(90 days)
Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast. This protective pad protects the skin, ensures that bony prominences are adequately padded to prevent undesired pressure and/or chafing from the cast and compensates for normal amounts of swelling to the affected area immediately after the injury. The polyester fibers help repel water and dry rapidly.
Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast.
The provided text is a 510(k) premarket notification letter from the FDA to Clinitex Medical Corporation regarding their Clinitex Stockinette and Clinitex Cast Padding devices.
This type of document is an approval letter for marketing medical devices based on the concept of "substantial equivalence" to devices already on the market prior to May 28, 1976. It does not contain information about:
- Acceptance criteria the device had to meet.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established for training sets.
The letter simply states that the FDA has reviewed the submission and found the devices to be substantially equivalent to predicates, thereby allowing them to be marketed, subject to general controls provisions of the Act.
Therefore, I cannot provide the requested information based on the given input. The requested details are typically found in clinical study reports or performance validation sections of a 510(k) submission, not in the FDA's clearance letter itself.
§ 888.5940 Cast component.
(a)
Identification. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.(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 § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.