(28 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The intended use describes pain relief, which is a common application for non-AI medical devices.
Yes
The device is intended for "symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain," which are therapeutic applications.
No
The device is intended for pain relief, which is a therapeutic purpose, not a diagnostic one.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, the device IF4100 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain." This describes a therapeutic or pain management device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, based solely on the provided text, the IF4100 is a device intended for pain relief and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IF4100 is intended to be used in symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.
Product codes
GXY, LIH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three parallel lines that curve and flow together.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2001
Daniel Lee General Manager ApexMedical Corp. 10th Fl., No.31, Lane 169, Kang Ning Street., His-Chih Chen, Taipei Hsien, Taiwan, R.O.C.
Re: 510(k) Number K013813 Trade/Device Name: Apex Medical IF 4100 Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous Electrodes and Interferential Stimulator Regulatory Class: Class II and Unclassified Product Code: GXY and LIH Dated: November 12, 2001 Received: November 16, 2001
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard cate of the Medical Device Amendments, or to conninered phor to May 20, 1978, are onceance with the provisions of the Federal Food, Drug, de vices mat have been recure approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, mercere, mantel of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elaboried (so a controls. Existing major regulations affecting your device can may or subject to back additions, 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Drines and regulations administered by other Federal agencies. You must or uny I 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 form in the quarty by roovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Daniel Lee
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manieung of substantial equivalence of your device to a legally prematics notification. The PDF interessification 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 If you desire specific acrice for your sovices diagnostic devices), please contact the Office of additionally 21 CFTC Furt 0671. Additionally, for questions on the promotion and advertising of Compliance at (301) 591 1857 - 1252 - 1252 - 12 - 12 - 4639. Also, please note the your devices, proads of Misbranding by reference to premarket notification" (21CFR Part 807.97). It guiation entities, "Thisoranang onesponsibilities under the Act may be obtained from the Outler general miormation on Journational 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/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Image /page/1/Picture/5 description: The image shows a handwritten letter 'f' in cursive. The letter has a loop at the top and a tail that extends to the left. The stroke width is consistent throughout the letter.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number : _K013813 Device Name : Apex Medical IF 4100
Indications For Use:
IF4100 is intended to be used in symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
Susan Walk
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013813