(106 days)
For relief of minor physical discomforts incurred by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.
(a) Elasticized fitment to support and compress an injured part of the body. (b) Anatomically contoured for adjustable fit and firmness for personal comfort and control of slippage and bunching of fabric. (c) Absortek fiber absorbs perspiration and transfers heat and moisture away from skin (d) Fabric treated with agent to resist growth of odor-causing bacteria and mildew (e) Non-intrusive magnetic panel encased in fabric.
The provided text is a 510(k) summary for a medical device called "Back in Action" Compression & Support with Anti-Bacterial Agent and Magnet. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Explanation Based on Document Content:
The 510(k) summary explicitly states its reliance on demonstrating substantial equivalence to a predicate device (ComfortCare Compression and Support with Anti-Bacterial and Magnet, K013244). It emphasizes that:
- "The properties of 'Back in Action' devices demonstrate the same technological characteristics in design as an elastic bandage, woven fabric, fiber, finish, composition, anti-microbial agent, application, compression/support function, layered absorption/venting mechanisms, magnets and Indications for Use - as granted to ComfortCare products under K 013244..."
- "There are no material modifications that affect or change the fundamental technology and science for a similar legally marketed device."
This means that the device's acceptability is based on its similarity to an already cleared device, not on specific performance metrics established through new clinical trials with acceptance criteria. No new performance study or clinical data is detailed in the provided text.
§ 880.5075 Elastic bandage.
(a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(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. The device also is 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, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.