(186 days)
The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.
The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician. The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. Prismaflex® System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodialfiltration (CVVHDF).
The provided text is a 510(k) summary for the Prismaflex® System 3.20. It details the device's intended use, comparison to a predicate device, and non-clinical testing. However, it does not include the specific information requested about acceptance criteria for device performance studies, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, or any information regarding multi-reader multi-case studies or standalone algorithm performance.
The document states that the non-clinical testing for the Prismaflex® System 3.20 demonstrated its safety and effectiveness and that it "performs as well as or better than the legally marketed predicate device." This implies that the acceptance criteria for the new device were alignment with or improvement upon the performance of the predicate device (Prismaflex™ System 1.04).
Below is a summary of the available information and an explicit statement of what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document implicitly uses the performance of the predicate device as the acceptance criteria for the modified device. The table below compares the specifications of the modified device to the predicate device. For some parameters, the modified device's performance aligns with the predicate, while for others (like Dialysate Flow Rate Accuracy, Replacement Flow Rate Accuracy, Pre-Blood Pump Accuracy, and Patient Fluid Removal Performance Range Accuracy), the modified device states a specific accuracy, which could be considered its performance target (acceptance criteria) and reported performance.
| Parameter | Predicate Device (Prismaflex™ System 1.04) Acceptance Criteria (Implied) | Modified Device (Prismaflex® System 3.20) Reported Performance |
|---|---|---|
| Indications for Use | For continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. | For Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. Prescribed by a physician. |
| Dedicated Disposable Sets Available in U.S. | M60/M100, HF1000 & HF1400 | M60/M100, HF1000 & HF1400 |
| Syringe Sizes | 10, 20 & 30 ml | 10, 20, 30 & 50 ml |
| Anticoagulation | User-controllable as continuous or bolus | User-controllable as continuous or bolus |
| Dialysate Flow Rate (CVVHD & CVVHDF) | 0 to 8000 ml/hr (CVVHD), 0 to 4000 ml/hr (CVVHDF); Increment: 50 ml/hr | 0 to 8000 ml/hr; Increment: 50 ml/hr |
| Dialysate Flow Rate Accuracy | ±10% of user-set rate | ± 30 ml/hr |
| Replacement Flow Rate (CVVH & CVVHDF) | 0 to 8000 ml/hr (CVVH), 0 to 4000 ml/hr (CVVHDF); Increment: 50 ml/hr | 0 to 8000 ml/hr; Increment: 50 ml/hr |
| Replacement Flow Rate Accuracy | ±10% of user-set rate | ± 30 ml/hr |
| Blood Flow Rate | 10-450 ml/min. (depends on therapy/set combination) | 10-450 ml/min. (depends on therapy/set combination) |
| Blood Flow Rate Accuracy | ±10% of user set point (maintained under specific pressure conditions) | ±10% of user set point (maintained under specific pressure conditions) |
| Pre-Blood Pump Flow Rate (SCUF) | 0 to 1,000 ml/hr | 0 to 1,000 ml/hr |
| Pre-Blood Pump Flow Rate (CVVH, CVVHD, CVVHDF) | 0 to 8,000 ml/hr | 0 to 8,000 ml/hr |
| Pre-Blood Pump Accuracy | ±10% of user-set rate | ± 30 ml/hr |
| Effluent Pump Flow Rate | 0 to 10,000 ml/hr (depending on therapy) | 0 to 10,000 ml/hr (depending on therapy) |
| ECG Discharger | YES | YES |
| Therapies | SCUF, CVVH, CVVHD, CVVHDF | SCUF, CVVH, CVVHD, CVVHDF |
| Pumps | Blood access line, Dialysate inlet line, Effluent outlet line, Replacement solution line, Pre blood pump line | Blood access line, Dialysate inlet line, Effluent outlet line, Replacement solution line, Pre blood pump line |
| Scales | Dialysate, Replacement, Effluent, Pre blood pump | Dialysate, Replacement, Effluent, Pre blood pump |
| Transmembrane Pressure | User settable: +70 to +300 mmHg; Default: +300 mmHg | User settable: +70 to +300 mmHg; Default: +300 mmHg |
| Dialysate Conductivity and Temperature | Not controlled by Prismaflex | Not controlled by Prismaflex |
| Patient Fluid Removal Performance Range | 0 to 2,000 ml/hr; Increment: 10 ml/hr | 0 to 2,000 ml/hr; Increment: 10 ml/hr |
| Patient Fluid Removal Performance Range Accuracy | ± 30 ml/hr, ± 600 ml/24hr (Scales calibrated at ambient temperature, change < ± 3° C) | ± 30 ml/hr, ± 70 ml/3hr, ± 300 ml/24hr (Scales calibrated at ambient temperature, change < ±3°C) |
| Access Pressure | -250 to +300 mmHg | -250 to +300 mmHg |
| Return Pressure | -50 to +350 mmHg | -50 to +350 mmHg |
| Access Pressure and Return Pressure Accuracy | ±10% of reading or ± 8mmHg (whichever is greater) | ±10% of reading or ± 8mmHg (whichever is greater) |
Missing Information:
The document is a 510(k) summary for a medical device (Prismaflex® System 3.20), not an AI/ML-based device for diagnostic or prognostic purposes. As such, the requested information categories are largely not applicable as they pertain to studies involving algorithms, data sets, and human expert evaluation in a clinical/diagnostic context.
Here's a breakdown of why each item from your request is not present in the provided text:
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document describes "non-clinical testing" including component-level hardware testing, software testing, and human factors evaluations. It does not mention clinical trials or data sets derived from human patients in the way an AI/ML device would.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images or diagnoses) is not relevant here. The testing described is technical validation of a medical device's performance specifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to review of cases, typically for diagnostic accuracy.
- 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 device is a renal replacement therapy system, not an imaging or diagnostic AI. Human improvement with or without AI assistance is not a relevant outcome measure for this device type.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical system with embedded software, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be engineering specifications and measurements (e.g., actual flow rates vs. set flow rates, pressure measurements, etc.), not clinical ground truth derived from expert consensus or pathology.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set of data.
- How the ground truth for the training set was established: Not applicable. See point 8.
Summary of the Study that Proves the Device Meets Acceptance Criteria (from the document):
The study consisted of non-clinical testing designed to demonstrate the safety and effectiveness of the Prismaflex® System 3.20. This testing included:
- Component-level hardware testing
- Testing to support declarations of conformity to standards cited in the 510(k) submission.
- Testing required by process to ensure compliance with other international standards applicable to hemodialysis machines.
- Static and dynamic software testing, including:
- Unit testing
- Code inspections
- Testing targeted to the changes implemented in software version 3.20
- Regression testing
- Human factors evaluations
- Testing performed by internal and external independent personnel with appropriate skills.
The "successful non-clinical testing" is stated to demonstrate that the Prismaflex® System 3.20 "performs as well as or better than the legally marketed predicate device (Prismaflex™ System 1.04)." This indicates that the performance criteria (acceptance criteria) for the new device were implicitly established by the performance of the predicate device, and the non-clinical tests confirmed that the modified device met or exceeded those established baselines across its operational specifications.
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K072093
Page 1 of 5
·
:
5.0 510(K) SUMMARY
| Submitter's Name | Gambro |
|---|---|
| Address | 14143 Denver West ParkwayLakewood, Colorado 80401 |
| EstablishmentRegistration Number | 2087532 |
| Date of Summary | July 27th, 2007 |
| Telephone NumberFax Number | (303) 231-4094(303) 542-5138 |
| Contact Person | Thomas B. Dowell, Regulatory Affairs Project Manager |
| Name of the Device | Prismaflex® System 3.20Catalogue Number: 107493 |
| Common or Usual Name | Hemodialysis Delivery System |
| Classification Name | Classification Name: High Permeability Hemodialysis SystemDevice Class: IIProduct Code: 78KDIRegulation Number: 876.5860 |
| Indications for Use | The Prismaflex® System is intended for Continuous RenalReplacement Therapy (CRRT) for patients with acute renal failureand/or fluid overload weighing 20 Kilograms or more. Alltreatments administered via the Prismaflex® must be prescribed via aphysician. |
| Identification of theLegally Marketed Device(Predicate Device) | PrismaflexTM System 1.04Catalogue Number: 6023014700Classification Name: High Permeability Hemodialysis SystemDevice Class: IIProduct Code: 78KDIRegulation Number: 876.5860 |
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KC73093
Page 2 of 5
Traditional 510(k) Prismaflex® System 3.20
510(k) SUMMARY, continued
The Prismaflex® System is intended for Continuous Renal Replacement Device Description Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician. The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. Prismaflex® System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodialfiltration (CVVHDF).
Device Comparison Table
| PREDICATE | MODIFIED DEVICE | |
|---|---|---|
| PrismaflexTM System 1.04 | Prismaflex® System 3.20 | |
| Indication for Use | The PrismaflexTM is indicated forcontinuous solute and/or fluidremoval in patients with acute renalfailure or fluid overload. Alltreatments administered by thePrismaflexTM must be prescribed by aphysician. | The Prismaflex® System is intendedfor Continuous Renal ReplacementTherapy (CRRT) for patients withacute renal failure and/or fluidoverload weighing 20 Kilograms ormore. All treatments administered viathe Prismaflex® must be prescribedvia a physician. |
| DedicatedDisposable SetsAvailable in U.S. | M60/M100HF1000 & HF1400 | M60/M100HF1000 & HF1400 |
| Syringe | 10, 20 & 30 ml | 10, 20, 30 & 50 ml |
| Anticoagulation | User-controllable as continuous orbolus | User-controllable as continuous orbolus |
| Dialysate Flow Rate | CVVHD: 0 to 8000 ml/hrCVVHDF: 0 to 4000 ml/hrIncrement: 50 ml/hr | CVVHD & CVVHDF0 to 8000 ml/hrIncrement: 50 ml/hr |
| Dialysate Flow RateAccuracy | ±10% of user-set rate | ± 30 ml/hr |
| Replacement FlowRate | CVVH: 0 to 8000 ml/hrCVVHDF: 0 to 4000 ml/hrIncrement: 50 ml/hr increment | CVVH & CVVHDF:0 to 8000 ml/hrIncrement: 50 ml/hr |
| Replacement FlowRate Accuracy | ±10% of user-set rate | + 30 ml/hr |
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KC7222
Page 3 of 5
| PREDICATE | MODIFIED DEVICE | |
|---|---|---|
| Prismaflex System 1.04 | Prismaflex® System 3.20 | |
| Blood Flow Rate | 10-450 ml/min. | 10-450 ml/min. |
| Flow rate depends on the Prismaflex | Flow rate depends on the Prismaflex | |
| therapy/set combination selected by | therapy/set combination selected by | |
| operator | operator | |
| ±10% of user set point | ±10% of user set point | |
| Accuracy of blood flow is maintained | Accuracy of blood flow is maintained | |
| Blood Flow Rate | if the inlet pressure is higher (less | if the inlet pressure is higher (less |
| Accuracy | negative) than -250 mmHg and the | negative) than -250 mmHg and the |
| outlet pressure is lower than +350 | outlet pressure is lower than +350 | |
| mmHg | mmHg | |
| Pre-Blood Pump | SCUF: 0 to 1,000 ml/hr | SCUF: 0 to 1,000 ml/hr |
| Flow Rate | CVVH, CVVHD, CVVHDF: | CVVH, CVVHD, CVVHDF: |
| 0 to 8,000 ml/hr | 0 to 8,000 ml/hr | |
| Pre-Blood Pump | ±10% of user-set rate | + 30 ml/hr |
| Accuracy | ||
| Effluent Pump Flow | 0 to 10,000 ml/hr depending on the | 0 to 10,000 ml/hr depending on the |
| Rate | therapy | therapy |
| ECG Discharger | YES | YES |
| SCUF | SCUF | |
| Therapies | CVVH | CVVH |
| CVVHD | CVVHD | |
| CVVHDF | CVVHDF | |
| Blood access line | Blood access line | |
| Pumps | Dialysate inlet line | Dialysate inlet line |
| Effluent outlet line | Effluent outlet line | |
| Replacement solution line | Replacement solution line | |
| Pre blood pump line | Pre blood pump line | |
| Scales | Dialysate | Dialysate |
| Replacement | Replacement | |
| Effluent | Effluent | |
| Pre blood pump | Pre blood pump |
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K073093
Page 4 of 5
Traditional 510(k)
Prismaflex® System 3.20
| PREDICATE | MODIFIED DEVICE | |
|---|---|---|
| PrismaflexTM System 1.04 | Prismaflex® System 3.20 | |
| TransmembranePressure | User settable:+70 to +300 mmHgDefault: +300 mmHg | User settable:+70 to +300 mmHgDefault: +300 mmHg |
| DialysateConductivity andTemperature | Dialysate Conductivity andTemperature are not controlled byPrismaflex | Dialysate Conductivity andTemperature are not controlled byPrismaflex |
| Patient FluidRemovalPerformance Range | 0 to 2,000 ml/hrIncrement: 10 ml/hr | 0 to 2,000 ml/hrIncrement: 10 ml/hr |
| Patient FluidRemovalPerformance RangeAccuracy | ± 30 ml/hr± 600 ml/24hrScales calibrated at ambienttemperature at which they will beused. Ambient temperature changeless than ± 3° C (5.4 °F) duringtreatment. | ± 30 ml/hr± 70 ml/3hr± 300 ml/24hrScales calibrated at ambienttemperature at which they will beused. Ambient temperature changeless than ±3°C (5.4 °F) duringtreatment. |
| Access Pressure andReturn Pressure | Access Pressure:-250 to +300 mmHgReturn Pressure:-50 to +350 mmHg | Access Pressure:-250 to +300 mmHgReturn Pressure:-50 to +350 mmHg |
| Access Pressure andReturn PressureAccuracy | ±10% of reading or ± 8mmHg(whichever is greater) | ±10% of reading or ± 8mmHg(whichever is greater) |
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KC7 2023
Page 5 of 5
Traditional 510(k) Prismaflex® System 3.20
510(k) SUMMARY, continued
| Description and | Conclusion of | Non-clinical Testing: |
|---|---|---|
| Testing | The non-clinical testing performed for the Prismaflex® System 3.20 includes component level hardware testing, testing required to support the declarations of conformity to standards contained in this 510(k) submission, testing required by process to ensure compliance with other international standards applicable to hemodialysis machines as well the static and dynamic software testing, e.g. unit testing, code inspections, testing targeted to the changes implemented in software version 3.20, regression testing, human factors evaluations and testing that was performed by internal and external independent personnel with the appropriate skills. |
The successful non-clinical testing demonstrates the safety and
effectiveness of the Prismaflex® System when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
FEB - 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas B. Dowell Regulatory Affairs Project Manager GAMBRO 14143 Denver West Parkway LAKEWOOD CO 80401
K072093 Re:
Trade/Device Name: Prismaflex® System 3.20 Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: December 21, 2007 Received: December 26, 2007
Dear Mr. Dowell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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. 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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Prismaflex® System 3.20
Indications for Use
510(k) Number (if known): K072093
Device Name: Prismaflex® System 3.20
Indications for Use:
The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hely Reimer
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number ___K912095
Page 17 of 131
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”