(109 days)
Not Found
No
The device description and intended use focus on a conductive garment that facilitates electrode placement for electrical stimulation. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device acts as an interface for electrical stimulators (NMES/TENS) and is used to facilitate the positioning of stimulating sites, rather than providing the therapeutic electrical stimulation itself.
No.
The device acts as an interface for electrical stimulators to facilitate positioning of stimulation sites, and does not mention any diagnostic capabilities.
No
The device description clearly states it is a "non-sterile, reusable conductive garment" constructed of various materials, indicating it is a physical hardware device, not software.
Based on the provided text, the Neurotech Recovery device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Neurotech Recovery Function: The description clearly states that the Neurotech Recovery is a conductive garment that acts as an interface between adhesive electrodes on the patient's skin and an electrical stimulator. It facilitates the positioning of stimulation sites for NMES or TENS.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely related to the delivery of electrical stimulation to the body surface.
Therefore, the Neurotech Recovery falls under the category of a medical device used for therapeutic purposes (electrical stimulation), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Neurotech Recovery is intended for home use. Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.
The Neurotech Recovery - Back Conductive Garment for the back and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the low back.
The Neurotech Recovery - Back Conductive Garment for the abdomen and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the abdominal area.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Neurotech Recovery is a non-sterile, reusable conductive garment for single patient use only. It acts as an interface between the adhesive electrodes on the patient's skin and the Neurotech Plus electrical stimulator which provides Neuromuscular Electrical Stimulation (NMES) or Transcutaneous Electrical Nerve Stimulation (TENS).
The Neurotech Recovery is available as two options, each targeting separate areas of the human anatomy;
-
- The Neurotech Recovery for the lower back which is constructed of the following materials: Main Panels: 89% Nylon & 11% Spandex laminated to Polyurethane, Silver Trace, Binding: 100% Cotton & Hook and Loop Fastener: 100% Nylon
-
- The Neurotech Recovery for the abdomen which is constructed of the following materials; Main Panels: 100% Nylon, Binding: 82% Nylon & 18% Elastane, Hook and Loop Fastener: 100% Nylon & Foam Padding: 100% Polyurethane
Included with each Neurotech Recovery conductive garment are conductive gel pads, an extender strap and instructions for use. The device is intended be available by prescription only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back, abdominal area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use, under a prescription order from a licensed practitioner.
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)
No clinical tests have been submitted as part of this premarket notification.
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
§ 882.1320 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/0 description: The image shows a handwritten text "K 112 934" enclosed in a circle. The text appears to be a combination of letters and numbers. The handwriting is simple and clear, making the text easily readable. The circle around the text emphasizes the content.
Image /page/0/Picture/2 description: The image shows the logo for bio-medical research ltd. The logo consists of the letters "bmr" in a bold, sans-serif font, with the words "bio-medical research ltd." written in a smaller font below. There is a curved line going through the letters "bmr".
Bio-Medical Research Ltd.
Parkmore Business Park West. Galway, Ireland Tel: +353 (0)91 774300 _- Fax: +353 (0)91 774301
This 510k Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Contact Details
| Name: | Anne-Marie Keenan |
|---|---|
| Address: | Bio-Medical Research Ltd., |
| Parkmore Business Park, West | |
| Galway, Ireland | |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774302 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | December 22, 2011 |
2. Device Name
| Trade Name of Device: | Neurotech Recovery |
|---|---|
| Common Name: | Conductive Garment |
| Regulation Number: | 21 CFR 882.1320 |
| Regulation Name: | Cutaneous Electrode |
| Product Code: | GXY |
| Device Class: | 2 |
3. Identification of Equivalent Legally Marketed Device
| 510(k) Number: | K070142 |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | System-Abs |
| 510(k) Number: | K082190 |
| Manufacturer: | Bio-Medical Research Ltd. |
Baxolve XP Conductive Garment Trade Name:
Directors: T. Kirwan (Chairman), Dr. P.A. Smith (Managing), Dr. B. McDonnell, C. Minogue, P. McGrath
1
K11293Y
4. Description of Device
The Neurotech Recovery is a non-sterile, reusable conductive garment for single patient use only. It acts as an interface between the adhesive electrodes on the patient's skin and the Neurotech Plus electrical stimulator which provides Neuromuscular Electrical Stimulation (NMES) or Transcutaneous Electrical Nerve Stimulation (TENS).
The Neurotech Recovery is available as two options, each targeting separate areas of the human anatomy;
-
- The Neurotech Recovery for the lower back which is constructed of the following materials: Main Panels: 89% Nylon & 11% Spandex laminated to Polyurethane, Silver Trace, Binding: 100% Cotton & Hook and Loop Fastener: 100% Nylon
-
- The Neurotech Recovery for the abdomen which is constructed of the following materials; Main Panels: 100% Nylon, Binding: 82% Nylon & 18% Elastane, Hook and Loop Fastener: 100% Nylon & Foam Padding: 100% Polyurethane
Included with each Neurotech Recovery conductive garment are conductive gel pads, an extender strap and instructions for use. The device is intended be available by prescription only.
5. Statement of Intended Use/Indications for Use
Intended Use:
The Neurotech Recovery is intended for home use. Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.
Indications for Use:
The Neurotech Recovery - Back Conductive Garment for the back and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the low back.
The Neurotech Recovery - Back Conductive Garment for the abdomen and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the abdominal area.
2
Image /page/2/Picture/0 description: The image shows a handwritten text "K 112 93 4" enclosed in an oval shape. The text appears to be a combination of an alphabet and numbers. The handwriting is simple and clear, with each character distinctly visible within the oval.
6. Summary of Technological Characteristics
There are no new technological characteristics that could affect safety or effectiveness of the Neurotech Recovery device. No clinical tests have been submitted as part of this premarket notification. The Neurotech Plus device complies with the following international standards:
- I.S. EN ISO 14971 2007 Medical devices Application of risk management to . medical devices
- EN ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process (ISO 10993-1:2009)
- EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in . vitro cytotoxicity (ISO 10993-5:2009)
- . EN ISO 10993-10:2002 & Amendment 1 2006 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2002/Amd. 1:2006
Based on substantial equivalence analysis carried out between the proposed Neurotech Recovery device and the listed predicates, we believe that the proposed device is safe and effective.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bio-Medical Research Ltd. c/o Ms. Anne-Marie Keenan Quality & Regulatory Engineer Parkmore Business Park West Galway. Ireland
JAN 2 0 2012
Re: K112934 -
Trade/Device Name: Neurotech Recovery Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 21, 2011 Received: December 22, 2011
Dear Ms. Keenan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave as nowe 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 for associated in the 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 r lease be actived that i Dr unation that your device complies with other requirements of the Act that I DA has intates and regulations administered by other Federal agencies. You must or any I caolar statures and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI it rail 607), lacemig (21 CFR 803); good manufacturing practice requirements as set de rice-related duverse ovents) (21 CFR Part 820); and if applicable, the electronic a form in the quality by bioline (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Anne-Marie Keenan
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/CDRH/CDRHOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Debra Falls
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Neurotech Recovery-Back
Indications for Use:
The Neurotech Recovery - Back Conductive Garment for the back and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the low back.
The Neurotech Recovery - Back Conductive Garment for the abdomen and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the abdominal area.
Prescription Use _X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112934