(92 days)
These Water Purification Devices are intended to be used as components of a water purification system to remove organic and inorganic substances from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
The BJJ&A water purification component for hemodialysis will be used with a hemodialysis system. The Water purffication system will remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate, bicarbonate, acetate and sterilant for dialyzer reprocessing.
The purified water will also be used in the equipment disinfection process, equipment rinsing and any other application the clinic/customer deems appropriate. This system will meet all the requirements put forth by the United States Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and any other laws that may apply.
The BJJ&A water purfication components, both activated carbon filtration and deionization, utilize no new water purification techniques.
Deionization tanks from both BJJ&A and AmeriWater are utilized to remove dissolved solids from the water. Both utilize mixed bed resin, consisting of anion and cation resin, to remove the charged particles from the water. Both utilize parts and materials which are "NSF" and/or FDA approved.
Activated carbon filtration is utilized by both BJJ&A and AmeriWater to filter out chlorine and chloramines from the water. BJJ&A uses carbon filter made from materials, which are FDA or NSF approved. Both companies use two carbon fitters in a series configuration. A minimum total contact time of 10 empty bed contact time minutes are incorporated into both designs as recommended by the FDA for chlorine and chloramines removal. Both BJJ&A and AmeriWater recommended the chlorine and chloramine levels be checked before each patient shift. Both companies recommend hard plumbed bypass piping of the carbon tanks not be allowed on either component. Both components will utilize an activated carbon with an lodine number of 900 or greater. BJJ&A always recommends using a dual carbon filter in series in every dialysis water system installed, including single patient systems.
The provided text is a 510(k) Premarket Notification Summary for "Water Purification Components for Hemodialysis" (K060942) by Bob J. Johnson & Associates, Inc. (BJJ&A). It outlines the device's purpose and its asserted substantial equivalence to a predicate device.
Key takeaway regarding device acceptance criteria and study:
The submission explicitly states that BJJ&A is claiming substantial equivalence to an existing legally marketed predicate device (AmeriWater Company Purification System, K99159). This means that, for this specific type of regulatory submission (510(k)), the "acceptance criteria" are demonstrating that the new device is as safe and effective as the predicate device. The "study" proving this substantial equivalence is primarily a comparison of features and principles of operation, rather than a clinical trial with performance metrics.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission claiming substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the same technological characteristics and principles of operation with a legally marketed predicate device, and does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance / Justification |
|---|---|
| Similar Intended Use | Both BJJ&A components and the predicate device (AmeriWater) are intended for water purification in hemodialysis systems to remove organic, inorganic substances, and microbial contaminants. |
| Similar Technological Characteristics | Deionization tanks: Both utilize mixed bed resin (anion and cation) to remove charged particles. Both use NSF and/or FDA approved parts/materials. Activated carbon filtration: Both use carbon filters to remove chlorine and chloramines. Both use two carbon filters in a series configuration. Both incorporate a minimum total contact time of 10 empty bed contact time minutes. Both recommend checking chlorine/chloramine levels before each patient shift. Both advise against hard plumbed bypass piping. Both utilize activated carbon with an Iodine number of 900 or greater. |
| Same Principles of Operation | The submission explicitly states: "The BJJ&A water purification components, both activated carbon filtration and deionization, utilize no new water purification techniques. The predicate device components we are claiming SE to, utilizes the exact same water purification principles." |
| Meet applicable standards (FDA, AAMI) | The system "will meet all the requirements put forth by the United States Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and any other laws that may apply." (This is a statement of intent for the overall system, which these components contribute to.) |
| No New Questions of Safety/Effectiveness | Implied by the comparison showing similar design, materials, and operation to a legally marketed device. |
2. Sample size used for the test set and the data provenance
- No "test set" in the traditional sense of a clinical or performance study. This 510(k) submission relies on a comparison to a predicate device.
- The "data provenance" would be the specifications and operational principles of the BJJ&A components and the predicate AmeriWater components, described in the summary. There is no mention of country of origin of data or whether it's retrospective/prospective, as it's not a data-driven performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" requiring expert consensus for ground truth establishment in this type of submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no "test set" and thus no need for an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is water purification components, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is water purification components, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this 510(k) submission is the established safety and efficacy of the legally marketed predicate device (AmeriWater K99159) as determined by the FDA's original clearance of that device. The manufacturer is asserting their new components are equivalent to these established standards.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI device.
In summary:
This 510(k) Premarket Notification primarily functions by showing that the BJJ&A water purification components are substantially equivalent to a predicate device (AmeriWater K99159) based on shared intended use, similar technological characteristics, and identical principles of operation. The "study" demonstrating this involves a detailed comparison of the BJJ&A components' design and function against the predicate device, rather than a clinical trial or performance study with a test set, experts, or ground truth in the manner typical for diagnostic or therapeutic devices.
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Image /page/0/Picture/0 description: The image shows the logo for Bob J. Johnson & Associates, Inc., a company specializing in total water treatment. The logo features a black square with a white star inside, followed by the text "BJJ&A" above a series of wavy lines, presumably representing water. Below the wavy lines is the text "Total Water Treatment" and "Bob J. Johnson & Associates, Inc.".
K060942
PAGE I OF III
Bob J. Johnson & Associates 16420 West Hardy Rd. Suite 100 Houston TX 77060 Ph. 281-873-5555 Fax 281-873-5544 www.bjja.com
JUL - 7 2006
Premarket Notification 510(K) Summary
Water Purification Components for Hemodialysis Regulatory Classification: 21 CFR 876.5665 Class II Product Code: 78 FIP
Note: In this summary the work "component" refers to an individual part of a water treatment system. Example: the activated carbon exchange tank or deionization exchange tank. The word system refers to the water purfication plant as a whole. Example: the water softener, activated carbon filter, reverse osmosis, storage tank, uttraviolet sterlizer, and pumping systems. We are claiming substantial equivance to components.
Bob J. Johnson & Assoc., Inc. (BJJ&A) is applying for a 501(k) premarket notification for our "Water Purification Components for Hemodialysis". The following is a summary of our submission document. The regulatory classification is class II CFR 876.5665(a), Product Code 78 FIP. The device we are claiming substantial equivalence to is marketed by AmeriWater Company. The registration number for this device is K99159, AmeriWater Company. Purification System. Regulatory Class: 11, 21 CFR 876.5665/Procode: 78 FIP.
The BJJ&A water purfication component for hemodialysis will be used with a hemodialysis system. The Water purffication system will remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate, bicarbonate, acetate and sterilant for dialyzer reprocessing.
The purified water will also be used in the equipment disinfection process, equipment rinsing and any other application the clinic/customer deems appropriate. This system will meet all the requirements put forth by the United States Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and any other laws that may apply.
The BJJ&A water purfication components, both activated carbon filtration and deionization, utilize no new water purification techniques, The predicate device components we are
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claiming SE to, utilizes the exact same water purification principles. The following is a comparison summary of the BJJ&A water treatment components and the predicate device,
Deionization tanks from both BJJ&A and AmeriWater are utilized to remove dissolved solids from the water. Both utilize mixed bed resin, consisting of anion and cation resin, to remove the charged particles from the water. Both utilize parts and materials which are "NSF" and/or FDA approved.
Activated carbon filtration is utilized by both BJJ&A and AmeriWater to filter out chlorine and chloramines from the water, BJJ&A uses carbon filter made from materials, which are FDA or NSF approved. Both companies use two carbon fitters in a series configuration. A minimum total contact time of 10 empty bed contact time minutes are incorporated into both designs as recommended by the FDA for chlorine and chloramines removal. Both BJJ&A and AmeriWater recommended the chlorine and chloramine levels be checked before each patient shift. Both companies recommend hard plumbed bypass piping of the carbon tanks not be allowed on either component. Both components will utilize an activated carbon with an lodine number of 900 or greater. BJJ&A always recommends using a dual carbon filter in series in every dialysis water system installed, including single patient systems.
The devices that BJJ&A are seeking 510K for are:
| SECTION F PRODUCT INFORMATION - APPLICATION TO ALL APPPLICATIONS | |||
|---|---|---|---|
| Common or usual name or classification | |||
| Water Purifcation Components for Hemodialysis | |||
| Trade or Proprietary or Model Name for This Device | Model Number | ||
| 1 | .25 cu ft Activated Carbon Exchange Tank | BJAC-.25 | |
| 2 | .54 cu ft Activated Carbon Exchange Tank | BJAC-.54 | |
| 3 | 1.2 cu ft Activated Carbon Exchange Tank | BJAC-1.2 | |
| 4 | 2.1 cu ft Activated Carbon Exchange Tank | BJAC-2.1 | |
| 5 | 3.6 cu ft Activated Carbon Exchange Tank | BJAC-3.6 | |
| 6 | .25 cu ft Deionization Exchange Tank | BJDI-.25 | |
| 7 | .54 cu ft Deionization Exchange Tank | BJDI-.54 | |
| 8 | 1.2 cu ft Deionization Exchange Tank | BJDI-1.2 | |
| 9 | 2.1 cu ft Deionization Exchange Tank | BJDI-2.1 | |
| 10 | 3.6 cu ft Deionization Exchange Tank | BJDI-3.6 |
Included in this document is labeling that is applied to the components of the water purification system for hemodialysis. AAMI water purification standards are also included.
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With an actual water quality analysis and Total Organic Carbon analysis from existing water purfication components for dialysis. Dimensional drawing and product specification sheet are included in this submittal along with owner's manual for each of the components.mn Proc
In summary, the BJJ&A water purification components and the AmeriWater predicate device components are very similar to one another. The core water purffication components and technology are exactly the same.
Note: The Renal Care Facilities will supply their own water purfication system, which consists of reverse osmosis system, ultra-filtration rack, water softeners, and storage, tanks. BJU8A will only be providing the activated carbon and deionization components to their systems.
Bob J. Johnson & Associates, Inc. 16420 West Hardy Road Suite 100 Houston, Texas 77060 Voice 281-873-5555 Fax 281-873-5544
O. E. Hiller
Jon E. Hulsev President & CEO
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL - 7 2006
Mr. Jon E. Hulsey President & CEO Bob J. Johnson & Associates, Inc. 16420 West Hardy Road, Suite 100 HOUSTON TX 77060
Re: K060942
Trade/Device Name: Carbon Exchange Tank Series BJAC and DI Exchange Tanks Series BJDI Regulation Number: 21 CFR $876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: March 31, 2006 Received: April 6, 2006
Dear Mr. Hulsey:
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.
Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by text that appears to be part of the organization's name or motto.
Promoting Fublic
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Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy Chogdon
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
510(k) Number (if known): K060942
Device Name: Carbon Exchange Tank Series BJAC and DI Exhange Tanks Series BJDI
Indications For Use:
These Water Purification Devices are intended to be used as components of a water purification system to remove organic and inorganic substances from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
Note: The Renal Care Facilities will supply their own water treatment system, which consists of water softeners, ultra-filtration, reverse osmosis system, alarms, monitors, tanks, and pumping stations. Bob J. Johnson & Associates will only be providing the activated carbon and deionization components to their systems.
Prescription Use XX______ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _____ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Beagdon
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060942
Page 1 of 2___
§ 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.