(57 days)
Various Preamendments General Purpose Straps
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No
The summary describes a simple physical restraint device made of nylon and foam with Velcro closures. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device's intended use is to reduce patient movement and is described as straps made of nylon or polyethol foam with Velcro closures, which do not inherently provide a therapeutic effect. It is a general-purpose restraining device rather than one designed for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
The device is described as a general purpose strap intended to reduce patient movement, not to diagnose a condition or disease.
No
The device description explicitly states the device is fabricated using physical materials (nylon, polyethol foam) and has a physical closure (Velcro®), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Reduce patient movement in recover, in bed, or other uses as determined by the health care professiona user." This describes a physical restraint or positioning device used on a patient's body.
- Device Description: The device is described as being made of nylon or nylon and polyethol foam with a Velcro closure. This is consistent with a physical strap or restraint.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of biological samples.
Therefore, this device falls under the category of a physical restraint or positioning device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Reduce patient movement in recover, in bed, or other uses as determined by the health care professiona user.
Product codes
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Device Description
The devices are fabricated using nylon or nylon and polyethol foam of various lengths and widths as described in advertising. The closure is Velcro® or Velcro®-like hook and loop.
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
health care professiona 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.
Various Preamendments General Purpose Straps
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.
0
Image /page/0/Picture/3 description: The image shows the logo for AliMed Inc. The logo consists of a black square with a white triangle inside, followed by the text "AliMed" in a bold, sans-serif font. To the right of "AliMed" is a registered trademark symbol, and then the word "inc." in a smaller font.
(617) 329-2900 • fax: (617) 329-8392
297 High Street Dedham, MA 02026
OCT 3 1 1996
510(k) SUMMARY Various General Purpose Straps
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: 21 August 1996
Trade Name: Universal Econo-Strap, QualCraft™ Universal Straps Common Name: Strap Classification Name: Patient Restraint
1
Legally Marketed Devices to Which Substantial Equivalence is claimed:
Various Preamendments General Purpose Straps
1
:
:
510(k) SUMMARY-continued
Description of Device: The devices are fabricated using nylon or nylon and polyethol foam of various lengths and widths as described in advertising. The closure is Velcro® or Velcro®-like hook and loop.
Intended Use of the Device: Reduce patient movement in recover, in bed, or other uses as determined by the health care professiona user.
| CODE | NAME | SIZE | FIRST
MANUFACTURED | USE |
|--------|-------------------|----------|-----------------------|------------------------|
| 7536 | Econo-strap | 3" x 72" | 1990 | General purpose strap |
| 7539 | Econo-strap | 4" x 75" | 1990 | General purpose strap |
| 91-277 | Universal 1 piece | 2" x 76" | 1989 | General purpose strap |
| 91-278 | Universal 1 piece | 3" x 76" | 1989 | General purpose strap |
| 91-279 | Universal 1 piece | 4" x 76" | 1989 | General purpose strap |
| 91-280 | Universal 1 piece | 6" x 76" | 1989 | General purpose strap |
| 91-281 | Universal 1 piece | 2" x 96" | 1989 | General purpose strap |
| 91-282 | Universal 1 piece | 3" x 96" | 1989 | General purpose strap |
| 91-283 | Universal 1 piece | 4" x 96" | 1989 | General purpose strap |
| 91-284 | Universal 1 piece | 6" x 96" | 1989 | General purpose strap |
| 91-285 | Universal 2 piece | 2" | 1989 | General purpose straps |
| 91-286 | Universal 2 piece | 3" | 1989 | General purpose straps |
| 91-287 | Universal 2 piece | 4" | 1989 | General purpose straps |
| 91-288 | Universal 2 piece | 6" | 1989 | General purpose straps |
| 91-596 | Universal 1 piece | 2" x 65" | 1994 | General purpose strap |
| 91-597 | Universal 1 piece | 3" x 65" | 1994 | General purpose strap |
| 91-598 | Universal 1 piece | 4" x 65" | 1994 | General purpose strap |
| 91-599 | Universal 1 piece | 6" x 65" | 1994 | General purpose strap |
2
510(k) SUMMARY-continued
Comparative Information: The firm has been unable to locate pre-Amendment catalogs, or similar materials, which relate to this type of general purpose strap. However, it is generally know that they were in use pror to May of 1976 and that they have continued to be supplied by other firms since that time.
Biocompatibility: Based on the materials used in construction of these straps, and the topological application with the normal use arrangement having some other material between the patient's skin and the strap, there is little likelyhood of a biocompatibility concern arising.
User Experience: The firm has received no information related to a death, serious injury or allegent reaction to the materials during the time these devices have been manufactured.