(210 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on standard medical device functionality for continuous renal replacement therapy.
Yes
The device is indicated for "continuous solute and/or fluid removal in patients with acute renal failure, or fluid overload," which are therapeutic interventions aimed at treating a medical condition.
No
The device is used for continuous solute and/or fluid removal (therapy) in patients with acute renal failure or fluid overload, not for diagnosing conditions.
No
The device description explicitly mentions a "Blood Monitor Pump" and "Ultrafiltration Controller," which are hardware components. The summary of performance studies also refers to testing and validating "functions of the bm25 Blood Monitor Pump with Ultrafiltration Controller," further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "continuous solute and/or fluid removal in patients with acute renal failure, or fluid overload." This describes a therapeutic intervention performed directly on the patient, not a test performed on a sample taken from the patient to diagnose or monitor a condition.
- Device Description: The device is described as a "Blood Monitor Pump" designed for "Continuous Renal Replacement Therapy." This further reinforces its role in treating the patient directly.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to perform a therapeutic procedure on the patient's blood.
N/A
Intended Use / Indications for Use
The bm25 Blood Monitor Pump is designed for continuous renal replacement therapy in patients with acute renal failure, as prescribed by a physician.
The bm 25 Blood Monitor Pump with Ultrafiltration Controller is indicated for continuous solute and/or fluid removal in patients with acute renal failure, or fluid overload as prescribed by a physician.
Product codes
78 KDI
Device Description
The bm25 Blood Monitor Pump is designed for use in Continuous Renal Replacement Therapy
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
All functions of the bm25 Blood Monitor Pump with Ultrafiltration Controller were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications.
Key Metrics
Not Found
Predicate Device(s)
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
JUL 1 0 1998
K974652
P1092
510(K) SUMMARY
| Submitter's name: | Ann Marie Pahlman |
|---|---|
| Address: | 1620 Waukegan Rd. MPRA-2E |
| McGaw Park, IL 60080 | |
| Phone: | 847 473 6078 |
| Fax: | 847 473 6952 |
| Contact: | Robert Wilkinson or Ann Marie Pahlman |
| Date Prepared: | July 9, 1998 |
| Trade name: | bm25 Blood Monitor Pump with Ultrafiltration Controller for Continuous Renal |
| Replacemnt Therapy | |
| Common name: | Blood Monitor Pump with Ultrafiltration Controlelr for Continuous Renal |
| Replacement | |
| Classification name: | High Permeability Hemodialysis System per 21 CFR 876.5860 |
| Equivalent predicates: bm11a Blood Monitor Pump (K970591), PRISMA™ System (K946279) | |
| Device Description: | The bm25 Blood Monitor Pump is designed for use in Continuous Renal |
| Replacement Therapy | |
| Intended Use: | The bm25 Blood Monitor Pump is designed for continuous renal replacement |
| therapy in patients with acute renal failure, as prescribed by a physician. | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to the | |
| predicate device | The general design and materials of the subject Blood Monitor Pump is the same |
| as the currently marketed bm1l a Blood Monitor Pump. The structure of the | |
| software modules was set up to distinguish between Master and Controller system | |
| errors. | |
| The characteristics displayed by the subject bm25 Blood Monitor Pump with | |
| Ultrafiltration Controller do not raise any new types of safety and effectiveness issues, | |
| when compared to the currently marketed bm11a Blood Monitor Pump and | |
| PRISMA™ System. | |
| The bm25 Blood Monitor Pump with Ultrafiltration Controller was designed to | |
| UL2601 - General electrical safety of medical equipment. A fault tree, hazard | |
| analysis, EMC testing, and software System integration validation were conducted on | |
| the bm25 Blood Monitor Pump with Ultrafiltration Controller |
1
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510(K) SUMMARY July 9, 1998 bm25 Blood Monitor Pump with Ultrafiltration Controller Page 2 of 2
N/A Clinical data:
All functions of the bm25 Blood Monitor Pump with Ultrafiltration Controller were Conclusions drawn tested and validated according to design specifications. Based on the validation from tests: results, all functions meet their respective required specifications.
Additional information requested by FDA: none to date
Official Correspondent:
Robert L. Wilkinson Director, Regulatory Affairs Renal Division
Prepared by:
Am Maria Rosa
Ann Marie Pahlman Manager Regulatory Affairs Renal Division
7/9/98
Date
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
JUL 10 1998
Mr. David E. Curtin, RAC Manager, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, IL 60085-6730 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K974652 bm25 Blood Monitor Pump with Ultrafiltration Controller Dated: April 9, 1998 Received: April 13, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI
Dear Mr. Curtin:
We have reviewed your Section 510%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 deving regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely vou
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K974652 510(K) Number (if known):
Device Name: bm 25 Blood Monitor Pump with Ultrafiltration Controller
Indications for Use: The bm 25 Blood Monitor Pump with Ultrafiltration Controller is indicated for continuous solute and/or fluid removal in patients with acute renal failure, or fluid overload as prescribed by a physician.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office Device Evaluation (ODE)
Robert R. Sathing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974652
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1/2/96