K170574 · B. Braun Avitum AG · KDI · Aug 11, 2017 · Gastroenterology, Urology
Device Facts
Record ID
K170574
Device Name
Diacap Pro Dialyzer
Applicant
B. Braun Avitum AG
Product Code
KDI · Gastroenterology, Urology
Decision Date
Aug 11, 2017
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5860
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Diacap Pro Dialyzer is designed for single use in acute and chronic hemodialysis.
Device Story
The Diacap Pro Dialyzer is a high-flux hemodialyzer used in acute and chronic hemodialysis. It consists of an asymmetric microporous hollow fiber membrane made of polysulfone and polyvinylpyrrolidone. During hemodialysis, blood flows through the hollow fibers while dialysate flows in the opposite direction in the surrounding compartment; the membrane facilitates the removal of waste products and excess fluid from the blood via diffusion and ultrafiltration. The device is intended for single use and is provided sterile and non-pyrogenic. It is operated by trained healthcare professionals in clinical settings. The device helps manage patients with renal failure by performing the function of the kidneys to maintain fluid and electrolyte balance.
Clinical Evidence
Performance testing included in-vitro functional testing (ultrafiltration rate, pressure drop, and clearances of urea, creatinine, and vitamin B12) per ISO 8637 and FDA guidance. Comparative mechanical hemolysis testing was performed against the predicate. Clinical evidence included an in-vivo ultrafiltration coefficient study. Results demonstrated the device performs similarly to the predicate.
Indicated for patients requiring acute or chronic hemodialysis.
Regulatory Classification
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).
Special Controls
*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.”
Predicate Devices
Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers (K071518)
Submission Summary (Full Text)
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Re:
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2017
B. Braun Avitum AG % Tracv Maddock Sr. Regulatory Affairs Specialist B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, PA 18109
> K170574 Trade/Device Name: Diacap Pro Dialyzer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: February 24, 2017 Received: February 27, 2017
Dear Tracy Maddock:
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.
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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); medical device reporting (reporting of medical devicerelated 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,
Joyce M. Whang-S
Benjamin R. Fisher, Ph.D. for 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K170574
Device Name
Diacan Pro Dialyzer
Indications for Use (Describe)
The Diacap Pro Dialyzer is designed for single use in acute and chronic hemodialysis.
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.
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| 1. 510(k) SUMMARY | K170574 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | B. Braun Avitum AG<br>Schwarzenberger Weg 73-79<br>34212 Melsungen, Germany<br>Establishment Registration Number: 3002879653 |
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500 |
| CONTACT: | Tracy Maddock<br>Sr. Regulatory Affairs Specialist<br>Phone: (610) 596-2545<br>Fax: (610) 266-4962<br>E-mail: tracy.maddock@bbraun.com |
| DATE | August 11, 2017 |
| DEVICE NAME: | Diacap Pro Dialyzer<br>Models: Diacap Pro 13H, Diacap Pro 16H,<br>Diacap Pro 19H |
| COMMON OR<br>USUAL NAME: | High Permeability polysulfone high flux dialyzer |
| DEVICE<br>CLASSIFICATION: | Class II per 21 CFR § 876.5860, Dialyzer, High Permeability<br>With or Without Sealed Dialysate System<br>Product Code: KDI<br>Classification Panel: Gastroenterology/Urology |
| PREDICATE DEVICE: | Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers, (K071518) |
# DESCRIPTION:
The Diacap Pro dialyzer is a polysulfone high flux dialyzer with the surface areas 1.3 sqm, 1.6 sqm, 1.9 sqm. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.
## INDICATIONS FOR USE:
The Diacap Pro Dialyzer is designed for single use in acute and chronic hemodialysis.
## SUBSTANTIAL EQUIVALENCE:
The Diacap Pro dialyzer is substantially equivalent to the Diacap HIPS dialyzer (K071518).
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## Comparison of Technological Characteristics with the Predicate Device
The proposed device has the same indications for use (for single use in acute and chronic hemodialysis) and the same principle of operation as the predicate device. The proposed device is similar in design with respect to components and materials of construction. Both devices are provided as sterile, nonpyrogenic, individually packaged devices.
A table summarizing the comparison between the Diacap Pro Dialyzer and the predicate device is provided below.
| | Proposed Device<br>B. Braun Avitum AG<br>Diacap Pro Dialyzer | | | Predicate Device<br>B. Braun Avitum AG<br>Diacap HI PS Dialyzers<br>(K071518) | | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------|-------|-------|--------------------------------------------------------------------------------------------|-------|-------|-------|
| Dialyzer model | 13H | 16H | 19H | 12 | 15 | 18 | 20 |
| Indications for use | Designed for single use in acute and<br>chronic hemodialysis | | | Designed for single use in acute and<br>chronic hemodialysis | | | |
| Membrane Type | Asymmetric microporous hollow<br>fiber | | | Asymmetric microporous hollow fiber | | | |
| Chemical<br>composition of<br>membrane | Polysulfone 90-99% by weight,<br>Polyvinylpyrrolidone 1-10% by<br>weight | | | Polysulfone 90-99% by weight,<br>Polyvinylpyrrolidone 1-10% by weight | | | |
| Effective<br>membrane surface<br>area (m2) | 1.3 | 1.6 | 1.9 | 1.2 | 1.5 | 1.8 | 2.0 |
| Number of fibers<br>(mean) | 8800 | 10840 | 12870 | 8180 | 10150 | 12250 | 13310 |
| Mean effective<br>(free) length of<br>fibers (mm) | 235 | | | 235 | | | |
| Fiber inner<br>diameter (nominal)<br>in µm | 200 | | | 200 | | | |
| Wall thickness<br>(nominal) | 37 µm with 2 layers:<br>separation layer: 1 µm thickness<br>support layer: 36 µm thickness | | | 40 µm with 2 layers:<br>separation layer: 1 µm thickness<br>support layer: 39 µm thickness | | | |
| Sterilization | Gamma | | | Gamma | | | |
| Volume, blood<br>compartment (mL) | 82 | 100 | 120 | 68 | 90 | 110 | 121 |
| Outer diameter<br>cylindrical part<br>(mm) | 39.6 | 42.6 | 47.6 | 39.6 | 42.6 | 47.6 | 47.6 |
| Outer diameter<br>(mm) blood cap | 54.0 | 57.4 | 62.4 | 54.0 | 57.4 | 62.4 | 62.4 |
| Length without<br>protection cap<br>(mm) | 294.0 | 294.6 | 294.6 | 293 | 293 | 293 | 293 |
| Connector blood<br>side | Designed According to ISO 8637 | | | Designed According to ISO 8637 | | | |
| Connector<br>dialysate fluid side | Designed According to ISO 8637 | | | Designed According to ISO 8637 | | | |
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The differences between the predicate device and the proposed device include:
- Alternative suppliers for PVP and PSU in addition to a new material supplier for A potting and silicone rubber
- Color change of blood port caps and protective caps A
- > Change in design characteristics of the membrane including new packaging density ( new surface areas), change in the wall thickness and change to the fiber microondulation.
The differences, between proposed device and predicate device, do not raise any new issues of safety and effectiveness
## Performance Testing
The proposed Diacap Pro dialyzers were subjected to functional and performance testing to assess the effects of the modified characteristics and to demonstrate equivalence with the predicate devices.
The following in-vitro testing was performed on the proposed device in accordance with the methods listed in the FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers and in ISO 8637.
- ultrafiltration rate
- pressure drop blood side and dialysate side ●
- clearances of urea, creatinine and vitamin B12 ●
The following comparative testing was performed on the proposed and predicate device:
- . mechanical hemolysis
The following clinical testing was performed on the proposed device in accordance with the methods listed in the FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers:
- in-vivo ultrafiltration coefficient
Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use.
## CONCLUSION:
Results of functional and performance testing conducted on the proposed device demonstrate that the Diacap Pro dialyzers are substantially equivalent to the predicate device.
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