(604 days)
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No
The device is a liquid sterilant/disinfectant and associated test strips, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is a sterilant/disinfectant for medical instruments, not a device used for treating a disease or condition in a patient.
No
The device, Peract™ 20 Liquid Sterilant/Disinfectant, is a germicide used for sterilizing or high-level disinfecting medical instruments. Its purpose is to kill microorganisms, not to diagnose a condition or disease. The test strips are used to verify the concentration of the sterilant itself, not to diagnose a patient.
No
The device is a liquid sterilant/disinfectant and associated test strips, which are physical chemical products, not software.
Based on the provided text, the Peract™ 20 Liquid Sterilant/Disinfectant itself is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the sterilization or high-level disinfection of medical and surgical instruments. This is a process applied to medical devices, not a test performed on biological samples to diagnose a condition.
- Mechanism of Action: The mechanism described is the oxidation of proteins and enzymes in microorganisms, which is a germicidal action, not a diagnostic test.
- Device Description: The description focuses on the chemical composition and packaging of a disinfectant.
- Performance Studies: The performance studies focus on the efficacy of the product in killing microorganisms and its compatibility with materials, not on diagnostic accuracy.
However, the Peract™ 20 Indicator Test Strips could be considered an IVD, depending on the specific regulatory definition being used. Here's the reasoning:
- Intended Use of Test Strips: The test strips are intended for "verifying the minimum effective concentration of peracetic acid in Peract™ 20 Liquid Sterilant/Disinfectant during reuse."
- Function: They are performing a test on the disinfectant solution to determine if it meets a specific chemical concentration. While not a test on a human biological sample, some regulatory bodies might classify tests performed on other substances (like disinfectants) to ensure their proper function in a medical context as a type of IVD.
In summary:
- Peract™ 20 Liquid Sterilant/Disinfectant: Not an IVD.
- Peract™ 20 Indicator Test Strips: Potentially an IVD, depending on the specific regulatory framework's definition of IVD, as they are performing a test to ensure the efficacy of a medical process.
Without a specific regulatory definition of IVD to apply, it's difficult to give a definitive "yes" or "no" for the test strips. However, the primary product (the liquid sterilant/disinfectant) is clearly not an IVD.
N/A
Intended Use / Indications for Use
Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion.
Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored.
Peract™ 20 Liquid Sterilant/Disinfectant should be used under the following contact conditions:
| Time | Temperature | Minimum Effective Concentration Peracetic Acid | |
|---|---|---|---|
| Sterilization | 8 hours | 68°F (20°C) | 500 ppm |
| High Level Disinfection | 25 minutes | 68°F (20°C) | 500 ppm |
Peract™ 20 Indicator Test Strips are intended for verifying the minimum effective concentration of peracetic acid in Peract™ 20 Liquid Sterilant/Disinfectant during reuse.
Product codes (comma separated list FDA assigned to the subject device)
MED
Device Description
Peract™ 20 Liquid Sterilant/Disinfectant is a single component germicide which does not require mixing or activation. The product is used full strength, without dilution. It is packaged in one gallon polyethylene bottles and has a one year shelf life.
The active ingredient in Peract™ 20 are peracetic acid and hydrogen peroxide. As discussed in Block's' article, the mechanism of microbial action is believed to be oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls.
Peract™ 20 Peracetic Acid Indicator Test Strips are provided to verify that the minimum effective concentration (MEC) (500 ppm peracetic acid) of Peract™ 20 is present. Three test strips are used with cach application.
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)
Efficacy Testing:
The following efficacy testing was performed on Peract™ 20 with all of the following conditions: at the minimum of its specifications, at the end of its shelf life, stressed to the end of its 14 day reuse period and at its MEC (500ppm PAA). The testing showed the product to be sporicidal, tuberculocidal, virucidal, fungicidal, and bactericidal.
AOAC sporicidal testing was performed on three lots of Peract™ 20 with the above noted conditions. Sporicidal simulated use testing was also performed on endoscopes to show efficacy as a sterilant on actual devices.
Tuberculocidal testing was performed on three lots of Peract™ 20 with the above noted conditions. Tuberculocidal simulated use testing was also performed on endoscopes to show efficacy as a high level disinfectant on actual devices.
Peract™ 20 was determined to be virucidal when tested against Poliovirus Type 2, Influenza A2 , Human Immunodeficiency Virus Type 1, and Herpes Simplex Virus Type 1. Peract™ 20 was considered fungicidal when tested against Trichophyton mentagrophytes. Use dilution testing showed the efficacy of Peract™ 20 against Staphylococcus aureus, Salmonello choleraesuis, Pseudomonas aeruginosa.
Clinical testing of used scopes further supports the efficacy of the germicide when used under the instructions of the directions for use. Testing determined residues of Peract™ 20 remaining on endoscopes after sterilization/disinfection and rinsing were not significant.
Biocompatibility Testing:
Standard patient toxicity testing evaluated the effect of residues, cytotoxicity, hemolysis, acute toxicity, and vaginal (mucosal membranc) irritation. All biocompatibility testing demonstrated that Peract™ 20 is safe for the patient when used according to the instructions for use.
Material Compatibility:
Material compatibility testing demonstrates that Peract™ 20 can be used with a wide range of materials and endoscopes. Testing included soaking and cycling common materials and endoscopes for the estimated lifetime of the items. Material compatibility testing demonstrated that Peract™ 20 is compatible with the materials and devices listed when used according to the instructions for use.
Stability:
Pcract™ 20 has a shelf life of one year. Stability studies were performed according to section (111)(F)(3) of the Liquid Chemical Germicide Document. Studies demonstrated that the chemical and physical stability of Peract™ 20 were within specifications at the expiration date.
Test Strips:
Peract™ 20 Indicator Test Strips demonstrated to consistently and accurately test the germicide at its minimum effective concentration of 500 ppm peracetic acid when three test strips were used.
Testing of the indicator strips was accomplished by showing: the efficacy of the strips when they were exposed to Peract™ 20; that they were stable over the labeled shelf life; and were stable in the opened bottle for 30 days. All of these tests were performed on a minimum of three lots of strips using Peract™ 20 diluted to various concentrations of PAA from much lower to much higher than the MEC of 500ppm PAA. The testing was also performed on solutions close to the MEC of 500ppm PAA to ensure the strips performed appropriately at concentrations around the MFC. The results of the testing showed the strips performed appropriately when three strips were used as called out in the directions for usc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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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.
Not Found
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).
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.
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PERACT™ 20 LIQUID STERILANT/DISINFECTANT AND PERACT™ 20 INDICATOR TEST STRIPS
OCT - 1 1997
510(k) Summary of Safety and Liffectiveness
Minntech Corporation, 14605 28th Ave. N, Mpls, MN 55447 800-328-3345 Telephone: Official Contact: Robert Johnson Vice President, Regulatory Affairs and Quality Assurance
Minntech Corporation has provided the following information to the U.S. Food and Drug Administration to support that Peract™ 20 Liquid Sterilant/Disinfectant is substantially equivalent to other sterilants currently in commercial distribution in the United States.
Device Description 1.
Peract™ 20 Liquid Sterilant/Disinfectant is a single component germicide which does not require mixing or activation. The product is used full strength, without dilution. It is packaged in one gallon polyethylene bottles and has a one year shelf life.
The active ingredient in Peract™ 20 are peracetic acid and hydrogen peroxide. As discussed in Block's' article, the mechanism of microbial action is believed to be oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls.
Peract™ 20 Peracetic Acid Indicator Test Strips are provided to verify that the minimum effective concentration (MEC) (500 ppm peracetic acid) of Peract™ 20 is present. Three test strips are used with cach application.
Intended Use ર્ભ
Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion.
Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored.
4 Block, Seymour S., Disinfection, Sterilization and Preservation; Chapter 9 Peroxygen Compounds (pages 167-181), Lea & Febiger, 1991.
1
| | Time | Temperature | Minimum Effective
Concentration
Peracetic Acid |
|----------------------------|------------|-------------|------------------------------------------------------|
| Sterilization | 8 hours | 68°F (20°C) | 500 ppm |
| High Level
Disinfection | 25 minutes | 68°F (20°C) | 500 ppm |
Peract™ 20 Liquid Sterilant/Disinfectant should be used under the following contact conditions:
Comparison to another Device in Commercial Distribution within the United 3. States:
Peract™ 20 Liquid Sterilant/Disinfectant is comparable in its intended use to other liquid sterilants currently on the market in the U.S. Peract™ 20 is similar in use and product claims to Cottrell's ProCide® NS and Johnson's Cidex®,
4. Summary
Minntech Corporation has performed testing to demonstrate that Peract™ 20 I jouid Sterilant/Disinfectnat and Peract™ 20 Indicator Test Strips are safe and effective when used according to the respective instructions for use.
Efficacy Testing 4.1
The following efficacy testing was performed on Peract™ 20 with all of the following conditions: at the minimum of its specifications, at the end of its shelf life, stressed to the end of its 14 day reuse period and at its MEC (500ppm PAA). The testing showed the product to be sporicidal, tuberculocidal, virucidal, fungicidal, and bactericidal.
AOAC sporicidal testing was performed on three lots of Peract™ 20 with the above noted conditions. Sporicidal simulated use testing was also performed on endoscopes to show efficacy as a sterilant on actual devices.
Tuberculocidal testing was performed on three lots of Peract™ 20 with the above noted conditions. Tuberculocidal simulated use testing was also performed on endoscopes to show efficacy as a high level disinfectant on actual devices.
Peract™ 20 was determined to be virucidal when tested against Poliovirus Type 2, Influenza A2 , Human Immunodeficiency Virus Type 1, and Herpes Simplex Virus Type 1. Peract™ 20 was considered fungicidal when tested against Trichophyton mentagrophytes. Use dilution testing showed the efficacy of Peract™ 20 against Staphylococcus aureus, Salmonello choleraesuis, Pseudomonas aeruginosa,
2
Clinical testing of used scopes further supports the efficacy of the germicide when used under the instructions of the directions for use. Testing determined residues of Peract™ 20 remaining on endoscopes after sterilization/disinfection and rinsing were not significant,
Biocompatibility Testing 4.2
Standard patient toxicity testing evaluated the effect of residues, cytotoxicity, hemolysis, acute toxicity, and vaginal (mucosal membranc) irritation.
All biocompatibility testing demonstrated that Peract™ 20 is safe for the patient when used according to the instructions for use.
Material Compatibility 4.3
Material compatibility testing demonstrates that Peract™ 20 can be used with a wide range of materials and endoscopes. Testing included soaking and cycling common materials and endoscopes for the estimated lifetime of the items.
Material compatibility testing demonstrated that Peract™ 20 is compatible with the materials and devices listed when used according to the instructions for use.
4.4 Stability
Pcract™ 20 has a shelf life of one year. Stability studies were performed according to section (111)(F)(3) of the Liquid Chemical Germicide Document. Studies demonstrated that the chemical and physical stability of Peract™ 20 were within specifications at the expiration date.
Test Strips 4.5
Peract™ 20 Indicator Test Strips demonstrated to consistently and accurately test the germicide at its minimum effective concentration of 500 ppm peracetic acid when three test strips were used,
Testing of the indicator strips was accomplished by showing: the efficacy of the strips when they were exposed to Peract™ 20; that they were stable over the labeled shelf life; and were stable in the opened bottle for 30 days. All of these tests were performed on a minimum of three lots of strips using Peract™ 20 diluted to various concentrations of PAA from much lower to much higher than the MEC of 500ppm PAA. The testing was also performed on solutions close to the MEC of 500ppm PAA to ensure the strips performed appropriately at concentrations around the MFC. The results of the testing showed the strips
3
performed appropriately when three strips were used as called out in the directions for usc.
Summary of Substantial Equivalence 5.0
Minntech Corporation has provided the above information within the 510(k) to support that Peract™ 20 Liquid Stcrilant/Disinfectant and Peract™ 20 Indicator Test Strips are safe and effective when used according to the respective directions for use.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized human figure embracing a bird, which is a common symbol associated with health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Lynn Lueders Director, Requlatory Affairs Minntech Corporation 14605 28th Avenue, North Minneapolis, Minnesota 55447
OCT - 1 1997
Re : K960513 Peract™20 Liquid Sterilant/Disinfectant Trade Name: Requlatory Class: Unclassified Product Code: MED Dated: July 14, 1997 Received: July 15, 1997
Dear Ms. Lueders:
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, Druq, 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 -----regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
5
Page 2 - Ms. Lueders
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 regulation (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 qeneral 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 and the country of the first
6
Indications for Use
Kacos 13
510(k) Number (if known):
Device Name;
Peract™ 20 Liquid Sterilant/Disinfectant and Peract™ 20 Indicator Test Strips
Intended Use:
Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion.
Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored.
Peract™ 20 Liquid Sterilant/Disinfectant should be used under the following contact conditions:
| | Time | Temperature | Minimum Effective
Concentration
Peracetic Acid |
|----------------------------|------------|-------------|------------------------------------------------------|
| Sterilization | 8 hours | 68°F (20°C) | 500 ppm |
| High Level
Disinfection | 25 minutes | 68°F (20°C) | 500 ppm |
Peract™ 20 Indicator Test Strips are intended for verifying the minimum effective concentration of peracetic acid in Peract™ 20 Liquid Sterilant/Disinfectant during reuse.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the counter use ) (Optional Format 1-2-96)
Chine S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number