(26 days)
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No
The document describes a chemical sterilant/disinfectant solution and its performance characteristics, with no mention of AI or ML technology.
No.
SPOROX® II is a chemical sterilant and high-level disinfectant used for reprocessing heat-sensitive medical equipment, not a device used for treating patients.
No
This device is a chemical sterilant and disinfectant used for medical equipment, not a diagnostic tool that identifies or assesses medical conditions.
No
The device is a liquid chemical sterilant and disinfectant, which is a physical substance, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SPOROX® II is a "liquid chemical sterilant for the sterilization or high level disinfection of heat sensitive medical equipment." This describes a product used to clean and disinfect medical devices, not to perform diagnostic tests on biological samples.
- Device Description: The description focuses on the chemical composition and mechanism of action as a germicide.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on biological markers.
- Reagents or kits for laboratory testing.
Therefore, SPOROX® II is a disinfectant/sterilant for medical equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MED
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Attachment 4
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
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.
Continued on next page
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5.0 Intended Use:
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.
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
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.
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
OR
Over-The-Counter Use X