MAKY 21.1 DIALYZER REPROCESSING SYSTEM

K024076 · Hdc Maquinolas, LLC · LIF · Sep 26, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K024076
• Device Name: MAKY 21.1 DIALYZER REPROCESSING SYSTEM
• Applicant: Hdc Maquinolas, LLC
• Product Code: LIF · Gastroenterology, Urology
• Decision Date: Sep 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

The MAKY 21.1 is indicated for use in automating the in-vitro rinsing, cleaning, testing and disinfection of hollow fiber type hemodialyzers in accordance with the AAMI Recommended Practice for Reuse of Hemodialyzers when such automation is chosen for use by a prescribing physician. It is also indicated for record keeping of these functions.

Device Story

MAKY 21.1 Dialyzer Reprocessing System automates maintenance of hollow-fiber hemodialyzers. System performs rinsing, cleaning, testing, and disinfection cycles. Inputs include dialyzers and chemical agents (peracetic acid, bleach, glutaraldehyde, formaldehyde). Device automatically dilutes cleaning/disinfection agents (except glutaraldehyde, user-diluted). Operates via pre-programmed or custom cycles. Used in clinical settings to ensure dialyzer reuse compliance with AAMI standards. Output includes processed dialyzers and maintenance records. Benefits include standardized, automated reprocessing, reducing manual labor and ensuring adherence to safety protocols for dialyzer reuse.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included verification of system functions, in-vitro validation of chemical dilution concentrations, and material compatibility testing with system-used chemicals.

Technological Characteristics

Automated reprocessing system for hollow-fiber dialyzers. Features pre-programmed and custom cycle configurations. Supports peracetic acid, bleach, glutaraldehyde, and formaldehyde. Automated dilution system for cleaning/disinfection agents. Materials tested for chemical compatibility. Standalone system.

Indications for Use

Indicated for automated in-vitro rinsing, cleaning, testing, and disinfection of hollow fiber hemodialyzers per AAMI standards, as prescribed by a physician. Includes record-keeping functionality.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Minntech Corporation Renatron II Dialyzer Reprocessing System (K904210)
• Mesa Medical, Inc. Echo MM1000 Dialyzer Reprocessing System (K834447)

Submission Summary (Full Text)

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SEP 26 2003
HDC MAQUINOLAS, LLC

## KO24076 III. 510(K) SUMMARY

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 Maquinolas, LLC<br>129A Citizens Blvd.<br>Simpsonville, KY 40067<br>Telephone: [phone] |
|-------------------|---------------------------------------------------------------------------------------------------|
| Contact person: | Mr. Hugh Doss, Manager |

December 6, 2002 Date of Summary:

Device Name: MAKY 21.1 Dialyzer Reprocessing System

Device Classification Name: Dialyzer Reprocessing System (78 LIF)

Device Description: The MAKY 21.1 Dialyzer Reprocessing System is designed and manufactured to reprocess standard, high efficiency, and high flux hollow-fiber dialyzers. Each type of dialyzer can be processed by one of two pre-programmed cycles, or by a custom cycle configured by HDC Maquinolas, LLC. Custom cycles meet the same minimum requirements as the pre-programmed cycles. The MAKY 21.1 may be configured to utilize one of two approved cleaning agents (peracetic acid, bleach), and one of three approved disinfection agents (peracetic acid, glutaraldehyde, formaldehyde). The MAKY 21.1 will automatically dilute the cleaning and disinfection agents, with the exception of glutaraldehyde, which must be diluted by the user.

Intended Use: The MAKY 21.1 is indicated for use in automating the in-vitro rinsing, cleaning, testing and disinfection of hollow fiber type hemodialyzers in accordance with the AAMI Recommended Practice for Reuse of Hemodialyzers when such automation is chosen for use by a prescribing physician. It is also indicated for record keeping of these functions.

Legally Marketed Devices to which Equivalence is Claimed: The legally marketed predicate devices are:

- 미 Minntech Corporation Renatron II Dialyzer Reprocessing System (K904210), determined to be substantially equivalent to a legally marketed (preAmendment) device on November 27, 1990.
- 내 Mesa Medical, Inc. Echo MM1000 Dialyzer Reprocessing System (K834447), determined to be substantially equivalent to a legally marketed (preAmendment) device on December 16, 1983.

Descriptive Summary of Technological Characteristics and Those of Predicate Devices: The features of the MAKY 21.1 are equivalent to those of other dialyzer reprocessing systems currently in distribution in the United States.

Performance Data: Each function of the MAK Y 21.1 System was tested to see if it performed as intended. Any errors or failures detected during testing were corrected. In-vitro testing was also performed to assure the MAKY 21.1 properly diluted the cleaner/disinfectant concentrate to the inuse concentrations of active ingredients. All materials have been tested for material compatibility with the chemicals used in the system as specified in the labeling. The results from these tests show that the MAKY 21.1 performed as expected.

Conclusion: The information and data provided in this 510(k) Notification establish that the MAK Y 21.1 Dialyzer Reprocessing System is substantially equivalent to the legally marketed predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 26 2003

HDC Maquinolas, LLC c/o Lori Kleinschrodt Holder, RAC, CQE, CQMgr. Regulatory Affairs Consultant 8508 Beacon Bend Lane PEARLAND TX 77584

Re: K024076

Trade/Device Name: MAKY 21.1 Dialyzer Reprocessing System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LIF Dated: June 27, 2003 Received: June 30, 2003

Dear Ms. Holder:

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.

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 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 【】. INDICATIONS FOR USE STATEMENT

December 6, 2002

Page 1 of 1

K024076 510(k) Number:

Device Name: MAKY 21.1 Dialyzer Reprocessing System

Indications for Use: The MAKY 21.1 is indicated for use in automating the in-vitro rinsing, cleaning, testing and disinfection of hollow fiber type hemodialyzers in accordance with the AAMI Recommended Practice for Reuse of Hemodialyzers when such automation is chosen for use by a prescribing physician. It is also indicated for record keeping of these functions.

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

NancyC brodson

(Division Sign-Off) Division of Reproductive, dominal, and Radiological Device 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use