(89 days)
No
The description focuses on impedance measurement and does not mention AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as a non-invasive monitor intended for determining changes in fluid status, indicating a diagnostic or monitoring function rather than a direct therapeutic one. It helps manage patients but does not treat them.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "monitoring and management of patients with fluid management problems," implying it gathers information to assess and guide patient care, which is a diagnostic function.
No
The device description explicitly states it is a "non-invasive, battery powered impedance monitor" and requires "disposable, self-adhesive silver i silver chloride electrodes," indicating it is a hardware device with associated software.
Based on the provided text, the ZOE Fluid Status Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). This device is described as non-invasive and works by applying an electrical current to the body and measuring impedance. This is an in vivo (within the living body) measurement.
- The intended use and device description clearly indicate it's a monitoring device used on the patient. It measures a physiological parameter (electrical impedance) directly from the patient's body.
Therefore, the ZOE Fluid Status Monitor falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The ZOE Fluid Status Monitor is intended for patients:
- With fluid management problems
- Taking diuretic medication
- Living with Heart Failure
- Living with End-stage Renal Disease
- Recovering from Coronary Artery Disease related event
- Suffering from Recurrent Dehydration
This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Product codes
DSB
Device Description
The ZOE Fluid Status Monitor Model ZOE3 is a non-invasive, battery powered impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems.
The ZOE Fluid Status Monitor Model ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance also known as Zo, decreases when fluid increases and increases when fluid decreases.
The ZOE Fluid Status Monitor Model ZOE3 is designed for use with disposable, self-adhesive silver i silver chloride electrodes that are readliy available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!
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
This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Special 510(k) Premarket Notification - ZOE Fluid Status Monitor Model: ZOE3
Image /page/0/Picture/1 description: The image shows the logo for Noninvasive Medical Technologies, Inc. The logo consists of three concentric arcs on the left, followed by the letters "NMT". To the right of "NMT" is the text "Noninvasive Medical Technologies, Inc.". The text is in a simple, sans-serif font.
K133301 Page 1 of 2
JAN 222 2014
510(k) Summary
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
| APPLICANT | Noninvasive Medical Technologies, Inc. |
|---|---|
| 6412 S. Arville St. | |
| Las Vegas, NV 922614 | |
| Tel: (888) 906-0413 | |
| Fax: (702) 614-4170 | |
| OFFICIAL CORRESPONDENT | Dr. Marc O'Griofa MD (MB BCh BAO) |
| Chief Technology/Medical Officer | |
| Tel: (888) 906-0413 | |
| Fax: (702) 614-4170 | |
| mogriofa@nmtinc.org | |
| DATE PREPAIRED | October 19.2012 |
| TRADE NAME | ZOE Fluid Status Monitor |
| MODEL | ZOE3 |
| COMMON OR CLASSIFICATION NAME | Impedance Plethysmograph |
| DEVICE CLASSIFICATION | Class II per 21CFR §870.2770 |
| PRODUCT CODE | DSB |
| PREDICATE DEVICE NAMES | ZOE Fluid Status Monitor |
The ZOE Fluid Status Monitor Model ZOE3 is substantially equivalent to the following currently marketed Predicate Device.
| Manufacturer | Device Name | 510-K Number | Decision Date |
|---|---|---|---|
| Noninvasive Medical | |||
| Technologies, Inc. | ZOE Fluid Status Monitor | K112830 | 11/13/2012 |
| ZOE Fluid Status Monitor | K131509 | 06/28/2013. |
Device Description:
The ZOE Fluid Status Monitor Model ZOE3 is a non-invasive, battery powered impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems.
The ZOE Fluid Status Monitor Model ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance also known as Zo, decreases when fluid increases and increases when fluid decreases.
The ZOE Fluid Status Monitor Model ZOE3 is designed for use with disposable, self-adhesive silver i silver chloride electrodes that are readliy available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!
Labeling:
/
Federal (United States) Law restricts this device to sale by or on the order of a physician or licensed healthcare professional.
1
Special 510(k) Premarket Notification – ZOE Fluid Status Monitor Model: ZOE3
Indications for Use:
The ZOE Fluid Status Monitor is intended for patients: With fluid management problems
K133301 Page 2 of 2
- . Taking diuretic medication
- Living with Heart Failure �
- Living with End-stage Renal Disease .
- Recovering from Coronary Artery Disease related event .
- Suffering from Recurrent Dehydration ◆
This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Predicate Device Discussion:
The ZOE Fluid Status Monitor Model ZOE3 has the same method of operation and is functionally equivalent to the predicate devices K112830 (November 13, 2012) & K131509 (June 28, 2013). The ZOE Fluid Status Monitor has the identical indications for use as the ZOE Fluid Status Monitor K112830 (November 13, 2012) & K131509 (June 28, 2013)
Performance Characteristics:
There is no performance standards published for Product Code DSB Impedance Plethysmograph (870.2770)
Quality and Safety Testing:
Noninvasive Medical Technology is presently certified to ISO13485 2003 as of 9/27/09 by IQ Net and NEMKO AS./ Registration Number 908132) All products are designed and manufactured under Quality Management System. The following quality assurance measures were applied to the Zoe Fluid Status Monitor:
- Risk Analysis .
- . Requirements Review
- . Design reviews
- Code Inspections ●
- Verification and Validation .
- H/W and S/W Implementation Verification Testing .
The ZQE Fluid Status Monitor Model ZOE3 will undergo testing to assess the overall electrical safety and EMI safety by an independent testing house. The ZOE Fluid Status Monitor with the electrical standards of the CAN/CSA C22.2 No. 60601-1:08 standard The ZOE will meet all electrical and electromagnetic compatibility (EMI) safety requirements, set forth in the European national Safety Requirements LVD Low voltage Directive testing to Safety of Medical Devices IEC 60601-1, 3rd edition, EMC testing to Emissions / Immunity Requirements for EMC/EMI requirements for Medical Devices IEC 60601-1-2 which reasonably assures the device is safe when used as directed for its prescribed intended use.
Conclusion:
The ZOE3 Fluid Status Monitor Model has the same method of operation and is functionally equivalent to the predicate devices. The ZOE3 Fluid Status Monitor has the identical indications for use as the predicate devices the ZOE Fluid Status Monitors K112830 (November 13, 2012) & K131509 (June 28, 2013) The ZOE3 Fluid Status Monitor does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate devices ZOE Fluid Status Monitor K112830 (November 13, 2012) & K131509 (June 28, 2013)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Noninvasive Medical Technologies, Inc. Marc O'Griofa MD 6412 S. Arville St. Las Vegas, NV 89118
K133301 Re:
Trade/Device Name: ZOE3 Fluid Content Monitor Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: December 20, 2013 Received: December 23, 2013
Dear Marc O'Griofa:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical device
3
Page 2 - Marc O'Griofa
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding 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 Division of Small 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.
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Premarket Notification - ZOE Fluid Status Monitor Model: ZOE3
Indications for Use Statement
510(k) Number
K133301 Page 1 of 1
Previously Cleared as: K112830 (11/13/2012) & K131509 (06/28/1013)
Device Name: ZOE Fluid Status Monitor Model: ZOE3
Indications for Use:
The ZOE Fluid Status Monitor is intended for patients:
- With fluid management problems o
- Taking diuretic medication .
- Living with Heart Failure .
- � Living with End-stage Renal Disease
- Recovering from Coronary Artery Disease related event ●
- Suffering from Recurrent Dehydration .
This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
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)
Digitally signed by
Owen P. Faris -S
Date: 2014.01.22
05:48:01-05'00'
October 24, 2013 : Noninvasive Medical Technologies, Inc.