MD 420/440/460/470/480/490 by ISOPURE CORP.

The MD 420-490 series reverse osmosis system is intended to purify water for hemodialysis when used as a component of a complete water purification system.

Device Description

The MD 420-490 Series is a Reverse Osmosis Machine used in purifying water. The MD 420-490 series features an advanced electronic package including a PLC with software and validation procedures and a Touch-screen. The new advanced system has the capability to monitor both the pre-treatment and posttreatment of the water room. The data can be printed for a daily log or modem to a remote location. The machine is now simpler, quieter, and easier to maintain, run, and service compared to the MD 400 A-F. The PLC can monitor all aspects of the water room including the RO, pre-treatment, storage tank, line and loop pressures, temperatures, and flows. The system will display membrane % rejection and % recovery. All of this data is sent back to the RO where it is displayed. The data also has the capability to be modemed to a remote location. The hydraulic design of the machine remains unchanged for the original 510(k) application, however, we now use SCH 80 PVC pipe and 316L Stainless Steel piping in place of the tubing originally used of the HD- MD series.

AI/ML Overview

The provided document describes a 510(k) submission for a medical device, the MD 420/440/460/470/480/490 Multi-Patient Reverse Osmosis (RO) Machine. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be presented for a diagnostic or AI-driven device.

Instead, this document is a summary of the substantial equivalence determination for a modified RO machine for hemodialysis water purification. The "study" here is essentially the comparison to a predicate device and a discussion of non-clinical tests to determine substantial equivalence.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity, accuracy). The acceptance criteria implicitly revolve around maintaining the safety and effectiveness of the predicate device while incorporating new electronic and design features.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Intended Use	Must purify water for Hemodialysis as a component of a complete water purification system.	"The MD 420-490 series is intended to purify water for Hemodialysis when used as a component of a complete water purification system." (Stated as maintained from predicate)
Safety	No adverse changes in safety from the predicate device.	"Based on the information submitted, there are no changes in the safety of effective issues." (Stated by FDA and manufacturer)
Effectiveness	No adverse changes in effectiveness from the predicate device in purifying water for hemodialysis.	"Based on the information submitted, there are no changes in the safety of effective issues." (Stated by FDA and manufacturer)
Functionality (New Features)	Advanced electronic package (PLC, touchscreen) must monitor pre-treatment and post-treatment, print data, and allow remote modem communication. Improved design for quieter operation, easier maintenance, and reduced failures.	The device "features an advanced electronic package including a PLC with software and validation procedures and a Touch-screen. The new advanced system has the capability to monitor both the pre-treatment and post-treatment of the water room. The data can be printed for a daily log or modem to a remote location." The machine is "simpler, quieter, and easier to maintain, run, and service compared to the MD 400 A-F."
Material Changes	Use of SCH 80 PVC pipe and 316L Stainless Steel piping must not compromise performance or safety.	The hydraulic design "remains unchanged for the original 510(k) application, however, we now use SCH 80 PVC pipe and 316L Stainless Steel piping in place of the tubing originally used of the HD- MD series." (Implies these materials maintain required performance)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. This submission is not based on a clinical trial with a "test set" of patients or data in the way a diagnostic device would be. It's an engineering and design modification approval.
Data Provenance: The "data" primarily consists of engineering specifications, design comparisons, and the rationale for modifications. It's not based on patient data from a specific country or collected retrospectively/prospectively from a clinical population. It's an internal design and safety/effectiveness assessment by the manufacturer, reviewed by the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. "Ground truth" in the context of this document refers to the established safety and effectiveness of the predicate device and the engineering assessment that the modifications do not negatively impact these aspects. This would involve internal engineering expertise from Isopure Corporation and regulatory review by the FDA (specifically, the Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices). No external medical experts are mentioned as establishing "ground truth" for a specific test set.

4. Adjudication Method for the Test Set:

Not applicable. There is no specific test set requiring adjudication in the context of this 510(k) submission. The FDA's substantial equivalence review process serves as the "adjudication" of the overall submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This device is a water purification system, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No. This device is an electromechanical system, not an algorithm. Its "performance" is its ability to purify water, not to interpret data in an autonomous way.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the established safety and effectiveness of the predicate device (MD 400 Series Multi-Patient Reverse Osmosis (RO) Water Treatment System) and the engineering and regulatory assessment that the modified device (MD 420-490 Series) maintains this level of safety and effectiveness despite design changes and the addition of features like a PLC. It's based on technical specifications, regulatory standards, and the intended use of water purification for hemodialysis.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as it's not an AI/ML device with a training set.

Summary

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JAN 2 4 2000

Image /page/0/Picture/1 description: The image shows the word "isopure" in a bold, sans-serif font. Below the word, there is a graphic of a series of wave-like shapes. The word and the graphic are both in black, contrasting with the white background. The overall design is simple and eye-catching.

1993200

Ph. (502) 267-(800)-280- PURF Ph. 8x. (502) 267 11700 Commonwealth Drive, I ouisville. Kv. 40290

510 (K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K993200.

1. Submitter's Identification: Isopure Corporation 11700 Commonwealth Drive Suite 605 Louisville, Kentucky 40299
  Date Summary Prepared: September 20, 1999
1. Name of The Device: MD 420/440/460/470/480/490 Multi- Patient Reverse Osmosis (RO) Machine.
1. Predicate Device Information: Multi-Patient Reverse Osmosis (RO) Water Treatment System MD 400 Series.
1. Device Description: The MD 420-490 Series is a Reverse Osmosis Machine used in purifying water.
1. Intended Use: The MD 420-490 Series is intended to purify water for Hemodialysis when used as a component of a complete water purification system.
Comparison to Predicated Device: () The MD 420-490 series features an advanced electronic package including a PLC with software and validation procedures and a Touch-screen. The new advanced system has the capability to monitor both the pre-treatment and posttreatment of the water room. The data can be printed for a daily log or modem to a remote location.

Manufacturers of Advanced Water Purification and Reclamation Technologies

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Discussion of Non-Clinical Test Performed for Determination of Substantial 7) Equivalence are as follows: Based on the information submitted, there are no changes in the safety of effective issucs.
Discussion of Clinical Test Performed: 8) N/A
1. Conclusions:

As was true for the original registered HD400A-F Reverse Osmosis (RO) nachine device, the intended use of the modified RO machine device, i.e. the MD 420-490 series, is intended to purify water for Hemodialysis when used as a component of a complete water purification system.

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EXHIBIT A:

SECTION 1: DEVICE MODIFICATION DESCRIPTION

1.1 Intended Use: As was true for the original registered HD400A--F Reverse Osmosis (RO) Machine device (510(k) application #K944385), the intended use of the modified RO machine device, i.e., the MD420-490 series, is intended to purify water for Hemodialysis when used as a component of a complete water purification system. The device name change from MD 400 A-F to MD 420-490 was to facilitate recognition of a medical device (MD) 400 series as multi-patent and 20-90 as the total machine membranes 420 (2 membranes) 440 (4 membranes) etc. The text of the original 510(k), though of limited explicit information characteristic of its time of submission, is included for reference (See Exhibit E: Section 10).

1.2 Rationale: The rationale for modifying the original registered device is straightforward. First, the original design, although very useful at the time, now proves to be very nosey and cluttered with pipes, valves, etc. This made the machine very hard to operate and maintenance proved very costly. Second, the horizontal position of the Goulds pump resulted in complete pump failures costing IPS large sums of money in pump failures resulting in the sale of the company in 1998 to Isopure Corp. Third, with the FDA now requiring a complete registration of the entire water system, this machine with the use of a PLC, will record data for all aspects of the water system tying the pre-treatment and storage tank back to the RO for one central location for all of the data. This information is also modemable to a remote location. Fourth, the machine is now simpler, quieter, and easier to maintain, run, and service compared to the MD 400 A-F.

1.3 Background: It was, and remains, the opinion of the applicant that the change from a mechanical device entrained changes attendant to a automated device, were subject to documentation for the models of the original registered device series (MD400A-F, now MD 420--490). The PLC change and entrained changes are listed later in this exhibit (See Exhibit A: Section 1.9, "Table of Differences"). Marketing of these devices continues. In addition, long before changing to the new PLC, MD 400D-- E models were constructed and sold using the same original circuitry to meet the growing purified water volume demands of the dialysis market. The MD400 D-- E devices, now the MD 420-490 also underwent alteration and are equipped with PLC circuitry. Again, it was felt that the PLC could offer a much broader control of the entire system per the FDA requirements. The original conductivity control a Myron L conductivity controller used to monitor the conductivity of the water and also control the " Diversion to Drain" of the machine remains the same as on the original registration. The PLC can monitor all aspects of the water room including the RO, pre-treatment, storage tank, line and loop pressures, temperatures, and flows. The system will display membrane % rejection and % recovery. All of this data is sent back to the RO where it is displayed. The data also has the capability to be modemed to a remote location. Isopure would also like to offer a "Remote Monitoring Service" where we would call up the machine from our location, review the data of the water room and fax or e-mail the results back to the clinic for their reports. The hydraulic design of the machine remains unchanged for the original 510(k) application, however, we now use SCH 80 PVC pipe and 316L Stainless Steel piping in place of the tubing originally used of the HD- MD series.

lsopure

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

24 2000 JAN

Mr. Kevin Gillespie President and CEO Isopure Corporation 11700 Commonwealth Drive Louisville, KY 40299

Re: K993200 MD 420/440/460/470/480/490 Reverse Osmosis Machine Dated: October 24, 1999 Received: October 28, 1999 Regulatory Class: Il 21 CFR §876.5665/Procode: 78 FIP

Dear Mr. Gillespie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K993200

Device Name: MD 420/440/460/470/480/490 Multi-patient Reverse Osmosis (RO) Machine

Indications For Use:

The MD 420-490 series reverse osmosis system is intended to purify water for hemodialysis when used as a component of a complete water purification system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K993200 510(k) Number _

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.