← Product Code [IXA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA) · K970090 # SOLO-SLED (K970090) _Solo-Sled, LLC · IXA · Apr 21, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K970090 ## Device Facts - **Applicant:** Solo-Sled, LLC - **Product Code:** [IXA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA.md) - **Decision Date:** Apr 21, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1850 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended 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. ## Device Story Solo-Sled is an injection-molded ABS plastic sleeve designed to house 14 x 17 radiographic film cassettes. Device features rounded edges, reinforced corners, and two handles; aerodynamic design with low-friction surface. Used in clinical settings (e.g., bedside portable radiography) by a single technologist to slide cassettes under patients without manual lifting. Eliminates need for multiple staff to move patients; reduces patient pain/discomfort during imaging. Device is radiolucent, artifact-free, and does not alter image quality or technical factors. ## Clinical Evidence Bench testing only. Physics testing confirmed the device is artifact-free and does not alter radiographic image quality or technical factors. Material safety verified via MSDS for ABS plastic. ## Technological Characteristics Material: Acrylonitrile Butadiene Styrene (ABS) plastic. Form factor: Injection-molded sleeve with rounded edges, reinforced corners, and two handles. Dimensions: Accommodates 14 x 17 radiographic film cassettes. Energy source: None (manual operation). Connectivity: None. Sterilization: Not specified. ## Regulatory 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. ## Special Controls *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. ## Reference Devices - Radiographic Film Cassette ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K970090 APR 21 1997 # Premarket Notification ## 510(k) Summary [As required by Section 807.92 (c)] Page 7-1 {1} Page 7-2 # SOLO-SLED, LLC 2413 Vance Avenue • P.O. Box 3718 • Chattanooga, Tennessee 37404 423-698-5253 • FAX 423-624-1356 Submitter's Name: Patricia A. Roddy Address: Solo-Sled, LLC 2413 Vance Avenue P.O. Box 3718 Chattanooga, TN 37404 Phone: 423-698-5253 Fax #: 423-624-1356 Contact: Patricia A. Roddy Trade Name: Solo-Sled Common Name: Cassette Positioner Classification Name: 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. Page 7-3 {3} Page 7-4 # 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. In summary the Solo-Sled is a safe and effective device to position and remove a $14 \times 17$ radiographic cassette for portable radiographic examinations on critically ill and terminal patients. Page 7-5 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K970090](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K970090) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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