BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM

K090759 · Biodrain Medical, Inc. · JCX · Apr 1, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090759
• Device Name: BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
• Applicant: Biodrain Medical, Inc.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Apr 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The BioDrain STREAMWAY™ Fluid Management System (FMS) is intended to be used in areas such as Operating Rooms, Intensive Care Units, Pathology Suites, Emergency Rooms, Surgical Centers and Doctors' Offices to collect and dispose of fluid waste.

Device Story

Wall-mounted powered suction pump system; collects surgical fluid waste via disposable suction tube; measures collected fluid volume; disposes waste into hospital drainage system. Features self-cleaning cycle for internal mechanism. Used in ORs, ICUs, ERs, and surgical centers; operated by clinical staff. Benefits include safe removal and automated disposal of surgical waste, reducing manual handling.

Clinical Evidence

Bench testing only. Testing included packaging, electrical safety, and adherence to FDA's Guidance for Powered Suction Pumps and Premarket Submissions for Software Contained in Medical Devices. Risk analysis and system validation performed. No clinical data required as device has no direct patient contact.

Technological Characteristics

Wall-mounted powered suction pump; connects to hospital vacuum and drainage lines. Includes disposable suction tubes and cleaning solution containers; reusable cleaning solution adapter. Software-controlled operation. Electrical safety compliance. No direct patient contact.

Indications for Use

Indicated for collection and disposal of fluid waste in clinical settings including operating rooms, ICUs, pathology suites, emergency rooms, surgical centers, and doctors' offices.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• ORwell™ Fluid Collection and Disposal System (K080845)
• Neptune Waste Management System (K012991)

Submission Summary (Full Text)

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K090759

Page 1/2

## APR - 1 2009

## 510(k) Summary

## BioDrain STREAMWAY™ Fluid Management System (FMS)

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R § 807.92. |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | BioDrain Medical, Inc. |
| Submitter | BioDrain Medical, Inc.<br>2060 Centre Pointe Boulevard, Suite 7<br>Mendota Heights, MN 55120<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | Chad A. Ruwe<br>EVP Operations |
| Date Prepared | March 14, 2009 |
| Device Trade Name<br>Device Common Name | BioDrain STREAMWAY™ Fluid Management System (FMS)<br>Powered Suction Pump |
| Classification Name | Apparatus, Suction, Ward Use, Portable, AC-Powered (21 CFR<br>878.4780. Product Code JCX |
| Classification Panel | General & Plastic Surgery |
| Predicate Devices | ORwell™ Fluid Collection and Disposal System (K080845); Neptune<br>Waste Management System (K012991) |
| Intended use | The BioDrain STREAMWAY™ Fluid Management System<br>(FMS) is intended to be used in areas such as Operating Rooms,<br>Intensive Care Units, Pathology Suites, Emergency Rooms,<br>Surgical Centers and Doctors' Offices to collect and dispose of<br>fluid waste. |
| Device Description | The BioDrain STREAMWAY™ FMS system has been designed<br>to safely remove surgical fluid waste during a surgical<br>procedure. The device is wall mounted in the room in which the<br>procedure is being conducted. It is connected to the<br>hospital/clinic vacuum line system, the hospital/clinic drain<br>system, and electrical power. The device removes waste via a<br>disposable suction tube (not provided with system) from the<br>patient and surrounding area, measures the volume of fluid<br>collected, and disposes of the waste into the hospital drainage<br>system. The device has a self cleaning cycle to clean the internal<br>mechanism of the device. The cleaning solution container and<br>the suction tube to the operative field are disposable. The<br>cleaning solution adapter is reusable. |
| Performance data | Bench testing was performed to support a determination of substantial<br>equivalence and consisted of packaging, electrical safety testing and<br>all testing identified in the FDA's Guidance for Powered Suction<br>Pumps, September 30, 1998 and Premarket Submissions for Software<br>Contained in Medical Devices. Results from this testing provide<br>assurance that the proposed device has been designed and tested to<br>assure conformance to the requirements for its intended use. A risk<br>analysis of the system and its software was performed and testing was<br>conducted to validate the systems overall operations. Biocompatibility<br>testing is not applicable since the proposed device has no direct patient<br>contact. |
| Summary of Substantial<br>Equivalence | The BioDrain STREAMWAY™ Fluid Management System<br>(FMS) has the following similarities to the predicate devices: |
| | ● Similar fundamental scientific technology (all predicates)<br>● Similar operating principle (all predicates)<br>● Fluid collection disposables (all predicates)<br>● Vacuum ranges<br>● Suction Mode<br>● Overflow prevention mechanisms<br>● Suction inlet port dimensions<br>● Electrical Compliance Requirements |
| Conclusion | Based on the similar indications for use, technological characteristics<br>and performance testing, BioDrain Medical, Inc. believes the<br>BioDrain STREAMWAY™ Fluid Management System (FMS)<br>is substantially equivalent to the ORwell™ Fluid Collection and<br>Disposal System (K080845) and the Neptune Waste Management<br>System (K012991). |

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features 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 seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PR - 1 2009

BioDrain Medical, Inc. % Regulatory Technology Services LLC Mr. Mark Job 1394 25th Street Northwest Buffalo, Minnesota 55313

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K090759

Trade/Device Name: BioDrain STREAMWAY™ Fluid Management System (FMS) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: March 20, 2009 Received: March 23, 2009

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Mark Job

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

> Sincerely yours, Mark N. Me

Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K090759

Device Name: BioDrain STREAMWAY™ Fluid Management System (FMS)

Indications for Use:

The BioDrain STREAMWAY™ Fluid Management System (FMS) is intended to be used in areas such as Operating Rooms, Intensive Care Units, Pathology Suites, Emergency Rooms, Surgical Centers and Doctors' Offices to collect and dispose of fluid waste.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krone for MXM 3/31/09
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K090259