(9 days)
No
The description focuses on mechanical fluid management, measurement, and disposal, with no mention of AI/ML terms or functions.
No
This device is designed to collect and dispose of fluid waste during surgical procedures, not to treat or cure a disease or condition in a patient.
No
The device description indicates its function is to collect, measure, and dispose of fluid waste, and it performs a self-cleaning cycle. There is no mention of it diagnosing medical conditions.
No
The device description clearly outlines a physical, wall-mounted system with connections to hospital infrastructure (vacuum, drain, electrical power) and includes components like a suction tube, cleaning solution container, and adapter. While it mentions software in the performance studies, the core functionality and description are centered around hardware.
Based on the provided information, the BioDrain STREAMWAY™ Fluid Management System (FMS) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect and dispose of fluid waste from surgical procedures and other medical settings. This is a physical process of waste management, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The description details a system for suctioning, measuring, and disposing of fluids. It doesn't mention any analysis or testing of the fluid itself for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on the collected fluid.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. The BioDrain STREAMWAY™ FMS is a medical device for managing waste fluids, not for performing diagnostic tests.
N/A
Intended Use / 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.
Product codes
JCX
Device Description
The BioDrain STREAMWAY™ FMS system has been designed to safely remove surgical fluid waste during a surgical procedure. The device is wall mounted in the room in which the procedure is being conducted. It is connected to the hospital/clinic vacuum line system, the hospital/clinic drain system, and electrical power. The device removes waste via a disposable suction tube (not provided with system) from the patient and surrounding area, measures the volume of fluid collected, and disposes of the waste into the hospital drainage system. The device has a self cleaning cycle to clean the internal mechanism of the device. The cleaning solution container and the suction tube to the operative field are disposable. The cleaning solution adapter is reusable.
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
Operating Rooms, Intensive Care Units, Pathology Suites, Emergency Rooms, Surgical Centers and Doctors' Offices
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)
Bench testing was performed to support a determination of substantial equivalence and consisted of packaging, electrical safety testing and all testing identified in the FDA's Guidance for Powered Suction Pumps, September 30, 1998 and Premarket Submissions for Software Contained in Medical Devices. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operations. Biocompatibility testing is not applicable since the proposed device has no direct patient contact.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ORwell™ Fluid Collection and Disposal System (K080845), Neptune Waste Management System (K012991)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.
0
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
submitted in accordance with the requirements of 21 C.F.R § 807.92. |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | BioDrain Medical, Inc. |
| Submitter | BioDrain Medical, Inc.
2060 Centre Pointe Boulevard, Suite 7
Mendota Heights, MN 55120
Tel: 651-389-4000
Fax: 651-389-4805 |
| Contact Person | Chad A. Ruwe
EVP Operations |
| Date Prepared | March 14, 2009 |
| Device Trade Name
Device Common Name | BioDrain STREAMWAY™ Fluid Management System (FMS)
Powered Suction Pump |
| Classification Name | Apparatus, Suction, Ward Use, Portable, AC-Powered (21 CFR
878.4780. Product Code JCX |
| Classification Panel | General & Plastic Surgery |
| Predicate Devices | ORwell™ Fluid Collection and Disposal System (K080845); Neptune
Waste Management System (K012991) |
| 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 Description | The BioDrain STREAMWAY™ FMS system has been designed
to safely remove surgical fluid waste during a surgical
procedure. The device is wall mounted in the room in which the
procedure is being conducted. It is connected to the
hospital/clinic vacuum line system, the hospital/clinic drain
system, and electrical power. The device removes waste via a
disposable suction tube (not provided with system) from the
patient and surrounding area, measures the volume of fluid
collected, and disposes of the waste into the hospital drainage
system. The device has a self cleaning cycle to clean the internal
mechanism of the device. The cleaning solution container and
the suction tube to the operative field are disposable. The
cleaning solution adapter is reusable. |
| Performance data | Bench testing was performed to support a determination of substantial
equivalence and consisted of packaging, electrical safety testing and
all testing identified in the FDA's Guidance for Powered Suction
Pumps, September 30, 1998 and Premarket Submissions for Software
Contained in Medical Devices. Results from this testing provide
assurance that the proposed device has been designed and tested to
assure conformance to the requirements for its intended use. A risk
analysis of the system and its software was performed and testing was
conducted to validate the systems overall operations. Biocompatibility
testing is not applicable since the proposed device has no direct patient
contact. |
| Summary of Substantial
Equivalence | The BioDrain STREAMWAY™ Fluid Management System
(FMS) has the following similarities to the predicate devices: |
| | ● Similar fundamental scientific technology (all predicates)
● Similar operating principle (all predicates)
● Fluid collection disposables (all predicates)
● Vacuum ranges
● Suction Mode
● Overflow prevention mechanisms
● Suction inlet port dimensions
● Electrical Compliance Requirements |
| Conclusion | Based on the similar indications for use, technological characteristics
and performance testing, BioDrain Medical, Inc. believes the
BioDrain STREAMWAY™ Fluid Management System (FMS)
is substantially equivalent to the ORwell™ Fluid Collection and
Disposal System (K080845) and the Neptune Waste Management
System (K012991). |
1
K090759 page 2/2
2
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
3
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
4
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