(28 days)
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.
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.
Here's an analysis of the provided text regarding the CRIT-LINE MONITOR III, structured to answer your questions:
Acceptance Criteria and Device Performance Study for CRIT-LINE MONITOR III
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Device Performance (Reported Result) |
|---|---|
| Correlation coefficient value near 1 (i.e., .90 or greater) for internally calculated ABF vs. externally calculated ABF. | Correlation coefficient: 0.94 |
| - | Average difference between methods: 46 ml/min |
| - | Standard deviation of difference: 200 ml/min |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 29 data points
- Data Provenance: Retrospective (though collected specifically for this validation, it's not a prospective interventional trial based on the description).
- 16 data points from Victoria Hospital in London Ontario, Canada (April 8th and April 9th, 1999)
- 13 data points from Central Valley Dialysis in Salt Lake City, Utah (June 22nd and June 24th, 1999)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth. The "ground truth" (or reference method) was established by calculating Access Blood Flow (ABF) values externally using CRIT-LINE MONITOR III hematocrit measurements fed into a formula via a calculator or spreadsheet program (which was the previously approved method, K982412).
4. Adjudication Method for the Test Set
No adjudication method is described. The comparison was statistical between two calculated values (one internally by the device, one externally using device-generated hematocrit data and a formula).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a monitor measuring physiological parameters; it's not an AI system for image interpretation or diagnosis that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a way. The study's purpose was to validate the internal calculation of ABF by the CRIT-LINE MONITOR III. This internal calculation is essentially the "algorithm only" performance, compared against the established external calculation method which uses data generated by the same device (CLM III hematocrit measurements) but processes it outside the device. The study is evaluating the device's self-contained ABF calculation capability.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" was the previously approved method of ABF measurement, which involved:
- Measuring hematocrit values using the CLM III.
- Calculating ABF values externally via a calculator or spreadsheet program using these measured hematocrit values.
- This method itself had a 510(k) clearance (K982412).
Essentially, the ground truth was a reference calculation method using device-generated data.
8. The Sample Size for the Training Set
The document does not mention a separate training set. The CRIT-LINE MONITOR III is a physical device with a software modification for internal calculation. The description implies the software was developed based on existing understanding of the ABF formula and then validated with the 29 data points as the "test set" against the established external calculation method. It's unlikely that machine learning or a training set in the modern sense was used for this type of device in 1999.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is mentioned, this question is not applicable. The device's internal ABF calculation functionality was evaluated against a pre-existing, legally marketed method of calculating ABF.
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Image /page/0/Picture/0 description: The image shows the date JUL 30 1999 at the top left. Below the date is the text "- IN-LINE DIAGNOSTICS-" with a logo in the middle. The logo is a black square with a white zig-zag line in the middle.
510(k) SUMMARY
K99222
1. Submitter's Information
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:
June 25th, 1999
Name of Device: 3.
CRIT-LINE MONITOR III (CLM II)
Common Name:
Non-invasive hematocrit, blood volume and oxygen saturation monitor
Classification Name:
Hemodialysis system monitor accessory
4. Identification of legally marketed device which the submitter claims equivalence:
The ABF values which were calculated by the CLM III have been compared to the approved method of ABF measurement where measured hematocrit values of the CLM III are gathered and calculated via an external source (i.e. calculator, spreadsheet, etc.) in order to obtain an Access Blood Flow value.
The 510 (k) # for the external source method of determining Access Blood Flow is K982412.
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Kinzler
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It is IDC's intention to show in this submission that the ABF values gathered by the CLM III are substantially equivalent to the values resulting from the already approved method of ABF determination using the CLM III and an external source (i.e. calculator, spreadsheet, etc.)
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 intended use of the CRIT-LINE III Monitor is as a non-invasive hematocrit, oxygen saturation and access blood flow-measuring device.
7. Technological Characteristics of the Subject Devices:
Since the CLM III has not changed in any way except for the software modification concerning the measurement of Access Blood flow, please refer to the original CLM III 510(k) submission for a complete device description (see #K972470).
8. Discussion of Clinical Tests Performed:
ABF measurements were validated by comparing statistical data between ABF values calculated internally by the CLM III and ABF values gathered by taking CLM III hematocrit measurements and placing these measurements into a formula where they could be calculated externally by a calculator or spreadsheet program.
Sixteen data points were taken on April 8th and April 9th, 1999 at Victoria Hospital in London Ontario Canada and an additional 13 data points were taken on June 22nd, and June 24th, 1999 at Central Valley Dialysis in Salt Lake City Utah.
A correlation coefficient statistically generated was used as the comparison ' criteria to evaluate the internally calculated CLM III ABF data against CLM III. ABF data gathered via the external method. A coefficient value near 1 (i.e. . 90 or greater) denotes a strong correlated relationship of the data. Twenty-nine data points were gathered with a resulting coefficient value of .94. The average difference between the two methods of ABF measurement was 46 ml/min with a standard deviation of 200 ml/min.
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Conclusions 9.
In conclusion, based on comparison with the legally marketed CLM III external method for Access Blood Flow Measurement, the subject CLM III is safe and effective for internal ABF measurement and performs as well as the legally marketed CLM III external method.
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Image /page/3/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Matthew L. Haynie Director of Quality Assurance/Regulatory Affairs In-Line Diagnostics Corporation 117 West 200 South P.O. Box 685 Farmington, UT 84025-0685
Re: K992227 CRIT-LINE III Monitor for Access Blood Flow (Modification) Dated: June 25, 1999 Received: July 2, 1999 Requiatory Class: II 21 CFR §876.5820/Procode: 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 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 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 (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 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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease 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
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510(k) Number (if known): K992227
Device Name: CRIT-LINE III MONITOR
i/
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)
David A. Seymore
vision Sign-Off) vision of Reproductive, Abdominal, El and Radiological De 510(k) Number
§ 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.