(495 days)
The Mega Pure Cart ( MPC1), is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. The MPC is A portable unit and is designed for single patient use only within a Hospital or Clinic setting.
The Mega Pure Cart ( MPC1), is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. The MPC is a portable unit and is designed for single patient use only within a Hospital or Clinic setting. The Mega Pure Cart purifies potable feed water through deionization. Deionization is used to remove 99.99+% of ions from water. Deionization alone does not remove particulates, organics, bacteria, viruses or endotoxins. The system is designed for hemodialysis application to treat carbon filtered potable water. Inappropriate use can result in the formation of Nitrosamines in the effluent of the deionizer. The purpose of the pretreatment section of the system is to condition the feed water supplying the deionizers. Conditioning the feed water will include: check valves to prevent backflow into the potable water source, one carbon tank and one carbon cartridge equipped with a test port between them to test for water conductivity, pH and chlorine/chloramines residual. This carbon is granular activated carbon with 12 x 40 mesh size and a iodine number of greater than 900. The purpose of the post treatment is to remove bacteria and endotoxins or lower them to within acceptable limits allowed by AAMI standards. The post treatment section of the system will include: sub micron/ ultra filter after the deionizer. The alarm system will consist of two temperature compensated audible/visual alarms. The first alarm located after DI cartridge #1 and #2 is a 1meg ohm alarm and the second alarm is a temperature compensated audible/visual alarm and is pre set a 1 Meg ohm for final water quality. Routine monitoring of the test port #1 is necessary to detect any chlorine/chloramines breakthrough. Should any of the alarms sound during the treatment, the treatment should stop immediately and follow the DI cartridge exchange procedure listed in the operator's manual.
The Mega Pure Cart (MPC1) is a deionization system with pre and post-treatment stages intended for use with hemodialysis systems. It purifies potable feed water to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate, and for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the adherence to a specific standard. The device performance is reported in terms of the volume of purified water produced under different feed water conditions.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Purified water meets requirements of ANSI/AAMI RD 62:2001, Water Treatment For Hemodialysis Applications. | Feed Water 1: 266 ppm TDS, 16 gpg water hardness -> 175 gallons of purified water produced meeting ANSI/AAMI RD 62:2001 requirements. |
| Feed Water 2: 197 ppm TDS, 6 gpg water hardness -> 225 gallons of purified water produced meeting ANSI/AAMI RD 62:2001 requirements. | |
| Alarm system provides temperature compensated audible/visual alarms at 1 Meg ohm for final water quality (after DI cartridge #1 & #2, and as final water quality). | The alarm system consists of two temperature compensated audible/visual alarms, with the second alarm preset at 1 Meg ohm for final water quality. Note: The document doesn't explicitly state that the alarms functioned correctly during a test, but rather describes their design. |
| Pre-treatment (carbon tanks/cartridges) prevents chlorine/chloramines breakthrough for safe use in hemodialysis. | Routine monitoring of test port #1 is necessary to detect chlorine/chloramines breakthrough. Note: The document doesn't explicitly state the performance of the carbon tanks/cartridges in preventing breakthrough during a test, but highlights the monitoring necessity. |
| Post-treatment (sub micron/ultra filter) removes bacteria and endotoxins to within acceptable AAMI limits. | The post-treatment section is designed to remove bacteria and endotoxins or lower them to within acceptable limits allowed by AAMI standards. Note: The document doesn't explicitly state the performance of the filter in achieving these limits during a test, but describes its design intent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The sample size is extremely limited. The document describes two "tests" or scenarios:
- One test with feed water of 266 ppm TDS and 16 gpg water hardness.
- Another test with city water of 197 ppm TDS and 6 gpg water hardness.
The sample size for each test appears to be a single evaluation (e.g., "Mega Pure Cart will produce typically 175 gallons...", "there was 225 gallons of purified water produced"). This is not reflective of a robust statistical sample size for device validation.
- Data Provenance: The document does not specify the country of origin for the data. The nature of the tests ("Based on a feed water quality...", "there was also a test ran...") suggests these were prospective tests performed by the manufacturer to demonstrate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth is based on meeting the defined requirements of the ANSI/AAMI RD 62:2001 standard. The measurement of "purified water" meeting these requirements would typically involve laboratory analysis of water quality parameters, but the document does not detail who performed these analyses or their qualifications.
4. Adjudication Method for the Test Set
No adjudication method is described. The assessment appears to be a direct measurement against the ANSI/AAMI RD 62:2001 standard.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The device is a water purification system, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
This concept is not applicable to this device. The device is a physical water purification system, not an algorithm. Its performance is intrinsic to its design and function in purifying water, with alarms providing operational feedback to a human operator, but not as part of an 'algorithm only' scenario.
7. Type of Ground Truth Used
The ground truth used is based on compliance with a recognized technical standard: ANSI/AAMI RD 62:2001, "Water Treatment For Hemodialysis Applications." This standard defines the acceptable levels of various contaminants in water used for hemodialysis.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this medical device. Water purification systems do not use machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
{0}------------------------------------------------
OCT 20 2004
510(k) Summary
This 510(k) Summary is provided as part of the Premarket Notification to comply with the provisions of the safe Medical Devices Act of 1990 requiring that either a summary be included in a submission or a statement that a summary is available upon request.
Submitter
Robert A Oliver Mega Services 11730 Lost Meadows Cibolo, TX. 78108 210-945-8448 210-861-2549 12-30-2003
Device Name
Mega Pure Cart or MPC1
Common or usual name
Deionization system with pre and post treatment for Acute dialysis.
Classification name
Water purification system for hemodialysis (21CFR 876.5665)
Device Description
The Mega Pure Cart ( MPC1), is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. The MPC is a portable unit and is designed for single patient use only within a Hospital or Clinic setting.
The Mega Pure Cart purifies potable feed water through deionization. Deionization is used to remove 99.99+% of ions from water. Deionization alone does not remove particulates, organics, bacteria, viruses or endotoxins. The system is designed for hemodialysis application to treat carbon filtered potable water. Inappropriate use can result in the formation of Nitrosamines in the effluent of the deionizer. The purpose of the pretreatment section of the system is to condition the feed water supplying the deionizers. Conditioning the feed water will include: check valves to prevent backflow into the potable water source, one carbon tank and one carbon cartridge equipped with a test port between them to test for water conductivity, pH and chlorine/chloramines residual. This carbon is granular activated carbon with 12 x 40 mesh size and a iodine number of greater than 900. The purpose of the post treatment is to remove bacteria and endotoxins or lower them to within acceptable limits allowed by AAMI standards. The post treatment section of the system will include: sub micron/ ultra filter after the deionizer.
K 031832
PAGE 1
{1}------------------------------------------------
The alarm system will consist of two temperature compensated audible/visual alarms. The first alarm located after DI cartridge #1 and #2 is a 1meg ohm alarm and the second alarm is a temperature compensated audible/visual alarm and is pre set a 1 Meg ohm for final water quality. Routine monitoring of the test port #1 is necessary to detect any chlorine/chloramines breakthrough. Should any of the alarms sound during the treatment, the treatment should stop immediately and follow the DI cartridge exchange procedure listed in the operator's manual.
Based on a feed water quality of 266 ppm of TDS and 16 gpg of water hardness. Mega Pure Cart will produce typically 175 gallons of purified water that meets requirements of the standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD 62:2001, Water Treatment For Hemodialysis Applications. There was also a test ran with the city water quality of 6 gpg of water hardness and a TDS of 197 ppm, and there was 225 gallons of purified water produced.
Predicate Device K022747
The Mega Pure Cart and pretreatment and water purification are substantially equivalent to HydroPure system for dialysis, which utilize carbon and deionization cylinders to purify water for hemodialysis.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three streams emanating from its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
Mr. Robert Oliver Mega Services 106 Lost Meadows Drive CIBOLO, TX 78108
Re: K031832
Trade/Device Name: Mega Pure Cart Portable Water Purification System (Model MPC1) Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: September 13, 2004 Received: September 17, 2004
Dear Mr. Oliver:
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 (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 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.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin hanceing of substantial equivalence of your device to a legally premarket notification: "The PDF missification 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 If you desire specific advice for your do room of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation on your responsibilities under the Act from the 807.97). Tou may ootain other guitemational and Consumer Assistance at its toll-free number (800) DIVISION of Sinan Manufacturers, 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
{4}------------------------------------------------
510(k) K031832
Company Name: Mega Services
Device Name: Mega Pure Cart
Model Number: MPC1
Indications For Use:
The Mega Pure Cart ( MPC1), is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. The MPC is A portable unit and is designed for single patient use only within a Hospital or Clinic setting.
Concurrence of CDRH, Office of Device
Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
§ 876.5665 Water purification system for hemodialysis.
(a)
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.(b)
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.