(90 days)
Over the Counter, OTC:
Bleed-X™ is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations and abrasions.
Prescription, Rx:
Traumadex™ is intended as a topical dressing for the local management of bleeding wounds such as cuts, lacerations and abrasions. Under the care of a health care professional, Traumadex™ may be used for the temporary treatment of severely bleeding wounds such us surgical wounds (post-operative, donor sites, dermatological), cuts, lacerations and traumatic injuries.
Medafor, Inc.'s Bleed-X™ and Traumadex™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells.
The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal plateler activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
The given text describes Medafor, Inc.'s Bleed-X™ and Traumadex™ containing Hemadex™ Clotting Beads. Here's an analysis of the acceptance criteria and the studies performed, based only on the provided information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it refers to the efficacy demonstrated through various studies and concludes that the device is "safe and effective for the control of bleeding wounds and perform in a manner equivalent and similar to the predicates." The reported performance is summarized qualitatively.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biological Compatibility | Achieved (per ISO 10993-1 and FDA G95-1) |
| Sterility Assurance Level | Achieved SAL of 1 x 10^-6 (per AAMI/ANSI/ISO 11137 and EN552) |
| Control of Bleeding (Efficacy) | Demonstrated in porcine model and human clinical investigation. Human study showed "accelerated rate of bleeding control in the presence of the particles." |
| Safety | Demonstrated through biocompatibility testing and clinical investigation. |
| Equivalence to Predicate Devices | Believed to be equivalent and similar based on various studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: A "non-significant risk clinical investigation using human subjects" was conducted.
- Sample Size: The exact sample size for the human clinical investigation is not specified in the provided text.
- Data Provenance: The study used "human subjects," implying prospective human clinical data. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding experts used to establish ground truth or their qualifications for the human clinical investigation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The human clinical investigation involved a "side by side comparison of Bleed-X™ / Traumadex™ and a control of normal clotting," but it doesn't describe an MRMC design or the effect size of human readers with/without AI assistance (which is not relevant for this device).
6. If a Standalone (Algorithm Only) Performance Study was done
This device is a topical dressing, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable or described.
7. The Type of Ground Truth Used
For the human clinical investigation, the ground truth was likely based on observation of bleeding control and rate of clotting in a "side by side comparison" against "normal clotting." The document states it demonstrated "an accelerated rate of bleeding control."
8. The Sample Size for the Training Set
The document does not mention a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
The document does not mention a training set or how its ground truth would be established, as this is not an AI/ML device.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.