(119 days)
The INF 4160 PLUS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
INF 4160 PLUS is an Interferential Current Therapy Device. It generates a set of symmetric sinusoidal electrical signals which are delivered to the user or patient through lead cables to the electrode pads placed on the skin. The electric signals stimulate the nerves underneath. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
This device, the INF 4160 PLUS, is being cleared through a 510(k) submission, which means it asserts substantial equivalence to a predicate device. This type of submission often focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical studies with specific acceptance criteria as might be seen for novel devices.
Based on the provided document, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Compliance with EN60601-1 Safety requirement | INF 4160 PLUS complies with EN60601-1. |
| EMC Requirements: Compliance with EN60601-1-2 EMC requirements | INF 4160 PLUS complies with EN60601-1-2. |
| Quality System: Design control follows FDA quality system requirement | Design control follows FDA quality system requirement. |
| Software Verification: Software verification carried out according to FDA software guidance | Software verification has been carried out according to the FDA software guidance. |
| Operating Principle: Same as predicate device (IF-4000) | The operating principle is the same. |
| Intended Use: Same as predicate device | The intended use is the same. |
| Power Sourcing Method: Same as predicate device (battery or AC adaptor) | The power sourcing method is the same; both can operate with battery or AC adaptor. |
Study Proving Device Meets Acceptance Criteria:
The document states: "INF4160 PLUS complies with the following standard. EN60601-1 Safety requirement EN60601-1-2 EMC requirements." and "The design control follows the FDA quality system requirement and the software verification has been carried out according to the FDA software guidance."
The primary "study" or demonstration of meeting acceptance criteria for this 510(k) submission is the comparison to the predicate device (IF-4000 [510(k) No.: K952683]) and compliance with relevant safety and EMC standards. There was no clinical testing performed for this device, as explicitly stated in section 8. The conclusion relies on the similarity in operating principle, intended use, and power sourcing to the predicate device, along with adherence to non-clinical standards and quality system requirements.
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set was used, as no clinical testing was performed.
- Data Provenance: Not applicable. Since no clinical testing was conducted, there's no data provenance from patient samples to report. The evidence relies on technical comparisons and compliance with engineering standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No clinical test set or ground truth established by experts for clinical performance was used.
4. Adjudication Method for the Test Set
- Not applicable. As no clinical test set was used, there was no adjudication method employed.
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
- No. This is not an AI-powered device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (Interferential Stimulator) and not an algorithm or AI product. Its performance is inherent in its electrical signal generation and delivery, not in an 'algorithm-only' sense.
7. The type of ground truth used
- The "ground truth" in this context is established by regulatory standards and successful clearance of the predicate device. The fundamental premise is that if the new device is sufficiently similar to a previously cleared device and meets applicable non-clinical safety standards, it is considered safe and effective.
- Predicate Device Equivalence: The primary ground truth is the established safety and effectiveness of the predicate device, IF-4000 (K952683).
- Regulatory Standards: Compliance with EN60601-1 (Safety) and EN60601-1-2 (EMC) serves as a ground truth for physical and electrical safety.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no training set in that sense.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth for a training set to establish.
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K092780 Device 510(k) number: _
1. Applicant Information
| Date Prepared: | Aug 20, 2009 | JAN - 7 2010 |
|---|---|---|
| Submitter: | Fuji Dynamics Ltd.Unit 1-3, 23/F., Laws Commercial Plaza788 Cheung Sha Wan Road, KowloonHong Kong | |
| Contact Person: | LEE, Ching Kong Felix | |
| Tel: | (852) 2786 4218 | |
| Fax: | (852) 2744 6775 |
General Device Information 2.
| Trade Name: | INF 4160 PLUS |
|---|---|
| Model Code: | D-FJ31F |
| Common Name: | Interferential Stimulator |
| Product Code: | LIH |
| Classification: | unclassified |
3. Predicate Device Information:
IF-4000 [510(k) No.: K952683]
4 Device Description
・
INF 4160 PLUS is an Interferential Current Therapy Device. It generates a set of symmetric sinusoidal electrical signals which are delivered to the user or patient through lead cables to the electrode pads placed on the skin. The electric signals stimulate the nerves underneath. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
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5 Intended Use:
INF4160 PLUS is intended to use as
- Symptomatic relief and management of chronic intractable pain .
- Adjunctive treatment for the management of post-traumatic or post-surgical . pain.
d Comparison to Predicate Device:
INF4160 PLUS has the following similarities when compared to the predicate device.
- The operating principle is the same. 트
- 트 The intended use is the same.
- 프 The power sourcing method is the same; both can operate with battery or AC adaptor.
7 Non-clinical Testing:
INF4160 PLUS complies with the following standard. EN60601-1 Safety requirement EN60601-1-2 EMC requirements
The design control follows the FDA quality system requirement and the software verification has been carried out according to the FDA software guidance.
Clinical Testing 8
None
9 Conclusions:
INF 4160 PLUS has the same intended use and the same technical characteristics as the predicate device, IF-4000 [510(k) No .: K952683].
INF4160 PLUS is as safe and as effective as the predicate device.
Therefore, the INF4160 PLUS is substantially equivalent to the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Fuji Dynamics Limited c/o Mr. Ching Kong Lee Product Development Manager Unit 1-3, 23/F, Laws Commercial Plaza 788 Cheung Sha Wan Road Kowloon, Hong Kong China
JAN - 7 2010
Re: K092780
Trade/Device Name: INF 4160 PLUS Regulation Number: Unclassified Regulation Name: Interferential Current Therapy Regulatory Class: Unclassified Product Code: LIH Dated: November 26, 2009 Received: November 30, 2009
Dear Mr. Lee:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Kesia Alexander Jr
Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: INF 4160 PLUS
Indications For Use:
The INF 4160 PLUS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
X Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Joe C Callaway
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K092780 510(k) Number
D-1/1
§ 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).