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

SPOROX® II 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 II ® Sterilizing & 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 II® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.

Device Description

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

AI/ML Overview

This document describes the premarket notification (510(k)) for SPOROX® II, a liquid chemical sterilant/high-level disinfectant. It does not contain information about an AI/ML powered medical device. Therefore, it is not possible to describe acceptance criteria, a study proving the device meets those criteria, or other details typically associated with AI/ML device evaluations.

The provided text details the substantial equivalence of SPOROX® II to a predicate device, SPOROX®, for its intended use as a liquid chemical sterilant and high-level disinfectant for heat-sensitive medical equipment. The evaluation focused on antimicrobial efficacy, stability, safety, and material compatibility.

To address your request by interpreting the closest analogous information available:

The "acceptance criteria" and "device performance" in this context relate to demonstrating substantial equivalence to the predicate device, SPOROX® (K970230).

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (SPOROX® II)
Antimicrobial Efficacy	Equivalent antimicrobial efficacy to the predicate device, SPOROX®. This implies a certain level of germicidal activity (sterilization/high-level disinfection) against relevant microorganisms as per AOAC and EPA methodology.	"Reckitt & Colman Inc. has conducted confirmatory testing that demonstrated SPOROX® II has equivalent antimicrobial efficacy to the predicate device, SPOROX®. The studies utilized appropriate AOAC and EPA methodology."
Stability	Minimum of two years stability when unopened and stored according to label instructions. Product can be reused for up to 21 days when used at 20°C according to label instructions.	"The Company also conducted stability studies demonstrating that SPOROX® II like SPOROX® has a minimum of two years stability if unopened and stored according to label instructions, and that the product can be reused for up to 21 days when used at 20°C according to label instructions."
Safety Profile (Toxicology)	Substantially equivalent safety profile to SPOROX® for acute dermal toxicity, acute oral toxicity, primary eye irritation, primary skin irritation, skin sensitization, in-vitro hemolysis, neutral red uptake cytotoxicity assay, and 28-day repeat dose oral toxicity testing.	"These tests demonstrated that SPOROX® II has a substantially equivalent safety profile to SPOROX® for use as a liquid chemical sterilant and a high level disinfectant."
Material Compatibility	Compatibility with a number of different plastics, metals, and elastomers commonly used in medical devices (as noted in the product label). Additionally, compatibility with materials made with copper and brass, consistent with FDA's Guidance on Premarket Notification for Liquid Chemical Sterilants and High Level Disinfectants. (Exposure to 7.3% hydrogen peroxide for 500 hours at 20℃, equivalent to 1000 disinfectant cycles).	"The Company confirmed compatibility with medical devices equivalent to the predicate device, by conducting a rigorous evaluation on a number of different plastics, metals, and elastomers commonly used in medical devices and noted in the product label. In addition, the Company determined compatibility with materials made with copper and brass which is consistent with FDA's Guidance on The Content and Format of Premarket Notification on [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants. The materials were exposed to a SPOROX® II solution, containing 7.3% hydrogen peroxide content for 500 hours at 20℃ (equivalent to 1000 disinfectant cycles)."
Intended Use	Same intended use as SPOROX®: ready-to-use liquid chemical sterilant for sterilization or high-level disinfection of heat-sensitive medical equipment.	"SPOROX® II has the same intended use as SPOROX®."
Technological Characteristics (Formulation)	Same active ingredients as SPOROX® (hydrogen peroxide). Differences only in the inactive ingredients of the corrosion inhibitor system (improved in SPOROX® II).	"SPOROX® II is similar to the predicate device SPOROX®. SPOROX® II has the same active ingredients as SPOROX®. The only difference between the two products is in the inactive ingredients of the corrosion inhibitor system."

Since this is a submission for a chemical disinfectant, the following questions are not applicable to the provided document:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The "tests" here refer to chemical, biological (microbial), and material compatibility studies, not a "test set" of patient data for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. "Ground truth" in this context would implicitly be the established scientific methods and accepted standards (e.g., AOAC and EPA methodologies) for evaluating disinfectants, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This refers to expert review processes for AI/ML ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is entirely irrelevant for a chemical disinfectant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This refers to AI/ML algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For antimicrobial efficacy: Established microbiological standards and results from AOAC and EPA methods.
For stability: Chemical analysis over time and functional testing of reuse claims.
For safety: Live animal testing (e.g., acute dermal/oral, irritation), in-vitro cell assays, and 28-day repeat dose oral toxicity.
For material compatibility: Observation of materials (plastics, metals, elastomers) after prolonged exposure to the solution.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML model to train or associated ground truth.

Summary

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Attachment 4

K990703

510(k) Summary

SPOROX® II

Reckitt & Colman Inc. 1655 Valley Road Wayne, NJ 07474

1.0 Contact Person:

Mr. Sean McNear Senior Regulatory Affairs Specialist Reckitt & Colman Inc. 1800 Valley Road Wayne, NJ 07474

Phone: 973-686-7390 973-686-7396 Fax:

2.0 Name of Device:

SPOROX® II Trade Name: Hydrogen Peroxide Common Name: Classification names: Liquid Chemical Sterilant / High Level Disinfectant (MED) Unclassified (proposed class II)

3.0 Predicate Device:

The predicate device is SPOROX® Sterilizing & Disinfecting Solution 510(k) #- K970230 (1997) Marketed by Reckitt & Colman Inc.

Description of Device 4.0

Continued on next page

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5.0 Intended Use:

6.0 Technological Characteristics:

SPOROX® II is similar to the predicate device SPOROX®. SPOROX® II has the same active ingredients as SPOROX®. The only difference between the two products is in the inactive ingredients of the corrosion inhibitor system. SPOROX II has an improved corrosion inhibitor system that offers compatibility with materials and medical devices that contain copper and brass. SPOROX® II and SPOROX® are substantially equivalent in the safety and efficacy profiles.

Reckitt & Colman Inc. has conducted confirmatory testing that demonstrated SPOROX® II has equivalent antimicrobial efficacy to the predicate device, SPOROX®. The studies utilized appropriate AOAC and EPA methodology. The Company also conducted stability studies demonstrating that SPOROX® II like SPOROX® has a minimum of two years stability if unopened and stored according to label instructions, and that the product can be reused for up to 21 days when used at 20°C according to label instructions.

Additionally, as it did with SPOROX®, the Company conducted acute dermal toxicity, acute oral toxicity, primary eye irritation, primary skin irritation, skin sensitization, in-vitro hemolysis, neutral red uptake cyto toxicity assay, and 28 day repeat dose oral toxicity testing. These tests demonstrated that SPOROX® II has a substantially equivalent safety profile to SPOROX® for use as a liquid chemical sterilant and a high level disinfectant.

The Company confirmed compatibility with medical devices equivalent to the predicate device, by conducting a rigorous evaluation on a number of different plastics, metals, and elastomers commonly used in medical devices and noted in the product label. In addition, the Company determined compatibility with materials made with copper and brass which is consistent with FDA's Guidance on The Content and Format of Premarket Notification on [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants. The materials were exposed to a SPOROX® II solution, containing 7.3% hydrogen peroxide content for 500 hours at 20℃ (equivalent to 1000 disinfectant cycles).

Conclusion

Reckitt & Colman Inc. have demonstrated that SPOROX® II is as safe and effective as the predicate device. SPOROX®.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 30 1999

Mr. Sean McNear Senior Regulatory Affairs Specialist Reckitt & Colman, Inc. 1655 Valley Road P.O. Box 943 07474-0943 Wayne, New Jersey

Re: K990703 SPOROX® II Sterilizing and Trade Name: Disinfecting Solution Regulatory Class: Unclassified Product Code: MED March 3, 1999 Dated: Received: March 4, 1999

Dear Mr. McNear:

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 You may, therefore, Food, Drug, and Cosmetic Act (Act). 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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Sean McNear

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 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 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 Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

K990703 510(k) Number

Device Name SPOROX® II Sterilizing & Disinfecting Solution

Indications for Use

Olin S. Lin

(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Dev 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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.