(139 days)
No
The device description focuses on electrical stimulation parameters and physical characteristics, with no mention of AI or ML. The testing summary also does not indicate any AI/ML components.
Yes
The device is indicated for the symptomatic relief of pain, which is a therapeutic purpose. It delivers electric current to the body for this relief.
No
Explanation: The device is described as delivering electric current for symptomatic pain relief, not for diagnosing medical conditions. Its intended use focuses on treatment rather than diagnosis.
No
The device description clearly outlines a physical hardware device with an ABS casing, touch-sensitive panel, internal batteries, and electrode connections, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief of pain (chronic, post-traumatic, post-surgical). This is a therapeutic application, not a diagnostic one.
- Device Description: The device delivers electric current to the body via electrodes. This is a physical intervention, not a test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The KFH Energy device does not fit this description. It is a therapeutic device used for pain management.
N/A
Intended Use / Indications for Use
The KFH Energy device is indicated for the symptomatic relief of:
- Chronic Intractable Pain
- Post-Traumatic Pain
- Post-Surgical Pain
Product codes (comma separated list FDA assigned to the subject device)
84 GZJ
Device Description
The Kingfisher Healthcare NV KFH Energy model E1 is built in an ABS casing with controls and indicator integrated into a touch-sensitive opaque glass front panel, and designed to be comfortably held in the hand.
The approximate dimensions of the unit are 190 x 80 x 30 mm and complete with batteries the unit weighs approximately 350 g (including batteries).
The device is designed to deliver electric current in the range 300 to 600 microamperes at 100 Hz frequency to the body from four "AA" sized batteries (contained internally), for a predctermined time (30 or 60 minutes), through four adhesive skin electrodes (already found substantially equivalent through the 510(k) process). The output waveform is monophasic, rectangular with decay.
The ABS plastic housing is comprised of three parts:
- . upper housing
- lower housing, and .
- battery compartment cover .
The battery compartment cover is a clip fit to the lower housing, secured with a screw, which is sealed to the upper housing with a rubber gasket and retained in position by four screws. Two clectrical connectors are located in the housing, identified as C1 (channel 1) and C2 (channel 2), for connection of the four patient contacting electrodes.
The front glass panel is opaque and sealed to the upper housing by a self-adhesive gasket. Electrical circuitry is integrated into the rear of the glass panel allowing the front face to act as a "touch-sensitive" user interface. Two depressions are milled into the front face of the glass front panel to assist locating the fingers over the control areas: - a circular depression over the on/off control .
- a "ring" shaped depression over the output control area. The two sides of the . "ring" can be used to independently control the two output channels.
The elcctrical circuitry also contains the status indication light emitting diodes which can be seen through the glass panel: - . power on
- low battery warning .
- an output set-point indicator for each channel .
- six "count-down" timer indicators ( 10, 20, 30, 40, 50 and 60 min.) .
A controller board is located between the upper and lower housings. This is the FR4 based current generator rated at: 0 - 33 v d.c., 400 µA, 100 Hz.
The Kingfisher Healthcare NV KFH Energy model E1 will be packaged in a presentation cardboard case together with electrodes, leads, batteries, storage bag and the user manual.
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
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)
Non-Clinical Testing:
- Enclosure materials testing .
- Battery life testing .
- Device extended use reliability testing .
- Firmware functional performance .
- Device functional performance .
- Functional testing to product specification .
- . Connection testing
No clinical testing is included.
Summary of Testing:
From the above testing, Kingfisher Healthcare NV concludes that the KFH Energy Model E1 is substantially equivalent to the predicate products.
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.
K896948, K881753, K831145, K831144, K915210, K050435, K994265, K903394
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.
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Kung Fisher Healthcare. The logo consists of a stylized image of a kingfisher bird on the left, followed by the text "Kung Fisher Healthcare" on the right. Below the text is the phrase "Innovating for life" in a smaller font.
MAR 1 1 2008
Image /page/0/Picture/3 description: The image shows the logo for King Fisher Healthcare. The logo consists of a stylized image on the left and the text "King Fisher Healthcare" on the right. Below the logo is the text "Technology for Life" in a smaller font.
Kingfisher Healthcare NV Interleuvenlaan 62 Leuven Belgium, 3001 Phone 011 32 16397837 011 32 16397841 Fax
"510(k) Summary" As required by 21 CFR 807.92
Owner's Name
Kingfisher Healthcare NV
Address:
Interleuvenlaan 62 Leuven 3001 Belgium +32 16 39 78 37 Telephone Number: +32 16 39 78 41 Fax Number Sally Sennitt, MD, Medical Director Contact Person
Summary Prepared
Date
December 4, 2007
Classification name
Transcutaneous electrical nerve stimulator for pain relief Product Code 84 GZJ 21 CFR 882.5890 Regulation
Common/Usual Name KFH Energy model E1
Proprietary Name
Kingfisher Healthcarc NV KFH Energy model E1
510(k) Summary Section 1
Page 2 of 6
1
Image /page/1/Picture/1 description: The image shows a logo for King Fisher Healthcare. The logo includes the text "King Fisher Healthcare" in a vertically stacked format. Below the text is the tagline "Truly here for life" in a smaller font. To the left of the text is a stylized graphic, possibly representing a kingfisher bird.
Establishment Registration Number
The device will be manufactured by
Kingfisher Healthcare NV Interleuvenlaan 62 Leuven B-3001 Belgium Telephone +32 16 39 78 37 +32 16 39 78 41 Fax Establishment Registration Number: to be applied for
and
Fela Leiterplattentechnik GmbH Sturmbuehlstrasse 180 VS Schwenningen D-78056 Germany Telephone +49 7720 39 02 30 +49 7720 39 02 70 Fax Establishment Registration Number: to be applicd for
Fela Leiterplattentechnik GmbH is identified for completeness, however they are a supplier to Kingfisher Healthcare NV and not a Contract Manufacturer. Fela Leiterplattentechnik GmbH perform only certain agreed operations on instructions from Kingfisher Healthcare NV and deliver product for acceptance only to Kingfisher Healthcare NV.
Substantial Equivalence:
The Kingfisher Healthcare NV KFH Energy model E1 is substantially equivalent in design, use and materials to the:
Electromedical Products Intl Inc. Alpha Stim K896948, K881753, K831145, K831144 BioMedical Life Systems, Electro-nerve stimulator TENS model micro plus-A K915210 Lhasa Oms Inc, E Stim II K050435 Fuji Dynamics Ltd, Medisana Digital Tens K994265 Globalcare Intl., Inc, Globalcare Micro II and Microcare (TENS) K903394
510(k) Summary Section 1
2
Image /page/2/Picture/1 description: The image shows the logo for King Fisher Healthcare. The logo consists of a stylized black bird on the left and the text "King Fisher Healthcare" on the right. Below the text is the tagline "Technology for life" in a smaller font. The logo appears to be for a healthcare company that focuses on technology.
Comparison of Technological Characteristics
The Kingfisher Healthcare NV KFH Energy model E1 is a microcurrent TENS device for pain relief with an output similar to that of the above referenced legally market products. The Kingfisher Healthcare NV KFH Energy model E1 differs from some of the above products in that it is a dedicated microcurrent device and does not have a high-current mode.
The Kingfisher Healthcare NV KFH Energy model E1 is made of the same types of material as the products referenced above. The front display of the Kingfisher Healthcare
NV KFH Energy model E1 differs from the predicates in that it is made of a "wipc-clean" glass surface eliminating any possibility for contamination to build up around indicators or controls.
Patient Contact
Patient contact with the main device is limited to finger operation of the controls and made only with glass front panel or ABS casing (when held in the hand). Connection to the patient is made by electrodes which are already legally marketed:
| Electrodes: | Top-Rank Healthcare Equipment Co Ltd Adhesive Electrode |
|---|---|
| K070612 | |
| Gel: | Sekisui Plastic Co Ltd Technogel, included in electrodes above |
| K070612 |
Description of Product:
The Kingfisher Healthcare NV KFH Energy model E1 is built in an ABS casing with controls and indicator integrated into a touch-sensitive opaque glass front panel, and designed to be comfortably held in the hand.
The approximate dimensions of the unit are 190 x 80 x 30 mm and complete with batteries the unit weighs approximately 350 g (including batteries).
The device is designed to deliver electric current in the range 300 to 600 microamperes at 100 Hz frequency to the body from four "AA" sized batteries (contained internally), for a predctermined time (30 or 60 minutes), through four adhesive skin electrodes (already found substantially equivalent through the 510(k) process). The output waveform is monophasic, rectangular with decay.
3
Image /page/3/Picture/1 description: The image shows the logo for King Fisher Healthcare. The logo includes the company name in a simple, sans-serif font, with the words "King Fisher" stacked on top of "Healthcare". To the left of the text is a stylized graphic, possibly representing a bird or a leaf. Below the company name is the tagline "Journey for life" in a smaller, italicized font.
Housing
The ABS plastic housing is comprised of three parts:
- . upper housing
- lower housing, and .
- battery compartment cover .
The battery compartment cover is a clip fit to the lower housing, secured with a screw, which is sealed to the upper housing with a rubber gasket and retained in position by four screws. Two clectrical connectors are located in the housing, identified as C1 (channel 1) and C2 (channel 2), for connection of the four patient contacting electrodes.
Glass Front Panel
The front glass panel is opaque and sealed to the upper housing by a self-adhesive gasket. Electrical circuitry is integrated into the rear of the glass panel allowing the front face to act as a "touch-sensitive" user interface. Two depressions are milled into the front face of the glass front panel to assist locating the fingers over the control areas:
- a circular depression over the on/off control .
- a "ring" shaped depression over the output control area. The two sides of the . "ring" can be used to independently control the two output channels.
The elcctrical circuitry also contains the status indication light emitting diodes which can be seen through the glass panel:
- . power on
- low battery warning .
- an output set-point indicator for each channel .
- six "count-down" timer indicators ( 10, 20, 30, 40, 50 and 60 min.) .
Controller Board
A controller board is located between the upper and lower housings. This is the FR4 based current generator rated at: 0 - 33 v d.c., 400 µA, 100 Hz.
The Kingfisher Healthcare NV KFH Energy model E1 will be packaged in a presentation cardboard case together with electrodes, leads, batteries, storage bag and the user manual.
The KFH Energy device is indicated for the symptomatic relief of:
- Chronic Intractable Pain .
- Post-Traumatic Pain .
510(k) Summary Section 1
4
K073008 KFH Response to Email of S. Hinckley 7 Feb 2008
Image /page/4/Picture/1 description: The image shows the logo for King Fisher Healthcare. The logo includes a stylized black shape on the left, resembling a leaf or abstract form. To the right of the shape, the text "King Fisher Healthcare" is stacked vertically. Below the shape and text, there is a tagline that reads "In biology for life" in a smaller font size.
- Post-Surgical Pain .
Testing:
Non-Clinical Testing
The following non-clinical testing has been included in the premarket notification to demonstrate substantial equivalence to the predicate device and meet the guidance in FDA's August 1994 "Guide for TENS 510(k) Content":
- Enclosure materials testing .
- Battery life testing .
- Device extended use reliability testing .
- Firmware functional performance .
- Device functional performance .
- Functional testing to product specification .
- . Connection testing
Clinical Testing Submitted
No clinical testing is included.
Summary of Testing:
From the above testing, Kingfisher Healthcare NV concludes that the KFH Energy Model E1 is substantially equivalent to the predicate products.
5
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kingfisher Healthcare NV % MeddiQuest Limited Mr. Neil R. Armstrong Business & Technology Center Bessemer Drive Stevenage Hertfordshire SG1 2DX United Kingdom
MAR 1 1 2008
Re: K073008
Trade/Device Name: KFH Energy Model E1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: February 28, 2008 Received: March 3, 2008
Dear Mr. Armstrong:
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 such 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); 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.
6
Page 2 - Mr. Neil R. Armstrong
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 our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K073008
Device Name: _ The Kingfisher Healthcare NV, KFH Energy model E1
Indications for Use:
The KFH Energy device is indicated for the symptomatic relief of:
- Chronic Intractable Pain
- Post-Traumatic Pain
- Post-Surgical Pain
AND/OR Over-The-Counter Use
Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heid R.P. John formxn
Division Sign-Off
Division of General, Restorative, and Neurological Devices
(Posted November 13, 2003) 510(k) Number
Page 1 of 1
Section 2