(148 days)
The FridaMom Anti-Nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
The FridaMom Anti-nausea Bands are adjustable wrist bands which apply pressure to the Neiguan (P6) acupressure point to relive symptoms of nausea. The bands consist of an adjustable strap with a hemi-spherical button which applies pressure to the acupressure point.
The FridaMom Anti-Nausea Bands do not involve AI; therefore, many of the requested categories are not applicable. The device is a physical acupressure band.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device K193374) | Reported Device Performance (FridaMom Anti-Nausea Bands) |
|---|---|
| Intended to reduce symptoms of nausea due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure). | Intended to reduce symptoms of nausea due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure). |
| Applies pressure to the Neiguan (P6) acupressure point. | Applies pressure to the Neiguan (P6) acupressure point. |
| Pressure applied: 0.74 lbf (Normal), 0.26 lbf (Loose) (for Primary Predicate) | Variable Pressure that ranges from 0.52 lbf to 0.80 lbf. |
| Biocompatible materials (e.g., Cloth and Velcro, Medical Grade Stainless Steel). | Biocompatible materials (Silicone, ABS). Assessed for biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This device is not an AI/software device that uses a test set in the traditional sense. The "test" involved pre-clinical force measurements on human wrists and biocompatibility testing of materials.
- Data Provenance: The pre-clinical testing involved measurements on the 1st, 50th, and 99th percentile size female wrists to assess the force applied. The biocompatibility testing followed ISO standards, suggesting laboratory testing. No information on country of origin is specified for these tests. The study is best described as pre-clinical testing for equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device is based on physical properties (force applied, material biocompatibility) and comparison to predicate devices, not expert human assessment of diagnostic output.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study that involves human readers or adjudication.
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:
- Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" equivalent for acceptability in this submission primarily relies on:
- Substantial Equivalence: Comparison to legally marketed predicate devices (TumEase Acupressure Bracelets and Acu-strap Travel and Motion Sickness Band) in terms of intended use, technological characteristics (pressure application, materials, dimensions), and safety/efficacy.
- Pre-clinical Testing Results: Measurements of force applied to the Neiguan (P6) acupressure point on human wrists and biocompatibility testing of the device materials.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device that uses a training set.
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June 29, 2022
FridaBaby, LLC % Angela Lassandro Medical Device Consultant I-Squared Group, LLC 111 Ohlinger Road Shoemakersville, Pennsylvania 19555
Re: K220289
Trade/Device Name: FridaMom Anti-Nausea Bands Regulatory Class: Unclassified Product Code: MVV Dated: May 31, 2022 Received: June 1, 2022
Dear Angela Lassandro:
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 medical devices and radiation-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,
for Amber Ballard, PhD 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) K220289
Device Name FridaMom Anti-Nausea Bands
Indications for Use (Describe)
The FridaMom Anti-Nausea Bands are intended to reduce symptoms of nausea which 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 as required by 807.92(c) | ||
|---|---|---|
| Company Information: | FridaBaby, LLC82 NE 26th St, Suite 101Miami, FL 33137, USA | |
| Contact Name: | Angela F. LassandroMedical Device Consultantangela@isquared.group484.886.8165 | |
| Date Prepared: | 29 June 2022 | |
| Device Name: | FridaMom Anti-Nausea Bands | |
| Common Name: | Acupressure device | |
| Classification: | Class: Unclassified (Pre-Amendment)Product Code: MVV | |
| Equivalent Device: | TumEase Acupressure Bracelets (K193374, primary predicate)Acu-strap Travel and Motion Sickness Band (K041877, secondary predicate) | |
| Device Description: | The FridaMom Anti-nausea Bands are adjustable wrist bands which apply pressure to the Neiguan (P6) acupressure point to relive symptoms of nausea. The bands consist of an adjustable strap with a hemi-spherical button which applies pressure to the acupressure point. | |
| Intended Use: | The FridaMom Anti-nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure). | |
| TechnologicalComparison: | In comparison to the equivalent devices, the FridaMom Anti-nausea Bands:have an identical intended use applies similar pressure profiles to the Neiguan (P6) acupressure point to relieve the symptoms of nausea offers variable pressure and tightness with similar materials does not have differences in safety and efficacy associated with minor technological differences in material and dimensions Refer to the Substantial Equivalence Table below for specific differences in material and dimensional specifications. As noted above, these differences have no impact in safety and efficacy of the device. | |
| Pre-Clinical TestingComparison: | The force applied to the Neiguan (P6) acupressure point was found to be substantially equivalent between the examined devices. Pre-clinical testing was conducted on the 1st, 50th, and 99th percentile size female wrists with the force applied by the | |
| subject device. The force applied by the subject device wasfound to be substantially equivalent tothe predicate devices for each wrist size. | ||
| Biocompatibility (cytotoxicity, sensitization and irritation) of thesubject device was demonstrated per ISO 10993-1, ISO 10993-5 andISO 10993-10 | ||
| Clinical DataComparison: | Clinical data are not required for the determination of substantialequivalence. | |
| Equivalent Safety andEfficacy Conclusions: | Based on the technological and pre-clinical testing the FridaMomAnti-nausea Bands are substantially equivalent to the predicatedevices. Detailed substantial equivalence discussion is shown inthe Substantial Equivalence Table below. |
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510(k) Summary – K220289
Substantial Equivalence Table
| FridaMom Anti-nausea Bands(Subject Device) | TumEase Acupressure Bracelets(Primary Predicate) | Acu-Strap Travel and Motion Sickness Band(Secondary Predicate) | Substantial EquivalenceDiscussion | |
|---|---|---|---|---|
| (Subject Device) | (Secondary Predicate) | |||
| Classification | Unclassified; Product Code MVV | Unclassified; Product Code MVV, K193374 | Unclassified; Product Code MVV, K041877 | |
| Indications | The FridaMom Anti-Nausea Bandsare intended to reduce symptomsof nausea which may beexperienced due toTravel/Motion,Pregnancy/Morning Sickness,Chemotherapy, and Anesthesia(post-procedure). | The acupressure bracelets are intended toreduce symptoms of nausea. Nausea may beexperienced due to Travel/Motion,Pregnancy/Morning Sickness, Chemotherapy,and Anesthesia (post-procedure). | The Acu-Strap TM Travel and Motion Sickness Bandis intended for the relief of nausea.Nausea may be experienced due to Travel (MotionSickness), Pregnancy (Morning Sickness), Anesthesiaor Chemotherapy. | Identical with only slightgrammatical or formattingdifferences which have noimpact on the safety or efficacy. |
| BandDimensions | Length: 240.78mm (9.48 in)Width: 16.00 mm (0.63 in) | Length: 330.2 mm (13 in)Width: 25.4 mm (1 in) | Not publicly available | The most significanttechnological attribute of thedevices is the ability to applypressure to the Neiguan (P6)pressure point which has beenshown to be substantiallyequivalent. The dimensions ofthe subject device wereselected to accommodate wristsizes from the 1st to 90thpercentile of women. Theminor differences in dimensionsdo not impact the overall safetyand efficacy of the device. |
| BandMaterial | Silicone | Cloth and Velcro | Cloth and Plastic | The most significanttechnological attribute of thedevices is the ability to applypressure to the Neiguan (P6)pressure point which has beenshown to be substantiallyequivalent. Materials in bothdevices are well-established |
| materials which do not posesafety risks to the user. Thesubject device has beenassessed for biocompatibility.The minor differences inmaterial do not impact theoverall safety and efficacy of thedevice. | ||||
| PressurePointDimensions | Ø 10.16 mm (Ø 0.4 in) | Ø12.19 mm (Ø 0.48 in) | Not publicly available | The most significanttechnological attribute of thedevices is the ability to applypressure to the Neiguan (P6)pressure point which has beenshown to be substantiallyequivalent. The minordifferences in dimensions donot impact the overall safetyand efficacy of the device. |
| PressurePointMaterial | ABS | Medical Grade Stainless Steel (316) | Not publicly available | The most significanttechnological attribute of thedevices is the ability to applypressure to the Neiguan (P6)pressure point which has beenshown to be substantiallyequivalent. Materials in bothdevices are well-establishedmaterials which do not posesafety risks to the user. Thesubject devices has beenassessed for biocompatibility.The minor differences inmaterial do not impact theoverall safety and efficacy of thedevice. |
| PressurePointLocation | Neiguan (P6) | Neiguan (P6) | Neiguan (P6) | Identical |
| DeviceApplication& Features | Variable Pressure that ranges from0.52 lbf to 0.80 lbf(achieved through holes used toselect size)Non-elastic designUsed on both wrists | Adjustable:Lbf: 0.74 @ NormalLbf: 0.26 @ Loose | Non-variable pressure(one size)Elastic designUsed on both wrists | The subject and primarypredicate devices have a strapthat allows for variable tightnessusing a non-elastic design. Bothallow the user to control theamount of pressure andtightness of the band. Theminor differences in how thevariable tightness is achieved donot impact the overall safetyand efficacy of the device. Thesecondary predicate does notoffer variable pressure andrelies on elastic design toaccommodate wrist sizes. Thedifferences in how variablepressure are achieve do notraise issues of safety andefficacy.All devices are used on bothwrists simultaneously, raising no |
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510(k) Summary – K220289
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510(k) Summary – K220289
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