(259 days)
Not Found
No
The summary describes a disposable extracorporeal circuit (tubing and filter) for blood purification. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical components and their performance characteristics according to established standards.
Yes
The device is indicated for continuous renal replacement therapies (CRRT) for fluid management and reduction of uremic toxins, which are therapeutic interventions.
No
This device is designed for blood purification and fluid management, specifically for continuous renal replacement therapies, not for diagnosing medical conditions.
No
The device description explicitly states it is a "disposable, extracorporeal circuit" consisting of a "hollow fiber haemofilter/dialyser and tubing system," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "blood purification through a semipermeable membrane" for "continuous renal replacement therapies (CRRT)" to "perform fluid management and reduction of uremic toxins." This describes a therapeutic treatment performed directly on the patient's blood, not a diagnostic test performed on a sample of blood or other bodily fluid in vitro (outside the body).
- Device Description: The device is described as an "extracorporeal circuit" consisting of a "hollow fiber haemofilter/dialyser and tubing system." This is consistent with a system used for filtering and purifying blood outside the body during treatment.
- Lack of Diagnostic Language: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other language typically associated with IVD devices.
The device is a therapeutic device used for blood purification in patients with kidney issues.
N/A
Intended Use / Indications for Use
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.
The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
If patients suffer from acute kidney injury and / or volume overload, the Prismatlex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:
- · Slow Continuous UltraFiltration (SCUF)
- · Continuous Veno-Venous Hemofiltration (CVVH)
- · Continuous Veno-Venous HemoDialysis (CVVHD)
- Continuous Veno-Venous HemoDiaFiltration (CVVHDF)
to perform fluid management and reduction of uremic toxins.
The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The Prismaflex ST60/ST100/ST150 set is a disposable, extracorporeal circuit for use with the PrismaFlex system, or with the PrisMax system. The Prismaflex ST60/ST100/ST150 set consists of an AN69 ST hollow fiber haemofilter/dialyser and tubing system.
These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed :
- SCUF: Slow Continuous Ultrafiltration
- CVVH: Continuous Veno-Venous Hemofiltration
- CVVHD: Continuous Veno-Venous Hemodialysis
- CVVHDF: Continuous Veno-Venous Hemodiafiltration
The fluid pathways of the Prismaflex set are guaranteed sterile and pyrogen-free. The Prismaflex set is sterilized by ethylene oxide (EO).
The shelf life of the Prismaflex ST60/ST100/ST150 sets is 24 months from the date of sterilization. The device is intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribed by a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the Prismaflex ST set to evaluate the functional performance of the device. In summary, the Prismaflex ST set has successfully implemented performance requirements and subsequent outputs verifying and validating:
- . The Prismaflex ST set design validation meets the user needs and intended use and is substantially equivalent to the predicate.
- . The device complies with the standard ISO 8637-1 First edition 2017-11, Extracorporeal systems for blood purification - Part 1:Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. The testing specifically confirms the device meets the requirements for the mechanical characteristics (structural and blood compartment integrity), and the performance characteristics (solute clearances, sieving coefficients, ultrafiltration coefficient, volume and pressure drop of blood compartment, expiry date) according to this particular standard. The standard also includes requirements for biological safety, sterility and non pyrogenicity.
- . The device also complies with the standard ISO 8638 Third edition 2010-07-01, Cadiovascular implants and extracorporeal blood circuit for hemodialyzers hemodialfilters and hemofilters. The standard includes requirements for biological safety, sterility, non pyrogenicity, mechanical characteristics, expiry date and tubing compliance.
- . The labeling has been successfully implemented and meets the requirements of the above-mentioned standards.
- . Risk Assessment and control measures: The risk analysis confirms the device is approprietly designed and performs as expected and in a safe manner.
Biocompatibility evaluation for this device was conducted in accordance with ISO-10993-1 Fifth edition 2018-08, "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- . Cytotoxicity (per ISO 10993-5)
- Sensitization (per ISO 10993-10)
- Intracutaneous (Irritation) Reactivity (per ISO 10993-10) .
- Acute Systemic Toxicity (per ISO 10993-11) ●
- Material Mediated Pyrogen (per ISO 10993-11)
- Subacute/Subchronic Toxicity (per ISO 10993-11)
- Hemolysis (per ISO 10993-4)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 1, 2022
Baxter Healthcare Corporation % Maud Humbert Senior Manager, Global Regulatory Affairs Gambro Industries 7 Avenue Lionel Terray, BP 126 Meyzieu. F-69883 FRANCE
Re: K212216
Trade/Device Name: Prismaflex ST set (ST60/ST100/ST150 sets) Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: February 18, 2022 Received: March 3, 2022
Dear Maud Humbert:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212216
Device Name Prismaflex ST set
Indications for Use (Describe)
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.
The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
If patients suffer from acute kidney injury and / or volume overload, the Prismatlex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:
- · Slow Continuous UltraFiltration (SCUF)
- · Continuous Veno-Venous Hemofiltration (CVVH)
- · Continuous Veno-Venous HemoDialysis (CVVHD)
- Continuous Veno-Venous HemoDiaFiltration (CVVHDF)
to perform fluid management and reduction of uremic toxins.
The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif and the letters are evenly spaced.
510(k) Summary
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Fortunato Aldape Sr. Director, Global Regulatory Affairs One Baxter Parkway Deerfield, Illinois 60015
Telephone: T +1.224.948.4867 / M +1.224.358.8599
Date of Preparation: February 15, 2022
IDENTIFICATION OF THE DEVICE:
Common Name: High Permeability Hemodialyzer
Trade/Device Name: Prismaflex ST Set
Classification Panel: Gastroenterology/Urology
Regulation Number: 21 CFR 876.5860
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II
Product Code: KDI
Table 1. Code Numbers for Prismaflex ST set
| Code Number | Name |
|---|---|
| 107643US | Prismaflex ST60 set |
| 107636US | Prismaflex ST100 set |
| 107640US | Prismaflex ST150 set |
PREDICATE DEVICE:
Table 2. Predicate Device(s)
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| K041005 | Gambro Industries, France | Prismaflex M60 and M100 sets | 10/18/2004 |
4
| Baxter |
|---|
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| K080519 | Gambro Industries, France | Prismaflex M150 set | 06/13/2008 |
| K190910 | Gambro Industries, France | Prismaflex M60, M100 and M150 | |
| sets (intended for use with Prismax | |||
| system) | 07/25/2019 |
Table 2. Predicate Device(s)
DESCRIPTION OF THE DEVICE:
The Prismaflex ST60/ST100/ST150 set is a disposable, extracorporeal circuit for use with the PrismaFlex system, or with the PrisMax system. The Prismaflex ST60/ST100/ST150 set consists of an AN69 ST hollow fiber haemofilter/dialyser and tubing system.
These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed :
- SCUF: Slow Continuous Ultrafiltration
- CVVH: Continuous Veno-Venous Hemofiltration
- CVVHD: Continuous Veno-Venous Hemodialysis
- CVVHDF: Continuous Veno-Venous Hemodiafiltration
The fluid pathways of the Prismaflex set are guaranteed sterile and pyrogen-free. The Prismaflex set is sterilized by ethylene oxide (EO).
The shelf life of the Prismaflex ST60/ST100/ST150 sets is 24 months from the date of sterilization. The device is intended for single use.
INDICATIONS FOR USE:
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.
The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical
5
condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
If patients suffer from acute kidney injury and / or volume overload, the Prismaflex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:
- Slow Continuous UltraFiltration (SCUF)
- Continuous Veno-Venous Hemofiltration (CVVH)
- Continuous Veno-Venous HemoDialysis (CVVHD)
- . Continuous Veno-Venous HemoDiaFiltration (CVVHDF) to perform fluid management and reduction of uremic toxins.
The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Prismaflex ST set has the same intended use and the same technological characteristics compared to its predicate, the Prismaflex M set, in term of design, material, chemical composition, function and operation.
The safety and performance of Prismaflex ST set was evaluated through non-clinical testing. The bench and pre-clinical testing assessed the following aspects of the device:
- Structural integrity
- Membrane integrity
- Ultrafiltration rate
- Clearances
- Sieving coefficients
- Blood pressure drop
- Total volume of blood in the set
- Priming efficacy
- Shelf life
- Sterilization validation
6
Image /page/6/Picture/0 description: The image shows the text 'K212216' and 'Page 4 of 5' in the upper left corner. Below this text is the word 'Baxter' in a stylized, bold, blue font. The word 'Baxter' appears to be a logo or brand name. The image seems to be a page from a document.
- . Pvrogenicitv / LAL
- . EO residuals
- . Biocompatibility
DISCUSSION OF NONCLINICAL TESTS:
Performance Data:
Performance testing was conducted on the Prismaflex ST set to evaluate the functional performance of the device. In summary, the Prismaflex ST set has successfully implemented performance requirements and subsequent outputs verifying and validating:
- . The Prismaflex ST set design validation meets the user needs and intended use and is substantially equivalent to the predicate.
- . The device complies with the standard ISO 8637-1 First edition 2017-11, Extracorporeal systems for blood purification - Part 1:Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. The testing specifically confirms the device meets the requirements for the mechanical characteristics (structural and blood compartment integrity), and the performance characteristics (solute clearances, sieving coefficients, ultrafiltration coefficient, volume and pressure drop of blood compartment, expiry date) according to this particular standard. The standard also includes requirements for biological safety, sterility and non pyrogenicity.
- . The device also complies with the standard ISO 8638 Third edition 2010-07-01, Cadiovascular implants and extracorporeal blood circuit for hemodialyzers hemodialfilters and hemofilters. The standard includes requirements for biological safety, sterility, non pyrogenicity, mechanical characteristics, expiry date and tubing compliance.
- . The labeling has been successfully implemented and meets the requirements of the above-mentioned standards.
- . Risk Assessment and control measures: The risk analysis confirms the device is approprietly designed and performs as expected and in a safe manner.
Biocompatibility:
The biocompatibility evaluation for this device was conducted in accordance with ISO-10993-1 Fifth edition 2018-08, "Biological evaluation of medical devices Part 1:
7
Image /page/7/Picture/0 description: The image shows the text "K212216" and "Page 5 of 5" at the top. Below that is the Baxter logo in blue, with the text in a bold, italicized font. The text and logo appear to be part of a document or report.
Evaluation and testing within a risk management process," as recognized by FDA and FDA guidance document Use of International Standard ISO-10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- . Cytotoxicity (per ISO 10993-5)
- Sensitization (per ISO 10993-10)
- Intracutaneous (Irritation) Reactivity (per ISO 10993-10) .
- Acute Systemic Toxicity (per ISO 10993-11) ●
- Material Mediated Pyrogen (per ISO 10993-11)
- Subacute/Subchronic Toxicity (per ISO 10993-11)
- Hemolysis (per ISO 10993-4)
CONCLUSION:
The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the Prismaflex ST set is as safe, as effective, and performs as well as the predicate device.
The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is currently marketed for the same intended use.