(181 days)
Not Found
No
The device description details a standard TENS stimulator with fixed parameters and no mention of adaptive or learning capabilities. The performance studies focus on electrical characteristics and conformance to standards, not AI/ML performance metrics.
Yes
The device is indicated for use in reducing pain and stiffness associated with rheumatoid arthritis, which is a therapeutic purpose.
No
The device is indicated for use as an "adjunctive therapy in reducing the level of pain, and stiffness associated with pain," which describes a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "rechargeable battery operated TENS stimulator" and describes hardware components like electrodes and a voltage regulated output circuit.
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 application, not a diagnostic one.
- Device Description: The device is a TENS (Transcutaneous Electrical Nerve Stimulator) stimulator. TENS devices deliver electrical impulses to the body for pain relief. This is a physical therapy modality, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device directly interacts with the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Bionicare® Stimulator System Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffiess associated with pain, from rheumatoid arthritis of the hand.
Product codes (comma separated list FDA assigned to the subject device)
NYN
Device Description
The Bionicare Stimulator System, Model BIO-1000" is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. Electrodes are applied to the hand and arm using a standard clectrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08). The signal is applied across the cathodic hand electrode and the anodic arm electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, arm
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)
The descriptive characteristics presented are precise enough to ensure the substantial equivalence of the Bionicare to a legally marketed predicate device. The descriptive characteristics include the data provided in the device comparison uable above, as well as, the findings of performance testing. In particular, the performance data provides greater detail regarding the Bionicare's electrical characteristics, its conformance with voluntary standards, American National Standards Institute Standard for Transcutancous Electrical Nerve Stimulators ANSI/AAMI NS4-1985, items 3.1-3.1.3.1.3. 3.2.5, 4.0 - 4.2.5. Underwriters Laboratories Standard for Medical and Dental Equipment, UL 544 - July 8, 1994, Performance Section 42-Leakage Current, FDA Guide for TENS 510(k) Content, Draft August 1994, Munzner/Hinckley.
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
人
510(k) SUMMARY Bionicare® Stimulator System, Model BIO-1000'' September 14, 1998
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA) and I C.F.R § 807.92 . The information provided in the 510(k), premarket notification was in accordance with 21 C.F.R § 807.87 and the SMDA.
Submitter of 510(k) and Manufacturer 1.0
Murray Electronics 260 Schilling Circle Hunt Valley, MD 21031
| Attention: | Kent C. Hoffman |
|---|---|
| Telephone: | 410 771-0380 extension 231 |
| Facsimile: | 410 771-5576 |
2.0 Name of Device
Trade Proprietary Name 2.1
Bionicane® Stimulator System, Model BIO-1000"
Common/Usual Name 2.2
TENS (Transcutaneous Electrical Nerve Stimulator)
2.3 Classification Name
Transculaneous electrical nerve stimulator for pain relief (21CFRS 882.5890, class II).
Identification of Predicate Device 3.0
队员 下一
Bionicare® Stimulator System, Model BIO-1000™ Murray Electronics 510(k) Number K971437, July 22, 1997
4.0 Device Description
The Bionicare Stimulator System, Model BIO-1000" is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed
146
1
frequency of 100 ± 5 Hertz. Electrodes are applied to the hand and arm using a standard clectrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08). The signal is applied across the cathodic hand electrode and the anodic arm electrode.
5.0 Indications for Use
The Bionicare® Stimulator System Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffiess associated with pain, from rheumatoid arthritis of the hand.
6.0 Substantial Equivalence
The Bionicare® Stimulator System, Model BIO-1000™ for rheumatoid arthritis of the hand is substantially equivalent to a legally marketed predicate TENS an interest. The indications for use and technological characteristics of the Bionicare® Stimulator System, Model BIO-1000" for rheumatoid arthritis of the hand and the Bionicare® Stimulator System, Model BIO-1000™ for osteoarthritis of the knee, a legally marketed predicate device, are substantially equivalent. The technical characteristics of these devices are described in Table 6.0.1.
| Applicant Device | Predicate Device | |
|---|---|---|
| Manufacturer | Murray Electronics | Murray Electronics |
| Device | Bionicare Stimulator | Bionicare Stimulator |
| Model No. | BIO-1000 | BIO-1000 |
| Rheumatoid Arthritis (Hand) | Osteoarthritis (Knee) | |
| Output Voltage | 0-12 volts | 0-12 volts |
| Frequency | 100 Hertz | 100 Hertz |
| Pulse Width | .64 ms¹ | .64 ms¹ |
| Waveform | monophasic spike-pulse | monophasic spike-pulse |
| Pulse Charge | 20 $\mu$ C | 20 $\mu$ C |
| ANSI NS4 | Meets Std. | Meets Std. |
| Channels | single | single |
| Battery Power | 12 v rechargeable | 12 v rechargeable |
| Dimensions | 13.2 x 8.5 x 4.5 cm | 13.2 x 8.5 x 4.5 cm |
| Weight (Less Battery) | 235 grams | 235 grams |
| Charger | yes | yes |
Table 6.0.1 Device Comparison Table: Bionicare vs. Predicate Device
Pulse width fixed, mensured at 50% pulse amplitude
ANISHA ANY NEA 1994 1994 1994 1994 1
ANSI/AAMI NS4-1985. Iroms 3.1-3.1.2.1, 3.2-3.2.5, 4.1-4.2.3.2.
2
. . . -
:
, t
142
Performance Data
The descriptive characteristics presented are precise enough to ensure the substantial equivalence of the Bionicare to a legally marketed predicate device. The descriptive characteristics include the data provided in the device comparison uable above, as well as, the findings of performance testing. In particular, the performance data provides greater detail regarding the Bionicare's electrical characteristics, its conformance with voluntary standards, American National Standards Institute Standard for Transcutancous Electrical Nerve Stimulators ANSI/AAMI NS4-1985, items 3.1-3.1.3.1.3. 3.2.5, 4.0 - 4.2.5. Underwriters Laboratories Standard for Medical and Dental Equipment, UL 544 - July 8, 1994, Performance Section 42-Leakage Current, FDA Guide for TENS 510(k) Content, Draft August 1994, Munzner/Hinckley.
3
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized eagle with three human profiles incorporated into its design, representing the department's focus on health and human well-being.
Public Health Scrvice
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
JUN - 8 2006
Mr. Kent C. Hoffman General Manager Murray Electronics 260 Schilling Circle Hunt Valley, MD 21031
Re: K983228
Trade Name: Bionicare® Stimulator System, Model BIO-1000™ Regulatory Class: II Product Code: NYN Dated: December 15, 1998 Received: December 15, 1998
Dear Mr. Hoffman:
This letter corrects our substantially equivalent letter of March 16, 1999.
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 or a promatitos approvisions 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 ( vice 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.
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Page 2 – Mr. Kent C. 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. Mikkelsen
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/4/Picture/7 description: The image is a circular seal with the letters "FDA" in large, bold font in the center. Above the letters, the text "1906-2006" is visible. Below the letters, the word "Centennial" is written in a cursive font. The seal has a dotted border around the edge.
Protecting and Promoting Public Health
5
Indications For Usc
Device Name
Bionicare® Stimulator System, Model BIO-1000™
. . . .
Indications For Use
The Bionicare Stimulator System Model BIO-1000" is indicated for use as an The Blonicare "Sumulator System Model DFO-1000" is and stiffiess associated with pain, from rheumatoid arthritis of the hand.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQITHER PAGE) Consisterence of CDRH, Office of Device Evaluation (ODE)
Prescription Usex (Per 21 CFR 801.109) OR
Over-The-Counter:
(Optional Format 1-2-96)
(DHA
Division of G 510(k) Number