(269 days)
The PostureTek Shirt provides training to help the wearer use his own muscles to maintain the desired posture, thereby correcting poor posture and improving appearance.
The POSTURETEK spinal curvature monitor is designed to be worn as a shirt, bra, tank top, or the like. Threaded in the garment is a monofilament, the tension of which changes depending upon the wearer's posture. If the wearer's posture is poor, an electronic disc located in the armpit region of the garment gently vibrates, alerting the wearer to correct his or her posture. The POSTURETEK device is easy to use, discrete, and durable.
The provided text is a 510(k) summary for the PostureTek Spinal Curvature Monitor. It focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving specific performance acceptance criteria or clinical trials.
Therefore, the requested information cannot be extracted from the given text as the document does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance studies.
- Type of ground truth used (e.g., pathology, outcomes data), beyond the general concept of "improper posture."
- Sample size for a training set.
- How ground truth for a training set was established.
The 510(k) summary states the device's intended use is to "provide training to help the wearer use his own muscles to maintain the desired posture, thereby correcting poor posture and improving appearance." It establishes substantial equivalence to existing devices (ZEGRA Posture Trainer K#081540 and Spine Tuner K#951244) based on having the "same intended use of improving posture" and "similar general technological characteristics." It describes the device's mechanism of operation (monofilament tension changes triggering a vibration alert for poor posture) but does not include any performance metrics, clinical study results, or specific acceptance criteria for its effectiveness.
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K 093553
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510(k) SUMMARY
AUG 1 3 2010
Perseus Athletics LLC POSTURETEK Spinal Curvature Monitor
Name of Device
Trade or Proprietary Name: Common Name: Classification Name: Product Code:
POSTURETEK posture trainer spinal curvature monitor LZW
Preparation Date
August 12, 2010
510(k) Sponsor
Perseus Althetics, LLC 8 Turtleback Road Essex, MA 01929
510(k) Sponsor Contact
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 (202) 783-5070 · Phone: Facsimile: (202) 783-2331
Intended Use
The PostureTek Shirt provides training to help the wearer use his own muscles to maintain the desired posture, thereby correcting poor posture and improving appearance.
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Technological Characteristics and Substantial Equivalence
The POSTURETEK spinal curvature monitor is designed to be worn as a shirt, bra, tank top, or the like. Threaded in the garment is a monofilament, the tension of which changes depending upon the wearer's posture. If the wearer's posture is poor, an electronic disc located in the armpit region of the garment gently vibrates, alerting the wearer to correct his or her posture. The POSTURETEK device is easy to use, discrete, and durable.
The POSTURETEK spinal curvature monitor is substantially equivalent to the ZEGRA Posture Trainer (K#081540) and the Spine Tuner (K#951244) for purposes of FDA market authorization. All of these devices alert the wearer when improper posture occurs. Although the precise mechanics of their systems may vary, the devices are substantially equivalent in that they have the same intended use of improving posture and have similar general technological characteristics.
40666312.doc
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Perseus Athletics LLC % Fish & Richardson P.C. · Mr. Keith A. Barritt 1425 K Street, N.W. 11Th Floor Washington, District of Columbia 20005
AUG 1 3 2010
Re: K093553
Trade/Device Name: PostureTek Regulatory Class: Unclassified Product Code: LZW Dated: August 10, 2010 Received: August 11, 2010
Dear Mr. Barritt:
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. Iisting 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 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.
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Page 2 - Mr. Keith A. Barritt
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.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
AUG 1 3 2010
్రాని
510(k) Number (if known): 093553
PostureTek Device Name:
. Indications For Use:
The PostureTek Shirt provides training to help the wearer use his own muscles to maintain the desired posture, thereby correcting poor posture and improving appearance
દ્મ 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K093551
10(k) Numbe
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