(269 days)
No
The device description and performance studies focus on mechanical compression and do not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is described as "Applied...for the purposes of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities." This intended use, which is to alleviate or reduce the symptoms of a medical condition (pain), classifies it as having a therapeutic purpose.
No
The device is a brace intended to temporarily reduce lower back pain; it does not measure or detect any physiological data to diagnose a condition.
No
The device description clearly describes a physical brace with a pressure pad and Velcro strap, indicating it is a hardware device, not software only.
Based on the provided information, the Beactive Brace is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Beactive Brace Function: The Beactive Brace is a physical device applied externally to the body. It works by applying pressure to a muscle to temporarily reduce pain. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "temporarily reducing lower back pain that radiates down the leg." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a physical brace with a pressure pad and strap, not equipment for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, chemical reactions, or any other processes associated with IVD devices.
Therefore, the Beactive Brace falls under the category of a physical medical device used for pain management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Beactive Brace is applied to the upper calf just below the knee such that the pressure pad presses against the soleus muscle located just to the outside of the knee for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
Product codes
PMV
Device Description
The Beactive® Brace is a brace intended to temporarily reduce lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is an adjustable, cylindrically-shaped band that fits over the upper calf on either leg. Integrated into the wall of the brace is a disk-shaped protrusion (pressure pad) that projects inward the leg. The pressure pad presses against the soleus muscle located just to the back of the knee. The pressure pad exerts even pressure on the soleus muscle near its origin at the fibula. The Velcro strap is designed to focus the pressure on the pressure pad on the calf. As a soleus muscle compression brace, it uses both compression as well as anterior glide forces onto the proximal tibiofibular joint to temporarily reduce low back pain.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper calf, soleus muscle, fibular head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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
Clinical Study:
Primary effectiveness endpoint: Subjects evaluated the pain they experienced on a standard 10-point pain scale. They evaluated the worst and least pain:
- before using the Brace (qualifying),
- while performing the motion that caused the worst pain after applying the Brace,
- while at rest when wearing the Brace, and
- after a week of wearing the Brace.
Secondary effectiveness endpoint: Subjects completed an Oswestry Disability Index Questionnaire before wearing the brace and after a period of time (four days or one week) of wearing the Brace.
Effectiveness: The clinical trials provide evidence that the Beactive® Brace temporarily reduced low back pain that radiates down the leg associated with normal household or work activities for a majority of subjects and produced clinically significant reduction in pain (≥30%) in 52% of subjects. The pain index reported at 15 minutes and 1 hour while performing activity or being in the position in which the pain was worst declined clinically significantly 32% at 15 minutes and 40% at 1 hour. In the case of the Beactive® Brace studies, a minority of subjects reported no change or an increase in pain score. Labeling cautions that the user should cease using the brace and consult a physician if the pain increases. Similarly, the scores for the disability index before and after the study demonstrate a clinically significant improvement in 12% of subjects in the treatment group.
Safety: Subjects experienced no adverse events during the clinical trials. Some subjects experienced an increase in pain; however, the instructions caution that the user should cease using the Brace if they experience an increase in pain. Some individuals may be sensitive to the materials of the Brace; however, labeling cautions that the user should stop using the Brace if the skin becomes irritated.
Summary: Based on the clinical performance as documented in the clinical study, the Beactive® Brace was found to have a safety and effectiveness profile that is similar to other limb orthosis devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3475 Limb orthosis.
(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
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Image /page/0/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 an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
Natures Pillows, Inc. c/o Thomas C. Knott Benjamin L. England and Associates, LLC 810 Landmark Drive. Suite 126 Glen Burnie, MD 21061
Re: K151476
Trade/Device Name: Beactive® Brace Regulation Number: 21 CFR 890.3475 Regulation Name: Limb Orthosis Regulatory Class: Class I Product Code: PMV Dated: 01/20/2016 Received: 01/21/2016
Dear Mr. Knott,
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. 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 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
1
CFR Part 807); labeling (21 CFR Part 80; medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J.Hoffmann -A
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151476
Device Name Beactive Brace
Indications for Use (Describe)
The Beactive Brace is applied to the upper calf just below the knee such that the pressure pad presses against the soleus muscle located just to the outside of the knee for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K151476 (per 21 CFR 807.92)
l. SUBMITTER
| Submitted By: | Benjamin L. England And Associates, LLC |
|---|---|
| Address: | 810 Landmark Drive Suite 126 |
| Glen Burnie, MD 21061 | |
| Phone: | (410) 220-2800 |
| Fax: | (443) 583-1464 |
| E-mail: | tcknott@fdaimports.com |
| Contact: | Thomas C. Knott, Senior Regulatory Consultant |
Date Prepared: February 26, 2016
II. SUBJECT DEVICE
| Name of Device: | Beactive® Brace |
|---|---|
| Common or Usual Name: | Orthosis, limb, for back pain |
| Classification Name: | Limb Orthosis |
| Regulatory Class: | Class I Exempt |
| Product Code: | PMV |
| Classification | 21 CFR 890.3475 |
III. PREDICATE DEVICE
| Primary | K821582 | Warm'n Form Sports Supports | Product Code IQI |
|---|---|---|---|
| Predicate | (Jerome Medical) | 21 CFR 890.3475 Limb Orthosis | |
| Reference | K003128 | Modification to Relief Brief | Product Code NJB |
| Predicate | (The JM Kohn Co.) | 21 CFR 890.3490 Truncal Orthosis |
IV. DEVICE DESCRIPTION
The Beactive® Brace is a brace intended to temporarily reduce lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is an adjustable, cylindrically-shaped band that fits over the upper calf on either leg. Integrated into the wall of the brace is a disk-shaped protrusion (pressure pad) that projects inward the leg. The pressure pad presses against the soleus muscle located just to the back of the knee. The pressure pad exerts even pressure on the soleus muscle near its origin at the fibula. The Velcro strap is designed to focus the pressure on the pressure pad on the calf. As a soleus muscle compression brace, it uses both compression as well as anterior glide forces onto the proximal tibiofibular joint to temporarily reduce low back pain.
V. INDICATIONS FOR USE
4
The Beactive® Brace is applied to the upper calf just below the knee such that the pressure pad presses against the soleus muscle located just to the outside of the back of the knee for the purposes of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is intended for over-the-counter distribution.
VI. COMPARISON WITH THE PREDICATE DEVICE
Spasms of the soleus muscle cause the fibular head to move in posterior direction, which strains the peroneal nerve. The Brace falls within the definition of 21 CFR 890.3475 because it provides pain reduction by repositioning the fibular head, which aligns body structures for functional improvement or corrects deformities. It is similar to a limb orthosis such as K821582 supports lower limb structures. The reference predicate was cleared for use as a lumbo-sacral support and as an acupressure device for the purpose of reducing menstrual pain symptoms (including cramps, abdominal pain, and backache) and reducing pain medication use associated with menstruation.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Beactive® Brace was conducted and the battery of testing included the following tests:
- . Cytotoxicity
- Sensitization
- Irritation
Clinical Study
Primary effectiveness endpoint: Subjects evaluated the pain they experienced on a standard 10point pain scale. They evaluated the worst and least pain:
- before using the Brace (qualifying),
- . while performing the motion that caused the worst pain after applying the Brace,
- while at rest when wearing the Brace, and
- after a week of wearing the Brace.
Secondary effectiveness endpoint: Subjects completed an Oswestry Disability Index Questionnaire before wearing the brace and after a period of time (four days or one week) of wearing the Brace.
Effectiveness
The clinical trials provide evidence that the Beactive® Brace temporarily reduced low back pain that radiates down the leg associated with normal household or work activities for a majority of subjects
5
and produced clinically significant reduction in pain (≥30%) in 52% of subjects. The pain index reported at 15 minutes and 1 hour while performing activity or being in the position in which the pain was worst declined clinically significantly 32% at 15 minutes and 40% at 1 hour. In the case of the Beactive® Brace studies, a minority of subjects reported no change or an increase in pain score. Labeling cautions that the user should cease using the brace and consult a physician if the pain increases.
Similarly, the scores for the disability index before and after the study demonstrate a clinically significant improvement in 12% of subjects in the treatment group.
Safety
Subjects experienced no adverse events during the clinical trials. Some subjects experienced an increase in pain; however, the instructions caution that the user should cease using the Brace if they experience an increase in pain. Some individuals may be sensitive to the materials of the Brace; however, labeling cautions that the user should stop using the Brace if the skin becomes irritated.
Summary
Based on the clinical performance as documented in the clinical study, the Beactive® Brace was found to have a safety and effectiveness profile that is similar to other limb orthosis devices.
VIII. CONCLUSION
The intended use of the Beactive® Brace is the same as other limb orthosis devices with the additional indication of temporarily reducing low back pain that radiates down the leg associated with normal household or work activities. The primary predicate K821582 Warm'n Form Sports Support is a limb orthosis that provides firm support of the muscles and stimulates an injured leg to provide gentle compression. The referenced predicate K003128 is a truncal orthosis device that is indicated for reducing pain symptoms. The Beactive Brace's pressure pad is a different technology from typical limb orthosis devices. However, it raises no new safety issues. Clinical stow that it is effective in temporarily reducing low back pain that radiates down the leg associated with normal household or work activities. Therefore, the subject device is substantially equivalent to the predicate devices.
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