(73 days)
Not Found
No
The device description details a simple electrical stimulator with fixed parameters and no mention of adaptive or learning capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for use "as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand," which clearly defines it as a therapeutic device.
No
The intended use states that the device is indicated for use as an adjunctive therapy in reducing pain and stiffness. It is not described as being used to diagnose a medical condition.
No
The device description explicitly states it is a "portable, rechargeable, battery-operated dual-channel device" and lists hardware components like "electrodes, lead wires and a signal generator." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce pain and stiffness associated with rheumatoid arthritis of the hand. This is a therapeutic use, applied directly to the patient's body.
- Device Description: The device is a stimulator that delivers electrical pulses through electrodes applied to the hand. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such activity.
Therefore, the BioniCare Stimulator, Model BIO-1000™, is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BioniCare® Stimulator Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
Product codes
GZJ, NYN
Device Description
The BIO-1000 is a portable, rechargeable, battery-operated dual-channel device that utilizes a voltage regulated output circuit to generate a spike-shaped monophasic pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz.
The device consists of electrodes, lead wires and a signal generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC & 2005
Section 5. 510(k) Summary
510(k) Summary
Submitter Information:
Kent Hoffman Executive Vice President Rescarch, Development And Regulatory Affairs and Chief Technical Officer BioniCare Medical Technologies Inc. 47 R. Loveton Circle Sparks, MD 21152 (410) 472-1888
Date Prepared:
July 11, 2005
Name and Classification of Device:
Transcutaneous electrical nerve stimulator for pain relief, Class II, 21 CFR 882.5890, Product Code GZJ
Device:
BioniCare® Stimulator Model BIO-1000™
Predicate device:
BioniCare® Stimulator Model BIO-1000™, K030332 and K983228
Device Description:
The BIO-1000 is a portable, rechargeable, battery-operated dual-channel device that utilizes a voltage regulated output circuit to generate a spike-shaped monophasic pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz.
The device consists of electrodes, lead wires and a signal generator.
Statement of Intended use:
BioniCare® Stimulator Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
Summary of technological characteristics of New Device Compared to Predicate Device:
1
The new device's signal generator is identical to that in K030332. The electrical connection to the glove electrode was slightly modified so that if the insulating outer glove is removed, the conductive middle glove becomes nonconductive. A garment was added through which the lead wires travel to simplify use of the device and mitigate any tangling inconvenience or extremely remote strangling hazard.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
JUN - 8 2006
Kent Hoffman Executive Vice President Research, Development and Regulatory Affairs and Chief Technical Officer BioniCare Medical Technologies, Inc. 47 R. Loveton Circle Sparks, Maryland 21152
Re: K052625
Trade/Device Name: BioniCare® Stimulator, Model BIO-1000™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NYN Dated: September 22, 2005 Received: September 23, 2005
Dear Mr. Hoffman:
This letter corrects our substantially equivalent letter of December 5, 2005.
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 (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 Eederal Register.
3
Page 2 - Mr. Kent Hoffman
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.
This letter will allow you to continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Millican
Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/3/Picture/7 description: The image shows a circular seal with the text "FDA Centennial" in the center. The letters "FDA" are large and bolded. The seal is surrounded by a dotted border. The text "1906-2006" is at the top of the seal.
1 Promoting Public . Health
4
Indications for Use
510(k) Number (if known):_K052625
Device Name: BioniCare Stimulator, Model BIO-1000™
Indications For Use: The BioniCare Stimulator, Model BIO-1000™, is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
Prescription Use_J (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)
2
(Division Sign-Off) Division of General, Restorative. and Neurological scries 3
510(k) Number KO'S 262 > 262 >