The HD01-series monitors are intended for use by trained medical personnel on patients receiving hemodialysis treatment, for the routine monitoring of the following patient and blood handling diagnostic parameters:

Access recirculation: a check on proper dialysis needle placement and dialysis pump setting in relation to flow in the access device. Access recirculation would prevent the patient of receiving its full hemodialysis prescription. Access recirculation that cannot be mitigated by altering needle placement should be referred to the attending physician, for a change in the patient hemodialysis prescription and as a possible indication of deteriorating flow in the access device.

Access flow: allows the routine monitoring of patency of the access device. A substantial decrease in flow passing through the shunt or fistula from the initial level may indicate deterioration of the access, and should be referred to the attending physician for further diagnostic assessment and treatment.

Delivered bloodflow: a check on the hemodialysis pump setting, to confirm that the patient receives the hemodialysis treatment prescribed by the attending physician.

Device Description

The HD01 uses transit-time ultrasound principles to make the flow measurements and register sound velocity indicator dilution curves. Standard Stewart-Hamilton equations are employed for the various calculations. Portions of these technologies are covered under Transonic Systems' USA and worldwide patents and patents pending.

All Transonic HD01-series hemodialysis monitor devices consists of the following components:

"HD01 flow/dilution meter" or "HD01 meter": A bench-top, line power operated electronic measurement unit with serial RS232 data output link;
"Dual flow/dilution sensor", individually referred to as "arterial sensor" and "venous sensor": Two plastic-encased ultrasonic sensors, connecting to the HD01 unit, to be clipped onto the patient arterial and venous hemodialysis blood lines;
"Monitor software" also referred to as "software": Computer software to be installed on an IBM-PC compatible computer, which performs the various device function calculations (R%, QA etc.) from the signals produced by the HD01 meter.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the Transonic HD01-SERIES HEMODIALYSIS MONITOR, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Device Function	Acceptance Criteria (Predicate Device)	Reported Device Performance (Transonic HD01)
Access Recirculation	3-Sample BUN recirculation on B. M. Hitachi 911 Analyzer	Transonic HD01-R%
Absolute Accuracy	Clinical zero recirculation offset: 3 to 12%. Accuracy at higher recirculation levels: not available.	Clinical zero recirc. accuracy: $\pm$ 2%. Accuracy at higher recirculation levels: The larger of: $\pm$ 2% or $\pm$ 5% of reading (bench-validated).
Repeatability	Clinical data: 2% $\pm$ 14.4%, 20% $\pm$ 9.6%, 40% $\pm$ 3.6%. Clinical correlation coefficient .81.	Absolute, bench: 2% $\pm$ 2%, 20% $\pm$ 2%, 40% $\pm$ 2%. Clinical correlation coefficient .98.
Access Flow	Color Doppler Duplex Sonography Philips P700 w. CVI-Q option	Transonic HD01-QA
Accuracy	$\pm$ 14%, subject to tight alignment and operator training conditions.	$\pm$ 50 ml/min or $\pm$ 15% of access flow, whichever is larger.
Repeatability	Clinical: correlation coefficient = 0.52.	Clinical: correlation coefficient = 0.978, mean absolute error = 5.0 $\pm$ 3.8%.
Delivered Bloodflow	Fresenius 2008 Dialysis System (pump performance)	Transonic HD01-QB
Total Accuracy	Pump calibration by RPM to flow. No accuracy tolerance specified for changes in tubing ID and inlet pressure. Literature cites up to 50% error.	$\pm 6%$ of flow reading + zero offset; Max. zero offset = $\pm 8$ ml/min (adjustable to zero). Total combined error: $\pm 8%$ for a typical flow in 400 ml/min range.
Delivered Bloodflow (Comparison to Transonic T101D/T201D)	Transonic T101D/T201D with 8C clamp-on flow probe	Transonic HD01-QB with H4D clamp-on sensor
Total Accuracy	$\pm 5%$ of flow reading + zero offset; Max. zero offset = +50 ml/min.	$\pm 6%$ of flow reading + zero offset; Max. zero offset = +8 ml/min.
Max. relative error	$\pm 2%$ of flow reading + zero offset.	$\pm 2%$ of flow reading + zero offset.
Typical flow resolution	5 ml/min.	1 ml/min.
Flow range	-10 to 10 L/min.	-2 to +2 L/min.

2. Sample size used for the test set and the data provenance

The document does not explicitly state a specific "test set" sample size or its provenance (country of origin, retrospective/prospective). Instead, it references numerous publications (14 distinct publications cited) for each device function (Access Recirculation, Access Flow, Delivered Bloodflow) as evidence for effectiveness. These publications would contain the specific study designs, sample sizes, and data provenance. For example, for "Access Recirculation," studies like Depner et al., 1995, and Krivitski, 1995, are cited.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the summary. The studies referenced would likely detail how ground truth was established, but the summary document itself does not specify the number or qualifications of experts for defining ground truth in a general test set.

4. Adjudication method for the test set

The document does not describe a specific adjudication method for a test set. This type of information would typically be found within the detailed methodologies of the individual studies cited.

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

This document describes a medical device for measuring physiological parameters (blood flow, recirculation) and does not involve "human readers" interpreting images or data in a way that would typically necessitate an MRMC comparative effectiveness study with AI assistance. Therefore, no such study is described, and no effect size for AI assistance is provided. The device itself is the measurement tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Transonic HD01 is a standalone device in the sense that it performs its measurements (flow, dilution curves, calculations) automatically based on the input from the sensors. The "monitor software" performs the calculations from the signals. While a trained medical operator selects the measurements and performs procedures like saline injection, the core measurement and calculation process for R%, QA, etc., is done by the algorithm without human intervention in the interpretation of raw sensor data into the reported values. The effectiveness studies cited are implicitly standalone algorithm performance studies, validated against established clinical methods.

7. The type of ground truth used

The ground truth used for validation varies depending on the function:

Access Recirculation:
- Comparison with BUN recirculation measurements using a Boehringer Mannheim Hitachi 911 Analyzer.
- Comparison with Urea Dilution methods.
Access Flow:
- Comparison with Magnetic Resonance Angiography (MRA).
- Comparison with Duplex Ultrasonography.
- Validation in animal models (sheep).
Delivered Bloodflow:
- Comparison with hemodialysis pump readouts (Fresenius 2008 Dialysis System).
- Comparison with volumetric (beaker-stopwatch) calibration.
- Comparison with another Transonic flowmeter (T101D/T201D).

8. The sample size for the training set

The document does not explicitly mention a "training set" or its sample size. This summary focuses on the device's validation against predicate devices and published studies. If machine learning or AI models were used in the device development, the training set information would be detailed internally or in specific technical documents, not typically in a 510(k) summary focused on substantial equivalence. The "HD01 flow/dilution meter" and "Monitor software" are described, but the method of their development (e.g., if they involved a "training set" in a modern AI sense) is not elaborated.

9. How the ground truth for the training set was established

As no specific "training set" is mentioned in the context of machine learning, there is no information provided on how its ground truth was established. The device utilizes "transit-time ultrasound principles" and "Standard Stewart-Hamilton equations" for its calculations, which are established physical and mathematical principles, rather than being learned from a labeled training set in the way a modern AI would be.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Transonic Systems Inc. The logo includes the company name in bold, black letters, with the tagline "Excellence in Quantitative Hemodynamics" underneath. To the right of the logo are handwritten characters, including "K960817" and "P197".

FEB | | 1997

Supplement 2. Appendix 2.

510(K) SUMMARY (Revision dd. Nov. 12 1996) # K960817

This summary of 5100k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, by:

Cornelis J. Drost, President Contact Person: Transonic Systems Inc. 34 Dutch Mill Road Ithaca NY 14850 Phone: (607) 257-5300

2.1 Device Identification & SE Claims.

TRANSONIC HD01-SERIES HEMODIALYSIS MONITOR Trade name: Common name: Hemodialysis monitor

Devices in this model family:	Model name:	Legally marketed device to which SE is claimed:
Access recirculation monitor:	HD01-R%	BUN on Boehringer Mannheim Hitachi 911 Analyzer
Access flow monitor	HD01-QA	Philips P700 ultrasound system with CVI-Q option
Delivered bloodflow monitor	HD01-QB	Fresenius 2008 Dialysis System (pump readout only)

2.2 Device Description.

The following measurements can be made with the HD01:

Access recirculation: The percentage of dialyzed blood delivered by the venous needle that traverses the access device in reverse direction to be removed again via the arterial needle.

Access flow: The rate of blood flow in mL/min entering the native fistula or artificial graft at the site of the arterial needle.

Delivered blood flow: The rate of blood flow, in the hemodialysis venous blood line.

34 Dutch Mill Rd., Ithaca, NY 149586.97979000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Fax: 607-257-7256; Internet: www.transonic.com

{1}------------------------------------------------

All Transonic HD01-series hemodialysis monitor devices consists of the following components:

- "HD01 flow/dilution meter" or "HD01 meter": A bench-top, line power operated electronic measurement unit with serial RS232 data output link;
- "Dual flow/dilution sensor", individually referred to as "arterial sensor" and "venous sensor": Two plastic-encased ultrasonic sensors, connecting to the HD01 unit, to be clipped onto the patient arterial and venous hemodialysis blood lines;
- "Monitor software" also referred to as "software": Computer software to be installed on an IBM-PC compatible computer, which performs the various device function calculations (R%, QA etc.) from the signals produced by the HD01 meter.

The various HD01 devices differ in their indications for use through the supplied software routines. For a combination device with all the monitor functions a trained medical operator may select the following measurements:

2.2a. Access recirculation measurement:

A volume of about 5 ml of 0.9% saline is injected before the venous line bubble trap, using standard sterile procedures. The venous transit time sensor identifies the resulting indicator dilution curve. The monitor also analyzes the arterial sensor signal during the time where the venous bolus can directly recirculate (via access device or catheter) to the arterial line, but before cardiopulmonary recirculation can take place (i.e. before the same bolus recycles through the heart into the arterial line). If direct recirculation is identified, the meter calculates flow-corrected "access recirculation" from the areas of these two indicator dilution curves and the instantaneous flow in the blood lines.

2.2b Access flow measurement:

For this measurement the two blood lines are reversed at the point where the two hemodialysis needle tubings are connected to the hemodialysis blood lines, employing the flow clamps present on the lines and standard patient care procedures. The access flow measurement is made upon injection of about 10 ml of 0.9% saline in the same injection port of the venous blood line (before the bubble trap): the venous sensor records its indicator dilution curve. The injected bolus now enters the patient via the arterial needle, which much be placed facing upstream in the artery to assure complete mixing. The venous needle samples the indicator concentration in the mixed blood stream; the arterial line sensor registers its indicator dilution curve. The sensors also record the instantaneous blood flow through the lines. The HD01 calculates the flow through the access device from the ratio of these two indicator dilution curves and the instantaneous delivered bloodflow.

2.2d Delivered bloodflow:

This flow reading is continuously displayed on a digital display of the HD01 unit. Whenever an indicator dilution measurement is made the reading is also reported on the computer display.

{2}------------------------------------------------

Intended Uses of the HD01-series of Devices. 2.3

1960817

P 3077

Delivered bloodflow: a check on the hemodialysis pump setting, to confirm that the patient receives the hemodialysis treatment prescribed by the attending physician.

Contraindications:

The H4D dual flow/dilution sensor is for clip-on use only onto the sterile tubing specific to the flow sensor, and never on arteries or veins.

Safe and effective use of these devices depend on correct application technique, adequate precaution and readiness for emergencies.

Caution: Not intended for fetal or ophthalmic use.

Caution: Federal law resticts this device to sale by or on the order of a physician.

2.4 Summary of Technological Comparison with Predicate Devices.

Access recirculation monitor:

The Transonic HD01-R% device uses transit-time ultrasound indicator dilution sensing technology.

A BUN-recirculation measurement done with the Boehringer Mannheim Hitachi 911 Analyzer consists of: taking three blood samples from the patient during hemodialysis; analyzing these samples on the Hitachi 911 for blood urea nitrogen level; calculating access recirculation from the three BUN levels.

Access flow monitor:

The Transonic HD01-OA device uses transit-time ultrasound indicator dilution sensing technology, and transit-time ultrasound flow sensing technology.

The Philips P700 ultrasound system with CVI-Q option uses time domain Doppler ultrasound to measure average bloodflow velocity in the vessel, and the cross sectional area of the vessel by ultrasound sonography.

{3}------------------------------------------------

K960817

PHOT

Delivered bloodflow monitor:

HD01-QB device uses transit-time ultrasound indicator dilution sensing technology, and transittime ultrasound flow sensing technology.

Fresenius 2008 Dialysis System converts the RPM of the hemodialysis pump into a readout of flow, under the assumption that the tubing cross sectional area is a constant.

2.5 Safety.

The HD01-series devices meet all requirements of:

- UL544 & IEC 601-1;
The European Economic Council Directive 89/336/EEC (electromagnetic compatibility); *
Ultrasound intensity levels applied by the H4D clamp-on flow/dilution sensors are 25 to 40 dB * below FDA CDRH maximum pre-amendment levels for "Fetal Dopper and Other" applications.

All procedures required to execute these measurements (saline injection, change in blood line connections) are standard clinical procedures in which hemodialysis nurses are well trained.

The HD01 procedures introduce no extra components into the hemodialysis circuit; at no place is patient sterility compromised.

2.6 Effectiveness.

Since it's introduction in November 1994, the following publications have appeared in print to attest to the effectiveness of these hemodialysis monitoring methods. (Numbers refer to the ordering in 510(k) Appendix 10, and the additional numbers in Supp. 1 App.5)

Access recirculation

1. Depner, T.A., Krivitski, N.M., MacGibbon, D., "Hemodialysis Access Recirculation (Rc) Measured by Ultrasound Dilution", ASAIO Journal, Vol. 41, p. M749-M753, 1995.
1. George, T.O., Priester-Coary, A., Dunea, G., Daugirdas, J.T., "Access Recirculation (AR) by Ultrasonic Dilution Compared to a 20 Sec Slow Flow Urea Method", Am.Soc. of Nephrol. Abstr. p. 489, 1995.
1. Krivitski, N.M., "Accuracy of Hemodialysis Access Recirculation Measurement", "Vascular Access for Hemodialysis V", A Symposium on Dialysis Access, Abstract (in press).
1. MacDonald, J., Sosa, M., Nudo, S., Glidden, D., Sands, J.J., "Identifying a new reality: Zero Access Recirculation", American Nurses Association Journal, Vol. 23, No.2, p. 172, 1996.
1. Sands, J., Krivitski, N.M., "Access Recirculation in Hemodialysis", "Vascular Access for Hemodialysis V", A Symposium on Dialysis Access, Abstract (in press).
1. Subra, J.F., Choulet, P., Tollis, F., Trouvé, R., Riberi, P., "Hemodialysis Access Recirculation Evaluation by Ultrasonic Dilution Method," Europ. Dial. & Transpl. Assoc. Abstracts, p. 287, 1996.
1. Visser, C.A., Kloppenburg, W.D., deJong, P.E., Huisman, R.M., "Access Recirculation in Hemodialysis detected by Ultrasound Dilution and Urea Dilution Methods, " Eur.Dial.& Transpl. Assoc. Abs. p.297, 1996.

Access flow

1. Bosman, P.J., Boereboom, F.T.J., Bakker, C.J., Mali, W.P., Eikelboom, B.C., Blankenstijn, P.J., Koomans, H.A., "A New Fick-Principle Based Method for Measuring Blood Flow in Hemodialysis Grafts Validated by Magnetic Resonance Angiography", American Society of Nephrology Abstracts, p. 484, 1995.
1. Depaer, T.A., Krivitski, N.M., "Clinical Measurement of Blood Flow in Hemodialysis Access Fistulae and Grafts by Ultrasound Dilution", ASAIO Journal, Vol. 41, p. M746-M749, 1995.
1. Dobson, A., Harvey, H.J., Gleed, R.D., "Validation in Sheep of the Ultrasound Dilution Technique for Hemodialysis Graft Flow." Abstract, ASAIO Vol.. 42, No.2, p.81, 1996.
1. Krivitski, N.M., "Novel Method to Measure Access Flow during Hemodialysis by Ultrasound Dilution

Supp.2 Appendix 2 p.4

{4}------------------------------------------------

K960817 0507

Technique", ASAIO Journal, Vol. 41, p. M741-M745, 1995.

1. Krivitski, N.M., "Theory and Validation of Access Flow Measurement by Dilution Technique during Hemodialysis", Kidney International, Vol. 48, p. 244-250, 1995.
1. Krivitski, N.M., Dobson, A., Gleed, R.D., "Vascular Access Flow Changes with Normal or Reversed Hemodialysis Blood Flow, " ASAIO Journal Abstracts, Vol. 42, No.2, p.80, 1996.
1. Sands, J.J., "Blood Flow Measurement in PTFE Hemodialysis Grafts by Ultrasound Velocity Dilution", American Society of Nephrology Abstracts, p. 501, 1995.
1. Sands, J.J., Glidden, D., Miranda, C., "Access Flow Measuremed during Hemodialysis," ASAIO Abstracts, Vol 42 p.80, 1996.
1. Sands. J.J., Glidden, D., Miranda, C., "Hemodialysis Access Flow Measurement Comparison of Ultrasound Dilution and Duplex Ultrasonography, " ASAIO Abstracts, Vol 42, No.2, p. 76, 1996.

Delivered bloodflow:

Transonic Systems' transit-time flowmetering using clamp-on sensors is a mature technology, well-proven in independent customer validations over the past several years. One such validation of the Transonic probe was compared with a hemodialysis pump and volumetric (beaker-stopwatch) calibration is:

Depaer, T.A., Rizwan, S., Stasi, T.A., "Pressure effects on roller pump blood flow during hemodialysis", 9. ASAIO Journal, May 1990.
1. Sands, J., Glidden, D., Jascavage, W., "Difference between Delivered and Prescribed Blood Flow (Qb) in Hemodialysis", Abstract, ASAIO Vol.42, No.2, p.76, 1996.

Summary comparisons between the HD01 devices and the predicate devices:

	3-Sample BUN recirculation onB. M. Hitachi 911 Analyzer	Transonic HD01-R%
Indications:	Hitachi 911 is for measurement of bloodurea nitrogen in blood samples;personnel calculates recirculation fromthree blood samples.	For assessment of adequate delivery ofundialysed blood into HD machine fromnative fistula, artificial graft orcatheterized veins.
Effectiveness
Absolute Accuracy	Clinical zero recirculation offset:3 to 12%Accuracy at higher recirculation levels:not available	Clinical zero recirc. accuracy:$\pm$ 2 %Accuracy at higher recirculation levels:The larger of: $\pm$ 2% or $\pm$ 5% ofreading (bench-validated)
Repeatability	Clinical data:2% $\pm$ 14.4%20% $\pm$ 9.6%40% $\pm$ 3.6%Clinical correlation coefficient .81	absolute, bench: 2% $\pm$ 2%20% $\pm$ 2%40% $\pm$ 2%Clinical correlation coefficient .98

{5}------------------------------------------------

רוצט817 p6077

	Color doppler duplex sonographyPhilips P700 w. CVI-Q option	Transonic HD01-QA
Indications:	For the transcutaneous measurement ofbloodflow in arteries and veins	For measurement of blood flow innative HD fistula or HD artificialgrafts.
Safety:
Ultrasonic	Operator must ensure that maximumUltrasonic irradiation levels are notexceeded for specific applications.	Ultrasonic irradiation level is 320 timeslower than CDRH permitted level forperipheral vessel use. (See appendix 2)
Effectiveness
Accuracy	$\pm$ 14%, subject to tight alignment andoperator training conditions	$\pm$ 50 ml/min or $\pm$ 15% of access flow,whichever is larger.
Repeatability	clinical: correlation coefficient = 0.52	clinical: correlation coefficient = 0.978,mean absolute error = 5.0 $\pm$ 3.8%

	Fresenius 2008 Dialysis System:dialysis pump performance	Transonic HD01-QBwith H4D clamp-on sensor
Indications:	To adjust and monitor deliveredbloodflow in the Fresenius 2008 DialysisSystem	To measure flow through sterile tubingused in extracorporeal blood systems,such as hemodialysis blood lines.
Effectiveness
Total accuracy	Pump calibration is done by convertingRPM into indication of flow.No accuracy tolerance is specified forchanges in tubing inside diameter andinlet pressure.Literature cites up to 50% error in flowindication before tubing collapse isvisually evident (Depner9).	$\pm 6%$ of flow reading + zero offset;Max. zero offset = $\pm 8$ ml/min(adjustable to zero)Total combined error: $\pm 8%$ for atypical flow in 400 ml/min. range

Supp.2 Appendix 2 p.6

볼

{6}------------------------------------------------

K960817 p707

	Transonic T101D/T201Dwith 8C clamp-on flow probe	Transonic HD01-QBwith H4D clamp-on sensor
Indications:	To monitor instantaneous and averagevolume flow of blood or other liquidsthrough standard laboratory tubing usedwith adult and pediatric patients. Citedexamples are: CP bypass, ECMO,hemodialysis, A-V hemofiltration.	To measure flow through sterile tubingused in extracorporeal blood systems,such as hemodialysis blood lines;To make differential comparisonsbetween removed and delivered flow.
Safety:
Method:	Transit-time ultrasound using clamp-onsensors applied onto patient blood lines	Identical
Electrical:	ETL listed to meet UL544 specs:Input leakage current < 100 μAPatient leakage current < 10 μA	Meets UL544 specs:Input leakage current < 50 μAPatient leakage current < 10μAPatient isolation > 2500V
Ultrasonic	Ultrasonic irradiation level is 175 timeslower than CDRH permitted level forperipheral vessel use. (See appendix 9)	Ultrasonic irradiation level is 320 timeslower than CDRH permitted level forperipheral vessel use. (See appendix 2)
Effectiveness	(with predicate 8C probe for 1/2"OD tubing)	(w. H4D sensor for 1/4" OD tubing)
Total accuracy	±5% of flow reading + zero offset;Max. zero offset = +50 ml/min(adjustable to zero)	±6% of flow reading + zero offset;Max. zero offset = +8 ml/min(adjustable to zero)
Max.relative error	±2% of flow reading + zero offset	±2% of flow reading + zero offset
Typical flowresolution	5 ml/min	1 ml/min
Flow range	-10 to 10 L/min	-2 to +2 L/min

2.7 Summary of Safety and Effectiveness.

The bench and clinical tests cited above demonstrate that, like the predicate devices, the HD01series of hemodialysis monitors is safe and effective for its intended use.

のお気になる。

Cornelia L. Davis

Cornelis J. Drost, President Transonic Systems Inc. 34 Dutch Mill Road Ithaca NY USA 14850

Nov. 12, 1996 Preparation date

1999 - 1999

Supp.2 Appendix 2 p.7

Regulation Number and Section

§ 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.