(79 days)
Not Found
No
The device description and performance studies indicate a simple mechanical acupressure band with no mention of AI or ML technology.
Yes
The device is intended to reduce symptoms of nausea, which is a therapeutic purpose. Additionally, it applies pressure to a specific acupressure point (Nei-Kuan or P6), which is a physical intervention aimed at alleviating a medical symptom.
No
The device is intended to reduce symptoms of nausea by applying pressure to an acupressure point, not to diagnose any condition.
No
The device description explicitly states it is made of "comfortable fabric band straps with Velcro closures and a dome on the buckle," indicating it is a physical, hardware-based device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Bonine Acupressure Bands Function: Bonine Acupressure Bands work by applying physical pressure to an acupressure point on the wrist. They do not involve any testing of biological samples.
- Device Description: The description clearly states it's a fabric band with a dome that applies pressure. There is no mention of reagents, sample collection, or laboratory analysis.
- Intended Use: The intended use is to reduce symptoms of nausea through physical pressure, not through diagnostic testing.
Therefore, based on the provided information, Bonine Acupressure Bands fall under the category of a physical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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).
Product codes
MVV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist; Nei-Kuan or (P6) acupressure point.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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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3
Bonine Acupressure Bands 510(k) Summary K211823
| Submission Sponsor: | WellSpring Pharmaceutical Corporation
5911 North Honore Avenue, Suite 211
Sarasota, FL 34243 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Mikel Alberdi
Drug Device Consulting
13014 N. Dale Mabry Hwy., #326
Tampa, FL 33618
Phone: (813) 708-8303
Email: 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 Bracelets
K193374
510(k) Holder: MumEase
Secondary Predicate:
Sea-Band
K033268
510(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).
4
Comparison to Predicate Devices:
| Trade Name | Bonine Acupressure
Bands | TumEase Acupressure
Bracelet
K193374 | Sea-Band
K033268 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MVV | MVV | MVV |
| Regulation
Number | Unclassified | Unclassified | Unclassified |
| Regulation
Name | Device, Acupressure | Device, Acupressure | Device, Acupressure |
| 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). | The acupressure
bracelets are intended to
reduce symptoms of
nausea.
Nausea can be caused
by a variety of causes
some examples include
Travel/Motion,
Pregnancy/Morning
Sickness,
Chemotherapy and
Anesthesia (post-
procedure). | The Sea-Band Limited
"Sea-Band" is indicated
for the relief of nausea.
Nausea is a symptom
that may experienced
due to a variety of
causes, for example:
Travel/Motion
•
Pregnancy (Morning
Sickness)
•
Chemotherapy
•
Post Operative |
| Over-The-
Counter Use | Yes | Yes | Yes |
| How Supplied | Two bands per box | Two bracelets in a
plastic case | Supplied in pairs in a
plastic case |
| Band
Material | Nylon fabric with
Velcro closure | Cloth and Velcro
Strap | Not publicly available |
| Band
Dimension | 10.5 in x 1 in | 13 in long by 1 in wide | Not publicly available |
| Pressure Point
Button
Material | Polypropylene | Medical Grade Stainless
Steel (316) | Not publicly available |
| Pressure Point
Button
Dimension | Diameter: 0.52 in
Height: 0.26 in | Diameter: 0.48 in | Not publicly available |
| Contact
Pressure | Tight: 7.8 psi
Medium: 5.7 psi
Loose: 4.5 psi | Not publicly available. | Not publicly available |
| Where used | Wrist; Nei-Kuan or (P6)
acupressure point. | Wrist (over thin
fabric); Nei-Kuan or
(P6) acupressure point. | Wrist; Nei-Kuan or (P6)
acupressure point. |
| Device
Application | Worn on both wrists | Worn on both wrists | Worn on both wrists |
5
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.