(39 days)
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is indicated for the relief of emetic (nausea and vomiting) symptoms associated with Post-Operative Anesthesia.
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip 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″ 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pressure Right® device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for clinical performance. Instead, it frames the evaluation in terms of "substantial equivalence" to a predicate device and "reducing postoperative nausea and vomiting." Therefore, the table below reflects the general claims and the study's aim rather than precise, pre-defined thresholds.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Sea-Band) | Device determined to be substantially equivalent. |
| Relief of emetic (nausea and vomiting) symptoms associated with Post-Operative Anesthesia (Primary Indication) | Study performed as part of a multi-model antiemetic strategy for reducing postoperative nausea and vomiting. |
| Adhesive abilities of the Pressure Right® device. | Study includes evaluation of adhesive abilities of the Pressure Right® device. |
| Pressure equivalence to predicate device | Bench testing evaluated pressure equivalence. |
| Biocompatibility with intact skin for prolonged use | Materials evaluated for biocompatibility requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for the clinical study. It only mentions "Use of disposable acupressure device as part of a multi-model antiemetic strategy for reducing postoperative nausea and vomiting."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available in the provided text. The document refers to a "clinical study" but does not detail how "ground truth" (e.g., actual presence/severity of nausea/vomiting) was established or by whom.
4. Adjudication Method for the Test Set
This information is not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the device is a physical acupressure strip, not an AI or imaging device that would typically involve human readers interpreting cases.
- Effect size of human readers with AI vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? No, the device is a physical medical device. The "clinical study" would inherently involve human subjects using the device.
7. The Type of Ground Truth Used
The type of "ground truth" for the clinical study would likely relate to the subjective experience of nausea and vomiting reported by patients, potentially measured through standardized scales. However, the document does not explicitly state the method for establishing ground truth or the specific outcome measures used to assess "nausea and vomiting relief."
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The Pressure Right® device is a physical device, not an AI algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
- How ground truth was established: Not applicable. As it's not an AI device, there is no "training set" or corresponding ground truth establishment process in this context.
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K110563
Therapeutics 101, Inc. (dba Pressure Point, Inc.) Traditional 510(k) Premarket Submission Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip
· SECTION 5 - 510(k) SUMMARY
APR - 8 2011
Submission Correspondent
Emergo Group, Inc. www.emergogroup.com/
Address
י ל
611 West Fifth Street Third Floor Austin, TX 78701
Phone
(512) 327-9997
Fax
(512) 327-9998
Contact
Julie Powell, Vice President, Quality Assurance jpowell@emergogroup.com
Submission Sponsor
Therapeutics 101, Inc. (dba Pressure Point, Inc.) 36 Green Meadow Drive Tinton Falls, NJ 07724 Phone: 732-747-6049 FDA Establishment Registration #: none, they will obtain number prior to marketing device.
Date Prepared
February 21, 2011
Trade Name
Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip
Classification Name Device, Acupressure
Regulation Number NA
Product Code MVV
Classification Panel
Neurology
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Therapeutics 101, Inc. (dba Pressure Point, Inc.) Traditional 510(k) Premarket Submission Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip
Device Class Unclassified
Predicate Device
Sea-Band, by Sea-Band UK LTD 510(k) # K033268
Indications for Use
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is indicated for the relief of emetic (nausea and vomiting) symptoms associated with Post-Operative Anesthesia.
Device Description
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip 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″ 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.
Summary of Non-Clinical Data Submitted
The following testing has been performed to support substantial equivalence:
- Bench testing to evaluate the pressure equivalence of the Pressure Right® device compared . to the marketed predicate (Sea-Band) device.
- . Materials with patient contact were evaluated for biocompatibility requirements with intact skin for prolonged use.
Summary of Clinical Data Submitted
The following clinical study has been performed on the Pressure Right® device to support substantial equivalence:
- Use of disposable acupressure device as part of a multi-model antiemetic strategy for . reducing postoperative nausea and vomiting. Study includes evaluation of adhesive abilities of the Pressure Right® device.
Safety and Effectiveness
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, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
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Therapeutics 101, Inc. (dba Pressure Point, Inc.) Traditional 510(k) Premarket Submission Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip .
It has been shown in this 510(k) submission that the differences between the Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip and the predicate device do not raise any questions regarding its safety and effectiveness. The Pressure Right® device, as designed and manufactured, is therefore determined to be substantially equivalent to the referenced predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Therapeutics 101, Inc. (dba Pressure Point, Inc.) c/o Julie Powell Vice President, Quality Assurance Emergo Group. Inc 611 West Fifth Street Third floor Austin, TX 78701
APR = 8 2511
Re: K110563
Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip
Regulatory Class: unclassified Product Code: MVV Dated: February 24, 2011 Received: February 28, 2011
Trade/Device Name:
Dear Ms. 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. Ilsting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kesia Alexander
Malviná B. Eydelman. M.D. Director
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Therapeutics 101, Inc. (dba Pressure Point, Inc.) Traditional 510(k) Premarket Submission Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip
SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known): K110563
Device Name
Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip
Indications for Use
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is indicated for the relief of emetic (nausea and vomiting) symptoms associated with Post-Operative Anesthesia.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Seon.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and This. .
Section 4: Page 1 of 1 510(k) Number
K 110 563
N/A