(437 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is simple.
No
The "Intended Use / Indications for Use" explicitly states, "This device is intended for cosmetic use." Devices intended for cosmetic use are not typically classified as therapeutic devices, which are designed to treat or prevent diseases.
No
The "Intended Use / Indications for Use" explicitly states, "This device is intended for cosmetic use," which is not a diagnostic purpose.
No
The device description explicitly states it is a hand-held, battery-operated device consisting of a main operating unit and an external electrode, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is "intended for cosmetic use." IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. Cosmetic use is not within the scope of IVD intended uses.
- Device Description: The description of the device as a "hand-held, battery operated device consisting of a main operating unit (InterX 1000) and an external electrode (Derma 200)" aligns with a device that interacts with the body externally, not one that analyzes biological samples.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic purposes, or any of the typical characteristics associated with IVDs.
Therefore, based on the provided text, this device is intended for cosmetic purposes and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for cosmetic use.
Product codes (comma separated list FDA assigned to the subject device)
NFO, GXY
Device Description
The InterX 1000/Derma 200 Stimulator for Cosmetic Use is a hand-held, battery operated device consisting of a main operating unit (InterX 1000) and an external electrode (Derma 200).
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)
Bench and clinical testing were conducted to demonstrate performance for the device's intended use.
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.
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.
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
§ 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
Section 5 - 510(k) Summary
Submitter Information Neuro Resource Group, Inc. 1100 Jupiter Road, Suite 190 Plano, TX 75074 Establishment Registration # 3004786509
APR - 4 2008
Contact
Krista Oakes, Vice President of Regulatory Affairs Telephone: 972-849-5167 Fax: 972-665-1814 Email: kristao@nrg-unlimited.com
Date Prepared April 3, 2008
Product Name InterX 1000/Derma 200 Stimulator for Cosmetic Use
Predicate Devices
Manufacturer 510k Reference Device Neuro Resource Group K042912 InterX 5000 K011935 Rejuvenique Salton Facemaster of Beverly Hills K040871 Facemaster
Product Description
The InterX 1000/Derma 200 Stimulator for Cosmetic Use is a hand-held, battery operated device consisting of a main operating unit (InterX 1000) and an external electrode (Derma 200).
Intended Use This device is intended for cosmetic use.
Comparison to Predicate Device
This device is equivalent in technology to the InterX 5000 device, currently marketed by our firm under K042912, with changes to accommodate new indications for cosmetic use. These indications are equivalent to devices cleared under K040871 and K011935.
Performance Testing & Conclusions
This device complies with performance standard requirements (21 CFR 898.12) relating to patient lead wires and electrodes. Bench and clinical testing were conducted to demonstrate performance for the device's intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neuro Resource Group, Inc. % Ms. Krista Oakes Vice President, Regulatory Affairs 1100 Jupiter Road, Suite 190 Plano, Texas 75074
APR - 4 2008
Re: K070217
Trade Name: InterX 1000 Stimulator/Derma 200 Electrode for Cosmetic Use Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code NFO, GXY Dated: January 4, 2008 Received: January 7, 2008
Dear Ms. Oakes:
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.
2
Page 2 - Ms. Krista Oakes
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 yours,
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number:
Device Name: InterX 1000/Derma 200 Stimulator for Cosmetic Use
Indications for Use:
This device is intended for cosmetic use.
Prescription Use XX (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)
Neil R. P. Boyle-Gorman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070217