(79 days)
Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Bonine Acupressure Bands are acupressure devices made of comfortable fabric band straps with Velcro closures and a dome on the buckle. Bonine Acupressure Band's acupressure dome provides gentle pressure on the Nei-Kuan or P6 pressure point in the wrist. The amount of pressure applied is fully adjustable and allows the user to increase or decrease as needed. Bonine Acupressure Bands are provided for over-the-counter use to be worn directly as desired on the consumer's wrists.
This document pertains to the 510(k) premarket notification for the Bonine Acupressure Bands (K211823), intending to demonstrate its substantial equivalence to legally marketed predicate devices. It focuses on the device's ability to reduce symptoms of nausea by applying pressure to the Nei-Kuan (P6) acupressure point on the wrist.
Crucially, no clinical testing was conducted for this device. The demonstration of substantial equivalence relies primarily on:
- Comparison of Indications for Use: The Bonine Acupressure Bands share the same intended use (reduction of nausea symptoms) as the predicate devices (TumEase Acupressure Bracelets and Sea-Band).
- Comparison of Technological Features: The device operates on the same principle as the predicates, i.e., acupressure on the P6 point for nausea relief.
- Bench Performance Testing: The primary and only performance testing reported is non-clinical/bench testing to compare the contact pressure of the Bonine Acupressure Bands to the predicate device.
Given that no clinical study was performed, the typical elements of acceptance criteria and study design (such as sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in this context. The acceptance criteria here are implicitly met by demonstrating comparable physical properties to the predicate.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical study was performed, the acceptance criteria are not in the format of clinical efficacy targets (e.g., sensitivity, specificity). Instead, the "acceptance criteria" revolve around demonstrating comparable physical characteristics to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Bonine Acupressure Bands) |
|---|---|
| Intended Use: Reduce symptoms of nausea (due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, Anesthesia). | Met: Same Indications for Use as predicate devices. |
| Technological Principle: Apply pressure to Nei-Kuan or P6 acupressure point on the wrist. | Met: Utilizes a dome on the buckle to apply pressure to the Nei-Kuan (P6) pressure point. |
| Contact Pressure: Comparable average contact pressure to the predicate device. | Met: Bench testing showed "comparable to the predicate device and was able to provide a similar average contact pressure." |
| Materials: Biocompatible and safe for skin contact. | Met: Described materials (nylon fabric, Velcro, polypropylene) are standard for such devices. |
| Over-The-Counter Use: Suitable for consumer use without prescription. | Met: Specified for Over-The-Counter Use, consistent with predicates. |
| Safety and Effectiveness: Does not raise new questions of safety or effectiveness compared to predicates based on technological differences. | Met: Stated that "any differences in the technological characteristics or materials do not raise any new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No clinical test set data was used.
- Data Provenance: Not applicable. The performance data is from non-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. No expert ground truth was established as no clinical data was analyzed.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. This type of study evaluates human reader performance, which is not relevant for a device cleared based on substantial equivalence to physical properties and intended use.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical, non-electronic device; there is no "algorithm" to evaluate in standalone performance.
7. Type of Ground Truth Used:
- Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used. The basis for equivalence is the physical and functional similarity to predicate devices already cleared for the same indications.
8. Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" in the machine learning sense. Its design is based on the known, effective principles of acupressure and the established designs of predicate devices.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set ground truth was established.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" in this context is the non-clinical bench performance testing and the comparison of device characteristics (intended use, technological principle, materials, how supplied, application method, and dimensions) to the legally marketed predicate devices.
The key finding from the performance testing was that the Bonine Acupressure Bands were "comparable to the predicate device and was able to provide a similar average contact pressure in the pressure point bench testing." This demonstrates that the device physically functions similarly to the predicate in applying pressure.
The entire 510(k) submission, by definition, aims to prove "substantial equivalence" to existing legally marketed devices, rather than proving de novo clinical efficacy. The FDA's clearance (K211823) indicates their acceptance of this demonstration based on the provided non-clinical data and comparisons to predicate devices.
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September 1, 2021
WellSpring Pharmaceutical Corporation % Mikel Alberdi President Drug Device Consulting 13014 N. Dale Mabry Hwy., #326 Tampa, Florida 33618
Re: K211823
Trade/Device Name: Bonine Acupressure Bands Regulatory Class: Unclassified Product Code: MVV Dated: June 11, 2021 Received: June 14, 2021
Dear Mikel Alberdi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber Ballard, PhD For Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211823
Device Name Bonine Acupressure Bands
Indications for Use (Describe)
Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
| 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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Bonine Acupressure Bands 510(k) Summary K211823
| Submission Sponsor: | WellSpring Pharmaceutical Corporation5911 North Honore Avenue, Suite 211Sarasota, FL 34243 |
|---|---|
| Submission Correspondent: | Mikel AlberdiDrug Device Consulting13014 N. Dale Mabry Hwy., #326Tampa, FL 33618Phone: (813) 708-8303Email: malberdi@drugdeviceconsulting.com |
| Date Prepared: | June 11, 2021 |
| Trade Name: | Bonine Acupressure Bands |
| Common Name: | Acupressure Bands |
| Product Code: | MVV |
| Classification Regulation: | Unclassified |
| Classification Panel: | Neurology |
| Device Class: | Unclassified - Pre-Amendment |
| Predicate Device(s): | Primary Predicate:TumEase Acupressure BraceletsK193374510(k) Holder: MumEaseSecondary Predicate:Sea-BandK033268510(k) Holder: Sea-Band Ltd |
510(k) Summary - K211823
Device Description:
Bonine Acupressure Bands are acupressure devices made of comfortable fabric band straps with Velcro closures and a dome on the buckle. Bonine Acupressure Band's acupressure dome provides gentle pressure on the Nei-Kuan or P6 pressure point in the wrist. The amount of pressure applied is fully adjustable and allows the user to increase or decrease as needed. Bonine Acupressure Bands are provided for over-the-counter use to be worn directly as desired on the consumer's wrists.
Indications for Use:
Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
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Comparison to Predicate Devices:
| Trade Name | Bonine AcupressureBands | TumEase AcupressureBraceletK193374 | Sea-BandK033268 |
|---|---|---|---|
| Product Code | MVV | MVV | MVV |
| RegulationNumber | Unclassified | Unclassified | Unclassified |
| RegulationName | Device, Acupressure | Device, Acupressure | Device, Acupressure |
| Indications forUse | Bonine AcupressureBands are intended toreduce symptoms ofnausea. Nausea may beexperienced due toTravel/Motion,Pregnancy/MorningSickness,Chemotherapy, andAnesthesia (post-procedure). | The acupressurebracelets are intended toreduce symptoms ofnausea.Nausea can be causedby a variety of causessome examples includeTravel/Motion,Pregnancy/MorningSickness,Chemotherapy andAnesthesia (post-procedure). | The Sea-Band Limited"Sea-Band" is indicatedfor the relief of nausea.Nausea is a symptomthat may experienceddue to a variety ofcauses, for example:Travel/Motion•Pregnancy (MorningSickness)•Chemotherapy•Post Operative |
| Over-The-Counter Use | Yes | Yes | Yes |
| How Supplied | Two bands per box | Two bracelets in aplastic case | Supplied in pairs in aplastic case |
| BandMaterial | Nylon fabric withVelcro closure | Cloth and VelcroStrap | Not publicly available |
| BandDimension | 10.5 in x 1 in | 13 in long by 1 in wide | Not publicly available |
| Pressure PointButtonMaterial | Polypropylene | Medical Grade StainlessSteel (316) | Not publicly available |
| Pressure PointButtonDimension | Diameter: 0.52 inHeight: 0.26 in | Diameter: 0.48 in | Not publicly available |
| ContactPressure | Tight: 7.8 psiMedium: 5.7 psiLoose: 4.5 psi | Not publicly available. | Not publicly available |
| Where used | Wrist; Nei-Kuan or (P6)acupressure point. | Wrist (over thinfabric); Nei-Kuan or(P6) acupressure point. | Wrist; Nei-Kuan or (P6)acupressure point. |
| DeviceApplication | Worn on both wrists | Worn on both wrists | Worn on both wrists |
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Bonine Acupressure Bands 510(k) Summarv K211823
Performance Testing - Nonclinical/Bench
The performance of Bonine Acupressure Bands was comparable to the predicate device and was able to provide a similar average contact pressure in the pressure point bench testing.
Performance Testing - Clinical
Not applicable. No clinical testing was conducted.
Substantial Equivalence
Bonine Acupressure Bands have the same intended use and similar characteristics as the predicate devices. The information and data provided in this submission demonstrates that any differences in the technological characteristics or materials do not raise any new questions of safety or effectiveness.
Based on comparison of indications for use, technological features, and performance testing, the Bonine Acupressure Bands has been shown to be substantially equivalent to the legally marketed predicate devices. This device does not raise any new safety or effectiveness questions as compared to the predicate devices.
N/A