(90 days)
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).
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.
The provided document is a 510(k) summary for the TumEase Acupressure Bracelets, which is a regulatory submission to the FDA. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence.
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical performance metrics for clinical outcomes. Instead, it focuses on establishing substantial equivalence to predicate devices based on various specifications, and the "performance testing" section describes bench testing related to force applied.
Here's a breakdown of the comparison to predicate devices, which serves as the basis for demonstrating equivalence:
| Specification | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (TumEase) | Comparison Result |
|---|---|---|---|
| Indication for Use | Pressure Right® (K142471): Drug-free, 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.Acu-Strap (K041877): Intended for the relief of nausea. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy. | 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). | Equivalent |
| Over the Counter Use | Yes (for both predicates) | Yes | Equivalent |
| How Supplied | Pressure Right® (K142471): Two Wrist Straps with Instructions for Use in pouch.Acu-Strap (K041877): Not publicly available. | Two bracelets in a plastic case with Instructions for Use. | Equivalent |
| Materials | Pressure Right® (K142471): Medical Grade: Lustran ABS 348; Plastic. Other wrist Band components: 3M Transpore Surgical Tape (adjustable).Acu-Strap (K041877): Not publicly available. | Medical Grade Stainless Steel (316). Other wrist Bracelet components: Cloth and Velcro Strap. | Equivalent |
| Dimensions | Pressure Right® (K142471): Diameter: 0.52 inches, Band: 5.5 inches long and 1 inch wide. | Pressure point: Diameter: 0.48 inches; Bracelet is 13 inches long by 1 inch wide. | Equivalent |
| Adjustable | Yes (for Pressure Right® - tape)Not publicly available (Acu-Strap, but described as "nonadjustable" in performance testing section) | Adjustable: The functionality of the Velcro strap allows each patient the ability to find the right amount of pressure for themselves based on their condition and needs. | Equivalent |
| Contact Pressure | Pressure Right® (K142471): 5 to 7 lbs/sq. inch (Per their 510k)Acu-Strap (K041877): Fixed pressure (not quantified, but described as fixed and within TumEase range). | Lbf: 0.74 @ Normal, Lbf : 0.26 @ Loose. The "medium/normal" wear condition for the TumEase product is very close to the fixed pressure for the Acu-Strap product. TumEase product can provide the user with a range of pressures, and the Acu-Strap fixed pressure is inside of the TumEase pressure range. | Equivalent |
| Where Used | Wrist (over thin fabric); P6 (for both predicates) | Wrist (over thin fabric); P6 | Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only describes bench testing for "Performance Testing." It does not provide a specific sample size for this bench test, nor does it detail the number of units tested.
- Data Provenance: The bench testing involved comparing the TumEase product to the "Acu-Strap product." The origin of the Acu-Strap product or the environment of the test is not specified, but it's understood to be a controlled laboratory or engineering environment for mechanical testing. No patient data or clinical data provenance is mentioned as no clinical studies were conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "test set" described is for mechanical/bench testing of physical properties (force applied), not clinical performance requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for clinical studies where multiple experts independently evaluate data and consensus is needed. The testing performed was bench testing of physical attributes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The device is a physical acupressure bracelet, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" was based on measured physical properties (force applied) of the TumEase device and a predicate device (Acu-Strap). The fixed pressure of the Acu-Strap served as a reference point.
8. The sample size for the training set
Not applicable. The device is a physical product and does not involve machine learning or a "training set" in the context of AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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
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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 |
| SubmissionCorrespondent: | 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
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(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 forUse | The acupressurebracelets areintended to reducesymptoms of nausea.Nausea can becaused by a variety ofcauses someexamples includeTravel/Motion,Pregnancy/MorningSickness,Chemotherapy andAnesthesia (post-procedure). | Pressure Right® is adrugfree, Single-Use,Pressure- SensitiveAcupressure Wrist Strip,externally applied,which is indicated forrelief of nauseasymptoms associatedwith chemotherapy,postoperative,pregnancy (morningsickness) andtravel/motion. | The Acu-Strap Traveland Motion SicknessBand is intended forthe relief of nausea.Nausea may beexperienced due toTravel (MotionSickness), Pregnancy(Morning Sickness),Anesthesia orChemotherapy. | Equivalent |
| Over theCounter Use | Yes | Yes | Yes | Equivalent |
| HowSupplied | Two bracelets in aplastic case withInstructions for UseContact Point: | Two Wrist Straps withInstructions for Use inpouch.Contact Point: | Not publicly available | Equivalent |
| Materials | Medical GradeStainless Steel (316)Other wrist Braceletcomponents:Cloth and VelcroStrap | Medical Grade: LustranABS 348; PlasticOther wrist Bandcomponents:3 M Transpore SurgicalTape (adjustable). | Not publicly available | Equivalent |
| Dimensions | Pressure point:Diameter: 0.48 | Diameter: 0.52 inchesBand: 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 | ||
| ContactPressure | Lbf: 0.74 @ NormalLbf : 0.26 @ Loose | 5 to 7 lbs/sq. inch(Per their 510k) | Equivalent | |
| Where Used | Wrist (over thinfabric); 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.
N/A