(63 days)
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.
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.
The provided text is for a 510(k) summary for a patient restraint device (belts) and does not contain any information about acceptance criteria or a study proving device performance in the context of medical AI/software.
The document discusses:
- Device Name: Patient Restraints
- Intended Use: To secure patients on ambulance cots, backboards, stretchers, or wheelchairs.
- Device Description: Nylon or polypropylene belts with quick-release buckles.
- Substantial Equivalence Claim: Compares the device to previously approved protective restraints, asserting similarity in indications, design, and features.
- Biocompatibility: States that the materials (nylon or polypropylene) have been in use with no adverse effects, similar to predicate devices.
- Comparison Table: Highlights similarities with a predicate device (Morrison Medical Products) in indication, mode of operation, material, and sterility.
Crucially, under the "Substantial Equivalence Comparison" section, it explicitly states:
"The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical."
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because the document explicitly states that such data was not used for this submission. The device approval (at the time of this 510(k) summary) was based on substantial equivalence to predicate devices, not on direct performance testing against acceptance criteria.
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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
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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 aambulance cot, backboard,stretcher or wheelchairs. | Secure the patient on aambulance cot, backboard,stretcher or wheelchairs. |
| Mode Of Operation | Strap with male connector onone end and female on theother lock together. | Strap with male connector onone end and female on the otherlock 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
§ 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.