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.
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.

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.

AI/ML Overview

The provided text does not contain a detailed description of acceptance criteria or a specific study proving the device meets those criteria, as typically outlined in present-day regulatory submissions. This submission dates back to 1997, and the level of detail regarding performance data in summary sections was often less extensive than what is expected today.

However, based on the available information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. It broadly claims "accuracy and repeatability" for the device's performance.

Acceptance Criteria (Implied)	Reported Device Performance
Performs as intended	Demonstrated to perform as intended
Accuracy	Demonstrated with accuracy
Repeatability	Demonstrated with repeatability

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the summary. The text indicates that "Complete results of performance testing of the Edema System have been included in Sections 14 and 17 of this submission," but these sections are not included in the provided excerpt. Therefore, the sample size for the test set and the data provenance (e.g., country of origin, retrospective/prospective) are unknown.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. There is no mention of expert involvement in establishing ground truth for any test set.

4. Adjudication Method for the Test Set

This information is not provided in the summary.

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

There is no indication of an MRMC comparative effectiveness study involving human readers or AI assistance. The device mentioned is an "Edema System," which is an "Impedance Plethysmograph" used to measure body composition in terms of edema. It's an older technology and does not appear to involve AI in the way modern devices do for interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is likely standalone in the sense that it provides measurements. However, the summary does not explicitly describe a standalone performance study in the context of an "algorithm only" as understood for AI/CAD devices. The software "monitors the impedance values...along with additional biological data," implying a processing algorithm, but no specific study of its isolated performance is detailed.

7. The Type of Ground Truth Used

This information is not explicitly stated in the summary. Given the nature of an "Impedance Plethysmograph," ground truth would likely involve direct physical measurements of edema or comparison with established clinical methods for assessing edema (e.g., volumetric measurements, weighted difference, or clinical assessment by a physician). However, the specific method is not mentioned.

8. The Sample Size for the Training Set

This information is not provided in the summary. The document mentions "Specialized software monitors the impedance values," suggesting an algorithm that might have been trained, but no details on training data or its size are included.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the summary.

Summary

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OCT 23 1997

K962783

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 GeminiBeaverton, OR 97008
c.	Company Phone:	(503) 626-8000
d.	Contact Person:	Richard WootenPresidentBioAnalogics, 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™ BodyComposition 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

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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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:

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

Over-The-Counter Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.