(88 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device using a microprocessor and calculations based on measured parameters, not AI/ML algorithms.
No.
The device is a monitor that measures physiological parameters and does not directly treat or provide therapy to patients.
Yes
The device is explicitly stated to be a "non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor" and "estimates access recirculation and access blood flow in hemodialysis patients." These functions involve measuring and providing information about a patient's physiological state and conditions, which falls under the definition of a diagnostic device.
No
The device description explicitly states that the CLM III consists of a microprocessor and is used in conjunction with a physical "In-Line Diagnostics Blood Chamber" and a sensor. This indicates the presence of hardware components beyond just software.
Based on the provided information, the CRIT-LINE MONITOR III (CLM III) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as a "non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients." It also estimates access recirculation and access blood flow. While it measures blood parameters, it does so in vivo (within the patient's body) through a sensor connected to a blood chamber that is part of the dialysis circuit.
- Device Description: The description explicitly states the sensor reads critical blood parameters as blood passes through the blood chamber, which is connected to the dialysis tubing circuit. This indicates the measurements are taken directly from the blood flowing through the extracorporeal circuit during dialysis, not from a sample of blood that has been removed from the body and tested in a laboratory setting.
- Lack of IVD Characteristics: IVD devices typically involve testing biological samples (like blood, urine, tissue) outside of the body to provide information about a patient's health status. The CLM III's operation is integrated into the dialysis process and measures parameters directly from the circulating blood.
Therefore, the CLM III functions as a monitoring device used during a medical procedure (hemodialysis) rather than an IVD device that analyzes samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The CLM III is used as a non-invasive hematocrit, oxygen saturation and blood volume monitor. These parameters are measured in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for the dialysis patient. Based on the data that the monitors provide, the dialysis technician increases and decreases the rate at which fluid is removed from the patient's blood in order to maximize fluid removal without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
Recently, it has come to the attention of In-Line Diagnostics (IDC), that the CLM III can also be used to measure Access Blood Flow (ABF) which is the rate at which blood is flowing through the dialysis patient's access site. This measurement can be made without any software or hardware changes to the current device. ABF is a good indicator of a site's condition (i.e. how deteriorated or blocked that site has become). Providing a quick easy method of determining ABF would eliminate the need for more expensive, time-consuming methods such as X-ray.
It is IDC's intention to show in this submission that the ABF values gathered by the CLM III technique are substantially equivalent to the values gathered by the Transonic HD01 Monitor and as a result be allowed to claim ABF as an additional feature to the CLM III.
The CRIT-LINE MONITOR III, (CLM III), is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
Product codes
78 MQS
Device Description
The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
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
dialysis technician
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
The CLM III ABF values were compared to the Transonic HD01 ABF values during two separate studies in March and April 1998. One study took place on 30 patients at the University of Utah Dialysis Program and Veterans Hospital in Salt Lake City, Utah and the other study took place on 14 patients at Victoria Hospital South in London, Ontario Canada.
During the study, a formal protocol was followed in which hematocrit data was gathered during normal dialysis sessions. During the session, ultrafiltration rates were adjusted and the arterial and venous lines were temporarily reversed. During this time, hematocrit values were gathered at four-minute intervals. These hematocrit values were then calculated into a formula (i.e. with a calculator or spreadsheet) to calculate an AFB value. This ABF value was then compared to the Transonic HD01 ABF value which was measured at the conclusion of the four-minute measurements previously described.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CLM III ABF values were compared to the Transonic HD01 ABF values during two separate studies in March and April 1998. One study took place on 30 patients at the University of Utah Dialysis Program and Veterans Hospital in Salt Lake City, Utah and the other study took place on 14 patients at Victoria Hospital South in London, Ontario Canada.
When the CLM III ABF data was compared to the Transonic HD01 data, it was determined that the criteria for the CLM III values to be considered as substantially equivalent was a correlation coefficient value near 1 (i.e. .90 or greater).
The results from the two rests indicate that the above described criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient value near 1 (i.e. .90 or greater).
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the date "OCT - 9 1998" at the top left. Below the date is the text "-IN-LINE" in bold, followed by a logo with the text "CRIT-LINE" on top. To the right of the logo is the text "DIAGNOSTICS" in bold with a trademark symbol. The text and logo appear to be part of a company or product name.
510(k) SUMMARY
Submitter's Information 1.
Matthew L. Haynie In-Line Diagnostics (IDC) 117 West 200 South Farmington, UT 84025 Tel: 801-451-9000 Fax: 801-451-9007
510(k) Summary Prepared By:
Same as above
2. Date 510(k) Summary Prepared:
July 7, 1998
3. Name of Device:
CRIT-LINE MONITOR III (CLM III): Permission to claim additional feature of Access Blood Flow (ABF).
Common Name:
Non-invasive hematocrit, blood volume and oxygen saturation monitor
Classification Name:
Hemodialysis system monitor accessory
Identification of legally marketed device which the submitter claims 4. equivalence:
The ABF values, which have been calculated from of the hematocrit data measured by the CLM III, have been found to be substantially equivalent to the values measured by the Transonic HD01 Monitor (#K960817) which is currently being marketed by Transonic Systems, Inc.
1
Description of the Subject Devices: 5.
The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
Intended use of the Subject Device: 6.
The CLM III is used as a non-invasive hematocrit, oxygen saturation and blood volume monitor. These parameters are measured in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for the dialysis patient. Based on the data that the monitors provide, the dialysis technician increases and decreases the rate at which fluid is removed from the patient's blood in order to maximize fluid removal without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
Recently, it has come to the attention of In-Line Diagnostics (IDC), that the CLM III can also be used to measure Access Blood Flow (ABF) which is the rate at which blood is flowing through the dialysis patient's access site. This measurement can be made without any software or hardware changes to the current device. ABF is a good indicator of a site's condition (i.e. how deteriorated or blocked that site has become). Providing a quick easy method of determining ABF would eliminate the need for more expensive, time-consuming methods such as X-ray.
It is IDC's intention to show in this submission that the ABF values gathered by the CLM III technique are substantially equivalent to the values gathered by the Transonic HD01 Monitor and as a result be allowed to claim ABF as an additional feature to the CLM III.
7. Technological Characteristics of the Subject Devices:
As stated above, the CLM III can be used to measure ABF without any hardware or software changes. ABF values are calculated by an independent means (i.e. calculator or spreadsheet) from real time hematocrit measurements which are measured by the CLM III. As a result, the technological characteristics (both hardware and software) are exactly the same as in the previous submission of the CLM III (#K972470).
2
Discussion of Clinical Tests Performed: 8.
The CLM III ABF values were compared to the Transonic HD01 ABF values during two separate studies in March and April 1998. One study took place on 30 patients at the University of Utah Dialysis Program and Veterans Hospital in Salt Lake City, Utah and the other study took place on 14 patients at Victoria Hospital South in London, Ontario Canada.
During the study, a formal protocol was followed in which hematocrit data was gathered during normal dialysis sessions. During the session, ultrafiltration rates were adjusted and the arterial and venous lines were temporarily reversed. During this time, hematocrit values were gathered at four-minute intervals. These hematocrit values were then calculated into a formula (i.e. with a calculator or spreadsheet) to calculate an AFB value. This ABF value was then compared to the Transonic HD01 ABF value which was measured at the conclusion of the four-minute measurements previously described.
When the CLM III ABF data was compared to the Transonic HD01 data, it was determined that the criteria for the CLM III values to be considered as substantially equivalent was a correlation coefficient value near 1 (i.e. . 90 or greater).
The results from the two rests indicate that the above described criteria were met.
9. Conclusions
In conclusion, based on comparison with the legally marketed Transonic HD01 Monitor, the subject CLM III is safe and effective and performs as well as the legally marketed Transonic HD01 Monitor.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized emblem on the right. The emblem features a series of curved lines that resemble an abstract representation of an eagle or a similar bird-like figure.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthew L. Havnie Director of Quality Assurance/Regulatory Affairs In-Line Diagnostics Corporation 117 West 200 South P.O. Box 685 Farmington, Utah 84025-0685
Re: K982412 CRIT-LINE III Monitor (for Access Blood Flow in Hemodialysis) Dated: July 7, 1998 Received: July 13, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 MQS
Dear Mr. Haynie:
OCT - 9 1998
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, 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. 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/cdrh/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 (if known): K982412
Device Name: CRIT-LINE III MONITOR with additional feature - Estimation of Access Blood Flow
Indications for Use:
The CRIT-LINE MONITOR III, (CLM III), is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription for Use _ (Per 21 CFR 801.109)
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Daniel A. Segner
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _