(770 days)
K 904109, K 002835
Not Found
No
The description focuses on standard bioelectrical impedance analysis and calculations, with no mention of AI or ML terms or methodologies.
No.
The device is described as an analyzer/monitor that supports the measurement of fluid volume differences to aid in clinical assessment, and it is explicitly stated that "This device is not intended to diagnose or predict lymphoedema of an extremity." It does not provide any treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "This device is not intended to diagnose or predict lymphoedema of an extremity." While it aids in clinical assessment of fluid volume differences, it's not a diagnostic tool itself.
No
The device description clearly states "The Imp XCA is a single frequency bioelectrical impedance analyser," indicating it is a hardware device that performs measurements. The PC software is described as an optional package for data management, not the primary medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Imp XCA and its associated software measure bioelectrical impedance directly on the patient's arm. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to aid in the clinical assessment of unilateral lymphoedema of the arm by measuring fluid differences in vivo.
Therefore, since the device operates by directly interacting with the patient's body and not by analyzing specimens in vitro, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Imp XCA: A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity.
Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.
Product codes
DSB, OBH
Device Description
The Imp XCA is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate extracellular fluid (ECF) allowing for the clinical assessment of unilateral Lymphedema of the arm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 904109, K 002835
Reference Device(s)
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
§ 870.2770 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
Image /page/0/Picture/0 description: The image shows the logo for ImpediMed. The logo is black and white and features the company name in bold, sans-serif font. The company name is surrounded by a stylized graphic of curved lines. At the top of the image, the text "K050415 PAGE 1 OF 5" is visible.
lmpediMed Ltd
Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia
Telephone: +61 (0)7 3423 1777
ABN 65 089 705 144
Email: enquires@impedimed.com
Facsimile: +61 (0)7 3423 1496
510 (k) Summary ImpediMed Imp XCA ExtraCellular Fluid Analysis
APPLICANT INFORMATION
Company Name and address:
Contact Name and numbers:
ImpediMed Ltd 4B/2404, Logan Road Eight Mile Plains Brisbane, QLD - 4113
Mr Roger Render VP Quality & Requlatory Phone: (+61) 7 3423 1777 Fax: (+61) 7 3423 1496 E-mail: rrender@impedimed.com
Date of summary prepared:
March 27 2007
DEVICE IDENTIFICATION
Trade/Proprietary name:
Classification name:
Regulation number/CFR section:
Product code:
, Classification panel:
Device class:
Imp XCA ExtraCellular Fluid Analysis
Impedance Plethysmograph
21 CFR 870.2770
DSB
Cardiovascular
Class II
510(k) 6.0 Letterhead SUmmary
page 1 of 5
0 1000 3 :
1
Image /page/1/Picture/0 description: The image shows the text "R030415 PAGE 2 OF 5" at the top. Below the text is a logo for "ImpediMed". The logo is black and white and features the company name in a stylized font with curved lines underneath.
Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496
Email: enquires@impedimed.com
| 1. | |
|---|---|
| Company: | Xitron Technologies, Inc |
| Device name: | Bio-Impedance Analyzer |
| 510 (K) number: | K 904109 |
| Product code: | DSB |
| Classification panel: | Cardiovascular |
| Device class: | Class II |
2.
lmpediMed Ltd
Garden City Office Park
Eight Mile Plains QLD 4113
Building 4B
Australia
PO Box 4612
| Company | Bodystat Ltd |
|---|---|
| Device name: | Bodystat Quad Scan 4000 |
| 510 (K) number: | K 002835 |
| Product code: | MNW |
| Classification panel: | Cardiovascular |
| Device class: | Class II |
2
Image /page/2/Picture/0 description: The image shows the logo for ImpediMed. The logo is black and white and features the company name in a bold, sans-serif font. The logo also includes a stylized graphic of curved lines that resemble a wave or a heartbeat. The text at the top of the image says "K050415" and "AGE 3 OF 5".
ImpediMed Ltd
Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496
Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia INTENDED USE / INDICATIONS FOR USE
Email: enquires@impedimed.com
The Imp XCA: A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity.
Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.
DEVICE DESCRIPTION
The Imp XCA is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate extracellular fluid (ECF) allowing for the clinical assessment of unilateral Lymphedema of the arm.
TECHNOLOGICAL CHARECTERISTICS
The ImpediMed Imp XCA ExtraCellular Fluid Analyzer is a battery powered, accurate, handheld, single frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.
Bioelectrical impedance analysis measures the impedance or opposition to the flow of an electric current through the body fluids contained mainly in the lean and fat tissue. Impedance is low in lean tissue, where intracellular fluid and electrolytes are primarily contained, but high in fat tissue. Impedance is thus related to total fluid volume. The tissue and organs of the body are composed of cells surrounded by a cell membrane. This membrane separates fluid inside
3
Image /page/3/Picture/0 description: The image shows the text "K050415 PAGE 4 OF 5" at the top. Below the text is a logo for "ImpediMed". The logo consists of the word "ImpediMed" in a bold, sans-serif font, with a stylized graphic of curved lines above and below the text.
ImpediMed Ltd
Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496
Email: enquires@impedimed.com
Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia
cells called intracellular fluid (ICF) from that surrounding the cells termed as extracellular fluid (ECF) that act as conductors to the flow of current through the body.
However, the cell membrane and tissue interfaces because they are 'imperfect capacitors' act as a barrier to penetration of current at low frequencies. Thus the total impedance and phase angle of alternating current flow will be frequency dependent.
Therefore, an alternating electric current has two possible pathways through a biological tissue; at low frequencies it will pass only through the extracellular fluid since the capacitance of the cell membrane acts as a barrier to penetration by the current, while at high frequencies the current will cross the cell membrane and take a path through both the ICF and ECF, i.e. the total fluid volume.
The ImpediMed Imp XCA is specifically designed for segmental bioelectrical impedance analysis to measure the ECF of the arms in which a small constant current, typically 200 uA± 10uA peak-to-peak at a fixed low frequency of 10 kHz is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltagesensing electrodes provides a measure of impedance. The performance of the device may be checked with the aid of a calibration circuit (supplied as an accessory) for quality assurance or servicing purposes.
Bioelectrical impedance basics, simple mathematics, bioelectrical and anthropometric parameters from peer reviewed published journal articles are used to convert measured impedance to a corresponding estimate of extracellular fluid ratio (extracellular fluid index or lymphoedema index), and extracellular fluid volume difference between the arms. These
4
Image /page/4/Picture/0 description: The image shows the logo for "ImpediMed" with the text in a stylized font. Above the logo, the text "K050415 PAGE 5 OF 5" is present. The logo is black and white and features a series of curved lines above and below the text.
ImpediMed Ltd
Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia
Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496
Email: enquires@impedimed.com
estimates can be used as alternatives to the current circumferential measurements and water immersion methods, to indicate trends and to assist in the assessment of the development of Lymphedema.
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and head. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2007
Mr. Roger Render VP Quality Regulatory ImpediMed Limited 4B / 2404 Logan Road Brisbane Queensland 4113 AUSTRALIA
Re: K050415
Trade/Device Name: Imp XCA with Lymphoedema Analysis PC Software Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OBH Dated: Undated Received: March 29, 2007
Dear Mr. Render:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.
6
Page 2 - Mr. Roger Render
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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at (240) 276-3150. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
Device Name: Imp XCA with Lymphoedema Analysis PC Software
(1) Imp XCA – A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity.
(2) Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.
Prescription Use _ (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)
Page 1 of 1
Nancy C Brogdon
Division of Reproductive, Abdominal, a Radiological Device 510(k) Number