(203 days)
K911315/A
Not Found
No
The summary describes a blood monitor pump for renal replacement therapy and does not mention any AI or ML capabilities.
Yes
The device is intended for continuous renal replacement therapy, which is a treatment for acute renal failure, indicating a direct therapeutic purpose.
No
Explanation: The device is described as a "Blood Monitor Pump" used for "continuous renal replacement therapy" and various "extracorporeal therapies." These functions indicate it is a therapeutic device designed for treatment, not for diagnosing a condition.
No
The device description explicitly states it is a "Blood Monitor Pump," which is a hardware device used for extracorporeal therapies. The summary focuses on the pump's functions and validation, not on software features.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for continuous renal replacement therapy in patients with acute renal failure. This is a therapeutic treatment performed directly on the patient's blood outside the body (extracorporeal therapy).
- Device Description: The device is a "Blood Monitor Pump" used for procedures like Hemofiltration, Hemodiafiltration, and Ultrafiltration. These are all processes that filter or remove substances from the blood.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any diagnostic testing on a specimen. It is a therapeutic device that processes the patient's blood.
Therefore, based on the provided information, the bm11a Blood Monitor Pump is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The bm11a Blood Monitor Pump is designed for continuous renal replacement therapy in patients with acute renal failure, as prescribed by a physician.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI
Device Description
The bm11a Blood Monitor Pump is designed for use in the following extracorporeal therapies: - Continuous Venovenous Hemofiltration (CVVH) - Continuous Venovenous Hemodiafiltration (CVVHD) - Slow Continuous Ultrafiltration (SCUF)
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)
All functions of the bm11a Blood Monitor Pump were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications.
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.
K911315/A
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
970591
:
510(K) SUMMARY
i
------ 9 1997
| 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: | May 20, 1997 |
| Trade name: | bm11a Blood Monitor Pump for Continuous Renal Replacement |
| Common name: | Blood Monitor Pump for Continuous Renal Replacement |
| Classification name: | High Permeability Hemodialysis System per 21 CFR 876.5860 |
| Equivalent predicate: | bm11 Blood Monitor Pump (K911315/A) |
| Device Description: | The bm11a Blood Monitor Pump is designed for use in the following extracorporeal |
| therapies: |
- Continuous Venovenous Hemofiltration (CVVH)
- Continuous Venovenous Hemodiafiltration (CVVHD)
- Slow Continuous Ultrafiltration (SCUF) |
| Intended Use: | The bm11a 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 BM11 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 bm11a Blood Monitor Pump do not raise
any new types of safety and effectiveness issues, when compared to the currently
marketed bm11 Blood Monitor Pump.
The bm11a Blood Monitor Pump 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 bm11a Blood Monitor Pump. |
.
1
510(K) SUMMARY January 31, 1997 bm11a Blood Monitor Pump Page 2 of 2
N/A Clinical data:
All functions of the bm11a Blood Monitor Pump were tested and validated Conclusions drawn according to design specifications. Based on the validation results, all functions from tests: 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:
Aron Masis Perea
5/20/97
Date
Ann Marie Pahlman Manager Regulatory Affairs Renal Division
2
Image /page/2/Picture/17 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 9 1997
Ms. Ann Marie Pahlman Manager Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085-6730
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K970591
bm ! 1a Blood Monitor Pump Dated: May 20, 1997 Received: May 21, 1997 Regulatory class: III 21 CFR §876.5860/Product code: 78 KDI
Dear Ms. Pahlman:
We have reviewed your Section 510(k) 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, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 device on our labeling 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 question 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/cdrh/dsmamain.html".
Sincerely yours,
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
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
bm11a Blood Monitor Pump Device Name: ____________________
Indications for Use: The bm11a Blood Monitor Pump is designed for continuous renal replacement therapy in patients with acute renal failure, as prescribed by a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sathing/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K972059
OR
Prescription Use
(Per 21 CFR 801.109)
រូប
Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)