(111 days)
DRYalysate™ Concentrate is intended for use for patients being treated by hemodialysis. The primary patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.
The device consists of packaged dry chemicals which, when mixed and dissolved with AAMI quality water, according to the directions for use, makes an acid concentrate that can be used by current proportioning type hemodialysis machines to make dialysate.
DRYalysate™ Concentrate will be packaged and sold in two convenient boxed sizes; a 'single dose' package designed to make enough dialysate concentrate (5 Liters) for one patient for one treatment and a 'bulk' package which contains enough powder to make 50 liters of dialysate at a time.
Once the package of chemicals is mixed according to the instructions for use, the resulting liquid concentrate is used in the hemodialysis process in proportioning type hemodialysis machines in exactly the same way that existing concentrates are used.
The provided text describes a 510(k) submission for a medical device called DRYalysate™ Concentrate, a powdered dialysate concentrate for hemodialysis. The document focuses on demonstrating substantial equivalence to predicate devices and does not detail specific acceptance criteria, performance metrics, or study designs in the way an AI/ML device submission would.
Therefore, many of the requested details about acceptance criteria, study methodologies, and ground truth establishment (which are common for AI/ML device evaluations) are not present in the provided text. The submission for DRYalysate™ Concentrate primarily relies on chemical formulation comparison and clinical studies to demonstrate safety and effectiveness for a chemical product, not a diagnostic or AI-powered device.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it claims:
- "The three clinical studies and other testing data submitted provide the necessary and sufficient evidence to support that Advanced Renal Technologies DRYalysate™ Concentrate is cafe and effective and substantially equivalent to currently marketed products."
The "performance" is implicitly deemed equivalent to existing, legally marketed dialysate concentrates based on its chemical formulation and clinical use. The key aspect here is "substantial equivalence" to predicate devices, rather than meeting specific performance thresholds against a diagnostic gold standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "three clinical studies" but does not provide details on:
- Sample size for any test set or clinical studies.
- Data provenance (e.g., country of origin).
- Whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The device is a chemical concentrate, not a diagnostic tool requiring expert interpretation for ground truth establishment. Clinical studies for such a device would typically focus on patient outcomes, tolerability, and efficacy in maintaining appropriate blood chemistry during dialysis, not on diagnostic accuracy based on expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in diagnostic imaging or clinical trials where expert consensus is needed to establish a "ground truth" for a decision, which is not relevant to a dialysate concentrate.
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
This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic imaging devices, especially AI-assisted ones. This device is a chemical concentrate for hemodialysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. "Standalone" performance refers to AI algorithm performance without human intervention, which does not apply to a chemical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically discussed for diagnostic or AI/ML devices is not directly applicable here. For a hemodialysis concentrate, the "truth" would be evaluated based on:
- Chemical composition and stability: Ensuring the concentrate, when mixed, produces the intended dialysate according to AAMI quality water standards.
- Clinical outcomes data: Demonstrating safety and effectiveness in patients undergoing hemodialysis, likely focusing on blood chemistry parameters, patient well-being, and comparison to existing products.
The document states "The three clinical studies and other testing data submitted provide the necessary and sufficient evidence to support that... DRYalysate™ Concentrate is safe and effective." This suggests clinical outcomes data and laboratory testing of chemical properties would form the basis of the "truth."
8. The sample size for the training set
This information is not applicable and not provided. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no training set for this type of device.
In summary, the provided 510(k) summary is for a chemical medical device (dialysate concentrate) and therefore lacks the detailed information regarding study design, acceptance criteria based on performance metrics, and ground truth establishment that would be typically found in an FDA submission for an AI/ML powered diagnostic device. The primary claim for this device is "substantial equivalence" to existing predicate devices based on its chemical formulation and intended clinical use.
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510 (k) SUMMARY
The information contained on the following pages is required to be included pursuant to $807.87 (h) of 21 CFR which cross-references to the requirements of $807.92. The information follows the order asked for in §807.92:
SUBMITTER
Submitter:
Advanced Renal Technologies
Address:
2151 N. Northlake Way, Suite #200 Seattle, WA 98103
Phone:
Robin Callan
(206) 545-3570
Date prepared:
Contact person:
" " January 9, 1998
DEVICE NAME
Proprietary Name:
DRYalysate™ Concentrate.
Common/Usual Name:
- Acid Concentrate, 'A' component of bicarbonate dialysate, "A Concentrate" and granulated or powdered dialysate concentrate for hemodialysis.
Classification Name:
Dialysate Concentrate for Hemodialysis.
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PREDICATE DEVICES
1980659
DRYalysate™ Concentrate is a powdered concentrate substantially equivalent to the powdered dialysate products supplied by Fresenius USA sold as Granuflo™ Dry Acid Concentrate (originally granted FDA marketing approval as Granulyte™ Powder Dialysate Concentrate; 510 (k) #'s K911459 and K922005), Dial Medical's DMF (Dial Medical of Florida, Inc.) Hemodialysis Concentrates; 510 (k) # K864265, and Granite Chemical's GC-1000, GC-2000 and GC-3000 formulas; 510 (k) # K901471, all of which have been determined equivalent to pre-enactment devices.
Available dialysate concentration formulations supplied by these predicate device manufacturers were provided.
DEVICE DESCRIPTION
The device consists of packaged dry chemicals which, when mixed and dissolved with AAMI quality water, according to the directions for use, makes an acid concentrate that can be used by current proportioning type hemodialysis machines to make dialysate.
DRYalysate™ Concentrate will be packaged and sold in two convenient boxed sizes; a 'single dose' package designed to make enough dialysate concentrate (5 Liters) for one patient for one treatment and a 'bulk' package which contains enough powder to make 50 liters of dialysate at a time.
Once the package of chemicals is mixed according to the instructions for use, the resulting liquid concentrate is used in the hemodialysis process in proportioning type hemodialysis machines in exactly the same way that existing concentrates are used.
A list of available DRYalysate™ final dialysate formulations was provided.
STATEMENT OF INTENDED USE
DRYalysate™ Concentrate is intended for use for patients being treated by hemodialysis. The primary patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.
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STATEMENT OF EQUIVALENCE
1296 501 3
1980659
The intended use of DRY alysate™ Concentrate is identical with that of currently marketed dialysate concentrates.
A comparison of the technological characteristics (chemical formulation) of DRYalysate™ Concentrate with currently marketed dialysate concentrates demonstrates that the only substantive change is the use of citric acid as the acidifying agent, otherwise the formulations are identical.
The concentration ranges of ART DRYalysate™ Concentrates were provided.
ASSESSMENT OF PERFORMANCE DATA
The three clinical studies and other testing data submitted provide the necessary and sufficient evidence to support that Advanced Renal Technologies DRYalysate™ Concentrate is cafe and effective and substantially equivalent to currently marketed products.
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Image /page/3/Picture/16 description: The image shows a circular seal or logo. The text around the top of the circle reads "U.S.A.", and the text around the bottom of the circle reads "DEPARTMENT OF HEALTH & HUM.". Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1998
Ms. Robin Callan President Advanced Renal Technologies 2151 N. Northlake Way, Suite 200 Seattle, WA 98103
Re: K980659 ART DRYalysate™ Concentrate Dated: May 14, 1998 Received: May 15, 1998 Regulatory Class: II 21 CFR $876.5820/Procode: 78 KPO
Dear Ms. Callan:
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 (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 (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 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 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/cdrb/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
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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510 (k) Number
None asigned at this time.
Device Name
DRYalysate™ Concentrate
Indications for Use
DRYalysate™ Concentrate is indicated for use for patients being treated by hemodialysis. The patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Sattley/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use
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§ 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.