(101 days)
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No
The device description and intended use clearly describe a physical accessory for positioning radiographic cassettes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates the positioning of radiographic cassettes, improving workflow and patient comfort during imaging, but it does not directly treat or diagnose any medical condition.
No
The device is described as an accessory for positioning radiographic film cassettes without causing pain to the patient or requiring multiple staff members. It does not perform any diagnostic function itself.
No
The device description explicitly states it is made from injection-molded ABS plastic and has physical handles and dimensions to accommodate a cassette, indicating it is a physical hardware device, not software.
Based on the provided information, the Solo-Sled device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Solo-Sled's Function: The Solo-Sled is described as a device designed to facilitate the positioning of radiographic film cassettes for imaging. It is an accessory to a radiographic film cassette and is used externally on the patient's body to aid in the imaging process.
- No Biological Sample Testing: The description does not mention the Solo-Sled being used to test any biological samples from the patient. Its purpose is purely mechanical, assisting in the physical placement of imaging equipment.
Therefore, the Solo-Sled falls under the category of a medical device used in imaging, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Solo-Sled is a device designed to allow one staff member to be able to position 14 x 17 cassettes behind chest and/or under the back of a patient without causing pain to the patient in lifting or moving them. Solo-Sled will allow positioning of cassettes without requiring two to three staff members to lift the patient once to place the cassette and then the second time to remove the cassette. The device is an accessory to a 14 x 17 radiographic film cassette.
Product codes
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Device Description
Solo-Sled is a device made from an artifact free (ABS) plastic acrylonitrile butadiene styrene which is injection molded. It has a smooth low resistance outer finish with reinforced edges for extra strength an patient comfort. It has two handles for ease of positioning by staff members. It has dimensions to accommodate a 14 x 17 cassette.
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
chest and/or under the back
Indicated Patient Age Range
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Intended User / Care Setting
one staff member, healthcare providers
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)
The Solo-Sled is made from high impact (ABS) plastic, Acrylonitrile Butadiene Styrene, which poses no health risk either by contact or use with patients. In addition, it does not possess properties that would irritate the skin, nor does it have the potential to be abrasive to the skin during use. A copy of the Material Safety Data Sheet (MSDS) is included for your reference.
The Solo-Sled device does not alter the radiographic image quality, create image distortion and is artifact free. The radiographic image quality and technical factors remain the same with and without the use of the Solo-Sled. The physics testing and findings are included for your reference.
In summary the Solo-Sied is a safe and effective device to position and remove a 14 x 17 radiographic cassette for portable radiographic examinations on critically ill and terminal patients.
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.
Radiographic Film Cassette
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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§ 892.1850 Radiographic film cassette.
(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(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 the limitations in § 892.9.
0
0090 K97
APR 21 1997
ﺮ
Premarket Notification 510(k) Summary
. .
[As required by Section 807.92 (c)]
1
2413 Vance Avenue · P.O. Box 3718 · Chattanooga, Tennessee 37404 423-698-5253 · FAX 423-624-1356
Submitter's Name: Address:
Patricia A. Roddy Solo-Sled, LLC 2413 Vance Avenue P.O. Box 3718 Chattanooga, TN 37404
Phone: Fax #: Contact: 423-698-5253 423-624-1356 Patricia A. Roddy
Trade Name: Common Name: Classification Name: Solo-Sled Cassette Positioner Accessory to Radiographic Film Cassette
2
Description of device: Solo-Sled is a device made from an artifact free (ABS) plastic acrylonitrile butadiene styrene which is injection molded. It has a smooth low resistance outer finish with reinforced edges for extra strength an patient comfort. It has two handles for ease of positioning by staff members. It has dimensions to accommodate a 14 x 17 cassette.
Intended Use of Device: Solo-Sled is a device designed to allow one staff member to be able to position 14 x 17 cassettes behind chest and/or under the back of a patient without causing pain to the patient in lifting or moving them. Solo-Sled will allow positioning of cassettes without requiring two to three staff members to lift the patient once to place the cassette and then the second time to remove the cassette. The device is an accessory to a 14 x 17 radiographic film cassette.
3
Substantial Equivalence Comparison
Substantial Equivalence:
Radiographic Film Cassette
The standard radiographic film cassettes are rectangular in design with hard, flat, square corners making them difficult to position or slide under a patient receiving a portable radiographic examination. Routinely, the patient is moved, pulled and tugged to position the 14 x 17 cassette. Portable radiographic examinations are performed on critically ill or terminal patients. In addition the process routinely requires two to three healthcare providers to lift the patient to place the cassette into position.
The Solo-Sled provides a "sleeve" with round edges and corners that houses the 14 x 17 radiographic cassette which is aerodynamic in design. It has low surface resistance which enables a single technologist to simply slide the cassette into position and remove the cassette by sliding Solo-Sled up and out.
4
Performance
Safety and Effectiveness:
The Solo-Sled is made from high impact (ABS) plastic, Acrylonitrile Butadiene Styrene, which poses no health risk either by contact or use with patients. In addition, it does not possess properties that would irritate the skin, nor does it have the potential to be abrasive to the skin during use. A copy of the Material Safety Data Sheet (MSDS) is included for your reference.
The Solo-Sled device does not alter the radiographic image quality, create image distortion and is artifact free. The radiographic image quality and technical factors remain the same with and without the use of the Solo-Sled. The physics testing and findings are included for your reference.
1
In summary the Solo-Sied is a safe and effective device to position and remove a 14 x 17 radiographic cassette for portable radiographic examinations on critically ill and terminal patients.