(675 days)
Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-virro cleaning and disinfection of hollow fiber dialyzers, classified as follows:
Conventional dialyzer, 21 CFR 876.5820, product code 78 FJI High permeability dialyzer, 21 CFR 876,5860, product code 78 KDI
The product is intended for use only with reprocessing systems, automated or manual, that have been validated by the system manufacturer for use with peracetic acid. The intended use of Peracidin is identical to that of Renalin.
Peracidial Dialyzer Reprocessing Concentrate is a stabilized mixture of hydrogen peroxide 27,0% and peroxyacetic acid 4,5%; inert ingredients are 68,5% (nominal concentrations). The concentrate is a clear colorless liquid, is highly acidic, and is completely soluble in water. Peracidim breaks down to acetic acid, water, and oxygen.
The provided text is a 510(k) summary for a medical device called "Peracidin Dialyzer Reprocessing Concentrate." This document is focused on demonstrating the substantial equivalence of this new device to a legally marketed predicate device (Renalin Cold Sterilant) for the purpose of regulatory clearance.
It does not contain the type of acceptance criteria, study design, or performance metrics typically found in clinical trials or software validation studies for devices that require proof of diagnostic or treatment efficacy based on human or clinical data. Instead, it relies on the established performance of the predicate device and the chemical composition of the new device.
Therefore, most of the requested information cannot be extracted directly from this document because the study described is a demonstration of chemical equivalence and known biocidal efficacy, rather than a study involving human subjects, diagnostic accuracy, or expert adjudication.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Criterion: Substantial Equivalence to a legally marketed predicate device (Renalin Cold Sterilant, K882564). | Performance: Peracidin is a stabilized mixture of hydrogen peroxide and peroxyacetic acid, with identical concentrations to Renalin. The technological characteristics are stated to be identical. |
| Criterion: Effective biocidal agent for in-vitro cleaning and disinfection of hollow fiber dialyzers. | Performance: Peroxyacetic acid (PA), the primary active ingredient in both Peracidin and Renalin, has been shown to be an effective biocidal agent. Its actions are bactericidal, sporocidal, tuberculocidal, pseudomonacidal, virucidal, and effective against non-tuberculous mycobacteria (NTM). The safety and effectiveness performance of Peracidin are stated to be identical to Renalin. |
| Criterion: Intended for use with reprocessing systems (automated or manual) validated for use with peracetic acid. | Performance: The device's indication for use explicitly states it is "intended for use only with reprocessing systems, automated or manual, that have been validated by the system manufacturer for use with peracetic acid." (This implies the device itself is compatible if used with such systems, rather than validating the systems themselves). |
| Criterion: Acceptable decomposition products with low or no toxicity. | Performance: Peracidin breaks down to acetic acid, water, and oxygen. The decomposition products have low or no toxicity. |
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 document describes the chemical composition of the product and references the established efficacy of its active ingredient, peroxyacetic acid, based on "extensive long-term clinical use and... well-documented in the scientific literature." It does not involve a specific test set of cases (e.g., patient data, images) for the device's performance that would require a sample size or data provenance in the typical sense of a clinical study.
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. No experts were used to establish ground truth for a test set in the context of this device's submission. The documentation relies on the established scientific literature regarding the biocidal efficacy of peroxyacetic acid.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method was used, as there was no test set requiring expert review or consensus.
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 device is a chemical disinfectant, not an AI-powered diagnostic or assistance tool. Therefore, no MRMC comparative effectiveness study was conducted, and the concept of "human readers improve with AI" is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a chemical disinfectant. It does not have an algorithm or human-in-the-loop component. Its efficacy is standalone chemical action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is the well-established scientific literature and long history of clinical use regarding the biocidal efficacy of peroxyacetic acid and its decomposition products' low toxicity. This is an extrapolation based on chemical equivalence to a predicate device and widely accepted scientific understanding, rather than new primary ground truth derived from a specific study for this device.
8. The sample size for the training set
- Not Applicable. This is a chemical product, not a machine learning model. There is no concept of a "training set" for this type of device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth established for one.
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2 1008 JUN
510(k) SUMMARY K962959
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
Submitter's Name: HDC Medical, Inc. 707 Farmingham Road Louisville, KY 40243 USA Telephone: (502) 267-7873 Contact Person: Hugh Doss, President
JOHNERS 20 65 - 20 - 20 - 2 - 1 - 1 - 1
Date of Summary: June 3, 1998
Device Name: Peracidin™ Dialyzer Reprocessing Concentrate
Device Classification: Liquid Chemical Disinfectant (80 MED)
Legally Marketed Device To Which Equivalence Is Claimed: Renalin Cold Sterilant (K882564), manufactured by Minntech Corporation, determined to be substantially equivalent to a pre-enactment device on January 9, 1989.
Device Description: Peracidial Dialyzer Reprocessing Concentrate is a stabilized mixture of hydrogen peroxide 27,0% and peroxyacetic acid 4,5%; inert ingredients are 68,5% (nominal concentrations). The concentrate is a clear colorless liquid, is highly acidic, and is completely soluble in water. Peracidim breaks down to acetic acid, water, and oxygen.
Intended Use: Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-virro cleaning and disinfection of hollow fiber dialyzers, classified as follows:
Conventional dialyzer, 21 CFR 876.5820, product code 78 FJI High permeability dialyzer, 21 CFR 876,5860, product code 78 KDI
The product is intended for use only with reprocessing systems, automated or manual, that have been validated by the system manufacturer for use with peracetic acid. The intended use of Peracidin is identical to that of Renalin.
Descriptive Summary Of Technological Characteristics And Those Of Predicate Device: Both Peracidin and Renalin are stabilized mixtures of hydrogen peroxyacetic acid. The products are liquid chemical disinfectants used for reprocessing of hollow fiber dialyzers. The concentrations of hydrogen peroxide and peractic acid in the two products are identical. The technological characteristics of Renalin and Peracidin are identical.
Performance Data: Peroxyacetic acid (PA), the primary active ingredient in both Renalin and Peracidin, has been shown to be an effective biocidal agent. Peracetic acid-based chemical germicides have a long history of use in dialyzer reprocessing. The actions of these germicides are bactericidal, sporocidal, tuberculocidal, pseudomonacidal, virucidal, and effective against non-tuberculous mycobacteria (NTM). The decomposition products have low or no toxicity. Efficacy and other performance characteristics are well-established by extensive long-term clinical use and are well-documented in the scientific literature. The safety and effectiveness performance of Peracidin are identical to the safety and effectiveness performance of Renalin.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a stylized eagle or bird symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 5 1898
HDC Medical, Incorporated C/O Ms. Lisa S. Jones Requlatory Affairs Consultant Devices for the Future, L.L.C. 9223 Ilona Lane 77025-4218 Houston, Texas
K962959 Re : Peracidin Dialyzer Reprocessing Concentrate Trade Name: Regulatory Class: Unclassified Product Code: MED Dated: May 5, 1998 Received: May 6, 1998
Dear Ms. Jones:
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 legally marketed predicate 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 of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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
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Page 2 - Ms. Jones
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) 594-4692. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
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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June 3, 1998
Page 1 of 1
510(k) Number: K962959
Device Name: Peracidin Dialyzer Reprocessing Concentrate
Indications for Use:
Peracidin Dialyzer Reprocessing Concentrate is indicated for the in vitro cleaning and disinfection of hollow fiber dialyzers. The product is intended for use only with dialyzer reprocessing systems, automated or manual, that have been validated for use with peracetic acid.
Qlin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801,109) OR
Over-the-Counter Use X
§ 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.