(675 days)
Not Found
No
The device is a chemical reprocessing concentrate, and the description focuses on its chemical composition and efficacy as a biocidal agent. There is no mention of software, algorithms, or any technology that would incorporate AI/ML.
No.
This device is a reprocessing concentrate used for cleaning and disinfection of dialyzers (medical devices), not a therapeutic device itself that directly treats a medical condition.
No
Explanation: The document clearly states that this product is a "dialyzer reprocessing concentrate" intended for "cleaning and disinfection of hollow fiber dialyzers" and acts as a "biocidal agent". It is used for maintaining medical equipment, not for diagnosing a medical condition in a patient.
No
The device description clearly indicates it is a liquid chemical concentrate, 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 for the "in-vitro cleaning and disinfection of hollow fiber dialyzers." This describes a process for cleaning and disinfecting medical devices (dialyzers), not for performing diagnostic tests on biological samples.
- Device Description: The device is a chemical concentrate used for reprocessing. This aligns with a disinfectant/sterilant, not a diagnostic test kit.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health.
The device is clearly intended for the reprocessing of medical devices used in dialysis, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MED
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.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Renalin Cold Sterilant (K882564)
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.
0
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.
1
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
2
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
3
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