BLOOD MONITOR PUMP

K970591 · Baxter Healthcare Corp · KDI · Sep 9, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970591
• Device Name: BLOOD MONITOR PUMP
• Applicant: Baxter Healthcare Corp
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Sep 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The bm11a Blood Monitor Pump is an extracorporeal device used for continuous renal replacement therapy (CRRT), including CVVH, CVVHD, and SCUF. It functions as a blood pump and monitor for patients with acute renal failure. The device is operated by healthcare professionals in a clinical setting. It monitors extracorporeal circuit parameters and controls fluid movement. The system incorporates software modules designed to distinguish between Master and Controller system errors to ensure operational safety. The device provides clinicians with real-time monitoring and control of the therapy, allowing for precise management of renal replacement, which benefits patients by maintaining fluid and solute balance during acute renal failure.

Clinical Evidence

No clinical data. Bench testing only. All functions were tested and validated against design specifications, including electrical safety (UL2601), EMC testing, and software system integration validation.

Technological Characteristics

Extracorporeal blood pump and monitor. Designed to UL2601 electrical safety standards. Features software-based error handling (Master/Controller distinction).

Indications for Use

Indicated for patients with acute renal failure requiring continuous renal replacement therapy (CVVH, CVVHD, or SCUF). Prescription use only.

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

• bm11 Blood Monitor Pump (K911315/A)

Submission Summary (Full Text)

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K970591
- 9 1997

# 510(K) SUMMARY

Submitter’s name: Ann Marie Pahlman

Address: 1620 Waukegan Rd. MPRA-2E
McGaw Park, IL 60080

Phone: [phone]

Fax: [phone]

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.

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510(K) SUMMARY

January 31, 1997

bm11a Blood Monitor Pump

Page 2 of 2

Clinical data: N/A

Conclusions drawn from tests: 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.

Additional information requested by FDA: none to date

Official Correspondent:

Robert L. Wilkinson
Director, Regulatory Affairs
Renal Division

Prepared by:

Ann Marie Pahlman
Manager Regulatory Affairs
Renal Division

5/20/97

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP - 9 1997

Ms. Ann Marie Pahlman
Manager Regulatory Affairs
Renal Division
Baxter Healthcare Corporation
1620 Waukegan Road
McGaw Park, Illinois 60085-6730

Re: K970591
bm11a 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, 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 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 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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510(k) Number (if known): K970591

Device Name: bm11a Blood Monitor Pump

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.


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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970591

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)