(203 days)
The bm11a Blood Monitor Pump is designed for continuous renal replacement therapy in patients with acute renal failure, as prescribed by a physician.
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)
The provided text describes a 510(k) summary for the bm11a Blood Monitor Pump, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness, rather than reporting on a study with acceptance criteria and device performance in the way a clinical trial might for a diagnostic AI device.
Therefore, the requested information cannot be fully extracted in the format requested as the submission pertains to a different type of device (a pump) and evaluation process. However, based on the available information, here's what can be gathered, addressing the relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission mentions "design specifications" and "required specifications" but does not explicitly list them or their corresponding performance metrics in a table. The summary states: "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."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The testing described is functional validation of a pump, not a diagnostic device using a "test set" of patient data. The validation was conducted on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of device performance for this pump, refers to engineering and functional specifications, not a medical "ground truth" established by experts.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as would be used for expert review of images or data in a diagnostic study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a blood monitor pump, not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical pump. The "standalone" performance would be its functional operation in a clinical setting, which is implicitly covered by the "all functions...meet their respective required specifications."
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be its design specifications and engineering requirements for flow rates, safety mechanisms, electrical performance, etc. The document mentions "UL2601 - General electrical safety of medical equipment," "fault tree, hazard analysis, EMC testing, and software System integration validation" as methods used to assess compliance with these requirements.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned or relevant for this device.
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970591
:
510(K) SUMMARY
i
------ 9 1997
| Submitter's name: | Ann Marie Pahlman |
|---|---|
| Address: | 1620 Waukegan Rd. MPRA-2EMcGaw 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 extracorporealtherapies:- Continuous Venovenous Hemofiltration (CVVH)- Continuous Venovenous Hemodiafiltration (CVVHD)- Slow Continuous Ultrafiltration (SCUF) |
| Intended Use: | The bm11a Blood Monitor Pump is designed for continuous renal replacementtherapy in patients with acute renal failure, as prescribed by a physician. |
| Summary of thetechnologicalcharacteristicscompared to thepredicate device | The general design and materials of the subject Blood Monitor Pump is the sameas the currently marketed BM11 Blood Monitor Pump. The structure of thesoftware modules was set up to distinguish between Master and Controller systemerrors.The characteristics displayed by the subject bm11a Blood Monitor Pump do not raiseany new types of safety and effectiveness issues, when compared to the currentlymarketed bm11 Blood Monitor Pump.The bm11a Blood Monitor Pump was designed to UL2601 - General electrical safetyof medical equipment. A fault tree, hazard analysis, EMC testing, and softwareSystem integration validation were conducted on the bm11a Blood Monitor Pump. |
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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
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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
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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)
§ 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.”