Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.

Device Description

The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.

The Pressure Right device has a three-quarter wrist size design (5.50″ long X 1.0″ wide) with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.

AI/ML Overview

This document describes a 510(k) submission for the "Pressure Right® Acupressure, Pressure-Sensitive Wrist Strip" (K142471). The primary goal of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, particularly the Sea-Band® (K033268) for over-the-counter (OTC) use and an earlier version of the Pressure Right® (K110563) for prescription use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly based on demonstrating performance equivalence to already cleared predicate devices, specifically regarding the pressure exerted and overall functionality. Since this is a 510(k) for an acupressure device, the primary performance measure highlighted is the typical contact pressure.

Acceptance Criteria (Implied)	Reported Device Performance (Pressure Right®)
Equivalent typical contact pressure to predicate devices (5-7 lbs/sq. in)	5-7 lbs/sq. in
Overall design and biocompatibility requirements met	Meets all requirements
Output meets design inputs and specifications	Passed testing

2. Sample Size Used for the Test Set and Data Provenance

For the specific 510(k) submission K142471 describing the "Pressure Right® Acupressure, Pressure-Sensitive Wrist Strip," no clinical testing was performed. The non-clinical performance data relied on bench testing to evaluate the pressure equivalence between the Pressure Right device and the marketed predicate Sea-Band device. Therefore, there is no specified "test set" in terms of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective status for this submission.

The document states: "There was no new clinical testing required to support the medical device as bench testing was performed to evaluate the pressure equivalence of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device."

However, it does mention that the predicate device, Pressure Right (K110563), was clinically tested, and that clinical data was included in its original submission (K110563). The details of the sample size and provenance for that predicate study are not provided in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable, as no clinical test set was used for this specific submission (K142471). Bench testing was conducted to assess physical attributes.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for this specific submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC comparative effectiveness study was not conducted for this submission. The submission primarily relies on demonstrating substantial equivalence through non-clinical bench testing and comparison to predicate devices, including their existing clinical data.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, in a sense. The "device" in question is a physical acupressure wrist strip. The performance evaluation was essentially a standalone assessment of its physical characteristics (primarily pressure output) compared to a predicate device, without a human-in-the-loop performance study for this specific submission.

7. The Type of Ground Truth Used

For this specific submission (K142471), the "ground truth" for the non-clinical bench testing was the measured typical contact pressure of the predicate Sea-Band device (5-7 lbs/sq. in). The new Pressure Right device was expected to demonstrate equivalent pressure.

For the predicate Pressure Right device (K110563), the document states it was "clinically tested" and had "proven safety and efficacy for the use of the device." This implies an existing body of clinical outcomes data (e.g., reduction in nausea symptoms) served as the ground truth for that prior submission, but the specifics are not detailed here.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device requiring a training set. The device is a physical acupressure wrist strip.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/algorithm-based device requiring a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized design of an eagle or bird-like figure with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2014

Pressure Point Inc. c/o Julie Powell, Vice President Quality Assurance Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K142471

Trade/Device Name: Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip

Regulatory Class: Unclassified Product Code: MVV Dated: September 2, 2014 Received: September 3, 2014

Dear Ms. Julie Powell:

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. The general controls provisions of the Act include requirements for annual registration. Isting 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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K142471

Device Name

Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip (Pressure Right)

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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510(k) Summary

for

Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist

1. Submission Sponsor

Pressure Point Inc. 36 Green Meadow Drive Tinton Falls, NJ 07724 USA Contact: Joseph DiLustro, CEO Phone: 1 732 747 6046

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: PHONE Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Julie Powell, VP, QA Email: project.management@emergogroup.com

3. Date Prepared

September 2, 2014

4. Device Identification

Trade/Proprietary Name: Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip (Pressure Right)

Common/Usual Name:	Pressure Band, Acupressure Device
Classification Name:	Unclassified - Device, Acupressure
Classification Regulation:	NA
Product Code:	MVV
Device Class:	U (unclassified)
Classification Panel:	Neurology

5. Legally Marketed Predicate Device(s)

Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip Manufactured by Pressure Point, Inc. 510(k) K110563

Sea-Band® Manufactured by Sea-Band UK LTD. 510(k) K033268

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6. Device Description

The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.

7. Indication for Use Statement

Pressure Right® is a drug-free, Single-Use, Pressure-Sensitive Acupressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion. For Over-the-Counter (OTC) use.

8. Substantial Equivalence Discussion

The following table compares the Pressure Right OTC device to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	Pressure Point, Inc.	Pressure Point, Inc.	Sea-Band UK Ltd.
Trade Name	Pressure Right	Pressure Right	Sea-Band
510(k)Number	Unknown	K110563	K033268
Product Code	MVV	MVV	MVV
RegulationNumber	Unclassified	Unclassified	Unclassified
RegulationName	Device, Acupressure	Device, Acupressure	Device, Acupressure
Indications forUse	Pressure Right® is a drug-free, Single-Use, Pressure-Sensitive AcupressureWrist Strip, externallyapplied, which is indicatedfor relief of nauseasymptoms associated withchemotherapy, post-operative, pregnancy(morning sickness) andtravel/motion.	Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip isindicated for the relief ofemetic (nausea andvomiting) symptomsassociated with Post-Operative Anesthesia.Prescription Use	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
Manufacturer	Pressure Point, Inc.	Pressure Point, Inc.	Sea-Band UK Ltd.
Trade Name	Pressure Right	Pressure Right	Sea-Band
	Over-The-Counter Use		Over-The-Counter Use
How Supplied	Pressure Right is suppliedwith 2 perforated WristStrips in a sealed pouchwith instructions for use.Pressure Right device alsocomes with a unique P6locator template to aid indetermining an individual'sP6 pressure point.	Pressure Right is suppliedwith 2 perforated WristStrips in a sealed pouchwith instructions for use.Pressure Right device alsocomes with a unique P6locator template to aid indetermining an individual'sP6 pressure point.	Sea-Band supplied inpairs in a plastic case.
Wrist StripMaterial	3M™ Transpore SurgicalTapeManufactured from a low-density perforatedpolyethylene film with ahypoallergenic, pressure-sensitive, acrylate adhesive.	3M™ Transpore SurgicalTapeManufactured from a low-density perforatedpolyethylene film with ahypoallergenic, pressure-sensitive, acrylate adhesive.	Elasticated wrist band -specific materialunknown
Wrist StripDimension	5.50" long X 1.00" wide	5.50" long X 1.00" wide	Unknown, various sizes
Pressure PointButtonMaterial	Acrylonitrile butadienestyrene (Lustran ABS 348),Medical Grade	Acrylonitrile butadienestyrene (Lustran ABS 348),Medical Grade	Hard Plastic
Pressure PointButtonDimension	0.52″ diameter x 0.27″ high	0.52″ diameter x 0.27″ high	0.52″ diameter x 0.27″high
TypicalContactPressure	5-7 lbs/sq. in	5-7 lbs/sq. in	5-7 lbs/sq. in
Where used	Wrist, on Nei-Kuan or (P6)acupressure point.	Wrist, on Nei-Kuan or (P6)acupressure point.	Wrist, on Nei-Kuan or(P6) acupressure point.
DeviceApplication	Worn on both wrists, viaPressure sensitive tape /adhesive.	Worn on both wrists, viaPressure sensitive tape /adhesive	Worn on both wrist, viaelastic band
TargetPopulation	Adults, 18 years and older	Adults, 18 years and older	Adults and Children agetwo and up

Table 5A - Device Comparison Chart: Similarities and Differences

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9. Non-Clinical Performance Data

Summary of Non-Clinical Data Submitted

The following testing has been performed to support substantial equivalence:

. Bench testing to evaluate the psi pressure performance of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device to determine pressure equivalence.

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As part of demonstrating safety and effectiveness of Pressure Right device and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Pressure Point completed a number of tests. The Pressure Right device meets all the requirements for overall design, biocompatibility, and has been confirmed that the output meets the design inputs and specifications. The Pressure Right device passed the testing stated above as shown by the acceptable results obtained.

10. Clinical Performance Data

There was no new clinical testing required to support the medical device as bench testing was performed to evaluate the pressure equivalence of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device. These results were comparable and support the expanded indications of the Pressure Right device.

The predicate device, Pressure Right was clinically tested and the clinical data included in the predicate submission K110563. The predicate Pressure Right device has been on the market for several years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The Pressure Right OTC device has the same indications for use, including OTC use as the predicate Sea-Band device. The Pressure Right OTC device prescription has identical technological characteristics as the Pressure Right predicate device. The new device does not raise different questions regarding its safety and effectiveness as compared to the predicate devices.

Regulation Number and Section

N/A