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.

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.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Beactive® Brace:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a numerical or pass/fail threshold manner. Instead, it describes general effectiveness and safety observations. Based on the provided "Effectiveness" and "Safety" sections, we can infer the following:

Acceptance Criteria (Implied)	Reported Device Performance
Effectiveness:
- Temporary reduction of lower back pain that radiates down the leg associated with normal household or work activities.	- Temporarily reduced low back pain that radiates down the leg associated with normal household or work activities for a majority of subjects. - Produced clinically significant reduction in pain (≥30%) in 52% of subjects. - Pain index reported at 15 minutes and 1 hour (while performing activity or in the worst pain position) declined clinically significantly: 32% (15 min) and 40% (1 hour). - Clinically significant improvement in the disability index (Oswestry Disability Index Questionnaire) in 12% of subjects in the treatment group (after four days or one week of wear).
Safety:
- Absence of adverse events.	- Subjects experienced no adverse events during the clinical trials. - Some subjects experienced an increase in pain, but labeling cautions the user to cease use and consult a physician if this occurs. - Some individuals may be sensitive to materials, but labeling cautions the user to stop if skin becomes irritated.
Biocompatibility:
- Meet biocompatibility standards for medical devices.	- Battery of testing included: Cytotoxicity, Sensitization, Irritation. (Results are not detailed beyond stating they were "conducted").

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample size for the clinical study. It refers to "a majority of subjects," "52% of subjects," and "12% of subjects," which indicates a quantitative study, but the total 'N' is missing.

Sample Size: Not specified (referred to as "subjects").
Data Provenance: Not explicitly stated (e.g., country of origin). It's a clinical study conducted as part of a 510(k) submission, suggesting it was likely conducted in accordance with FDA regulations, but whether it was prospective or retrospective is also not stated. However, the design of "before using," "while performing motion," "while at rest," and "after a week" suggests a prospective design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth independently for the clinical study. The "ground truth" for pain reduction and disability improvement was based on self-reported patient outcomes using established scales (10-point pain scale, Oswestry Disability Index Questionnaire).

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for the clinical study data or for establishing ground truth. The data appears to rely on direct patient reporting.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was performed or mentioned. The clinical study evaluated the Beactive® Brace itself, not its impact on human reader performance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Beactive® Brace is a physical medical device (limb orthosis), not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" study does not apply.

7. The Type of Ground Truth Used

For Clinical Study: Patient self-reported pain levels (10-point pain scale) and disability index scores (Oswestry Disability Index Questionnaire). This is considered outcomes data / patient-reported outcomes.
For Biocompatibility: Laboratory testing results (Cytotoxicity, Sensitization, Irritation). This is laboratory-based evidence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as it's not an AI/ML model.

Summary

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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

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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

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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 126Glen 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

V. INDICATIONS FOR USE

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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

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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.

--- END OF 510(K) SUMMARY ---

Regulation Number and Section

§ 890.3475 Limb orthosis.

Link to an amendment published at 90 FR 55994, Dec. 4, 2025. (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.