(74 days)
Not Found
No
The 510(k) summary describes a conventional hemodialyzer and does not mention any AI or ML components or functionalities.
Yes
The device is a hemodialyzer, designed for use in acute and chronic hemodialysis, which is a therapeutic process to remove waste products from the blood when the kidneys are no longer functioning.
No
The device description clearly states that Diacap LO PS and Diacap HI PS are "hemodialyzers," designed for use in "acute and chronic hemodialysis." This process involves filtering blood to remove waste products, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (hollow membrane, plastic cylinder, ports) and the performance studies involve bench and clinical testing of a physical device, not software.
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, not a test performed on a sample taken from a patient to provide diagnostic information.
- Device Description: The description details a hemodialyzer, which is a device used to filter blood outside the body. This is a treatment device, not a diagnostic device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Measuring biomarkers or analytes
The device is clearly a therapeutic medical device used in the treatment of kidney failure.
N/A
Intended Use / Indications for Use
The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) hemodialyzers are designed for single use in acute and chronic hemodialysis.
Product codes (comma separated list FDA assigned to the subject device)
FJI, KDI
Device Description
The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) are, respectively, conventional permeability and high permeability hemodialyzers. The hollow, polysulfone membrane is housed within a plastic cylinder with four ports: two ports for blood compartment access and two ports for dialysate access.
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)
Performance and safety evaluations of Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) were based upon bench and clinical testing. Ultrafiltration coefficients and clearances of urea, creatinine, phosphate and vitamin B12 were consistent with expected values for conventional and high permeability dialyzers. Hemocompatibility was confirmed by white cell and platelet counts and the evaluation of complement activation (C3a), intrinsic and extrinsic coagulation system (TAT and thrombocyte activation) and cell activation (thrombocyte and/or leukocyte adhesion and leukocyte activation).
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.”
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Ko71518p4 or 3
B. Braun Medizintechnologie G.m.b.H.
:
510(k) Notification Diacap LO PS and HI PS Hemodialyzers
.
510(k) SUMMARY in accordance with 21 CFR 807.92(c)
AUG 1 7 2007
:
:
1
| 1. Owner: | B. Braun Medizintechnologie
Schwarzenberger Weg 73-79
34212 Melsungen, Germany |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Susan Olinger
Corporate Vice President, Regulatory Affairs
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109
Telephone: (610) 596-2517
Fax: (610) 266 4962
Email: susan.olinger@bbraun.com |
Date of Preparation: May 31, 2007
2. Device Classification:
| Conventional | High Permeability | ||
|---|---|---|---|
| 1. | Common or Usual Name | Polysulfone Hemodialyzer | Polysulfone Hemodialyzer |
| 2. | Trade Name | Diacap LO PS 10 | |
| Diacap LO PS 12 | |||
| Diacap LO PS 15 | Diacap HI PS 10 | ||
| Diacap HI PS 12 | |||
| Diacap HI PS 15 | |||
| Diacap HI PS 18 | |||
| Diacap HI PS 20 | |||
| 3. | Classification Name | Hemodialysis system and | |
| accessories | High permeability | ||
| hemodialysis system | |||
| 4. | Regulation Number | 21 CFR §876.5820 | 21 CFR §876.5860 |
| 5. | Class | II | II |
| 6. | Classification Product | ||
| Code | FJI | KDI | |
| 7. | Classification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| 8. | Prescription Status | Prescription device as | |
| described in 21 CFR | |||
| §801.109 | Prescription device as | ||
| described in 21 CFR | |||
| §801.109 |
. 1
:
:
:
1
| Diacap Models | | Fresenius Models
510(k) number K970700 | |
|--------------------------------|-----------------|-------------------------------------------|-----------------|
| Trade Name | Surface Area m2 | Trade Name | Surface Area m2 |
| Low Flux Models (Conventional) | | | |
| LO PS 10 | 1.0 m2 | Hemoflow F5 | 1.0 m2 |
| LO PS 12 | 1.2 m2 | Hemoflow F6 | 1.3 m2 |
| LO PS 15 | 1.5 m2 | Hemoflow F7 | 1.6 m2 |
| | | Hemoflow F8 | 1.8 m2 |
| High Flux Models | | | |
| HI PS 10 | 1.0 m2 | Hemoflow F 50 NR | 1.0 m2 |
| HI PS 12 | 1.2 m2 | Hemoflow F 60 A | 1.3 m2 |
| | | Hemoflow F 60 B | |
| HI PS 15 | 1.5 m2 | Hemoflow F 70 A | 1.6 m2 |
| | | Hemoflow F 70 B | |
| | | Hemoflow F 70 NR | |
| HI PS 18 | 1.8 m2 | Hemoflow F 80 A | 1.8 m2 |
| | | Hemoflow F 80 B | |
| HI PS 20 | 2.0 m2 | Optiflux 200 A | 2.0 m2 |
3. Predicate Device
4. Device Description:
The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) are, respectively, conventional permeability and high permeability hemodialyzers. The hollow, polysulfone membrane is housed within a plastic cylinder with four ports: two ports for blood compartment access and two ports for dialysate access.
5. Intended Use:
The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) hemodialyzers are designed for single use in acute and chronic hemodialysis.
6. Substantial Equivalence Comparison:
Technical and clinical comparisons presented in the premarket notification submission are based upon the information requested in the August 7, 1998 Guidance for Industry and CDRH Reviewers, Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, section V. The evaluation of device materials and configuration, membrane characteristics, blood volumes, sterilization methods and the results of randomized clinical studies demonstrate that the Diacap LO PS and Diacap HI PS do not raise any new issues of safety and effectiveness when compared with the predicate device.
2
B. Braun Medizintechnologie G.m.b.H.
7. Performance Evaluations:
Performance and safety evaluations of Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) were based upon bench and clinical testing. Ultrafiltration coefficients and clearances of urea, creatinine, phosphate and vitamin B12 were consistent with expected values for conventional and high permeability dialyzers. Hemocompatibility was confirmed by white cell and platelet counts and the evaluation of complement activation (C3a), intrinsic and extrinsic coagulation system (TAT and thrombocyte activation) and cell activation (thrombocyte and/or leukocyte adhesion and leukocyte activation).
8. Conclusion:
The performance and safety data presented in the premarket notification support a finding of substantial equivalence between the Diacap LO PS (10, 12 and 15) and HI PS (10, 12, 15, 18 and 20) and the predicate devices already in commercial distribution in the United States.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines extending from its head, resembling feathers or wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
B. Braun Medizintechnologie G.m.b.H. c/o Ms. Susan Olinger Corporate Vice President, Regulatory Affairs B. Braun Medical, Inc. (U.S.) 901 Marcon Blvd. ALLENTOWN PA 18109
K071518 Re:
Trade/Device Name: Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15 18, 20) Hemodialyzers
AUG 1 7 2007
Regulation Number: 21 CFR §876.5860
Regulation Name: High permeability hemodialysis system Product Code: KDI
Regulation Number: 21 CFR §876.5820
Regulation Name: Hemodialysis system and accessories
Product Code: FJI
Regulatory Class: II
Dated: May 31, 2007 Received: June 4, 2007
Dear Ms. Olinger:
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 (Premarket Approval), 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.
Image /page/3/Picture/16 description: The image shows a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" prominently in the center, with the word "Centennial" written below. Three stars are arranged beneath the word "Centennial". The entire design is encircled by text, completing the circular shape of the logo.
Protecting and Promoting Public Health
4
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
21 CFR 876 xxxx 21 CFR 884.xxxx 21 CFR 892.xxxx . Other
240-276-0115 (Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0120 (Radiology); 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
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
5
B. Braun Medizintechnologie G.m.b.H.
510(k) Notification Diacap LO PS and HI PS Hemodialyzers
Indications for Use
510(k) Number (if known):
Device Name: Diacap LO PS (10,12,15) and Diacap HI PS (10,12,15,18,20) Hemodialyzers
Indications for Use: Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers are designed for single use in acute and chronic hemodialysis.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thhan
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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