(9 days)
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.
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.
The provided text describes the BioDrain STREAMWAY™ Fluid Management System (FMS) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary for a medical device (a fluid management system, essentially a powered suction pump). The FDA's 510(k) pathway is for devices that are "substantially equivalent" to already legally marketed devices (predicates), meaning they have the same intended use and technological characteristics as the predicate, or have different technological characteristics but do not raise new questions of safety and effectiveness.
Here's what can be inferred from the document based on the request:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device. The "acceptance criteria" in a 510(k) context generally revolve around demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: The document states "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."
- Specific performance results (e.g., flow rate, vacuum strength, volume measurement accuracy) are NOT provided in this summary. It only states that testing was performed and results provide assurance of conformance.
| Acceptance Criteria (Implied from 510(k) process) | Reported Device Performance (Summary) |
|---|---|
| Conformance to FDA Guidance for Powered Suction Pumps (Sept 30, 1998) | Bench testing performed, results provide assurance of conformance to requirements for intended use. |
| Conformance to Premarket Submissions for Software Contained in Medical Devices | Risk analysis of the system and its software performed, testing conducted to validate overall operations. |
| Electrical Safety | Bench testing performed. |
| Packaging Integrity | Bench testing performed. |
| Biocompatibility (if applicable) | Declared "not applicable" as the device has no direct patient contact. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "bench testing."
- Data Provenance: Not specified. Bench testing typically occurs in a lab setting rather than using patient data from a specific country or being retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information is typically relevant for studies involving human interpretation (e.g., imaging studies, AI diagnostics). The study described here is bench testing of a physical device.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are relevant for studies where human expert consensus is needed to establish ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study (MRMC) is for assessing the impact of a device (often AI) on human reader performance, typically in diagnostic imaging. The BioDrain STREAMWAY™ FMS is a fluid management system, and no such study is mentioned or relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the typical sense of AI algorithms. While the device itself operates "standalone" in its function, "standalone performance" usually refers to the performance of an AI algorithm independent of human intervention in a diagnostic context. The FMS is a physical piece of medical equipment. The "software" mentioned in the testing implies some control logic, but no "algorithm-only" performance metrics are provided.
7. The type of ground truth used:
- For physical performance aspects (e.g., vacuum, flow, electrical safety), the "ground truth" would be established by engineering specifications, industry standards, and regulatory guidance documents. The device's performance is measured against these established parameters.
- The document implies that testing was done to assure conformance to the requirements of its intended use, based on FDA guidance and internal design specifications.
8. The sample size for the training set:
- Not applicable. This device is hardware with some embedded software, not a machine learning model that requires a "training set" of data in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
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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 beingsubmitted 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 7Mendota Heights, MN 55120Tel: 651-389-4000Fax: 651-389-4805 |
| Contact Person | Chad A. RuweEVP Operations |
| Date Prepared | March 14, 2009 |
| Device Trade NameDevice Common Name | BioDrain STREAMWAY™ Fluid Management System (FMS)Powered Suction Pump |
| Classification Name | Apparatus, Suction, Ward Use, Portable, AC-Powered (21 CFR878.4780. Product Code JCX |
| Classification Panel | General & Plastic Surgery |
| Predicate Devices | ORwell™ Fluid Collection and Disposal System (K080845); NeptuneWaste 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 offluid waste. |
| Device Description | The BioDrain STREAMWAY™ FMS system has been designedto safely remove surgical fluid waste during a surgicalprocedure. The device is wall mounted in the room in which theprocedure is being conducted. It is connected to thehospital/clinic vacuum line system, the hospital/clinic drainsystem, and electrical power. The device removes waste via adisposable suction tube (not provided with system) from thepatient and surrounding area, measures the volume of fluidcollected, and disposes of the waste into the hospital drainagesystem. The device has a self cleaning cycle to clean the internalmechanism of the device. The cleaning solution container andthe suction tube to the operative field are disposable. Thecleaning solution adapter is reusable. |
| Performance data | Bench testing was performed to support a determination of substantialequivalence and consisted of packaging, electrical safety testing andall testing identified in the FDA's Guidance for Powered SuctionPumps, September 30, 1998 and Premarket Submissions for SoftwareContained in Medical Devices. Results from this testing provideassurance that the proposed device has been designed and tested toassure conformance to the requirements for its intended use. A riskanalysis of the system and its software was performed and testing wasconducted to validate the systems overall operations. Biocompatibilitytesting is not applicable since the proposed device has no direct patientcontact. |
| Summary of SubstantialEquivalence | 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 characteristicsand performance testing, BioDrain Medical, Inc. believes theBioDrain STREAMWAY™ Fluid Management System (FMS)is substantially equivalent to the ORwell™ Fluid Collection andDisposal System (K080845) and the Neptune Waste ManagementSystem (K012991). |
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K090759 page 2/2
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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 (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
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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
§ 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.