(88 days)
No
The 510(k) summary describes a simple electrically conductive garment (glove, sock, or sleeve) used as an electrode with existing electrical stimulators. There is no mention of any computational processing, algorithms, or learning capabilities, which are characteristic of AI/ML.
No
The device is an accessory (electrode garment) for therapeutic devices (TENS, HVPG, INF units) and is not a therapeutic device itself.
No
The device is described as an electrically conductive garment intended for use with existing electrical nerve stimulators to apply current to the body, not to diagnose a condition.
No
The device description clearly states it is a "Stretchable Electrically Conductive glove, sock, or sleeve," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The "Ultra Garment Electrode" is an electrically conductive garment used externally on the body in conjunction with electrical stimulators. It facilitates the delivery of electrical current to the patient's skin.
- Intended Use: The intended use clearly states it's for use as an electrically conducting garment with transcutaneous electrical nerve stimulators and other similar devices. This is a therapeutic or pain management application, not a diagnostic test performed on a biological sample.
The device description and intended use align with an external medical device used for electrical stimulation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The "Ultra Garment Electrode" is intended to be used as an electrically conducting garment to be prescribed for usage by a physician for use where an electrode is appropriate.
ULTRA GARMENTS: ARE USED WITH LEGALY MARKETED TRANSCUTAINEIOUS ELECTRICAL NERVE STIMULATORS, (LE.N.S.), HIGH VOLT PULSED GAVINIC STIMULATORS, (H.V.P.G.), AND INTERFERENTIAL. (INF), UNITS.
Product codes
GXY
Device Description
The Ultra Garment Electrode is a Stretchable Electrically Conductive glove, sock, or sleeve, Reusable.
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
Prescribed for usage by a physician.
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)
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
DEC 1 7 1999
Attachment A
510(k) Summary of Safety and Effectiveness
| Date Prepared: | September 15, 1999 |
|---|---|
| Submitter: | Newwave Medical, LLC |
| 1538 Haven Place | |
| Allen , TX 75002 | |
| (972) 396-5400 | |
| Contact Person: | Robert Armstrong |
| Trade (Proprietary) Name: | Ultra Garment Electrode |
| Common/Classification Name: | Cutaneous Electrode |
| Device Classification: | Class II |
| Predicate Devices: | SMD Electrodes (K943009) |
| Electro-Mesh Glove Electrodes | |
| Prizm Medical (K932299) | |
| Description of the Device | The Ultra Garment Electrode is a Stretchable |
| Electrically Conductive glove, sock, or sleeve, | |
| Reusable. | |
| Statement of Intended Use: | The "Ultra Garment Electrode" is intended to be |
| used as an electrically conducting garment to be | |
| prescribed for usage by a physician for use where | |
| an electrode is appropriate. | |
| Technological Characteristics: | The new device has the same technological |
| characteristics as the predicate devices. See | |
| Table 1 (next page) for a summary of the new | |
| device in comparison to those of the predicate | |
| devices. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1999
Robert Armstrong Newwave Medical LLC. 1538 Haven Place Allen, TX 75002
Re: K993130 Trade Name: Ultra-Garment Electrodes Regulatory Class: II Product Code: GXY Dated: September 15, 1999 Received: September 20, 1999
Dear Mr. Armstrong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Robert Armstrong
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Neil RP Ogden for
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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S10(k) NUMBER (IF KNOWN): K993130
DEVICE NAME: ULTRA-GARMENT
INDICATIONS POR USE:
RDTSCAN
ULTRA GARMENTS: ARE USED WITH LEGALY MARKETED TRANSCUTAINEIOUS ELECTRICAL NERVE STIMULATORS, (LE.N.S.), HIGH VOLT PULSED GAVINIC STIMULATORS, (H.V.P.G.), AND INTERFERENTIAL. (INF), UNITS.
NRo for
(Division Sign-Off) Division of General Restorative Devices K993130 510(k) Number .
(FLASSE DO NOT WRITE BRICH THIS LINE-CONTINUE ON ANOTH IF NEBOBD.)
Concurrence of CORK, Office of Device Braluation (
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Coun (Optional F