(209 days)
The QFlow™ 500 is intended for extravascular monitoring of microcirculation blood flow in buried tissues. Example of this application included (but are not limited to) 1) the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction, 2) monitoring soft tissue microcirculation following reconstructive surgery, such as oral and facial reconstruction, 3) monitoring cerebral blood flow during and following neurosurgery for head trauma.
The QFlow™ 500 has application where real-time determination of any tissue perfusion is desired, whether it is for measurement or monitoring utilization. The system may be used in the Intensive Care Unit, Operating Room, Radiology Suite or in a standard patient care room. However, the system is not designed for use during patient transport.
The QFlow™ 500 consists of a thermal diffusion probe and a monitor.
The QFlow™ 500 Perfusion System Probe thermally interacts with tissue. It contains two thermistors embedded at the distal tip of the probe. It is available in a range of lengths from 60 cm to 120 cm and less than 1 mm in diameter. The probe contains an EEPROM for the storage of probespecific calibration data, data on the cumulative time the probe has been in use, and a verification key to insure the origin of the probe. The probe connector physically connects the probe to the umbilical cord which connects to the monitor.
The QFlow™ 500 Monitor controls the thermistors in the Probe.
Perfusion data are displayed on the monitor. The current perfusion value, temperature and thermal conductivity are be displayed in numeric form. The data are also displayed in the form of a graph as a function of time.
The monitor is capable of storing data for up to 10 days. All of this stored data may be reviewed by the user at any time during this period. Printing of data is also an option from the monitor. There is also the capability of uploading data from the monitor to an external computer for further analysis.
The provided text describes a 510(k) summary for the Hemedex, Inc. QFlow$^{\text{TM}}$ 500 Perfusion Monitoring System. It outlines the device, its intended use, comparison to predicate devices, and the performance testing performed to demonstrate substantial equivalence.
However, the document focuses on compliance with electrical safety, thermal safety, electromagnetic compatibility, electromagnetic emissions, and probe integrity standards. It does not present acceptance criteria or reported device performance in terms of microcirculation blood flow measurement accuracy or clinical efficacy. The "Performance Testing" section lists various standards the device was tested for compliance with, but it does not detail the specific performance metrics or acceptance thresholds related to its core function of monitoring microcirculation blood flow.
Therefore, many of the requested items cannot be extracted from the provided text.
Here is an attempt to address the request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria and reported device performance are related to compliance with general safety and electrical standards, not the direct performance of blood flow monitoring.
| Acceptance Criterion (Type) | Reported Device Performance (Reference) |
|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (1988) 2nd Edition, + A1: 1991 + A2: 1995. UL2601, UL standard for Safety, Medical Electrical Equipment, Part 1: General Requirements for Safety, First Edition. |
| Thermal Safety | Compliance with IEC 60601-1 (1988) 2nd Edition, + A1: 1991 + A2: 1995. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC60601-1-2: 1993. |
| Electromagnetic Emissions | Compliance with EN 55011. |
| Probe Integrity | Compliance with ISO 10555 Sterile, single-use intravascular catheters Part 1: General Requirements. |
| Biocompatibility | Compliance with ISO 10993: 1997 Part 1: Guidance on selection of tests. |
Regarding the study that proves the device meets the acceptance criteria, the document states:
"Bench testing, animal studies and biocompatibility testing was performed on the QFlow 500."
"The QFlow™ 500 is tested for compliance with the following standards for electrical safety, thermal safety, electromagnetic compatibility, electromaqnetic emissions and probe integrity."
This indicates that these tests were conducted, and the device was found to comply with the listed standards. No further details about the specific studies, their methodology, or results are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the text. The document mentions "bench testing," "animal studies," and "biocompatibility testing" but does not detail the sample sizes, study design (retrospective/prospective), or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the text. The testing mentioned (compliance with standards) does not typically involve expert review for ground truth in the same way clinical diagnostic studies do.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the text. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which are not detailed here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not mentioned in the text. The device is a monitoring system, not an AI-assisted diagnostic tool that requires human reader improvement evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The QFlow™ 500 is a monitoring system that directly measures and displays perfusion data. Its "standalone" performance would refer to its accuracy and reliability in measuring the intended physiological parameter. While "bench testing" and "animal studies" were performed, the text does not explicitly describe a standalone performance study with specific metrics for blood flow measurement accuracy (e.g., compared to a gold standard measurement technique). It only states compliance with safety and integrity standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the compliance tests mentioned (electrical safety, thermal safety, etc.), the "ground truth" would be the specifications and requirements defined by the international and national standards themselves. For the stated purpose of "extravascular monitoring of microcirculation blood flow," the document does not specify the ground truth used to validate the device's accuracy in measuring blood flow.
8. The sample size for the training set
This information is not applicable/not provided. The QFlow™ 500 is a physical measurement device based on thermal diffusion principles, not a machine learning model that requires a "training set" in the context of AI.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the reasons stated in point 8.
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C013376
MAY 0 8 2002
510K Summary of Safety and Effectiveness
-
Sponsor Name 1.
Hemedex, Inc. 222 Third Street, Suite T123 Cambridge, MA 02142 USA -
- Device Name QFlow™ 500 Perfusion Monitoring System
-
- Identification of Predicate or Legally Marketed Device QFlow™ 500 is substantially equivalent to the following predicate devices:
-
Device Description 4.
The QFlow™ 500 has application where real-time determination of any tissue perfusion is desired, whether it is for measurement or monitoring utilization. The system may be used in the Intensive Care Unit, Operating Room, Radiology Suite or in a standard patient care room. However, the system is not designed for use during patient transport.
The QFlow™ 500 consists of a thermal diffusion probe and a monitor.
The QFlow™ 500 Perfusion System Probe thermally interacts with tissue. It contains two thermistors embedded at the distal tip of the probe. It is available in a range of lengths from 60 cm to 120 cm and less than 1 mm in diameter. The probe contains an EEPROM for the storage of probespecific calibration data, data on the cumulative time the probe has been in use, and a verification key to insure the origin of the probe. The probe connector physically connects the probe to the umbilical cord which connects to the monitor.
{1}------------------------------------------------
The QFlow™ 500 Monitor controls the thermistors in the Probe.
Perfusion data are displayed on the monitor. The current perfusion value, temperature and thermal conductivity are be displayed in numeric form. The data are also displayed in the form of a graph as a function of time.
The monitor is capable of storing data for up to 10 days. All of this stored data may be reviewed by the user at any time during this period. Printing of data is also an option from the monitor. There is also the capability of uploading data from the monitor to an external computer for further analysis.
5. Intended Use
The QFlow™ 500 is intended for extravascular monitoring of microcirculation blood flow in buried tissues. Examples of this application included (but are not limited to) 1) the monitoring of buried muscle or esophaqus following free muscle transfer or esophageal reconstruction, 2) monitoring soft tissue microcirculation following reconstructive surgery, such as oral and facial reconstruction, 3) monitoring cerebral blood flow during and following neurosurgery for head trauma.
6. Comparison of Technological Characteristics
All of the devices are indicated to provide blood perfusion measurements in any perfused tissue where blood flow information is desired. However, the manner in which the measurements are made is different.
The QFlow™ 500 uses thermal energy dissipated in a thermistor to measure the thermal conductivity of the tissue and a real-time measurement of tissue perfusion. The predicate devices use laser light energy which is scattered by reflective components within the tissue and is reflected back via a receiving fiber optic probe. This provides a measurement of blood flow within the tissue.
The QFlow 500 is substantially equivalent to the predicate devices listed, which provide the same or similar functions, as well as design and technological characteristics. The intended use, statement of indications, and technological characteristics for the QFlow 500 support the concept of substantial equivalence.
7 Performance Testing
Bench testing, animal studies and biocompatibility testing was performed on the QFlow 500.
The QFlow™ 500 is tested for compliance with the following standards for electrical safety, thermal safety, electromagnetic compatibility, electromaqnetic emissions and probe integrity:
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IEC 60601-1 (1988) 2nd Edition, + A1: 1991 + A2: 1995 Medical Electrical Equipment – General Requirements for Safety
IEC60601-1-2: 1993 Medical Electrical Equipment – Collateral Standard Electromagnetic Compatibility
EN 55011 Limits and Methods of Measurement of Radio Disturbance characteristics of Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment.
UL2601, UL standard for Safety, Medical Electrical Equipment, Part 1: General Requirements for Safety, First Edition
ISO 10555 Sterile, single-use intravascular catheters Part 1: General Requirements
Biological evaluation of medical devices ISO 10993: 1997 Part 1: Guidance on selection of tests.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 8 2002
Hemedex, Inc. c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, MA 01748
Re: K013376
Trade Name: QFlow 500 Perfusion Monitoring System Regulation Number: 21 CFR 870.2100 Regulation Name: Blood Flow Monitor Regulatory Class: Class II (two) Product Code: DPW Dated: February 11, 2002 Received: February 12, 2002
Dear Ms. Iampietro:
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.
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Page 2 - Ms. Debbie Iampietro
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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dough Teth
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Hemedex. Inc QFlow™ 500 Perfusion Monitoring System Premarket Notification
510(k) Number (if known): KO13376
Device Name: QFlow 500 Perfusion Monitoring System
Indications For Use:
The QFlow™ 500 is intended for extravascular monitoring of microcirculation blood flow in buried tissues. Example of this application included (but are not limited to) 1) the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction, 2) monitoring soft tissue microcirculation following reconstructive surgery, such as oral and facial reconstruction, 3) monitoring cerebral blood flow during and following neurosurgery for head trauma.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K03376
000 . 0
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).