(147 days)
Not Found
Not Found
No
The description explicitly states that calculations are based on "existing scientific formulas for single pool urea kinetic modeling," and there is no mention of AI, ML, or training/test sets.
No
Explanation: The device is a software program that calculates various parameters related to kidney hemodialysis treatment. It is intended to assist physicians in determining the effectiveness of treatment, not to directly treat a disease or condition. Therefore, it is not a therapeutic device.
Yes
The device calculates various parameters related to kidney hemodialysis treatment based on blood test results and existing scientific formulas. While it states it's not meant as the sole tool, it acts as an adjunct to assist the physician in making determinations about treatment effectiveness, which aligns with the function of a diagnostic aid.
Yes
The device description explicitly states it is a "stand-alone product used to calculate various parameters" and refers to it as "software computer program." There is no mention of any accompanying hardware component.
Based on the provided information, the CSAM CKHEMO rev 1.0 software computer program is an IVD (In Vitro Diagnostic).
Here's why:
- It uses test results from blood drawn from the human body. The intended use explicitly states that the calculations are based on "test results of blood drawn immediately prior to and upon completion of kidney hemodialysis treatment".
- It provides information for the purpose of diagnosis, monitoring, or treatment. The calculated values (Kt/V, KrU, NPCR, etc.) are directly related to assessing the effectiveness of kidney hemodialysis treatment and assisting the physician in making determinations about that treatment. While it's an adjunct and not the sole tool, it provides crucial data derived from in vitro testing (the blood tests) to inform clinical decisions.
The fact that it's a software program that performs calculations based on these test results doesn't negate its IVD status. The core function is to process and interpret data derived from in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate total urea clearance (Kt/V), total urea clearance (Kt/V) delivered using the natural log formula, residual renal urea clearance (KrU), normalized protein catabolic rate (NPCR), actual blood flow, urea reduction ratio, body water volume calculated by urea kinetic modeling, total body water volume calculated using Watson's formula, actual weight loss after treatment, percent deviation (%Dev), and treatment time. These values are calculated using the test results of blood drawn immediately prior to and upon completion of kidney hemodialysis treatment based on the existing scientific formulas for single pool urea kinetic modeling. The device software is not meant to serve as the sole tool for determining effectiveness of treatment but as an adjunct to assist the physician in making the determination.
Product codes
78 FKP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1999
Mr. Yoobong Kim CSAM, Inc. 1890 14th Street Bettendorf, lowa 52722 Re: K992255 CKHEMO Version 1.0 Dated: August 30, 1999 Received: September 1, 1999 Requiatory Class: II 21 CFR § 876.5820/Procode: 78 FKP
Dear Mr. Kim:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (QS) 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 regult 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 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) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of 1
510(k) Number (if Known): K992255
Device Name: CKHEMO, MODEL CKHEMO VERSION 1.0
Indications for Use:
The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate total urea clearance (Kt/V), total urea clearance (Kt/V) delivered using the natural log formula, residual renal urea clearance (KrU), normalized protein catabolic rate (NPCR), actual blood flow, urea reduction ratio, body water volume calculated by urea kinetic modeling, total body water volume calculated using Watson's formula, actual weight loss after treatment, percent deviation (%Dev), and treatment time. These values are calculated using the test results of blood drawn immediately prior to and upon completion of kidney hemodialysis treatment based on the existing scientific formulas for single pool urea kinetic modeling. The device software is not meant to serve as the sole tool for determining effectiveness of treatment but as an adjunct to assist the physician in making the determination.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Emil C. Seymore
vision Sion-Off Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)