(249 days)
Not Found
No
The description focuses on automated reprocessing cycles and mechanical functions, with no mention of AI or ML technologies for decision-making, analysis, or image processing.
No
The device is designed for reprocessing and preprocessing hemodialyzers, and it has no direct or indirect patient contact. Its function is to prepare medical devices, not to provide therapy itself.
No
The device is designed for reprocessing and preprocessing hemodialyzers, which are used to filter blood for patients with kidney failure. It does not diagnose any medical conditions or provide medical information about a patient's health. Its function is to prepare medical equipment for use, not to assess patient health.
No
The device description clearly indicates it is a physical machine with multiple stations, cycles, and the ability to handle fluids and chemicals, which are hardware components.
Based on the provided text, the Amuchina Automatic Reprocessing Machine (ARM) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for reprocessing and preprocessing hemodialyzers. This is a process performed on a medical device (the dialyzer) to prepare it for use or reuse in a patient. It does not involve testing a sample taken from a patient to provide diagnostic information.
- Device Description: The description focuses on the mechanical and chemical processes involved in cleaning and disinfecting the dialyzer. It does not mention any components or functions related to analyzing biological samples or providing diagnostic results.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing patient samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (substances in a sample)
- Providing diagnostic information about a patient's health status
- Using reagents or assays for diagnostic purposes
The device is clearly designed to maintain and prepare a medical device (the hemodialyzer) for its intended use in treating a patient, not to diagnose a condition in a patient.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LIF
Device Description
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.
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)
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.
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.
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
§ 876.5820 Hemodialysis system and accessories.
(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
JUL 15 2002
510(k) Summary
as required by section 807.92(c).
| Name: | Ludovico Glavotto
President |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Amuchina International, Inc.
8-8 Metropolitan Court
Gaithersburg, MD 20878 |
| Telephone:
FAX: | 301-330-7597
301-330-6432 |
| Contact Person: | Ludovico Glavotto |
| Date Summary
Prepared: | 01 November 2001 |
| Trade Name:
Common Name:
Classification Name: | ARM Automatic Reprocess Machine
dialyzer reprocessing system
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.
1
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 | |
| for reuse and Pre-processing | ||
| hemodialyzers prior to first | ||
| use | Reprocessing Hemodialyzers | |
| for multiple use and | ||
| Prepacking hemodialyzers | ||
| for specific patients | ||
| Number of Processing | ||
| Stations | 4 | 4 |
| Cleaning Solutions | Peracetic Acid/Hydrogen | |
| Peroxide | Peracetic Acid/ Hydrogen | |
| Peroxide | ||
| Bleach/Sodium Hypochlorite | ||
| Disinfectants | Peracetic Acid/Hydrogen | |
| Peroxide | Peracetic Acid/Hydrogen | |
| Peroxide | ||
| Formaldehyde | ||
| Cycles | Rinse, Clean, Flush, Test, | |
| Disinfect | Clean, Disinfect, Test | |
| Test Cycle Includes | Pressure Leak Test | |
| Total Blood Cell Volume | Pressure Leak Test | |
| Total Blood Cell Volume | ||
| Ultrafiltration Rate | ||
| Dialyzer Labels | ||
| Processing for Reuse | Includes: | |
| Bar Code | ||
| Patient Name | ||
| Patient Photograph (digital) | ||
| Dialyzer Lot Number | ||
| Dialyzer Serial Number | ||
| Number times reprocessed | ||
| Number times reused | ||
| Test Results | ||
| Dialyzer Status | Includes: | |
| Bar Code | ||
| Patient ID Number & Name | ||
| Social Security Number | ||
| Dialyzer Type (code #) | ||
| Dialyzer Code | ||
| Number times reused | ||
| Test Results | ||
| Dialyzer Status |
2
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.
3
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.
4
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (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" (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 (800) 638-2041 or (301) 443-6597 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
5
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)