(163 days)
CRIT-LINE II (CLMI)
Not Found
No
The summary describes a device that measures blood parameters using a microprocessor and sensor, but there is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision support. The intervention is based on the data provided to the technician, not an automated AI/ML system.
Yes
The device is used to measure hematocrit, oxygen saturation, and percent charge in blood volume in real-time for application in the treatment of dialysis patients, with the goal of providing a more effective treatment and guiding technician intervention to manage fluid removal. These functions directly relate to patient care and therapeutic management.
Yes
The device measures hematocrit, oxygen saturation, and percent change in blood volume, which are critical blood parameters used to monitor a patient's condition and guide medical intervention during dialysis. While it doesn't diagnose a disease, it provides diagnostic information that informs treatment adjustments.
No
The device description explicitly states that the CLMIII consists of a microprocessor and is used in conjunction with a Blood Chamber and sensor, indicating it is a hardware device with integrated software.
Based on the provided information, the CRIT-LINE Monitors (CLM II and CLM III) are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- CLM Function: The CLM devices measure parameters (hematocrit, oxygen saturation, percent change in blood volume) directly from the blood as it passes through a blood chamber that is part of the dialysis tubing circuit. While blood is involved, the measurement is happening in line with the patient's blood flow during dialysis treatment, not on a separate specimen analyzed in a lab setting.
- Intended Use: The intended use is to provide real-time data to a dialysis technician to guide adjustments to the dialysis treatment itself, specifically fluid removal. This is a monitoring and treatment guidance function, not a diagnostic function performed on a specimen outside the body.
Therefore, the CRIT-LINE Monitors are considered medical devices used for monitoring and guiding treatment during dialysis, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The family of CRIT-LINE Monitors (CLM's), include the CLM II (predicate device) and the CLM III. These devices are used to noninvasively to measure hematocrit, oxygen saturation and percent charge in blood volume. Both the CLM II and the CLM III measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. In addition, the CLM II and CLM III estimate the amount of blood that is recirculated back into the dialysis circuit instead of the patients circulating volume. Based on the data that the monitors provide, the dialysis technician intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
Product codes
78 MQS
Device Description
The CLMIII 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 CLMIII is used in conjunction with the In-Line Diagnostics, Inc. Blood Chamber. The Blood Chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM is connected to the Blood Chamber which reads critical blood parameters as the 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
Comparison testing to the predicate was performed on blood bank blood under simulated clinical conditions at In-Line Diagnostics, Inc.
Summary of Performance Studies
No Clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
CRIT-LINE II (CLMI)
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.
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K972470
DEC | | 1997
EXHIBIT #1 510(k) SUMMARY Page 1 of 3
510(k) SUMMARY
1. Submitter's Information:
m di
Matthew Haynie In-Line Diagnostics 4646 S. 1500 W., Suite 160 Riverdale, UT 84405 Tel: (801) 394-8669 Fax: (801) 394-8037
510(k) Summary Prepared by:
Thomas J. Bouchard mdi CONSULTANTS, INC. 55 Northern Blvd. Great Neck, NY 11021 Tel: (516) 482-9001
- June 27, 1997 Date 510(k) Summary Prepared: 2.
-
- Name of the Device
Trade or Proprietary Name:
Common Name:
CRIT-LINE Monitor III (CLMII)
Non-invasive hematocrit, blood volume and oxygen saturation monitor
Classification Name:
Hemodialysis system monitor accessory
- Identification of legally marketed device which the submitter claims equivalence. 4.
The CRIT-LINE III (CLMII) is substantially equivalent to the CRIT-LINE II (CLMI) currently marketed by In-Line Diagnostics in significant features, materials, dimensions and intended use ..
1
Description of the Subject Devices: ડ.
The CLMIII 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 CLMIII is used in conjunction with the In-Line Diagnostics, Inc. Blood Chamber. The Blood Chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM is connected to the Blood Chamber which reads critical blood parameters as the blood passes through the Blood Chamber
Intended Use of the Subject Devices: ર.
The CLMIII and the predicate CLMII are used as non-invasive hematocrit, oxygen saturation and blood volume monitors. Both measure hematocrit, percent change in blood volume and oxygen saturation 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 or decreases the rate at which fluid is removed from the blood in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
Technological Characteristics of the Subject Devices. 7.
Both the predicate CLMII and the CLMIII are identical in function and operate under the principles of light absorption through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT) and to calculate the related value of Blood Volume (BV).
The CLMIII uses a Motorola 61332A microprocessor which is also a member of the Motorola 68000 family of microprocessors used in the CLMII, but is more up-to-date and has incorporated within it all of the chip select logic, serial communications, timing and watchdog circuits. The code was consolidated into a more modular version to parallel the hardware layout. The measurements in both the CLMI and the CLMIII are accomplished by calibrated Analog to Digital Converters (ADC). The CLMII uses a multiplexer to switch between two circuits, whereas the CLMIII contains completely separate circuits.
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8. Discussion of Clinical Tests Performed:
No Clinical testing was performed. Comparison testing to the predicate was performed on blood bank blood under simulated clinical conditions at In-Line Diagnostics, Inc.
9. Conclusions:
m dii
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In summary, based on comparison with the legally marketed CLMII and tests of this device to IEC 601-1: 1988 and to the FDA Guidance for Premarket Notification Submission Appendix A Sections (ii) (a) and (ii) (b) for Electrostatic Discharge and Electromagetic Interference (EMI), the subject CLMIII is safe and effective and performs as well as the legally marketed CLMII.
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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its head facing to the right and its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1997
Mr. Matthew L. Haynie Director of Quality Assurance In-Line Diagnostics Corporation 4646 South 1500 West Suite 160 Riverdale, Utah 84405
K972470 In-Line Diagnostics CRIT-LINE Monitor III (for Hemodialysis Applications) Dated: October 8, 1997 Received: October 10, 1997 Regulatory Class: II 21 CFR §876.5820/Product Code: 78 MQS
Dear Mr. Haynie:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, 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 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 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/dsmamain.html".
Sincerely yours,
William Yu
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
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EXHIBIT A
Page 1 of 1
510(k) Number (if known): K972470
Device Name: CRIT-LINE Monitor III (CLM III)
Indications for Use:
The family of CRIT-LINE Monitors (CLM's), include the CLM II (predicate device) and the CLM III. These devices are used to noninvasively to measure hematocrit, oxygen saturation and percent charge in blood volume. Both the CLM II and the CLM III measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. In addition, the CLM II and CLM III estimate the amount of blood that is recirculated back into the dialysis circuit instead of the patients circulating volume. Based on the data that the monitors provide, the dialysis technician intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Robert R. Silling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K972470
Prescription Use
(PER21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)