist with 10 years of experience"). However, given the nature of the testing (sterilization validation, biological indicator processing, spore counts, SAL determination), it would require individuals with expertise in microbiology, sterilization science, and good laboratory practices. The AOAC and USP methods mentioned imply adherence to recognized standards that require specific technical proficiency.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there might be inter-reader variability.

For sterilization validation studies, the "ground truth" (i.e., presence or absence of viable microorganisms) is determined by objective microbiological culture methods. The outcome is generally binary (sterile or non-sterile) based on standardized test procedures. Therefore, an "adjudication method" in the sense of expert consensus for subjective interpretation is not applicable to this type of study. The results are based on objective laboratory measurements.

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.

MRMC studies are typically used to evaluate the diagnostic performance of a new medical imaging device or AI algorithm, often comparing human readers with and without AI assistance across multiple cases. This submission is for a sterilization device, not a diagnostic or imaging device, and its performance is measured by its ability to kill microorganisms, not by human interpretation or diagnosis. Therefore, such a study would not be relevant or appropriate for this device.

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

The STERRAD® 100S Sterilizer itself is an automated system. Its performance is evaluated in a standalone manner, meaning the effectiveness of the sterilization cycle is measured directly without human intervention influencing the microbial kill results. The "algorithm" here can be considered the predefined sterilization cycle parameters (temperature, vacuum, H₂O₂ injection, plasma phases).

The performance data presented throughout the summary (Dose-Response, Surface Sterilization, Lumen Sterilization, etc.) represent the standalone performance of the STERRAD® 100S system in achieving sterility. Human operators manage the loading and initiation of the cycle, but the cycle's sporicidal efficacy is intrinsic to the device's design and operating parameters, independent of real-time human interpretation during the sterilization process.

7. The Type of Ground Truth Used

The primary ground truth used for all sterilization efficacy studies is microbiological negativity / absence of viable microorganisms. This is established by:

Viable Spore Counts: Measuring the initial high load of B. stearothermophilus spores (typically 1 x 10⁶ or higher) on biological indicators (BIs) or inoculated test devices.
Culture Techniques: After the sterilization cycle, the BIs or test devices are incubated in appropriate growth media (e.g., TSB) to detect any surviving microorganisms. The absence of growth in these cultures confirms sterility for that sample.
Sterility Assurance Level (SAL): The ground truth is ultimately tied to achieving an SAL of 10⁻⁶, which is a statistical probability derived from these microbial inactivation studies, indicating that the probability of a single viable microorganism occurring on an item after sterilization is less than or equal to one in a million.

Additionally, pathology/histology (implied by "cytotoxicity and in vivo biocompatibility testing") was used to assess the ground truth for biocompatibility and lack of toxic residuals from the sterilization process.

8. The Sample Size for the Training Set

This document describes the validation and performance testing of a physical medical device (sterilizer) and not a software algorithm that requires a "training set" in the machine learning sense. Therefore, the concept of a "training set" as it relates to AI/ML is not applicable here.

The device's operational parameters were likely developed and refined through extensive R&D and engineering studies, which could be seen as an iterative process analogous to training, but not with a distinct "training set" of data in the AI context. The document refers to "Process Variables and Parameters: Rationale and Definition," and "A matrix experiment was performed that tested the process variables of chamber wall temperature and plasma power within specification limits." These experiments helped define the optimal cycle parameters, but are not a "training set" for an algorithm.

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

Since a "training set" in the AI/ML sense is not applicable to this device, the question of how its ground truth was established is also not applicable.

However, if one were to consider the development of the device's operational parameters as an analog to "training," the "ground truth" during this development phase would have been iteratively established through experimental results showing effective microbial kill under various conditions, leading to the optimized and validated cycle parameters. This would involve repeated microbiological assessments (as described in section 7) to determine which combinations of process variables achieve the desired level of sterility.

Summary

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ADVANCE! > < TERILLIZATION PRODUCTS®

on Johnson company REGULATORY AFFAIRS DEPARTMENT

JUN 1 5 2000

K991999

510(k) Summary

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 Manager of Regulatory Affairs Tel: (949) 453-6410 Fax: (949) 789-3900

Submission Date

June 11, 1999

Trade Name

STERRAD® 100S Sterilizer

Common Name

Hydrogen Peroxide Gas Plasma Sterilization System

Classification Name

Sterilizer, Class II

Legally Marketed Equivalent Device Name(s)

Hydrogen Peroxide Gas Plasma Sterilizer STERRAD® 100 Sterilization System STERRAD® 50 Sterilization System

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Description of Device

Statement of Intended Use

The STERRAD® 100S Sterilizer is designed for sterilization of both metal 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® 100S Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Metal and nonmetal lumened instruments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 100S Sterilizer.

Summary of Nonclinical Tests

VALIDATION TESTING

Testing was performed using the "overkill" approach.

PREVALIDATION TESTING

. Test Organism: B. stearothermophilus
. Process Variables and Parameters: Rationale and Definition: A matrix experiment was performed that tested the process variables of chamber wall temperature and plasma power

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within specification limits. The study showed that process lethality was unaffected over the range of process parameters tested.

. Characterization of the Pre-Exposure Plasma Phase: was performed to evaluate the effect of Pre-Exposure Plasma on the overall process little= was results of the studies showed that there is very little sporicidal activity in the Pre-Exy. The Plasma phase alone or in combination with the Exposure 1 and Exposure 2 process phases of

STERRAD® 100S PROCESS VALIDATION

Demonstration of a Dose-Response Relationship to Increasing Hydrogen Peroxide Injection

Volume

Dose-response testing was performed using various materials (representative of materials used in medical devices) as spore carriers.

B. stearothermophilus spore death kinetics data obtained for each material tested demonstrate a positive "dose response" to increasing volume of hydrogen peroxide injected under bollf-cycle conditions in the STERRAD® 100S Sterilization process. There were no spore survivors on any material with an injection volume of 720 µL or greater under half-cycle conditions. The nominal hydrogen peroxide injection volume for the half-cycle is 1440 µL. This result demonstrates that the dose response observation is not limited to a singular BI substrate or system and in naces case >6 SLR were observed in a half-cycle exposure. These results validate a 10% SAL for a STERRAD® 100S Sterilizer full-cycle.

Surface Sterilization of Medical Device Materials

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

Inoculated spore carriers (with at least 1 x 10° B. stearothermophilus endospores) made from these materials were placed in the STERAD® 100S Sterilizer validation load and then processed through the STERRAD® 100S Sterilizer at less than half-cycle conditions.

Results of these studies demonstrate an SAL of at least 106 for medical device surface sterilization in the complete STERRAD® 100S sterilization process for all materials listed as recommended for use in the STERRAD® 100S Sterilizer.

Mated Surfaces Sterilization

Half-cycle validation studies with mated biological indicator carriers were performed to demonstrate sterilization efficacy between mated surfaces of medical devices. Mated Bls with at least 1 x 10° B. stearothermophilus spores sandwiched in-between the mated metallic and polymer carriers were processed through the STERRAD® 100S Sterilization System at half-cycle conditions. An SAL of 106 was demonstrated for mated surface sterilization in the complete STERRAD® 100S Sterilization processs.

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Lumen Sterilization

Half-cycle and modified Total-kill Endpoint validation tests were performed using B. stearothermophilus endospores (>10° spores) inside stainless steel lumens (3 x 400 mm) placed within the STERRAD® 100S Sterilizer validation load of medical devices. There were no spore survivors after multiple half-cycles. These results demonstrate a SAL of 106 for the complete STERRAD® 100S Sterilization process.

ASP has conducted an additional test for nonmetallic lumens of 6 x 310 mm, similar to the testing that was performed for the predicate device. Stainless steel coupons inoculated with at least 10° spores of B. stearothermophilus were placed in the center of 6 x 310 mm polyethylene lumens as a test system for devices containing lumens with inner diameters of 6 mm or larger and lengths of 310 mm or shorter. The samples were processed with a validation load in the STERRAD® 100S Sterilizer under half-cycle conditions. Three cycles were performed with ten test samples in each cycle. All test samples were sterile. This result demonstrates an SAL of 10° for plastic lumens with inner diameters of 6 mm or larger and lengths of 310 mm or shorter processed in the STERRAD® 100S Sterilizer.

Tyvek-Mylar Pouched Device Sterilization

Half-cycle validation studies with 3 x 400 mm stainless steel straight lumens in Tyvek-Mylar pouches were performed to demonstrate sterilization efficacy with the STERRAD® 100S Sterilization System. The stainless steel lumens served to represent rigid stainless steel medical devices with lumens. Ten Tyvek pouched stainless steel lumens, with Bls (>10) B. stearothermophilus spores), were placed into a STERRAD® validation tray and processed through the STERRAD® 100S Sterilizer at half-cycle conditions. No spore survivors were observed with the half-cycle conditions.

Bacteriostasis Testing

A bacteriostasis study was performed with carriers of various materials. The materials were placed in open glass petri dishes and exposed to full cycle conditions in the STERRAD® 100S Sterilization system. Following exposure, the carriers were transferred to TSB and were then inoculated with less than 10 colony-forming units of B. stearothermophilus spores. All test carriers/materials demonstrated the desired outgrowth within the 14 day incubation period. however neoprene required the addition of catalase.

The test data indicate there is no bacteriostatic effect from the carriers processed through the STERRAD® 100S Sterilization System.

SUPPORTING MICROBIOLOGICAL TESTING

Sporicidal Microbiological Testing

AOAC Sporicidal Activity of Disinfectants tests using B. subtilis and Cl. sporogenes contaminated carriers (silk suture loops and penicylinders) were performed with the STERRAD® 100S Sterilization System. None of the carriers demonstrated growth.

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Microbiological Spectrum of Activity

Using the predicate device, the STERRAD® 100 Sterilization System, it was shown that a hydrogen peroxide gas plasma process readily sterilizes the representative organisms.

Simulated Use Testing

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 water (AOAC preparation) supplemented with 576 read of 100S sterilizer or by directly were treated of the sterilizer, i.e., without cleaning. Standard microbiological methods were used to determine the presence of surviving spores from each treatment.

The results show that the STERRAD® 100S process is minimally affected by the presence of an The results show that the ollenge. Even if the user does not properly wash the devices, the organic and morganio enancing. Intirates highly resistant spores in a diffusion restricted sterinzer is bith offectry attentions of scissors. When the devices are properly washed (i.e., environmont sater as the matter for the STERRAD® 100S Sterilizer) then a 6.1 log reduction is shown for the process.

In-Use Sterility Testing

Devices representative of surface-feature and lumen claims for the STERRAD® 100S Devices representant o or selected for sterility testing. Devices tested were used in routine surgeries at a local hospital and included stainless steel devices with open surfaces, mated or hinged surfaces and stainless steel lumened devices approximately 3 x 400 mm. The used miged baraoos bara and dried according to hospital protocol at the hospital site and transported to ASP to be sterilized in a STERRAD® 100S Sterilization System.

Sterility testing was performed in accordance with the USP testing methods.

The results of the In-Use testing demonstrated that the STERRAD® 100S Sterilizer successfully sterilizes actual surgical instruments used in clinical cases.

The STERRAD® 100S Sterilization System was shown to be an effective sterilizer of general surgical stainless steel instruments/devices that have open surfaces, mated or hinged surfaces and stainless steel lumened devices approximately 3 x 400 mm.

In Use Bacteriostasis and Fungistasis Test

Devices representative of surface features and lumen claims for the STERRAD® 100S Sterilization System were selected for bacteriostasis testing. Devices testing. Devices tested include those with stainless steel open surfaces, stainless steel mated or hinged surfaces and stainless steel lumened devices approximately 3 x 400 mm.

USP sterility testing methods were used as testing guidelines. This study was performed to validate that processed instruments do not exhibit bacteriostatic effects on

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microorganisms. After processing in the STERRAD® 100S Sterilization System, the devices (or swabs of the larger devices) were placed in TSB and FTM to which Cl. sporogenes. C. albicans or B. subtilis was added.

The results of this study demonstrate that there are no bacteriostatic effects seen with stainless steel open surfaces, stainless steel mated or hinged surfaces and stainless steel 3 x 400 mm lumened surgical instruments/devices when processed thorough the STERRAD® 100S Sterilization System.

TOXICITY TESTING OF PROCESSED MATERIALS

Cytotoxicity and in vivo biocompatibility testing of materials processed in the STERRAD® 100S Sterilizer showed that the sterilization process leaves no toxic sterilant residuals on the materials processed.

Overall Performance Conclusions

The nonclinical studies demonstrate that the STERRAD® 100S Sterilizer is safe and effective for sterilization of medical devices within the indications for the sterilizer and establish equivalence of the STERRAD® 100S Sterilizer to the predicate devices, the STERRAD® 100 Sterilizer and the STERRAD® 50 Sterilizer.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2000

Kevin Corrigan, R.A.C. Director, Regulatory Affairs Advanced Sterilization Products Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618

K991999 Re : STERRAD® 100S Sterilizer Trade Name: Regulatory Class: II Product Code: MLR May 17, 2000 Dated: Received: May 18, 2000

Dear Mr. Corrigan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the action islly equivalent (for the indications for device in babbeandary ure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major be bayour of becting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Corrigan

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your six ... puivalence of your device to a legally marketed predicate device results in a classification for your marketed predice awits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on comprimee as (bolly and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification™ (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours, strong of ANDA

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ADVANCED STERILIZATION PRODUCTS . a Johnrona Johnson company REGULATORY AFFAIRS DEPARTMENT

Indications for Use

510(k) Number:	To Be Assigned
Device Name	STERRAD ® 100S Sterilizer

Indications For Use:

The STERRAD® 100S Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use X
(Optional Format 1-2-96)

(Division
Division of Dental, Infecics Control,
and General Hospital Devices
510(k) Number K991999

DIVISION OF ETHICON, INC. . 33 TECHNOLOGY DRIVE . IRVINE, CA 92618 . (949) 581-5799 . FAX (949) 789-3900

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
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.(b)
Classification. Class II (performance standards).