(81 days)
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No
The summary describes a simple mechanical device for postural support and does not mention any AI/ML terms or functionalities.
No.
The device is intended for postural support and activities, not for treating a disease or condition. The mention of it potentially being a restraint also suggests a mechanical function rather than a therapeutic one.
No
Explanation: The "Intended Use / Indications for Use" section states that the products are "intended to provide postural support and a surface for activities," which does not describe a diagnostic function.
No
The device description clearly describes physical components (straps, tray) providing postural support, 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 provide postural support and a surface for activities." This describes a physical support device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical product that attaches to a wheelchair for postural support. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
Therefore, based on the provided text, this device falls under the category of a physical support or assistive device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint. These products are intended to provide postural support and a surface for activities.
Product codes
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Device Description
The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint. These products are intended to provide postural support and a surface for activities.
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)
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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.
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J. T. Poseu Co.
Image /page/0/Picture/2 description: The image is a black and white drawing of a four-leaf clover inside of a circle. The word "Quality" is written in cursive below the clover. The clover is solid black, and the circle is outlined in black. The drawing is simple and clean.
. I. Posey Co.
Customer Service
Toll Free: (800) 44-POSEY
Tel: (818) 443-3143
Fax: (818) 443-5014
SAFETY AND EFFECTIVENESS SUMMARY
5635 Peck Road · Arcadia, California 91006-0020 U.S.A
NOV 1 9 1996
JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 18, 1996
Phone # (818) 443-3143 FAX # (818) 443-5014
Reference Number: K963411
Trade Name: Posey® Laptop Trays Common Name: Laptop Trays Classification Name: Protective Restraints
The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint.
These products are intended to provide postural support and a surface for activities.
The devices used for comparative purposes are identical to the laptop trays as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is submitted in response to the agency's final rule published on March 4. 1996 in the Federal Register 21 CFR 880 and 21 CFR 890 Medical Devices, Protective Restraints - Revocation of Exemptions from 510(k) Pre-market Notification Procedures and Current Good Manufacturing Practice Repulation. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for comparison:
"Predicate device
FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for companson purposes in their submissions. It would also be appropriate to reference any approved 5.10(k)s that manufacturers have submitted for their products."
The laptop trays are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission, August 30,1996. The limb holders have been manufactured and in commercial distribution for up to 20 years.