(87 days)
KayBath acid concentrate dialysate is administered with bicarbonate dialysate and AAMI quality water in a 3 stream proportioning artificial kidney equipment to perform hemodialysis in the ES ID population
KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium and potassium), along with dextrose and glacial acetic acid. Pharmaceutical grade water, produced by a reverse osmosis pump under AAMI Standards, is used to mix the salts, dextrose and acetic acid. The solution is formulated and intended for the express purpose of performing hemodialysis. The acidified dialysate is proportioned inside commercially available hemodialysis machines with water and bicarbonate dialysate. The three streams of liquid unite to become the dialysate that runs countercurrent to the blood through the dialyzer at 500cc/min. The hemodialysis device provides the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate. The dialyzer consists of hundreds of hollow strands of a cellulosic or synthetic membrane inside a cylinder. The membrane serves as a selective barrier to the passage of molecules beyond a certain molecular weight. While the blood travels through the hollow strands, undesirable substances in the blood, such as urea, nitrogen, potassium, etc., pass through the semipermeable membrane into the dialysate and are flushed down the drains.
The provided document (K982813) is a 510(k) premarket notification for a medical device: Dialysate Concentrate for Hemodialysis (Liquid or Powder).
Based on the document, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance |
|---|---|---|
| Composition | Same range of chemical compositions as the predicate device. | KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium, potassium), dextrose, and glacial acetic acid. The composition is described as "quite precise and uniform" and there are "no significant differences between those marketed products and this proposed device" (referring to the predicate). |
| Intended Use | Same intended use as the predicate device (Bicarbonate Dialysis Bath Concentrate Solution). | Indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure, with the appropriate hemodialysis machine. This is stated to be "essentially the same as the indication statement of the predicate device." |
| Packaging & Labeling | Same packaging and labeling as the predicate device. | No specific details provided on packaging/labeling, but stated that "both devices utilize the same... packaging and formulations." |
| Formulation | Same formulations as the predicate device. | No specific details provided on formulation, but stated that "both devices utilize the same... formulations." |
| Safety and Effectiveness | Safe, effective, and performs as well as the predicate device, when used in accordance with industry standards. | Conclusion states the device "will be safe, effective, and perform as well as the predicate device, when used in accordance with industry standards." This is a prospective claim based on substantial equivalence, not a direct measurement of performance. |
2. Sample Size Used for the Test Set and Data Provenance
- No test set was used. The device received 510(k) clearance based on substantial equivalence to a predicate device, not on direct clinical or in-vitro testing of the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There was no test set or ground truth established for the proposed device through expert review. The submission relies on the established safety and effectiveness of the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No test set was used.
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 a concentrate solution for hemodialysis, not an AI-powered diagnostic device. Therefore, no MRMC study was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a concentrate solution for hemodialysis, not an algorithm.
7. The Type of Ground Truth Used
- "Predicate Device Equivalence Ground Truth": The ground truth for this submission is the established safety and effectiveness profile of the legally marketed predicate device (Fresenius USA, Acid Concentrate for Bicarbonate Dialysis, K810925). The fundamental assertion is that the proposed device, being chemically and functionally identical within expected ranges, thereby shares the same safety and effectiveness characteristics.
8. The Sample Size for the Training Set
- Not applicable. The device is a chemical concentrate, not a machine learning model. There was no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There was no training set. The "ground truth" for granting clearance was the existing regulatory approval and market performance of the predicate device, which would have had its own rigorous testing and validation historically.
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6 1998 NOV
510(k) SUMMARY
| SUBMITTER: | Bonnie Nakayama, RN, CNN, MBAKayBath, Inc.95-1509 Ainamakua Drive, #32Mililani, HI 96789Phone: (808) 626-0234 |
|---|---|
| CONTACT PERSON: | Bonnie Nakayama |
| DATE PREPARED: | August 1, 1998 |
| DEVICE NAME: | Dialysate Concentrate for Hemodialysis(Liquid or Powder) |
| CLASSIFICATION NAME: | Concentrate Solutions for HemodialysisAccessories to Hemodialysis |
| PREDICATE DEVICE: | Fresenius USA, Acid Concentrate forBicarbonate Dialysis |
Device Description:
KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium and potassium), along with dextrose and glacial acetic acid. Pharmaceutical grade water, produced by a reverse osmosis pump under AAMI Standards, is used to mix the salts, dextrose and acetic acid. The solution is formulated and intended for the express purpose of performing hemodialysis. The acidified dialysate is proportioned inside commercially available hemodialysis machines with water and bicarbonate dialysate. The three streams of liquid unite to become the dialysate that runs countercurrent to the blood through the dialyzer at 500cc/min. See Table 6-1. The hemodialysis device provides the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate. The dialyzer consists of hundreds of hollow strands of a cellulosic or synthetic membrane inside a cylinder. The membrane serves as a selective barrier to the passage of molecules beyond a certain molecular
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weight. While the blood travels through the hollow strands, undesirable substances in the blood, such as urea, nitrogen, potassium, etc., pass through the semipermeable membrane into the dialysate and are flushed down the drains.
| PROPORTIONING RATIO | ||
|---|---|---|
| Stream 1 | Stream 2 | Stream 3 |
| water | bicarbonate | acid |
| dialysate | dialysate | |
| 42.28 | 1.72 | 1 |
TABLE 6-1
The clinical application of high-efficiency and high-flux treatments in the 1980s carefully defined the dialysate composition used to achieve a stable dialysis treatment. Table 6-2 shows the typical composition of dialysate components used in commonly prescribed high-efficiency and high-flux treatments. A sodium concentration of 140-142 mEq/L provides the best ionic concentration for achieving isotonic ultrafiltration in patients during dialysis, so that excess water loss from the blood is averted. The presence of acetic acid in the acid concentrate provides the appropriate pH controls to prevent calcium carbonate precipitation in the proportioning and valve systems. Precipitation of calcium carbonate in the proportioners can score their internal aspects and freeze up the proportioning systems. The use of 4 mEq/L of acetic acid in the final acid concentrate provides a safety margin to ensure the pH of the dialysate is between 7.1 and 7.4. The small amount of acetic acid is metabolized in the patient to bicarbonate and provides additional buffer capacity.
| TYPICAL COMPOSITION of DIALYSATE | |
|---|---|
| Sodium | 100 mEq/L |
| Potassium | 0 to 3 mEq/L |
| Calcium | 2.5 to 3.5 mEq/L |
| Magnesium | 0.75 to 1 mEq/L |
| Acetic Acid | 2.5 to 4.5 mEq/L |
| Chloride | 100 to 107 mEq/L |
| Dextrose | 0 to 200 mg/dl |
TABLE 6-2
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Since different patients require different removal rates of certain substances, like calcium and potassium, a variety of different acidified dialysate formulas will need to be available:
| COMMONLY PRESCRIBED FORMULAS | ||
|---|---|---|
| Series No. | Potassium | Calcium |
| 4 | 1 mEq/L | 0 mEq/L |
| 5 | 1 mEq/L | 2.5 mEq/L |
| 6 | 1 mEq/L | 3.0 mEq/L |
| 7 | 2 mEq/L | 0 mEq/L |
| 8 | 2 mEq/L | 2.5 mEq/L |
| 9 | 2 mEq/L | 3.0 mEq/L |
TABLE 6-3
Predicate Devices:
KayBath acidified concentrate solutions are substantially equivalent to Fresenius USA hemodialysis concentrates in composition, intended use, packaging and labeling, in addition to all the other makers of this solution. The composition is quite precise and uniform. There are no significant differences between those marketed products and this proposed device.
| Device Name: | Fresenius USANaturalyte Acid Concentrate for BicarbonateDialysis |
|---|---|
| Intended Use: | Bicarbonate Dialysis BathConcentrate Solution |
| 510(k) Number: | K810925 |
| Approval Date: | April 6, 1981 |
| FDA Regulatory Class: | II |
Intended Use:
KayBath acid concentrate for bicarbonate dialysis is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure, with the appropriate hemodialysis machine. This indication statement is essentially the same as the indication statement of the predicate device.
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K78 2813 Page 4/4
Technological Characteristics:
In comparing the proposed device to the predicate device, both devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences.
Summary of Non-Clinical Tests:
No in vitro testing was performed to determine the chemical composition and range of composition at this time. There are no important descriptive differences in comparison to the currenlty marketed product. The descriptive characteristics are precise enough to ensure comparability will be achieved when the proposed device is produced according to this description.
Clinical Test Results: Clinical testing was not performed.
Conclusions:
KayBath concentrate solutions for bicarbonate dialysis will be safe, effective, and perform as well as the predicate device, when used in accordance with industry standards.
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Image /page/4/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of a human figure. The figure is composed of three curved lines that form the shape of a person's head and shoulders.
NOV 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bonnie Nakayama, R.N., C.N.N., M.B.A. KayBath, Inc. 95-547 Ukee Street, #110 Waipahu, HI 96797
Re: K982813 Concentrate Solutions for Hemodialysis Dated: July 15, 1998 Received: August 11, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 KPO
Dear Ms. Nakayama:
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 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 (OS) for Medical Devices: General regulation (2) 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 regulation may result 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 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), piease 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/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
7
KayBath Concentrate Solutions for Device Name: Bicarbonate Hemodialysis
Indications For Use: KayBath acid concentrate dialysate is administered with bicarbonate dialysate and AAMI quality water in a 3 stream proportioning artificial kidney equipment to perform hemodialysis in the ES ID population
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number.
Prescription Use ,Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.