(271 days)
Diasol -- Additives are used in conjunction with Diasol acid concentrate, AAMI standard water and Sodium Bicarbonate as Dialysate solution for concentralia, 2011 homodialysis in 3 stream homodialysis machines allowing the physician to customize the dialysate to meet the patient's needs .
puysesan additives, Infusates and Infusate additives are for use with sorbent regenerated Dulysis and allows physicians to customize the dialysate to meet the patient's needs.
Not Found
This is a response to the prompt based on the provided text, however, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically understood in the context of AI/ML-powered medical devices (performance metrics, test sets, ground truth establishment, etc.) does not apply to this document.
The document is a 510(k) clearance letter from the FDA for a conventional medical device, "Diasol - Additives," which are used in hemodialysis. The FDA's review for such devices primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than performance against predefined acceptance criteria for an AI algorithm.
Therefore, the requested information cannot be extracted from this document in its current form. The document does not describe any acceptance criteria, device performance metrics, study design, sample sizes, expert involvement, or ground truth for an AI/ML device.
However, if we were to interpret "acceptance criteria" and "device performance" in the context of a conventional medical device clearance (even though it's not explicitly about AI/ML), it would be related to meeting the standards of the predicate device and the safety and effectiveness for its intended use.
Given this limitation, I will respond by stating that the information requested for AI/ML device performance is not present in the provided document.
Analysis of the Provided Document Regarding AI/ML Device Performance:
The provided document is a 510(k) clearance letter from the FDA for a device named "Diasol - Additives," referenced under K020231. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The "Statement of Intended Use" describes "Diasol - Additives" as components used in conjunction with other materials (Diasol acid concentrate, AAMI standard water, and Sodium Bicarbonate) to form a dialysate solution for hemodialysis machines. It also mentions their use with sorbent regenerated dialysis to customize dialysate for patient needs.
Crucially, there is NO mention of any AI or Machine Learning component, algorithm, or software in this document. The device appears to be a chemical additive product used in a medical procedure, not an AI/ML powered diagnostic or therapeutic device.
Therefore, the questions regarding acceptance criteria, study data, sample sizes, ground truth, expert opinions, and MRMC studies, which are pertinent to the evaluation of AI/ML medical devices, are not applicable to the information contained in this FDA clearance letter.
Conclusion:
The provided document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML powered medical device. The device described, "Diasol - Additives," is a conventional medical product used in hemodialysis, and its clearance process, as reflected in this 510(k) letter, does not involve the type of AI/ML specific evaluations outlined in your prompt.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 2002
Re: K020231
Ms. Monica Abeles Diasol, Inc. 13212 Raymer Street NORTH HOLL YWOOD CA 91605
Trade/Device Name: Diasol - Additives Regulation Number: 21 CFR $876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II
Product Code: 78 KPO Dated: July 22, 2002 Received: July 23, 2002
Dear Ms. Abeles:
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 (PMA), it may be subject to 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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
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
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Diasol Inc.
b. STATEMENT OF INTENDED USE
Device Name : Diasol-Additives
Device Name . Diasol -- Additives are used in conjunction with Diasol acid concentrate, AAMI standard water and Sodium Bicarbonate as Dialysate solution for concentralia, 2011 homodialysis in 3 stream homodialysis machines allowing the physician to customize the dialysate to meet the patient's needs .
puysesan additives, Infusates and Infusate additives are for use with sorbent regenerated Dulysis and allows physicians to customize the dialysate to meet the patient's needs.
Please do not write below this line
Concurrence of CDRH, Office of device evaluation (ODE)
Prescription Use
Per 21 CFR 801.109
Over-the-counter Use
David A. Lippman
or
and Radiological 510(k) Number
§ 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.