(76 days)
No
The device description and performance summary focus on the physical components and functional performance of a hemodialyzer, with no mention of AI or ML.
Yes
The device is a hemodialyzer used to treat patients with kidney failure, directly performing a therapeutic function by filtering the blood.
No
Explanation: The device is a hemodialyzer used for filtering blood in dialysis treatments, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like membranes, housing, resin, and O-ring, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for single use in acute and chronic hemodialysis." This describes a therapeutic procedure performed on a patient to filter their blood, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a "high permeability dialyzer" composed of membranes and housing, designed to filter blood. This is consistent with a medical device used for treatment, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in a sample
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The Diacap® Polysulfone HiFlo 23 Hemodialyzer is a medical device used for treatment, specifically hemodialysis.
N/A
Intended Use / Indications for Use
The Diacap® Polysulfone HiFlo 23 Hemodialyzer is designed for single use in acute and chronic hemodialysis.
Product codes
KDI
Device Description
The Diacap® Polysulfone HiFlo 23 Hemodialyzer is a high permeability dialyzer intended to be used in acute and chronic hemodialysis. It is composed of polysulfone hollow fiber capillary membranes in a polycarbonate housing with a polyurethane potting resin and a silicone O-ring. The proposed Diacap HiFlo 23 hemodialyzer will be available in one model, the 23, which represents the effective surface area of 2.3m². The dialyzer is intended for single use and is provided sterile.
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
Not Found
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)
Verification and validation testing for the proposed dialyzer have been completed and all acceptance criteria have been met. The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Diacap® LO PS (10, 12, 15) and Diacap® HI PS (10, 12, 15, 18, 20) Hemodialyzers, (K071518)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
B. Braun Avitum AG Special 510(k) Premarket Notification Diacap Polysulfone HiFlo 23 Hemodialyzer
510(k) SUMMARY ഗ്
APR 9 8 2010
B. Braun Avitum AG APPLICANT: Schwarzenberger Weg 73-79 34212 Melsungen, Germany Establishment Registration Number: 3002879653
SUBMITTER:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
CONTACT:
Angela J. Caravella Sr. Regulatory Affairs Analyst Phone: 610-596-2966 Fax: 610-596-2502 E-mail: Angela.Caravella@bbraun.com
DEVICE NAME:
COMMON OR USUAL NAME:
DEVICE
High Permeability Hemodialysis System
Diacap® Polysulfone HiFlo 23 Hemodialyzer
Class II per 21 CFR § 876.5860 Product Code KDI
CURRENTLY MARKETED DEVICE (PREDICATE):
CLASSIFICATION:
DESCRIPTION:
Diacap® LO PS (10, 12, 15) and Diacap® HI PS (10, 12, 15, 18, 20) Hemodialyzers, (K071518)
The Diacap® Polysulfone HiFlo 23 Hemodialyzer is a high permeability dialyzer intended to be used in acute and chronic hemodialysis. It is composed of polysulfone hollow fiber capillary membranes in a polycarbonate housing with a polyurethane potting resin and a silicone O-ring. The proposed Diacap HiFlo 23 hemodialyzer will be available in one model, the 23, which represents the effective surface area of 2.3m². The dialyzer is intended for single use and is provided sterile.
INTENDED USE:
The Diacap® Polysulfone HiFlo 23 Hemodialyzer is designed for single use in acute and chronic hemodialysis.
18
1
B. Braun Avitum AG Special 510(k) Premarket Notification Diacap Polysulfone HiFlo 23 Hemodialyzer
SUBSTANTIAL EQUIVALENCE:
Diacap® Polysulfone HiFlo 23 Hemodialyzer has the same intended use and utilizes the same fundamental technology as the predicate device, the currently marketed Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers, (K071518). The Diacap HiFlo 23 Hemodialyzer is a modified version of the existing Diacap LO PS and HI PS dialyzers and can be considered an extension to the line of B. Braun Polysulfone Dialyzers.
The technological characteristics of the Diacap Polysulfone HiFlo 23 Hemodialyzer are equivalent to those of the existing Diacap polysulfone dialyzers. The Diacap Polysulfone HiFlo 23 Hemodialyzer is similar to the predicate device in material composition. Changes in the design of the proposed dialyzer include an increased surface area and two alternate materials have been added: polyurethane (PUR) potting resin and an alternate silicone material qualified for the dialyzer O-ring.
These changes do not pose a significant impact upon the fundamental technology of the Diacap polysulfone capillary dialyzers, as identified within the Risk Analysis. Verification and validation testing for the proposed dialyzer have been completed and all acceptance criteria have been met. The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUN -3 2010
B.Braun Avitum AG % Ms. Angela J. Caravella Sr. Regulatory Affairs Analyst B. Braun Medical, Inc. 901 Marcon Boulevard ALLENTOWN PA 18109-9341
Re: K100334
Diacap® Polysulfone HiFlo 23 Hemodialyzer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 30, 2010 Received: April 1, 2010
Dear Ms. Caravella:
This letter corrects our substantially equivalent letter of April 22, 2010. 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 (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 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. 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
3
Page 2 - Ms. Angela J. Caravella
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Herbert Kemen
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
B. Braun Avitum AG Special SIO(k) Premarket Notification Diacap Polysulfone HiFlo 23 Hemodialyzer
| 4. INDICATIONS FOR USE STATEMENT | |
|---|---|
| Page 1 of 1 | |
| 510(k) Number (if known): | K100334 |
| Device Name: | Diacap® Polysulfone HiFlo 23 Hemodialyzer |
| Indications For Use: | |
| The Diacap® Polysulfone HiFlo 23 Hemodialyzer is designed for single use in acute and chronic hemodialysis. | |
| Prescription Use X (Per 21 CFR 801.109) | OR Over-The-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 00334 510(k) Number.