(484 days)
Not Found
No
The device description focuses on the mechanical and hydraulic functions of a hemodialysis system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device, the DBB-05 Hemodialysis Delivery System, directly treats renal failure by performing hemodialysis, which is a therapeutic intervention.
No
Explanation: The device description clearly states that the DBB-05 Hemodialysis Delivery System is for the "delivery of dialysate and extracorporeal blood circuitry" for hemodialysis treatment. It focuses on processes like heating, deaerating, mixing, and pumping fluids, as well as controlling ultrafiltration and heparinization. These are all therapeutic functions aimed at treating renal failure, not diagnosing a condition.
No
The device description explicitly details hardware components such as a hydraulic unit, extracorporeal blood circuitry, pumps (heparin pump), and a balancing system, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the DBB-05 Hemodialysis Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure." This describes a therapeutic treatment performed on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a system for delivering dialysate and managing extracorporeal blood flow. It describes the process of filtering blood outside the body, which is a treatment, not a diagnostic process.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, etc.) to diagnose a condition or provide information for diagnosis. The device's function is to perform the hemodialysis procedure itself.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The DBB-05 Hemodialysis Delivery System is a therapeutic device used to treat renal failure by filtering the patient's blood.
N/A
Intended Use / Indications for Use
The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI
Device Description
The DBB-05 Hemodialysis Delivery System is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyser through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyser is controlled automatically by adjustment of the Ultra Filtration (UF) amount and UF rate by the dialyser. Heparinization of the external circulating blood is performed with the heparin pump either by continuous or one-shot injection before it is passed on to the dialyser.
The DBB-05 Hemodialysis Delivery System uses both acetate dialysis and bicarbonate dialysis. Using the various functions of the device, the conductivity and UF profile can be programmed. In addition, DBB-05 Hemodialysis Delivery System incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis treatment. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with the necessary protective systems for patient safety and correct operation.
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
adult and pediatric patients
Intended User / Care Setting
hemodialysis performed in hospitals and dialysis clinics by a qualified operator.
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)
Not Found
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.
DBB-05 Hemodialysis Delivery System [K023509]
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
CONFIDENTIAL
510(K) SUMMARY
DBB-05 HEMODIALYSIS DELIVERY SYSTEM
SEP 2 8 2007
510(K) NUMBER: K061519
Submitter's Information A.
| Name: | Nikkiso Co., LTD. |
|---|---|
| Address: | 43-2, Ebisu 3-Chome, Shibuya-ku |
| Tokyo, 150-8677, Japan | |
| Phone: | +81-3-3443-3771 |
| Fax: | +81-3-3473-4963 |
| Contact Person: | Masashi Yoshida, Manager Regulatory Affairs |
| Application Correspondent: | Fumiaki Kanai, PhD., President and CEO
MIC International |
| ---------------------------- | ------------------------------------------------------------- |
|---|
| Date Summary Prepared: | May 22, 2006 |
|---|---|
| ------------------------ | -------------- |
B. Device Information
| Trade/Device Name: | DBB-05 Hemodialysis Delivery System |
|---|---|
| Regulation Number: | 21 CFR §876.5860 |
| Regulation Name: | High permeability hemodialysis system |
| Regulatory Class: | Class II |
| Product Code: | 78 KDI |
| Classification Panel: | Gastroenterology/Urology |
Description of Device
The DBB-05 Hemodialysis Delivery System is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyser through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyser is controlled automatically by adjustment of the Ultra Filtration (UF) amount and UF rate by the dialyser. Heparinization of the external circulating blood is performed with the heparin pump either by continuous or one-shot injection before it is passed on to the dialyser.
PAGE 1 OF 3 ATTACHMENT 7
1
CONFIDENTIAL
510(K) SUMMARY
DBB-05 HEMODIALYSIS DELIVERY SYSTEM
510(K) NUMBER: K061519
Description of Device (continued)
The DBB-05 Hemodialysis Delivery System uses both acetate dialysis and bicarbonate dialysis. Using the various functions of the device, the conductivity and UF profile can be programmed. In addition, DBB-05 Hemodialysis Delivery System incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis treatment. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with the necessary protective systems for patient safety and correct operation.
C. Predicate Device Information
DBB-05 Hemodialysis Delivery System [K023509] (10/30/03)
Indications for Use/Intended Use D.
The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.
E. Substantial Equivalence
1. Is the product a device?
YES -- The DBB-05 Hemodialysis Delivery System is a device.
2. Does the new device have the same intended use?
YES - The intended use for the DBB-05 Hemodialysis Delivery System is equivalent to that for the Nikkiso DBB-05 Hemodialysis Delivery System and is as follows:
Intended Use: DBB-05 Hemodialysis Delivery System
The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.
2
Confidential.
510(K) SUMMARY
DBB-05 HEMODIALYSIS DELIVERY SYSTEM
510(K) NUMBER: K061519
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The DBB-05 Hemodialysis Delivery System is composed of a hydraulic. The technological characteristics of the DB-05 Hemodialysis Delivery System are equivalent to those of the original DB-05 Hemodialysis Delivery System [K023509] and raise no new types of safety or effectiveness questions.
4. Does descriptive or performance information demonstrate equivalence?
YES - Nikkiso Co., LTD. believes that the information provided in this submission clearly describes the DBB-05 Hemodialysis Delivery System and demonstrates that it is substantially equivalent to the original Nikkiso DBB-05 Hemodialysis Delivery System.
F. Safety Summary
Nikkiso CO., LTD. made several modifications to the original DBB-05 Hemodialysis Delivery System cleared under K023509. All design control activities including safety risk analysis and the verification and validation activities conducted as related to the risks proved that the modified DBB-05 Hemodialysis Delivery System is substantially equivalent in intended use, design, principle of operations, materials, specifications, performance, and contains the same fundamental scientific technology as the original DBB-05 Hemodialysis Delivery System.
Page 3 of 3 A TTACHMENT 7
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 stylized eagle-like symbol with three lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
SEP 2 8 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NIKKISO Co., Ltd. c/o Fumiaki Kanai, Ph.D President and CEO MIC International 4-2-1 Yushima, Bunkyou-ku Tokyo 113-0034 JAPAN
Re: K061519
Trade/Device Name: DBB-05 Hemodialysis Delivery System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: August 24, 2007 Received: August 29, 2007
Dear Dr. Kanai:
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/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a bold, stylized font. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. Three stars are printed below the word "Centennial". The logo is surrounded by a circular border with text, but the text is illegible.
4
Page 2 -
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K061519 page 1 of 1
response to fda letter dated june 21, 2006
Confidential
INDICATIONS FOR USE
510(k) Number: K061519
Device Name: DBB-05 Hemodialysis Delivery System
Indications for Use: The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.
Prescription Use ✓
(Part 21 CFR 801 Subpart D)
OR
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON OTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Carolyn Y Newland for N. Brogdon |
|---|---|
| DBB-05 HEMODIALYSIS DELIVERY SYSTEM (K061519) | (Division(Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices |
PAGE 1 OF 1 ATTACHMENT I510(k) Numbe