(29 days)
The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.
Like the predicate, the modified CRIT LINE Clip (CLiC) Blood Chamber is a non-invasive, disposable, optical cuvette with transparent lenses designed to connect between the arterial bloodline and the dialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) clear polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear view of the blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption and scattering to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.
The proposed device is the same as the predicate. CRIT LINE Clip (CLiC) Blood Chamber (K141281) with a change only to the internal geometry (taper) of the dialyzer connector (also referred to as the 'female DIN connector').
The provided document is a 510(k) premarket notification for a medical device called the "CRIT-LINE Clip (CLiC) Blood Chamber." This document is a submission to the FDA for a device that is largely the same as a previously cleared device, with a minor modification to the internal geometry of the dialyzer connector.
The document does not describe a study that proves the device meets acceptance criteria in the context of a human-in-the-loop AI system or standalone AI algorithm, as the prompt's questions suggest. Instead, it details engineering verification and validation tests to ensure that the modified physical device (a blood chamber) continues to meet performance and safety standards, particularly concerning its connection integrity.
Therefore, many of the questions asked in the prompt, which are highly relevant for AI/ML device evaluations (e.g., sample size for test/training set, expert qualifications, MRMC studies, ground truth establishment), are not applicable to the content of this document.
However, I can extract information related to the acceptance criteria and the engineering tests performed as described in the document.
Here's the analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Verification Test" and "Pass/Fail" results, effectively serving as acceptance criteria and reported performance for the engineering changes.
| Acceptance Criteria (Verification Test) | Reported Device Performance (Pass/Fail) |
|---|---|
| Performance Test: Mechanical Characteristic / Structural Integrity per ANSI/AAMI/ISO 8638:2010 (Confirm the bonding between the chamber and the DIN Connector P/N 55-4299) | PASS |
| Dialyzer Connector (Female DIN Connector): Liquid Leakage Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Air Leakage Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Separation Force Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Unscrewing Torque Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Ease of Assembly Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Resistance to Overriding Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Stress Cracking Test per ISO 594-2 | PASS |
| Endurance Performance Test per ISO 8368:2010 (Demonstrate the product performs at maximum labeled pressures without resulting in loose connection or leaks) | PASS |
| Bond Strength Test per ISO 8368:2010 (Confirm solvent bonding between the CLiC blood chamber's blue polycarbonate body and clear PVC DIN Connector meet specification) | PASS |
| Blood Pathway Volume (Priming Volume) Test per ISO 8368:2010 (Verify the established the blood pathway volume of the blood chamber meets specification) | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for each test. It refers to "verification and/or validation testing" but does not give numerical sample sizes for the mechanical and performance tests. The data provenance is implied to be from the manufacturer's internal testing. There is no mention of country of origin of data or whether it was retrospective or prospective, as these are not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device requiring clinical expert ground truth. The ground truth for these engineering tests is established by physical measurement against engineering specifications and international standards (e.g., ISO, ANSI/AAMI).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study requiring adjudication of expert readings.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for these engineering performance tests is based on adherence to established international standards (ISO 8638:2010, ISO 594-2, ISO 8368:2010) and internal product specifications. These are objective engineering measurements, not clinical ground truths.
8. The sample size for the training set
Not applicable. This device does not use a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This device does not use a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2015
Fresenius Medical Care North America Denise Oppermann Sr. Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451-1457
Re: K152953
Trade/Device Name: CRIT-LINE Clip (CLiC) Blood Chamber Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC Dated: October 6, 2015 Received: October 7, 2015
Dear Denise Oppermann,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152953
Device Name CRIT-LINE Clip (CLiC) Blood Chamber
Indications for Use (Describe)
The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left side of the logo, there is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
510(K) SUMMARY 5.
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR & 807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter StreetWaltham, MA02451-1457 |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior DirectorRegulatory Affairs – Devices |
| Preparation Date: | 10/06/2015 |
5.2. Device Name
| Trade Name: | CRIT-LINE® Clip (CLiC) Blood Chamber |
|---|---|
| Common Name: | CLiC Blood Chamber |
| Classification Name : | Accessories, Blood Circuit, Hemodialysis |
| Regulatory Class: | Class II per 21 CFR 876.5820 |
| Product Code/Classification Panel: | KOC / Gastroenterology-Urology |
5.3. Legally Marketed Predicate Device
The predicate device is FMC-RTG's CRIT-LINE Clip (CLiC) Blood Chamber originally cleared under K141281 (14 August 2014).
Device Description 5.4.
Like the predicate, the modified CRIT LINE Clip (CLiC) Blood Chamber is a non-invasive, disposable, optical cuvette with transparent lenses designed to connect between the arterial bloodline and the dialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) clear polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear view of the blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption and scattering to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.
The proposed device is the same as the predicate. CRIT LINE Clip (CLiC) Blood Chamber (K141281) with a change only to the internal geometry (taper) of the dialyzer connector (also referred to as the 'female DIN connector').
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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top and "MEDICAL CARE" on the bottom.
5.5. Intended Use
The CRIT-LINE® Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic hemodialysis therapy. The CLiC system non-invasively measures hematocrit and oxygen saturation. The percentage change in blood volume is calculated from the real time hematocrit. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatments.
5.6. Indications for Use
The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.
5.7. Comparison of Technological Characteristics with the Predicate Device
The proposed device has the same technological characteristics as the predicate, CRIT-LINE Clip (CLiC) Blood Chamber (K141281) as detailed in Table 1.
| Feature | Predicate Device(P/N CL10041021) | Proposed Device(P/N CL10041021) | Comment |
|---|---|---|---|
| CLiC Blood Chamber(K141281) | CLiC Blood Chamber | ||
| ClassificationProduct Code/ Regulation | KOC/876.5820 | KOC/876.5820 | Same |
| Feature | Predicate Device(P/N CL10041021) | Proposed Device(P/N CL10041021) | Comment |
| CLiC Blood Chamber(K141281) | CLiC Blood Chamber | ||
| Indications foruse | The CRIT-LINE Clip (CLiC)Blood Chamber is a sterile, singleuse, disposable, optical cuvettedesigned for use with the CLiCMonitor's sensor clip duringacute and chronic hemodialysistherapy to non-invasivelymeasure hematocrit, percentchange in blood volume, andoxygen saturation. The bloodchamber is connected betweenthe arterial bloodline and thedialyzer within the extracorporealcircuit during hemodialysistreatment. | The CRIT-LINE Clip (CLiC)Blood Chamber is a sterile,single use, disposable, opticalcuvette designed for use with theCLiC Monitor's sensor clipduring acute and chronichemodialysis therapy to non-invasively measure hematocrit,percent change in blood volume,and oxygen saturation. The bloodchamber is connected betweenthe arterial bloodline and thedialyzer within theextracorporeal circuit duringhemodialysis treatment. | Same |
| Principle ofOperation | Disposable cuvette secured to theextracorporeal circuit prior tohemodialysis treatment to providea clear viewing surface for theCLiC Monitor to transmit lightthrough the blood. | Disposable cuvette secured to theextracorporeal circuit prior tohemodialysis treatment toprovide a clear viewing surfacefor the CLiC Monitor to transmitlight through the blood. | Same |
| Configuration | Two, clear polycarbonate lensesare sonically welded to atranslucent, blue polycarbonatebody. A secure connection withthe arterial bloodline is madewith an integrally molded maleLuer-lock connector in the body.Connection to the hemodialyzeris made with a polyvinylchloride(PVC), female conical fittingwith external threads (DINconnector*) that is solventbonded to the chamber body.Each connection is capped: capsare removed prior to treatment tocover the internal blood area andthreads. | Two, clear polycarbonate lensesare sonically welded to atranslucent, blue polycarbonatebody. A secure connection withthe arterial bloodline is madewith an integrally molded maleLuer-lock connector in the body.Connection to the hemodialyzeris made with a polyvinylchloride(PVC), female conical fittingwith external threads (DINconnector*) that is solventbonded to the chamber body.Each connection is capped: capsare removed prior to treatment tocover the internal blood area andthreads. | Same |
| Feature | Predicate Device(P/N CL10041021)CLiC Blood Chamber(K141281) | Proposed Device(P/N CL10041021)CLiC Blood Chamber | Comment |
| BloodPathway | The blood pathway created by theCLiC chamber exposes the bloodto three different materials; PVC(DIN connector), clearpolycarbonate (lenses), and bluepolycarbonate (chamber body).The inside of each polycarbonatelens is molded with two mixingposts that align when the lensesare welded to the bluepolycarbonate body. Thesemixing posts are positioneddirectly below the male accessport. | The blood pathway created bythe CLiC chamber exposes theblood to three different materials;PVC (DIN connector), clearpolycarbonate (lenses), and bluepolycarbonate (chamber body).The inside of each polycarbonatelens is molded with two mixingposts that align when the lensesare welded to the bluepolycarbonate body. Thesemixing posts are positioneddirectly below the male accessport. | Same |
| DialyzerConnection(DINConnector*) | Female conical fitting withexternal threads, meeting ISO8638 and 594-2 performancerequirements. | Female conical fitting withexternal threads, meeting ISO8638 and 594-2 performancerequirements. | SubstantiallyEquivalent |
| ArterialBloodlineConnection | Male Luer-lock conical fittingwith internal threads, meetingISO 8638 and 594-2 performancerequirements. | Male Luer-lock conical fittingwith internal threads, meetingISO 8638 and 594-2 performancerequirements. | Same |
| ConnectionCaps | Caps do not come into contactwith the blood path and arediscarded prior to treatment.Provided to cover the blood pathaccess and protect the threads. | Caps do not come into contactwith the blood path and arediscarded prior to treatment.Provided to cover the blood pathaccess and protect the threads. | Same |
| Sensor Clipto LensInterface | Each lens employs an exterioruniform annular ring to interfacewith the complementary shrouddesign of the CLiC Monitor'ssensor clip. The shroud fills thearea between the annular ring onthe chamber and the outside edgeof the lens. Each lens features ananti-rotation detent whichinterlocks with complementarytabs on both sides of the clip toprevent rotation of the clip. | Each lens employs an exterioruniform annular ring to interfacewith the complementary shrouddesign of the CLiC Monitor'ssensor clip. The shroud fills thearea between the annular ring onthe chamber and the outside edgeof the lens. Each lens features ananti-rotation detent whichinterlocks with complementarytabs on both sides of the clip toprevent rotation of the clip. | Same |
| Feature | Predicate Device(P/N CL10041021) | Proposed Device(P/N CL10041021) | Comment |
| CLiC Blood Chamber(K141281) | CLiC Blood Chamber | ||
| SterilizationMethod | Gamma Radiation | Gamma Radiation | Same |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| SterileBarrier | Unit Packaging | Unit Packaging | Same |
| Single use orreuse | Single use only | Single use only | Same |
| BiologicalSafety | Biologically Safe | Biologically Safe | Same |
Device Description and Comparison to the Predicate Table 1:
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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Table 1: Device Description and Comparison to the Predicate
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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Table 1: Device Description and Comparison to the Predicate
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Image /page/7/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons, stacked on top of each other.
Table 1: Device Description and Comparison to the Predicate
*note: The term 'DIN Connector' is a legacy term used internally by FMC-RTG to describe the dialyzer connector and does not imply conformance to the German national standards Deutsches Institut für Normung (DIN) for locking connections.
Summary of Verification and/or Validation Data 5.8.
The application of Risk Management techniques was used to identify the appropriate verification and/or validation activities to support the proposed change. Based on the results of the testing, outlined in Table 2, FMC-RTG concludes that the modified connector does not introduce any new questions of safety and effectiveness to the finished device.
| Verification Test | Test Method Description | Pass / Fail |
|---|---|---|
| Performance Test: MechanicalCharacteristic / Structural Integrityper ANSI/AAMI/ISO 8638:2010 | Confirm the bonding between the chamberand the DIN Connector P/N 55-4299 | PASS |
| Dialyzer Connector (Female DINConnector): Liquid Leakage Testper ISO 594-2 | Ensure the connectors meet theperformance requirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DINConnector): Air Leakage Test perISO 594-2 | Assure leakage resistance to satisfy therequirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DINConnector): Separation Force Testper ISO 594-2 | Assure the separation force of the conicalfitting meets the ISO 594-2 requirements | PASS |
Table 2: Performance and Functional Testing
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Image /page/8/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
| Verification Test | Test Method Description | Pass / Fail |
|---|---|---|
| Dialyzer Connector (Female DINConnector): Unscrewing TorqueTest per ISO 594-2 | Assure an adequate unscrewing force tosatisfy the requirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DINConnector): Ease of Assembly Testper ISO 594-2 | Assure ease of assembly fit will satisfy therequirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DINConnector): Resistance toOverriding Test per ISO 594-2 | Assure the reference fitting resistsoverriding the test fitting to satisfy therequirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DINConnector): Stress Cracking Testper ISO 594-2 | Assure the female fitting will resist stresscracking to satisfy the requirements of ISO594-2 | PASS |
| Endurance Performance Test perISO 8368:2010 | Demonstrate the product performs atmaximum labeled pressures withoutresulting in loose connection or leaks | PASS |
| Bond Strength Test per ISO8368:2010 | Confirm solvent bonding between the CLiCblood chamber's blue polycarbonate bodyand clear PVC DIN Connector meetspecification | PASS |
| Blood Pathway Volume (PrimingVolume) Test per ISO 8368:2010 | Verify the established the blood pathwayvolume of the blood chamber meetsspecification. | PASS |
5.9. Conclusions
The only proposed change to the CLiC Blood Chamber relates to the internal geometry (taper) of the dialyzer connector. This change has no impact on the Intended Use, Indications for Use or the Technological Characteristic of the finished device.
Results of verification and/or validation testing demonstrate that the modified device meets the performance requirements of ISO 594-2. The safety and efficacy of the device for its intended use remain unchanged.
§ 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.