(463 days)
Not Found
No
The summary describes specialized software that monitors impedance values and biological data, but there is no mention of AI, ML, or related terms, nor is there any description of training or test sets typically associated with AI/ML development.
No
The device provides information for therapeutic and preventative instruction, but does not directly deliver therapy.
Yes
The device "measures body composition in terms of edema of the extremities" and provides "information which the physician or health care professional can utilize for therapeutic and preventative instruction in treating edema of the extremities," indicating its role in identifying and assessing the condition.
No
The device description explicitly mentions hardware components such as electrode sensors, placement leads, a 9-volt battery, and requires an IBM compatible computer workstation.
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. They are used to examine these samples outside of the body.
- Device Description: The Edema System measures body composition and impedance values using non-invasive electrode sensors placed on the patient's extremities. This is a measurement taken directly from the living body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to provide information for therapeutic and preventative instruction in treating edema of the extremities. While this information is used for medical purposes, it's derived from direct body measurements, not from analyzing a biological sample in a lab setting.
Therefore, the Edema System falls under the category of a medical device that performs measurements in vivo (within the living body), rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Edema System is a device intended to provide information which the physician or health care professional can utilize for therapeutic and preventative instruction in treating increased extremity edema.
Product codes
74 DSB.
Device Description
The Edema System is a device that measures body composition in terms of edema of the extremities. Specialized software monitors the impedance values taken from the patient along with additional biological data. The device is connected to the patient via non-invasive electrode sensors and placement leads. The device operates off of a 9-volt battery and is fully portable. The addition of an IBM compatible computer workstation is required to run the accompanying software program.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or health care professional
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
The Edema System has been demonstrated to perform as intended with accuracy and repeatability. Complete results of performance testing of the Edema System have been included in Sections 14 and 17 of this submission.
Key Metrics
accuracy and repeatability
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
OCT 23 1997
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 20:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 20.1
| a. | Company Name: | BioAnalogics, Inc. |
|---|---|---|
| b. | Company Address: | 9000 SW Gemini |
| Beaverton, OR 97008 | ||
| c. | Company Phone: | (503) 626-8000 |
| d. | Contact Person: | Richard Wooten |
| President | ||
| BioAnalogics, Inc. | ||
| e. | Date Summary Prepared: | July 1, 1996 |
~20.2. DEVICE IDENTIFICATION
、・・・・・・・
| a. | Trade/Proprietary Name: | Edema System |
|---|---|---|
| b. | Classification Name: | Impedance Plethysmograph |
IDENTIFICATION OF PREDICATE DEVICE · 20.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| BioAnalogics | Consultant™ Body | ||
| Composition Analyzer | K871040 | June 5, 1987 |
DEVICE DESCRIPTION 20.4
The Edema System is a device that measures body composition in terms of edema of the extremities. Specialized software monitors the impedance values taken from における
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the patient along with additional biological data. The device is connected to the patient via non-invasive electrode sensors and placement leads. The device operates off of a 9-volt battery and is fully portable. The addition of an IBM compatible computer workstation is required to run the accompanying software program. A complete description of the device has been included in Section 5 of this submission.
20.5 SUBSTANTIAL EQUIVALENCE
The Edema System is substantially equivalent to the Consultant™ Body Composition Analyzer in terms of its intended use as a device to provide the physician or health care professional with impedance information that can be utilized for therapeutic and preventative instruction in treating health disorders.
The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison chart provided in this 510(k) submission. Differences that exist between these systems relate to the software program which has been described in Section 18.
20.6 INTENDED USE
ﺃﻥ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
The Edema System is a device intended to provide information which the physician or health care professional can utilize for therapeutic and preventative instruction in treating edema of the extremities.
TECHNOLOGICAL CHARACTERISTICS 20.7
A comparison of the technological characteristics of the Edema System and the predicate device has been provided in this submission. Finished product
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specifications, schematic drawings, as well as a complete description of the software characteristics have been provided.
20.8 PERFORMANCE DATA
The Edema System has been demonstrated to perform as intended with accuracy and repeatability. Complete results of performance testing of the Edema System have been included in Sections 14 and 17 of this submission.
20.9 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
and the states
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three heads, all facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 1997
Mr. Rich Wooten BioAnaloqics, Inc. 7909 W.W. Cirrus Drive Beaverton, Oregon 97008
Re: K962783 Edema System Regulatory Class: II (two) Product Code: 74 DSB. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Dated: August 20, 1997 Received: August 22, 1997
Dear Mr. Wooten:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). נוספ 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Rich Wooten
This letter will allow you to beqin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
To Be Assigned By FDA:KG62783
Device Name:
510(k) Number:
Edema System
Indications For Use:
The Edema System is a device intended to provide information which the physician or health care professional can utilize for therapeutic and preventative instruction in treating increased extremity edema. --------
are to the many
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atl. A. Ciarkowski
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)