Sporox® Sterilizing & Disinfecting Solution is a ready-to-use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. Sporox® Sterilizing and Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20℃ to high level disinfect. Sporox® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.

Device Description

Sporox is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in Sporox, ® exerts i s germicide via a strong oxidation reaction of cellular components.

AI/ML Overview

The provided text describes Reckitt & Colman Inc.'s Sporox, a 7.5% hydrogen peroxide solution intended as a liquid chemical sterilant and high-level disinfectant. The submission (K970230) compares Sporox to the predicate device, Cidex Formula 7.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Germicidal Activity:	Sporocidal: Demonstrated using appropriate AOAC methods.
- Bactericidal	Demonstrated using appropriate AOAC methods.
- Fungicidal	Demonstrated using appropriate AOAC methods.
- Virucidal	Demonstrated using appropriate AOAC methods.
- Sporicidal	Demonstrated using appropriate AOAC methods.
- Tuberculocidal	Demonstrated using appropriate AOAC methods.
Biocompatibility/Toxicity:	Demonstrated for product safety by meeting FDA guidance on biocompatibility testing.
- Acute Dermal Toxicity	Testing conducted.
- Acute Oral Toxicity	Testing conducted.
- Primary Skin Irritation	Testing conducted.
- In-vitro Hemolysis	Testing conducted.
- Primary Eye Irritation	Testing conducted.
- Neutral Red Uptake Bioassay	Testing conducted.
- 28-day Oral Toxicity	Testing conducted.
Stability (Unopened): Minimum two years	Demonstrated minimum of two years stability when unopened and stored according to label.
Reuse Period: Minimum 21 days	Demonstrated 21 days reuse when used at 20℃ according to label.
Device/Material Compatibility: Compatibility with medical devices/materials as per labeling.	Demonstrated compatibility through studies with actual devices (simulated/clinical use) and rigorous evaluation of plastics, metals, elastomers exposed to Sporox for 500 hours at 20°C (equivalent to 1000 disinfectant cycles).
Residue Levels: Extremely low levels, below toxic/harmful effects.	Demonstrated extremely low residues, significantly below levels expected to induce toxic or harmful effects, consistent with FDA guidance.
High-Level Disinfection Contact Time: Specific conditions for heat-sensitive medical equipment.	30 minutes at 20℃ to high-level disinfect.
Minimum Effective Concentration (MEC):	6% (nominal is 7.5%).

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

The document does not explicitly state the sample sizes for the specific tests, particularly for the germicidal activity assays, toxicity studies, or material compatibility evaluations in terms of number of devices or organism cultures.

Provenance: The studies were conducted by Reckitt & Colman Inc. and involved standardized in vitro (e.g., AOAC methods for germicidal activity, biocompatibility tests) and in vivo (toxicity) studies.
- Actual Use Testing: Involves both "endoscopes after patient use" and "inoculated endoscopes." This suggests prospective or real-world application data, as well as controlled laboratory simulations.
- Clinical Setting: Documentation of Sporox use by the Mayo Clinic in the clinical setting was submitted, which implies retrospective clinical use data.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the various tests. The nature of the device (chemical sterilant/disinfectant) means ground truth is often established by:

Laboratory assays: Measured against established scientific standards (e.g., AOAC methods for log reduction, specified toxicity endpoints).
Clinical outcomes: For actual use testing, the "ground truth" would be the observed efficacy (sterilization/disinfection) and safety (lack of adverse effects) in a real-world or simulated clinical setting.
Compliance with guidance: Adherence to FDA guidance on biocompatibility and residue testing implies using established scientific protocols and benchmarks.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method like 2+1 or 3+1. These methods are typically used for interpreting subjective medical images or clinical findings. For chemical germicide testing, the results are generally objective and quantifiable (e.g., log reduction, chemical residue levels, observed toxicity endpoints), which do not typically require a panel adjudication process.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for evaluating the impact of AI-assisted diagnostic tools on human reader performance, typically in imaging. This device is a chemical disinfectant/sterilant, not a diagnostic tool requiring human interpretation of data where AI assistance would be applicable in this context.

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

Yes, the primary performance evaluation of Sporox is standalone (device-only performance). The entire suite of tests (germicidal activity, toxicity, stability, material compatibility, residue testing) evaluates the inherent properties and effectiveness of the Sporox chemical solution itself, without requiring human intervention in the performance evaluation beyond preparing the solution and conducting the tests. The "actual use testing" also assesses the device in a standalone capacity within the context of clinical reprocessing.

7. The Type of Ground Truth Used

The ground truth used is a combination of:

Expert Consensus/Standardized Methods: For germicidal activity, "appropriate AOAC use dilution, fungicidal, tuberculocidal and sporicidal methods" establish the ground truth for microbial inactivation based on widely accepted scientific standards.
Laboratory Benchmarks/Endpoints: For toxicity and biocompatibility studies, "FDA's guidance on biocompatibility testing" and specific endpoints (e.g., irritation, hemolysis) serve as the ground truth for safety.
Observed Efficacy and Safety: For actual use testing, the ground truth is the observed sterility/disinfection and lack of adverse effects during reprocessing of endoscopes and in the Mayo Clinic clinical setting.
Chemical Analysis: For residue testing, the ground truth involves quantifiable chemical levels compared against safe thresholds based on expert toxicological assessment.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. Sporox is a chemical germicide; it is not an AI/machine learning algorithm that requires training data. The data gathered from the various tests (germicidal, toxicity, stability, compatibility, residue) are for validation and characterization of the chemical product's performance against predefined criteria, not for training an algorithm.

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

As there is no training set for this type of device, this question is not applicable.

Summary

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RECKITT & COLMAN INC.

SECTION 4

K970230

510(k) SUMMARY ·

SPOROX®

OCT 2 9 1997

RECKITT & COLMAN INC. 225 SUMMIT AVENUE MONTVALE, NJ 07645

Date: October 24, 1997

This summary of 511)(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21CFR5807.92 as delineated in the Eederal Register, Vol. 59, No. 239, pg 6428 ff, December 14, 1994.

1,0 Conta :t Person:

Ms. Eileen J. Moyer Director of Regulatory Affairs Reckit: & Colman Inc. 1 Philips Parkway Montviale, NJ 07645

(201)573-6314 Phone: (201)573-6046 Fax:

Name of Device: 2.0

Sporox® Trade Name: Hydrogen Peroxide Common Name: Classification name(s): Liquid Chemical Sterilant / high level disinfectant (MED) Unclassified

Predicate Device: 3.0

Cidex' Formula 7 Long-Life Activated Dialdehyde Solution, manufactured by Johnson & Johnson (K924334).

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RECKITT & COLMAN INC.

Description of Devices: 4.0

Intendud Use: 5.0

Sporox® is intended to be used as a ready-to-use liquid chemical sterilant for the sterilization or high-level disinfection of heat-sensitive medical egujpment for which alternative methods of terminal reprocessing are not suitable or available.

Technological Characteristics: 6.0

Both Sporox® and the predicate device, Cidex, are liquid chemical sterilants for sterilization or high-level disinfection of heat-sensitive medical equipment for which alternative methods of terminal reprocessing are not suitable or available. They differ primarily in their active ingredient, the need fc r activation, contact conditions and reuse period. Cidex's active ingredient is 2.5% dialdehyde and, unlike Sporox, it requires activation. The contact time as a sterilant is 6 hours at 20°C for Sporox, and 10 hours at 25℃ for Cidex®. The contact time for disinfection is 30 minutes at 20℃ for Sporox® and 90 minutes at 25℃ for Cidex.® Finally, Sporox® can be reused for up to 21 days and Cidex can be reused for up to 28 days.

6.1 Nonclinical Tests (Toxicity / Stability)

Reckitt & Colman conducted testing that demonstrated Sporox's pactericidal, fungicidal, virucidal, sporicidal, and tuberculocidal activity, utilizing appropriate AOAC use dilution, fungicidal, uberculocidal and sporicidal methods. Additionally, the Company conducted acute dermal toxicity, acute oral toxicity, primary skin rritation, in-vitro hemolysis, primary eye irritation, neutral red iptake bioassay, and 28-day oral toxicity testing, consistent with -DA's guidance on biocompatibility testing. See FDA, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, #G95-1 (May 1, 1995). These tests demonstrated the product's safety for use as a Ilouid chemical sterilant. The Company also conducted stability studies demonstrating the product has a minimum of two years stability if unopened and stored according to label instruction, and that the product can be reused for up to 21 days when used at 20℃ according to label instructions.

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RECKITT & COLMAN INC.

Device / Material Compatibility Studies 6.2

The Company demonstrated the compatibility of Sporox with medical devices and device materials, as set forth in the product's labeling, by conducting studies with actual devices, in both simulated use and clinical applications, and by conducting a rigorous evaluation of a number of difference plastics, metals, and elastomers commonly used in medical devices and noted in the product label. The materials were exposed to a Sporox solution, containing 7.42% hydrogen peroxide content for 500 hours at 20°C (equivalent to 1000 disinfectant cycles).

6.3 Residue Testing

The Company conducted testing consistent with FDA's "Guidance on the Content and Format of 510(k) Submission for Liquid Chemical Germicides," demonstrating extremely low levels of residuals associated with reprocessing of even very complex medical devices. The levels were significantly below levels which are expected to induce toxic or harmful effects.

6.4 Actual Use Testing

Reckitt & Colman Inc. has submitted actual use testing and information that demonstrates the safety and efficacy of Sporox® for use as a liquid chemical sterilant. The company has submitted testing for Sporox® utilizing endoscopes after patient use and using inoculated endoscopes. The product was marketed previously for thirteen years with no experience of adverse effects. Documentation of Sporox® use by the Mayo Clinic in the clinical setting was submitted by the company.

The above nonclinical and device/material compatibility studies demonstrate that Sporox® is as safe and effective as Cidex® Formula 7 Long-Life Activated Dialdehyde Solution.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Eileen J. Moyer Director of Requlatory Affairs Reckitt & Colman, Incorporated One Philips Parkway Montvale, New Jersey 07645-1575

OCT 2 9 1997

Re : K970230 Trade Name: Sporox® Requlatory Class: Unclassified Product Code: MED Dated: October 16, 1997 ---October 17, 1997 Received:

Dear Ms. Moyer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Moyer

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion 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 obtained from the Division 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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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K970230 510(k) NUMBER:

Sporox® Sterilizing & Disinfecting Solution DEVICE NAME:

INDICATIONS FOR USE:

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

CONCURRENCE OF CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Division of Dental, Infection Control,and General Hospital Devices
510(k) Number(Per 21 CFR§801.109)	K970230
OR	Over-the-Counter Use X

Regulation Number and Section

§ 880.6885 Liquid chemical sterilants/high level disinfectants.

(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.