ARM AUTOMATIC REPROCESSING MACHINE

K013713 · Alcavis International Incorporated · LIF · Jul 15, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013713
• Device Name: ARM AUTOMATIC REPROCESSING MACHINE
• Applicant: Alcavis International Incorporated
• Product Code: LIF · Gastroenterology, Urology
• Decision Date: Jul 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

The Amuchina Automatic Reprocessing Machine (ARM) is a device designed for both (a) reprocessing hemodialyzers for reuse, and (b) preprocessing hemodialyzers prior to first use. Reprocessed hemodialyzer will be reused on the same patient on who originally used the hemodialyzer. Both the reprocessing and preprocessing procedures use peracetic acid/hydrogen peroxide based disinfectant.

Device Story

ARM Automatic Reprocessing Machine (ARM) is a standalone, microprocessor-controlled system for automated hemodialyzer reprocessing and preprocessing. Device features 4 stations for simultaneous processing. Input includes hemodialyzers; disinfectant concentrate (peracetic acid/hydrogen peroxide); and AAMI quality water. System performs automated cycles: rinse, cleaning, flush, volume/leak testing, and disinfection. Includes integrated camera for capturing patient photographs for dialyzer labeling to prevent cross-patient reuse. Operated by healthcare facility staff via interactive touch screen. Output includes reprocessed/preprocessed dialyzers and printed labels containing patient data, lot/serial numbers, and test results. System can function as standalone, server, or slave unit in a network. Benefits include standardized cleaning/disinfection, automated testing, and enhanced patient identification safety.

Clinical Evidence

Bench testing only. In-vitro testing confirmed proper dilution of cleaning/disinfectant agents. Functionality testing verified all cycles (rinse, clean, flush, test, disinfect) performed as programmed without errors or failures. No clinical data provided.

Technological Characteristics

Microprocessor-controlled system with interactive touch screen. 4-station configuration. Uses peracetic acid/hydrogen peroxide disinfectant. Requires AAMI quality water (30-115 psig, 15-25°C). Connectivity: standalone, server, or slave network capability. Integrated digital camera for patient identification. Dimensions/form factor: 4-station unit.

Indications for Use

Indicated for patients with End-Stage Renal Disease on chronic hemodialysis. Used for reprocessing hemodialyzers for reuse on the same patient and preprocessing hemodialyzers prior to first use.

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

• Seratronic DRS-4 Dialyzer Reprocessing System (K860674)

Submission Summary (Full Text)

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JUL 15 2002

K013713

## 510(k) Summary

as required by section 807.92(c).

| Name: | Ludovico Glavotto<br>President |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Amuchina International, Inc.<br>8-8 Metropolitan Court<br>Gaithersburg, MD 20878 |
| Telephone:<br>FAX: | 301-330-7597<br>301-330-6432 |
| Contact Person: | Ludovico Glavotto |
| Date Summary<br>Prepared: | 01 November 2001 |
| Trade Name:<br>Common Name:<br>Classification Name: | ARM Automatic Reprocess Machine<br>dialyzer reprocessing system<br>dialyzer reprocessing system, panel 78, procode LIF, unclassified |

Legally Marketed Device claiming Substantial Equivalence to, §807.92(a)(3):

Seratronic DRS-4 Dialyzer Reprocessing System, K860674

Description of Device, §807.92(a)(4):

The Amuchina ARM Automatic [Dialyzer] Reprocessing Machine is a stand alone device designed for the automated reprocessing of hemodialyzers for reuse and for the pre-processing of hemodialyzers prior to first use. The ARM Unit has 4 stations which can sequentially process up to 4 dialyzers at one time. The ARM Unit has no direct or indirect patient contact.

The ARM Unit uses a peracetic acid/hydrogen peroxide based disinfectant as both a cleaning solution and a disinfectant. The disinfectant concentrate is diluted to the inuse strength with AAMI quality water.

When reprocessing dialyzers, the ARM Unit uses the following cycles: Rinse, Cleaning, Flush, Volume & Leak Test, and Disinfection. When pre-processing dialvzers, the following cycles are used: Flush, Volume & Leak Test (only if instructed for by the user), and Disinfection.

For regularly scheduled maintenance, the ARM Unit has the following system cycles: System Rinse, System Disinfect, and System Self Test. Other cycles which are included in the ARM Unit include: Prime Pump for priming the chemical pump with the disinfecting agent, Line Volume Calibration for use in determining the total cell volume of the dialyzer, and System Void to purge fluids from the circuits prior to moving the machine.

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KO13713-

The ARM Unit incorporates the feature of including a patient photograph on the dialyzer label, thus reducing the possibility of reused dialyzers being used on the wrong patient.

Intended Use of Device, §807.92(a)(5):

The ARM Automatic [Dialyzer] Reprocessing Machine is a device to reprocess hemodialyzers for reuse on the same patient. The patient population are those patients who have End-Stage Renal Disease and are on chronic hemodialysis. The ARM Unit is designed to be either a stand-alone device or act as either a server or a slave Unit in a network of several ARM Units.

The ARM Unit also can pre-processes hemodialyzers prior to first use, where preprocessing is the medical policy of the health care facility.

Summary of Technological Characteristics of ARM Automatic Reprocessing Machine and the DRS-4 Dialyzer Reprocessing Systems, §807.92(a)(6):

| Freature | Amuchina ARM | Seratronics DRS-4 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Reprocessing hemodialyzers<br>for reuse and Pre-processing<br>hemodialyzers prior to first<br>use | Reprocessing Hemodialyzers<br>for multiple use and<br>Prepacking hemodialyzers<br>for specific patients |
| Number of Processing<br>Stations | 4 | 4 |
| Cleaning Solutions | Peracetic Acid/Hydrogen<br>Peroxide | Peracetic Acid/ Hydrogen<br>Peroxide<br>Bleach/Sodium Hypochlorite |
| Disinfectants | Peracetic Acid/Hydrogen<br>Peroxide | Peracetic Acid/Hydrogen<br>Peroxide<br>Formaldehyde |
| Cycles | Rinse, Clean, Flush, Test,<br>Disinfect | Clean, Disinfect, Test |
| Test Cycle Includes | Pressure Leak Test<br>Total Blood Cell Volume | Pressure Leak Test<br>Total Blood Cell Volume<br>Ultrafiltration Rate |
| Dialyzer Labels<br>Processing for Reuse | Includes:<br>Bar Code<br>Patient Name<br>Patient Photograph (digital)<br>Dialyzer Lot Number<br>Dialyzer Serial Number<br>Number times reprocessed<br>Number times reused<br>Test Results<br>Dialyzer Status | Includes:<br>Bar Code<br>Patient ID Number & Name<br>Social Security Number<br>Dialyzer Type (code #)<br>Dialyzer Code<br>Number times reused<br>Test Results<br>Dialyzer Status |

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SL 313

| Dialyzer Label | When Added to List for | (No label printed. If pre- |
|---------------------------|----------------------------|--------------------------------|
| Pre-processing | Pre-processing: | processing a dialyzer prior to |
| | Bar Code | first use, the DRS-4 system |
| | Status: Do Not Use | records the TCV, and the |
| | Dialyzer Model | KUF values foe each |
| | Dialyzer Lot Number | dialyzer, and enters the |
| | Dialyzer Serial Number | results in the database.) |
| | After Pre-processing: | |
| | Bar Code | |
| | Dialyzer Lot Number | |
| | Dialyzer Serial Number | |
| | Number times reprocessed | |
| | Number times reused | |
| Microprocessor controlled | Yes | Yes |
| Interactive Touch Screen | Yes | Yes |
| Operator can define some | Yes | Yes |
| parameters | | |
| Camera for Patient | Yes | No |
| Photograph | | |
| Water Requirements: | | |
| Pressure | 30-115 psig | 25-80 psig |
| Quality | AAMI Quality | AAMI Quality |
| Temperature | 15 - 25 degrees C | 24-35 degrees C |
| Flow | up to 1500 ml/min at 2 bar | 1800 ml/min @ 1.75 kg/cm |
| Drain Height | up to 16 inches | up to 16 inches max |

Non-Clinical Performance Data, §807.92(b)(1):

Each individual function of the ARM Unit was tested to see if they performed as intended/programmed. No errors or failures either-were detected and the performance characteristics of the down-stream processing procedures were not affected by the preceding test(s).

In-vitro testing was performed to assure the ARM Unit properly diluted the cleaner/ disinfectant concentrate to the in-use concentrations of active ingredients. The results from these tests show that the ARM Unit performed as expected.

Conclusions Drawn from Non-Clinical Performance Data, §807.92(b)(3):

The functionality tests on the ARM Unit demonstrate that the ARM Automatic Reprocessing Machine will perform as labeled for the reprocessing of hemodialyzers. The results of these tests demonstrate that the ARM Automatic Reprocessing Machine is substantially equivalent to the DRS-4 Dialyzer Reprocessing System. which is commercially distributed, for the same intended use that is the reprocessing of hemodialyzers for reuse.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with three human profiles embedded within the eagle's body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 5 2002

Mr. Gary Mishkin Vice President of Research and Development Alcavis International, Inc. 8-8 Metropolitan Court GAITHERSBURG MD 20878 Re: K013713 Trade/Device Name: ARM Automatic Reprocessing Machine Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LIF

Dated: April 12, 2002 Received: April 16, 2002

Dear Mr. Mishkin:

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. Iisting 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 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 this letter:

| 8xx.1xxx | [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" (21 CFR Part 807.97). 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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510(k) Number (if known):

Device Name: ARM Dialyzer Reprocess Unit

Indications for Use:

The Amuchina Automatic Reprocessing Machine (ARM) is a device designed for both (a) reprocessing hemodialyzers for reuse, and (b) preprocessing hemodialyzers prior to first use. Reprocessed hemodialyzer will be reused on the same patient on who originally used the hemodialyzer. Both the reprocessing and preprocessing procedures use peracetic acid/hydrogen peroxide based disinfectant.

8013713

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013713

**Prescription Use**
(Per 21 CFR 801.109)

(Optional Format 3-10-98)