(83 days)
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No
The 510(k) summary describes patient restraints, a purely mechanical device, and contains no mention of AI, ML, or any related technologies.
No
The device is described as patient restraints, used to limit movement for treatment, examination, or protection. It does not actively treat or diagnose a disease or condition, which is characteristic of a therapeutic device.
No
Explanation: The device is a patient restraint intended to limit movement for treatment or examination, not to diagnose a condition or disease.
No
The device description is "BioThane Patient Restraints," which are physical restraints, not software. The summary provides no information suggesting a software component.
Based on the provided information, the BioThane Patient Restraints are not an IVD (In Vitro Diagnostic) device.
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.
- Intended Use: The intended use of the BioThane Patient Restraints is to "limit the patient's movements... for treatment, examination, or protection." This is a physical restraint function, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples
- Detecting biomarkers or analytes
- Providing diagnostic information
Therefore, the BioThane Patient Restraints fall under the category of a physical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BioThane Patient Restraints are intended for medical purposes only. They are intended to limit the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
Product codes
FMO
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
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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
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§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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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 features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures or profiles arranged in a row, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1999
Ms. Claire Boron Marketing Assistant BioPlastics 34655 Mills Road North Ridgeville, Ohio 44039 USA
Re : K991591 BioThane™ Patient Restraint Trade Name: Requlatory Class: I Product Code: FMO May 5, 1999 Dated: Received: May 7, 1999
Dear Ms. Boron:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 wit h the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market the device, subject to the (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Boron
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to ene regaracion Choroson" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
V A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K991591 Device Name: BigThane Patient Restraint
Indications For Use:
BioThane Patient Restraints are intended for medical purposes only. They are intended to limit the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODF)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Fabrica Cascente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .