MODIFICATION OF CRIT-LINE MONITOR III (CLM III)

K982412 · In-Line Diagnostics Corp. · MQS · Oct 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982412
• Device Name: MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
• Applicant: In-Line Diagnostics Corp.
• Product Code: MQS · Gastroenterology, Urology
• Decision Date: Oct 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended 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.

Device Story

CLM III is a microprocessor-based monitor used in hemodialysis clinics by technicians. It connects to an In-Line Diagnostics blood chamber integrated into the dialysis tubing circuit. The device measures real-time hematocrit, oxygen saturation, and blood volume as blood passes through the chamber. To estimate Access Blood Flow (ABF), the technician performs a specific protocol involving ultrafiltration rate adjustments and temporary reversal of arterial and venous lines; hematocrit data is collected at four-minute intervals. These measurements are processed via an external calculator or spreadsheet using a specific formula to derive the ABF value. The output assists clinicians in managing fluid removal rates to prevent dialysis-related symptoms like nausea, cramping, and vomiting, and provides an indicator of dialysis access site condition (deterioration or blockage) without requiring invasive methods like X-ray.

Clinical Evidence

Two clinical studies (March/April 1998) involving 44 total patients (30 at University of Utah/Veterans Hospital, 14 at Victoria Hospital South). Protocol involved gathering hematocrit data during dialysis with arterial/venous line reversal. CLM III-derived ABF values were compared against Transonic HD01 measurements. Results showed a correlation coefficient of ≥ 0.90, meeting the pre-defined criteria for substantial equivalence.

Technological Characteristics

Microprocessor-based monitor with chip select logic, serial communication, timing, and watchdog circuits. Uses an In-Line Diagnostics blood chamber sensor. Connectivity: integrated into dialysis tubing circuit. Software: same as K972470; ABF calculation performed via external calculator/spreadsheet using real-time hematocrit data. No hardware or software changes required for ABF feature.

Indications for Use

Indicated for hemodialysis patients to monitor hematocrit, oxygen saturation, percent change in blood volume, access recirculation, and access blood flow.

Regulatory Classification

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.

Predicate Devices

• Transonic HD01 Monitor (K960817)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

# 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.

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## 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).

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## 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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

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(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _