(512 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The device description and intended use focus on mechanical positioning changes for pressure relief.
Yes
The device is intended for pressure relief or reduction for individuals with pressure sores or at high risk of developing them, and it achieves this through periodic positioning changes. This directly addresses health conditions.
No
Explanation: The device is described as providing "pressure relief or reduction by shifting the user's body weight" and enabling "postural change for persons having the following condition or injury: an existing pressure sore, or an individual at extreme risk of developing a pressure sore." This indicates a therapeutic or assistive function, not a diagnostic one.
Unknown
The provided text only describes the intended use of the device. It does not contain a device description, which is necessary to determine if the device is software-only or includes hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description of the iPUPc clearly indicates it is a mechanical seating system designed to provide physical positioning changes for wheelchair users. It directly interacts with the user's body for pressure relief, not by analyzing biological samples.
The intended use and device description focus on physical support and positioning, which are not characteristics of an IVD.
N/A
Intended Use / Indications for Use
The iPUPc is appropriate for use by any wheelchair user, who requires regular, periodic positioning changes without the aid of an attendant. These reqular, periodic positioning changes are needed for, but not limited to: Pressure relief or reduction by shifting the user's body weight from the buttocks to the thighs and the lower back. The iPUPc seating system could provide pressure relief by postural change for persons having the following condition or injury: an existing pressure sore, or an individual at extreme risk of developing a pressure sore. Any individual who needs pressure relief through regular periodic positional changes, who is unable to do so independently, can accomplish this through the iPUPc device.
Product codes
MOC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Any wheelchair user
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 890.5170 Powered flotation therapy bed.
(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
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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 consists of a stylized eagle with its head turned to the left and its wings forming a flowing, ribbon-like shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2008
Medical Technology Systems, Inc. % Ellis K. Nam, M.D. 6101 N. Sheridan Road, Suite #40D Chicago, IL 60660
Re: K063175 Trade/Device Name: iPUPc (Intelligent Pressure Ulcer Prevention Cushion) Regulatory Class: Unclassified Product Code: MOC Dated: December 14, 2007 Received: December 18, 2007
Dear Dr. Nam:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Ellis K. Nam. M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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8. Statement of Indications for Use
510(k) Number (if known): K063175
Device Name: iPUPc (Intelligent Pressure Ulcer Prevention Cushion)
Indications for Use:
The iPUPc is appropriate for use by any wheelchair user, who requires regular, periodic positioning changes without the aid of an attendant. These reqular, periodic positioning changes are needed for, but not limited to:
Pressure relief or reduction by shifting the user's body weight from the buttocks to the thighs and the lower back.
The iPUPc seating system could provide pressure relief by postural change for persons having the following condition or injury: an existing pressure sore, or an individual at extreme risk of developing a pressure sore.
Any individual who needs pressure relief through regular periodic positional changes, who is unable to do so independently, can accomplish this through the iPUPc device.
Prescription Use AND/OR Over-The-Counter Use × × (Part 21 CFR 801 Subpart D) (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)
Neil R.S. Ogle
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
510(k) Number K063175