(281 days)
Not Found
No
The 510(k) summary describes a chemical sterilizing and disinfecting solution and its performance in germicidal and biocompatibility testing. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
No.
Sporox is a liquid chemical germicide intended for the high-level disinfection of heat-sensitive medical equipment, not for direct therapeutic use on patients.
No
The device is a chemical germicide used for high-level disinfection of medical equipment, not for diagnosing medical conditions.
No
The device is a liquid chemical germicide, 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 is clearly stated as "high level disinfection of heat sensitive medical equipment." This is a process for reprocessing medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the chemical composition and mechanism of action as a germicide.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on germicidal activity and material compatibility, not diagnostic accuracy.
Therefore, Sporox® Sterilizing & Disinfecting Solution is a medical device used for reprocessing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MED
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
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).
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
RECKITT & COLMAN INC.
SECTION 4
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).
1
RECKITT & COLMAN INC.
Description of Devices: 4.0
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.
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.
2
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.
3
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
5
K970230 510(k) NUMBER:
Sporox® Sterilizing & Disinfecting Solution DEVICE NAME:
INDICATIONS FOR USE:
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.
(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 |