(63 days)
Not Found
No
The device description details a mechanical restraint system with no mention of software, algorithms, or any technology that would suggest AI/ML. The performance studies section explicitly states that substantial equivalence is not based on performance data, further indicating a lack of complex computational components.
No.
The device's intended use is to secure patients on transport or mobility equipment, not to treat or diagnose a medical condition. It functions as a restraint, which falls under protective or supportive devices rather than therapeutic ones.
No
The device description indicates that the Safety International Corp. Restraint Belt is used to secure patients, acting as a physical restraint, not for diagnostic purposes.
No
The device description clearly outlines physical components made of nylon web and metal buckles, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically secure patients on various transport and mobility devices (ambulance cot, backboard, stretcher, wheelchairs) and as wrist or ankle restraints. This is a physical function, not a diagnostic one.
- Device Description: The description details the physical components and materials of the restraint belts. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text explicitly states "Not Found" for key elements typically associated with IVDs, such as:
- Mentions image processing, AI, DNN, or ML (often used in diagnostic analysis).
- Input Imaging Modality.
- Anatomical Site (while restraints are applied to the body, they don't interact with internal anatomy for diagnostic purposes).
- Description of training/test sets, performance studies, and key metrics (Sensitivity, Specificity, etc.) which are crucial for evaluating the performance of diagnostic devices.
The device is a physical restraint used for patient safety and transport, not for diagnosing any medical condition.
N/A
Intended Use / Indications for Use
The Safety International Corp. Restraint Belt is designed to effectively secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. They are also used for application as wrist or ankle restraints in conjunction with the patient restraints already on the equipment on which the patient is being carried.
Product codes
880.6760
Device Description
The Safety International Corp.'s Patient Restraints are easy to use devices which are used to secure patients to a ambulance cot, backboard, stretcher or wheelchairs. The belts utilize 2 inch wide, 2 piece nylon web with quick release automatic push button buckle. Auto chrome plated metal push button buckle provides positive closure and resists rust and corrosion. Buckle end is sewn and the adjusted end provides adjustment on the size of the restraints for the patient by pulling the open end of the restraint and adjusting to the desired size. The belts are available in black, orange, burgundy, blue, red and yellow. The material used for the web is either nylon or polypropylene and has been in use with no adverse effects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence is not based on an assessment of any performance data, etimical or non-clinical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K850470, K780232, K760618, K812473, K771629
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
DEC - 2 1996
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 963906
Submitted By:
George Bolukbas, President Safety International Corp. 160 Lyman Rd. Casselberry, FL 32707 Tel (407) 830-0888 Fax (407) 830-4988
Date Prepared: September 26, 1996
Device Name
Proprietary Name: Patient Restraints
Common Name: Belts
Classification Name: Protective Restraints (880.6760)
Substantial Equivalence Claim
Safety International Corp. Belts are similar in indications, design and features to various Protective Restraints that FDA has found to be substantially equivalent to the preamendment devices. The following are some such devices:
| Manufacturer | Product | 510(k) Number |
|---|---|---|
| Abco | Restraint, Protective | K850470 |
| Biomet | Restraint, Protective | K780232 |
| Dowling Textile | Restraint, Protective | K760618 |
| Maddak | Restraint, Protective | K812473 |
| Medical Restraints | Restraints, Protective | K771629 |
Device Description
The Safety International Corp.'s Patient Restraints are easy to use devices which are used to secure patients to a ambulance cot, backboard, stretcher or wheelchairs. The belts utilize 2 inch wide, 2 piece nylon web with quick release automatic push button buckle. Auto chrome plated metal push button buckle provides positive closure and resists rust and corrosion. Buckle end is sewn and the adjusted end provides adjustment on the size of the restraints for the patient by pulling the open end of the restraint and adjusting to the
1
desired size. The belts are available in black, orange, burgundy, blue, red and yellow. The material used for the web is either nylon or polypropylene and has been in use with no adverse effects.
Intended Use
The Safety International Corp. Restraint Belt is designed to effectively secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. They are also used for application as wrist or ankle restraints in conjunction with the patient restraints already on the equipment on which the patient is being carried.
Biocompatibility
The material used for the web is either nylon or polypropylene and has been in use with no adverse effects. The same materials are used in the above mentioned substantially equivalent products.
| Safety International Corp. | Morrison Medical Products | |
|---|---|---|
| Indication | Secure the patient on a | |
| ambulance cot, backboard, | ||
| stretcher or wheelchairs. | Secure the patient on a | |
| ambulance cot, backboard, | ||
| stretcher or wheelchairs. | ||
| Mode Of Operation | Strap with male connector on | |
| one end and female on the | ||
| other lock together. | Strap with male connector on | |
| one end and female on the other | ||
| lock together. | ||
| Material | Nylon webbing. | Nylon webbing. |
| Sterility | Nonsterile/reusable | Nonsterile/reusable |
Substantial Equivalence Comparison
The determination of substantial equivalence is not based on an assessment of any performance data, etimical or non-clinical.
Submitter's Signature
11/22/96
Date
Date