MINNCARE HD

K133724 · Medivators, Inc. · NIH · Aug 27, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133724
• Device Name: MINNCARE HD
• Applicant: Medivators, Inc.
• Product Code: NIH · Gastroenterology, Urology
• Decision Date: Aug 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20°C.

Device Story

Minncare HD is a liquid chemical disinfectant solution containing stabilized hydrogen peroxide, peracetic acid, and acetic acid. It is used to disinfect hemodialysis water purification systems. The operator dilutes the solution to 1% (1:99 ratio) and applies it to the system for a minimum of 36 minutes at 20°C. The operator confirms the concentration at the furthest point of the distribution loop using indicator test strips. After disinfection, the system is rinsed, and residual levels are verified to be 1 ppm or less using residual test strips. The device is supplied in high-density polyethylene bottles.

Clinical Evidence

No clinical data. Performance supported by non-clinical bench testing, including physical/chemical property analysis, sporicidal, tuberculocidal, fungicidal, virucidal, and bactericidal efficacy testing, simulated-use disinfection efficacy, material compatibility, test strip performance, and stability testing.

Technological Characteristics

Liquid chemical disinfectant; active ingredients: peracetic acid and hydrogen peroxide. Supplied in high-density polyethylene (HDPE) bottles. Requires dilution to 1% concentration. Monitored via indicator test strips for minimum recommended concentration (MRC) and residual PAA levels. Shelf-life: 12 months.

Indications for Use

Indicated for the disinfection of water purification systems used in hemodialysis.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Hemoclean Disinfectant (K023064)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around the perimeter. At the center of the seal is a stylized representation of a human figure, composed of three overlapping profiles facing to the right. The seal is rendered in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 27, 2014

MEDIVATORS, INC. Mrs. Kinnari Shah Senior Regulatory Affairs Specialist 14605 28th Ave. North Minneapolis, MN 55447

Re: K133724

Trade/Device Name: Minncare HD® Disinfectant Regulation Number: 21 CFR 876.5665 Regulation Name: Disinfectant, subsystem, water purification Regulatory Class: II Product Code: NIH Dated: July 30, 2014 Received: July 31, 2014

Dear Mrs. Shah:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, sans-serif font. Below the company name is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue. The logo is clean and professional, conveying a sense of trust and reliability.

## Indications for Use

510(k) number (if known): K133724

Device Name: Minncare® HD Disinfectant

#### Indications for Use:

Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20°C.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, sans-serif font. Below the company name, in a smaller font size, is the text "A Cantel Medical Company" also in blue. The overall design is clean and corporate, suggesting a professional and medical-related business.

### Minncare® HD Disinfectant

#### 510(k) Summary

| Manufacturer: | Medivators Inc., a Cantel Medical Company |
|----------------------|------------------------------------------------------------------------|
| Address: | 14605 28th Avenue North<br>Minneapolis, MN 55447 USA<br>[phone] |
| Official Contact: | Kinnari Shah<br>Senior Regulatory Affairs Specialist |
| Date Prepared: | 13th August 2014 |
| Trade Name: | Minncare® HD Disinfectant |
| Common Name: | Water Purification System Disinfectant |
| Classification Name: | Disinfectant, subsystem, water purification |
| Product Code: | NIH |
| Device Class: | II |
| Classification Reg: | 876.5665 |
| 510k: | K133724 |

Medivators Inc. has supplied the following information to the US Food and Drug Administration to support substantial equivalence of the Minncare HD Disinfectants to other disinfectants currently cleared for sale in the U.S.

#### 1. Intended Use

Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20℃.

#### 2. Device Description

Minncare HD is a clear liquid disinfectant solution that consists of a stabilized mixture of hydrogen peroxide, peracetic acid and acetic acid. Minncare HD is intended to be used for hemodialysis water purification system disinfection when diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and applied for a minimum contact time of 36 minutes at 20℃. The active microbicidal ingredient is peracetic acid (PAA), and the recommended use concentration of 1%. The concentration of the use solution should be confirmed with 1% Minncare HD indicator test strips to have reached the furthest point of the distribution loop during the system disinfection contact time. Upon completion of disinfection the system must be rinsed to remove residual levels of the disinfectant. Residual levels should be

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Image /page/4/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, block letters. Below the company name is the text "A Cantel Medical Company" in a smaller, blue font. The logo is simple and professional, conveying a sense of trust and reliability.

checked using Minncare HD residual test strips to ensure residual levels of 1 ppm PAA or less. Minncare HD is supplied in cases containing high density polyethylene plastic bottles. Individual bottles are labeled with all information necessary to use the device safely.

#### 3. Comparison to Other Device in Commercial Distribution Within the United States

MEDIVATORS Inc. believes Minncare HD is substantially equivalent in formulation, performance and indications to its predicate device - Hemoclean Disinfectant which is cleared under 510k - K023064. Hemoclean is a peracetic acid based liguid chemical germicide disinfectant solutions with similar chemistry, intended use and disinfectant performance to Minncare HD. Below is the comparison between the subject and the predicate device -

| Item | Minncare HD<br>MEDIVATORS Inc. | Hemoclean<br>Disinfectant<br>KRD CO., LTD<br>(K023064) |
|------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------|
| Active Ingredient | Peracetic Acid/ Hydrogen<br>Peroxide | Peracetic Acid/ Hydrogen<br>Peroxide |
| Device Use Indication | Water Purification<br>Systems for Hemodialysis | Hemodialysis machines,<br>Water Purification<br>Systems and Dialyzers |
| Form | Liquid solution | Liquid solution |
| Dilution Required | Yes | Yes |
| Minimum Contact Time | 36 minutes | 10 minutes |
| Use Temperature | 20°C | 20°C |
| Minimum Use<br>Concentration | 1% | 3% |
| Active Ingredient<br>Nominal Concentration | 5% / 22% | 1.7%/5.3% |
| Single Use | Yes | Yes |
| Sterilization Claim | No | No |
| Use and Compatibility<br>with Water Purification<br>System | Yes | Yes |
| Shelf-Life | 12 months | 12 months |
| Test Strip Used to<br>Monitor MRC | Yes | Yes |

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#### 4. Summary of Non-Clinical Performance Data

FDA Guidance for content of premarket notification submissions for water purification system disinfectants (product code NIH) has not been established, and thus performance testing requirements were based on related FDA Guidance for Content and Format of Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/High Level Disinfectants (Jan 2000). However, it is important to note that Minncare HD is not intended to be used on critical or semi-critical devices and high-level disinfection is not claimed.

Performance testing has been conducted to show that Minncare HD is safe and effective for its intended use. The following types of data/information are provided in this submission in support of substantial equivalence to predicate device and to demonstrate that Minncare HD performs safely as intended.

- Detailed description of physical and chemical properties .
- Proposed labeling .
- Sporicidal, tuberculocidal, fungicidal, virucidal and bactericidal efficacy ●
- Simulated-use disinfection efficacy .
- . Material compatibility
- Test strip performance .
- Stability .
- Risk Analysis ●

#### 5. Conclusion

The performance testing data indicates that the subject device, Minncare HD, is substantially equivalent to the predicate device Hemoclean Disinfectant (K023064).