(84 days)
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No
The document describes a bicarbonate solution concentrate for hemodialysis, which is a chemical product, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
Yes
The device, "Bicarbonate Solution Concentrates for Bicarbonate Dialysis," is intended for use in hemodialysis, which is a therapeutic procedure to treat kidney failure.
No
Explanation: The device is a bicarbonate solution concentrate for dialysis, which is used for treatment rather than diagnosis. It works with a hemodialysis machine but does not independently diagnose conditions.
No
The device description clearly states "Bicarbonate Solution Concentrates for Bicarbonate Dialysis," which are physical chemical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "acute and chronic hemodialysis," which is a treatment performed on a patient's body (in vivo). IVDs are used to examine specimens taken from the body (in vitro).
- Device Description: "Bicarbonate Solution Concentrates for Bicarbonate Dialysis" is a solution used in the dialysis process, not a test or reagent used to analyze a sample.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device is a therapeutic device used in the process of hemodialysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The research indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor.
Product codes
78 KPO
Device Description
Bicarbonate Solution Concentrates for Bicarbonate Dialysis
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 16 1997
Rockwell Medical Supply, LLC % Jeffrey R. Shideman, Ph.D. President International Medical Products Corporation 4503 Moorland Avenue Minneapolis, Minnesota 55435
Re: K971053
Bicarbonate Solution Concentrates for Bicarbonate Dialysis ..... ........................... Dated: March 17, 1997 Received: March 24, 1997 Regulatory class: II 21 CFR §876.5820/Product code: 78 KPO
参 Dear Dr. Shideman:
We have reviewed your Section 510(k) notification of intent to market the device 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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) 594-4616. 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/dsmamain.html".
Sincerely yours,
hilliai Yi
Lillian Yin, Ph.D.
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
1
510K Notification
Rockwell Medical Supply, LLC. Bicarbonate Solution Concentrates for Bicarbonate Dialysis March 17th, 1997
The Rockwell Medical Supply, LLC. Bicarbonate Solution Concentrates for Bicarbonate The research indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Sather, Jr.
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971053
Prescription Use_L (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)