(90 days)
K/DEN number and list them here in a comma separated list exactly as they appear in the text:
Not Found
No
The device description and performance studies focus on mechanical pressure application and adjustment, with no mention of AI or ML technologies.
Yes
The device is intended to reduce symptoms of nausea, which is a therapeutic purpose.
No
The device is intended to reduce symptoms of nausea by applying pressure to an acupressure point, not to diagnose a condition.
No
The device description clearly describes a physical wrist bracelet with a bump and Velcro strap, indicating it is a hardware device, not software-only.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The TumEase Acupressure bracelet works by applying pressure to an acupressure point on the wrist. It does not involve testing any samples from the body.
- Intended Use: The intended use is to reduce symptoms of nausea through physical pressure, not through diagnostic testing.
The device description and intended use clearly indicate a physical therapy or complementary medicine approach, not an in vitro diagnostic method.
N/A
Intended Use / Indications for Use
The acupressure bracelets 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
The TumEase Acupressure bracelet is a wrist bracelet that has a small round bump on the inside face of the bracelet. This small bump is manually aligned with the P6 (Neiguan or Pericardium) acupressure point. The bracelet is affixed using a Velcro strap and the desire amount of pressure is applied. One key design feature is the ability to adjust the pressure level using the "tightness" of the Velcro strap. More pressure generally increases the desired anti-nausea affect. The functionality of the Veloro strap allows each patient the ability to find the right amount of pressure for themselves based on their condition and needs. In addition, the TumEase bracelets are designed to be cosmetically attractive. It is supplied to the counter (non-sterile). The acupressure bracelets are intended to be worn over a thin fabric. It can be used as frequently as needed by the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing (Bench):
Testing was conducted to compare the TumEase product to the Acu-Strap product in terms of force applied. The Acu-Strap product was selected for testing since it is approved and nonadjustable. The fixed applied pressure from the Acu-Strap product introduced less variability into the testing.
A key design advantage of the TumEase product is its adjustability in terms of acupressure delivery. This feature allows the patient to find a setting that is right for them.
As proven by the testing, the TumEase product can provide the user with a range of pressures and the Acu-Strap fixed pressure are inside of the TumEase pressure range. In addition, the "medium/normal" wear condition for the TumEase product is very close to the fixed pressure for the Acu-Strap product.
Therefore, the performance of the TumEase product was shown to be at least equivalent and could be better due to its ability to adjust to the patients' needs in terms of force delivered.
Clinical Testing:
No Clinical Testing was required for this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Acu-Strap (K041877), Pressure Right (K142471)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 4, 2020
MumEase % Bill Jacqmein CEO Medavice, Inc. 1321 Upland Drive; Suite 6792 Houston, Texas 77043
Re: K193374
Trade/Device Name: TumEase Acupressure Bracelets Regulatory Class: Unclassified Product Code: MVV Dated: December 5, 2019 Received: December 5, 2019
Dear Bill Jacqmein:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Heather Dean, PhD Acting Assistant Director, Acute Injury Devices Team 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)
Device Name
TumEase Acupressure Bracelets
Indications for Use (Describe)
The acupressure bracelets 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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510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | MumEase |
|---|---|
| Company Contact Person: | Catherine Varley, CEO |
| Phone: | (704) 499-0044 |
| Email: | Catherine.Varley@mumease.com |
| Submission | |
| Correspondent: | Bill Jacqmein, Regulatory Affairs Consultant |
| Address: | 11218 Zest Ct. NE, Blaine, MN 55449 |
| Phone: | (404) 216-6190 |
| Email: | bjacqmein@medavice.com |
| Date Prepared: | October 2019 |
| Proprietary Name: | TumEase Acupressure Bracelets |
| Common Name: | Pressure Band, Acupressure Device |
| Product Code: | MVV |
| Device Classification: | Unclassified |
| Predicate Devices: | Acu-Strap (K041877) |
| Pressure Right (K142471) |
Device Description:
The TumEase Acupressure bracelet is a wrist bracelet that has a small round bump on the inside face of the bracelet. This small bump is manually aligned with the P6 (Neiguan or Pericardium) acupressure point. The bracelet is affixed using a Velcro strap and the desire amount of pressure is applied. One key design feature is the ability to adjust the pressure level using the "tightness" of the Velcro strap. More pressure generally increases the desired anti-nausea affect. The functionality of the Veloro strap allows each patient the ability to find the right amount of pressure for themselves based on their condition and needs. In addition, the TumEase bracelets are designed to be cosmetically attractive. It is supplied to the counter
4
(non-sterile). The acupressure bracelets are intended to be worn over a thin fabric. It can be used as frequently as needed by the patient.
Indications for Use:
The acupressure bracelets are intended to reduce symptoms of nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Comparison to Predicate Devices:
| Specification | TumEase | Pressure Point
(K142471) | Acu-Strap (K041877) | Comparison Result |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Indication for
Use | 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). | Pressure Right® is a
drugfree, Single-Use,
Pressure- Sensitive
Acupressure Wrist Strip,
externally applied,
which is indicated for
relief of nausea
symptoms associated
with chemotherapy,
postoperative,
pregnancy (morning
sickness) and
travel/motion. | The Acu-Strap Travel
and Motion Sickness
Band is intended for
the relief of nausea.
Nausea may be
experienced due to
Travel (Motion
Sickness), Pregnancy
(Morning Sickness),
Anesthesia or
Chemotherapy. | Equivalent |
| Over the
Counter Use | Yes | Yes | Yes | Equivalent |
| How
Supplied | Two bracelets in a
plastic case with
Instructions for Use
Contact Point: | Two Wrist Straps with
Instructions for Use in
pouch.
Contact Point: | Not publicly available | Equivalent |
| Materials | Medical Grade
Stainless Steel (316)
Other wrist Bracelet
components:
Cloth and Velcro
Strap | Medical Grade: Lustran
ABS 348; Plastic
Other wrist Band
components:
3 M Transpore Surgical
Tape (adjustable). | Not publicly available | Equivalent |
| Dimensions | Pressure point:
Diameter: 0.48 | Diameter: 0.52 inches
Band: 5.5 inches long | Not publicly available | Equivalent |
| | inches; | and 1 inch wide | | |
| | Bracelet is 13 inches | | | |
| | long by 1 inch wide | | | |
| | Adjustable: | Adjustable: | Not publicly available | |
| Contact
Pressure | Lbf: 0.74 @ Normal
Lbf : 0.26 @ Loose | 5 to 7 lbs/sq. inch
(Per their 510k) | | Equivalent |
| Where Used | Wrist (over thin
fabric); P6 | Wrist; P6 | Wrist; P6 | Equivalent |
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Performance Testing (Bench)
Testing was conducted to compare the TumEase product to the Acu-Strap product in terms of force applied. The Acu-Strap product was selected for testing since it is approved and nonadjustable. The fixed applied pressure from the Acu-Strap product introduced less variability into the testing.
A key design advantage of the TumEase product is its adjustability in terms of acupressure delivery. This feature allows the patient to find a setting that is right for them.
As proven by the testing, the TumEase product can provide the user with a range of pressures and the Acu-Strap fixed pressure are inside of the TumEase pressure range. In addition, the "medium/normal" wear condition for the TumEase product is very close to the fixed pressure for the Acu-Strap product.
Therefore, the performance of the TumEase product was shown to be at least equivalent and could be better due to its ability to adjust to the patients' needs in terms of force delivered.
Clinical Testing
No Clinical Testing was required for this product.
Statement of Equivalence
Based on comparison of indications for use, technological features, and performance testing, the TumEase Acupressure Bracelet has been shown to be substantially equivalent to the legally marketed predicate device. This device does not raise any new safety or effectiveness questions as compared to the predicate devices.