(54 days)
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No
The device description and lack of mentions of AI/ML terms or performance studies indicate a simple mechanical device.
No
The device is described as an assembly of foam blocks and straps used to position and secure a patient. Its intended use does not involve treating, diagnosing, or preventing a disease or condition, which are characteristics of a therapeutic device. It serves a supportive, non-therapeutic function.
No
The device description and intended use indicate it is an accessory for patient positioning and restraint, not for diagnosing medical conditions.
No
The device description clearly states it is an "assembly of covered foam blocks to which five (5) restraining straps have been sewn," indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Position and secure a patient in the prone or supine positions." This is a physical positioning and restraint function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "covered foam blocks to which five (5) restraining straps have been sewn." This is a physical support and restraint device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Position and secure a patient in the prone or supine positions.
Product codes
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Device Description
The Strap Wedge is an assembly of covered foam blocks to which five (5) restraining straps have been sewn.
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.)
Not Found
Predicate Device(s)
Various Preamendments strap and support assemblies.
Reference Device(s)
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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.
0
Image /page/0/Picture/4 description: The image shows the logo for AliMed Inc. The logo consists of a black square with a white diamond inside, followed by the text "AliMed inc." in a bold, sans-serif font. Below the logo is the address "297 High Street, Dedham, MA 02026".
OCT 28 1996
510(k) SUMMARY
Strap Wedge
Applicant:
AliMed®, inc. 297 High Street Dedham, MA 02026
Contact: Jonathan C. Bretz
Telephone: 617-329-2900 FAX: 617-329-8392
Submitted by:
...
Curtin & Associates International 1200 East Street Dedham, MA 02026
Contact: Donald A. Lincoln
Telephone: 617-329-1955 FAX: 617-329-2529
Date this Summary was prepared: 30 August 1996
Trade Name: Strap Wedge
Common Name: Strap Wedge
Classification Name: Patient Restraint
Legally Marketed Devices to Which Substantial Equivalence is claimed:
Various Preamendments strap and support assemblies.
(617) 329-2900 · fax: (617) 329-8392
1
510(k) SUMMARY-continued
Description of Device: The Strap Wedge is an assembly of covered foam blocks to which five (5) restraining straps have been sewn.
Intended Use of the Device: Position and secure a patient in the prone or supine positions.
User Experience: There have been no reports of death or serious injury received by the firm during the time these devices have been manufactured. Device was first manufactured in September of 1995.
Biocompatibility: Based on the topological use of this device and the materials used, it is unlikely that biocompatibility difficulties would arise. In addition, the firm has received no information from users indicating that a biocompatibility question has developed.
Comparative Information: The firm has been unable to obtain pre-1976 information related to specific devices of this type. However, the use of covered foam padding and straps such as are incorporated in this device appear to have been in use before the Medical Device Amendment as well as after the date of the amendment.