← Product Code [DPT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPT) · K963703 # ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (K963703) _International Biophysics Corp. · DPT · Apr 8, 1998 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPT/K963703 ## Device Facts - **Applicant:** International Biophysics Corp. - **Product Code:** [DPT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPT.md) - **Decision Date:** Apr 8, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2120 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps. ## Device Story Accuflo™ Electromagnetic Flow Monitoring System monitors blood flow rates in extracorporeal cardiopulmonary bypass circuits. System components include a monitor display unit, a transducer, and a sterile flow-through probe. Principle of operation utilizes electromagnetic induction; two electromagnets create a uniform field within the flow-through cell, allowing a single electrode pair to detect signals. Output is a digital display of flow rate. Used in clinical settings during open heart surgery; operated by perfusionists or surgical staff. Unlike predicate systems integrated into specific pump consoles, Accuflo™ is a standalone system compatible with both centrifugal and roller pump circuits. Improved field uniformity enables higher accuracy (within 50 ml) compared to predicate systems. ## Clinical Evidence Bench testing only. Comparison of accuracy metrics provided: Accuflo™ reported accuracy within 50 ml compared to 300 ml for the predicate device. ## Technological Characteristics Components: monitor display, transducer, sterile flow-through probe. Materials: Polycarbonate. Construction: Insert injection molded. Sensing: Electromagnetic induction (2 electromagnets, 1 electrode pair). Connectivity: Standalone system. Sterilization: Ethylene Oxide. ## Regulatory Identification An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel. ## Predicate Devices - Biomedicus Bioprobe Electromagnetic Flow System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} R963703 T # 510(k) SUMMARY ## Accuflo™ Electromagnetic Flow Monitoring System The Accuflo™ Electromagnetic Flow Monitoring System is composed of three (3) components, a monitor display unit, a transducer and a sterile flow-through probe. The system is substantially equivalent to the Biomedicus Bioprobe Electromagnetic Flow System which is marketed by Medtronic, Inc. **TABLE OF COMPARISON:** APR - 8 1998 | CHARACTERISTIC | ACCUFLO™ SYSTEM | BIOPROBE SYSTEM | | --- | --- | --- | | Components | 3 | 3 | | Separate Monitor | Yes | Yes | | Digital Display | Yes | Yes | | Zero Offset Control | Yes | Yes | | Electromagnetic Transducer | Yes | Yes | | Electromagnets | 2 | 1 | | Disposable Flow Probe | Yes | Yes | | Construction | Insert Injection Molded | Insert Injection Molded | | Electrodes | 3 in a row | 3 pairs in a row | | Inside Diameter | 3/8" | 3/8" | | Material | Polycarbonate | Polycarbonate | | Sterilization | Ethylene Oxide | Ethylene Oxide | | Accuracy | Accurate within 50 ml | Accurate within 300 ml | ## DISCUSSION OF SIMILARITIES AND DIFFERENCES: The use of a single electromagnet in the Bioprobe System compromises the uniformity of field within the flow-through cell. To compensate for this, two pair of electrodes are used to pick up the signal on opposite sides of the probe wall. The use of two electromagnets in the Accuflo™ System enhances the uniformity of the field within the probe so that a single electrode pair can be used to pick up the signal with improved accuracy. The Biomedicus Bioprobe System is sold as an integral part of the Biomedicus Pump Console. The Accuflo™ System is a free standing system permitting expanded utilization of this more accurate flow measurement in non centrifugal, i.e., Roller Pump, pump systems. All remaining differences are cosmetic only. INTERNATIONAL BIOPHYSICS CORPORATION • 4020 S. INDUSTRIAL DRIVE SUITE 160 • AUSTIN, TEXAS 78744 • 512 326-3244 • FAX 512 326-3299 {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 H. David Shockley, Jr. President Official Correspondent International Biophysics Corporation 4020 S. Industrial Drive, Suite 160 Austin, TX 78744 APR - 8 1998 Re: K963703 Accuflo™ Electromagnetic Flow Monitoring System Regulatory Class: II (Two) Product Code: DPT Dated: January 8, 1998 Received: January 12, 1998 Dear Mr. Shockley: 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 requirements, 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. {2} Page 2 - Mr. H. David Shockley, Jr. 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) 594-4648. 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/cdrh/dsmamain.html." Sincerely yours, ![img-0.jpeg](img-0.jpeg) Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3} Page 1 of 1 510(k) Number (if known): K963703 Device Name: Accuflo Monitoring System Indications For Use: ## INTENDED USE The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![img-1.jpeg](img-1.jpeg) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K963703 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPT/K963703](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPT/K963703) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com