PERACIDIN DIALYZER REPROCESSING CONCENTRATE

K962959 · Hdc Medical, Inc. · MED · Jun 5, 1998 · General Hospital

Device Facts

• Record ID: K962959
• Device Name: PERACIDIN DIALYZER REPROCESSING CONCENTRATE
• Applicant: Hdc Medical, Inc.
• Product Code: MED · General Hospital
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Intended Use

Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-vitro 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.

Device Story

Peracidin Dialyzer Reprocessing Concentrate is a liquid chemical disinfectant used for the in-vitro cleaning and disinfection of hollow fiber dialyzers. The device is a stabilized mixture of hydrogen peroxide (27.0%) and peroxyacetic acid (4.5%). It is used in conjunction with automated or manual dialyzer reprocessing systems that have been validated for peracetic acid. The solution acts as a biocidal agent, providing bactericidal, sporocidal, tuberculocidal, pseudomonacidal, and virucidal activity. Upon use, the concentrate breaks down into acetic acid, water, and oxygen, which have low or no toxicity. The device is intended for use in clinical settings where dialyzer reprocessing is performed.

Clinical Evidence

No clinical data. Efficacy and performance characteristics are based on the established biocidal properties of peroxyacetic acid and extensive long-term clinical use documented in scientific literature.

Technological Characteristics

Stabilized liquid mixture of 27.0% hydrogen peroxide and 4.5% peroxyacetic acid; 68.5% inert ingredients. Clear, colorless, acidic, water-soluble. Functions as a chemical germicide.

Indications for Use

Indicated for in vitro cleaning and disinfection of hollow fiber dialyzers. Intended for use only with automated or manual reprocessing systems validated for peracetic acid.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Renalin Cold Sterilant (K882564)

Submission Summary (Full Text)

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JUN 5 1998
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: [phone]
Contact Person: Hugh Doss, President

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: Peracidin™ 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. Peracidin breaks down to acetic acid, water, and oxygen.

Intended Use: Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-vitro 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 peroxide and peroxyacetic acid. The products are liquid chemical disinfectants used for reprocessing of hollow fiber dialyzers. The concentrations of hydrogen peroxide and peracetic 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 5 1998

HDC Medical, Incorporated
C/O Ms. Lisa S. Jones
Regulatory Affairs Consultant
Devices for the Future, L.L.C.
9223 Ilona Lane
Houston, Texas 77025-4218

Re: K962959
Trade Name: Peracidin Dialyzer Reprocessing Concentrate
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 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

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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 regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/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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JUN-03-'98 09:00 ID:DEVICES FOR FUTURE TEL NO:713P6646070 #180 P02

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.

(Concurrence of CDRH, Office of Device Evaluation (ODE))

Chris S. Lim
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K962959

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-the-Counter Use ☑