(126 days)
K9882707, K944495
Not Found
No
The summary describes a photoplethysmography device that visualizes blood flow waveforms and compares it to predicate devices without mentioning any AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a monitor to visualize blood flow waveforms, and its intended use is to detect changes in blood flow, not to treat a condition.
Yes
The device monitors relative blood flow changes and visualizes blood flow waveforms to assist a medical practitioner in assessing changes in an extremity, which are diagnostic activities.
No
The device description explicitly mentions a "FloChec Plethysmograph Device (PPG)" and a "FloChec Sensor," indicating the presence of hardware components for data acquisition (photoplethysmography).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The FloChec Plethysmograph Device works by using photoplethysmography (PPG) to monitor relative blood flow changes in the extremity. It does this by placing a sensor on the skin to measure changes in light absorption due to blood flow.
- No Sample Analysis: The device does not analyze any samples taken from the body. It directly measures a physiological parameter (blood flow) on the body.
Therefore, the FloChec Plethysmograph Device falls under the category of a medical device that is used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FloCher Photoplethysmography is intended for use to provide visualization and evaluation of the blood flow wave form in an extremity. Testing was conducted to determine if the FloChec Photoplethysmography Device orovides a visual representation of the PPG wave form in the extremities. It was concluded that the FloChec is equivalent to the predicate device.
To monitor relative blood flow changes distal to the occlusion of a brachial, ulnar, or femoral artery.
From the physician history and clinical findings, the person has pain, claudication, or changes in blood flow to the extremity.
Product codes (comma separated list FDA assigned to the subject device)
JOM
Device Description
The FloChec Plethysmograph Device (PPG) is similar to the PPG portion of the Hokanson EC-6 but does not include a strain gauge PPG function that is included in the EC-6. The FloChec Sensor is similar to that of the Parks' Mini-Lab which used a single wave length IR emitter in the sensor. The device is not sterile. Use of the FloChec device by a medical practitioner allows visualizing of the blood flow wave forms in the extremities. In viewing the effects on the wave forms as a result of events such as direct external pressure being applied proximal to the sensor.
Refer to section 2.1 of this 510K for the description of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoplethysmography
Anatomical Site
extremity
Indicated Patient Age Range
adult use and not for pediatric or fetal use.
Intended User / Care Setting
medical practitioner, licensed physician, licensed healthcare practioner
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)
Testing was conducted to determine if the FloChec Photoplethysmography Device orovides a visual representation of the PPG wave form in the extremities. It was concluded that the FloChec is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hokanson EC-6 (K9882707), Parks Medical Mini-Lab (K944495)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo. The logo features a stylized silhouette of a person in motion, possibly dancing or performing some kind of athletic activity. The figure is set against a dark, abstract background that resembles a square or rectangle. The word "AVDITA" is written in small letters at the bottom right corner of the logo.
FEB 1 2 2010
ADVANCED VASCULAR DYNAMICS
A Semler Technologies Company
510(k) Summary
Herbert J. Semler 21 December 2009
Company: Advanced Vascular Dynamics Address: 1910 NW 23d Place
Portland, Oregon 97210 USA
Employer identification number is PIN - 9440 Contact Person: Herbert J. Semler, M.D.
Submitted device is FloChec Photoplethysmography Device.
Preparation Date: December 21, 2009.
Advanced Vascular Dynamics is a registered medical device manufacturer establishment, registration number 3035234. Small business number is SBD 107113.
Trade name is FloChec TM Photoplethysmographic Device.
Revised 510K Summary Herbert J. Semler December 21, 2009
Predicate Devices -- Hokanson EC-6 (K9882707), Parks Medical Mini-Lab (K944495)
The FloChec Plethysmograph Device (PPG) is similar to the PPG portion of the Hokanson EC-6 but does not include a strain gauge PPG function that is included in the EC-6. The FloChec Sensor is similar to that of the Parks' Mini-Lab which used a single wave length IR emitter in the sensor. The device is not sterile. Use of the FloChec device by a medical practitioner allows visualizing of the blood flow wave forms in the extremities. In viewing the effects on the wave forms as a result of events such as direct external pressure being applied proximal to the sensor.
FloCher Photoplethysmography is intended for use to provide visualization and evaluation of the blood flow wave form in an extremity. Testing was conducted to determine if the FloChec Photoplethysmography Device orovides a visual representation of the PPG wave form in the extremities. It was concluded that the FloChec is equivalent to the predicate device.
Caution: Federal Law restricts this device to sale by or on the order of a licensed healthcare practioner.
The submitted device is expected to retain the same classification as the predicate device, Hokanson Device, model EC-6 Plethysmograph, 510/k) number K982707. This device carries the classification of Class 2, Product code JOM.
Refer to section 2.1 of this 510K for the description of the device.
Advanced Vascular Dynamics
1
Indications for use would be unexplained pain or claudication discomfort in an extremity, based on the history and physical findings performed by a licensed physician. The device may be used to detect relative blood flow changes before, during and after applied pressure to the brachial, femoral, radial and ulnar arteries. The FloChec Device is not for diagnosis nor is it indicated for the treatment, prevention, cure or mitigation of a disease. The indications for the device are not different from those of the legally marketed device identified in the preceding paragraphs.
The device is contraindicated in subject's who do not have fingers or toes. The device has been tested in adults but not in children or the fetus.
Advanced Vascular Dynamics
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, suggesting flight or freedom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB 1 2 2010
Advanced Vascular Dynamics c/o Herbert Semler, M.D., F.A.C.C. Official Correspondent 1910 NW 23td Place Portland, OR 97210
Re: K093192
Trade/Device Name: FloChec TM Photoplethysmography Device Regulatory Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: II (two) Product Code: 74 JOM Dated: December 22, 2009 Received: January 6, 2010
Dear Dr. Semler:
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 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.
3
Page 2 - Herbert Semler, M.D., F.A.C.C.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tease of advisod that i Driver in the your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I editates and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cl K F art 607), laboring (21 OFF 803); good manufacturing practice requirements as set de vice-related adverse ovenis) (2) CFR Part 820); and if applicable, the electronic form in the quality byevelops (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific darree to: your CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation antires, the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the r ou may of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
FloChec™ Photo Plethysmography Device Device Name:
Indications For Use:
To monitor relative blood flow changes distal to the occlusion of a brachial, ulnar, or femoral artery.
From the physician history and clinical findings, the person has pain, claudication, or changes in blood flow to the extremity.
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1
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The device is for adult use and not for pediatric or fetal use.
| Rx X | or | OTC |
|---|---|---|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
| (Division Sign-Off) | ||
| Division of Cardiovascular Devices | ||
| 510(k) Number | K093192 | (Optional Format 3-10-98) |
Advanced Vascular Dynamics