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510(k) Data Aggregation
(29 days)
Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds:
- · Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- · Chronic vascular ulcers
- · Tunneled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
- · Draining wounds
Corplex P/Theracor P/Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
The provided text describes a 510(k) premarket notification for a medical device called Corplex P/Theracor P/Allacor P. It states that the device is identical to its predicate device (K231325) in most aspects, with a minor modification being the addition of an 8 cc configuration. The document explicitly states that this modification does not raise new questions of safety or effectiveness and therefore, no new clinical testing, biocompatibility testing, or extensive performance studies were required to demonstrate substantial equivalence.
Instead, the submission relies on the established performance of the predicate device and verification testing related to the minor design change.
Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment, which are typically associated with performance studies, are not explicitly present in this summary document because such extensive studies were deemed unnecessary for this 510(k) submission.
Here's an attempt to answer your questions based on the provided text, indicating where information is not available due to the nature of this submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for all characteristics. Instead, it relies on the device being "identical" or having "same" or "does not raise new questions of safety and effectiveness" compared to the predicate device. For the one specific test mentioned (Bioburden Testing), the outcome is a simple "PASS".
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (K242828) |
|---|---|---|
| Size/Volume | Must not raise new questions of safety and effectiveness compared to 1 cc, 2 cc, and 4 cc configurations. | 1 cc, 2 cc, 4 cc, 8 cc (The additional 8cc configuration was deemed to "not raise new questions of safety and effectiveness") |
| Nominal Particle Sizes | Same as predicate: Particles ranging from 0.1 mm to 2.0 mm (must pass through 2.00 mm aperture sieve and not pass through 0.106 mm aperture sieve, ASTM E11). | Particles ranging from 0.1 mm to 2.0 mm (Same as predicate: Particles must be able to pass through a 2.00 mm aperture calibrated sieve and not pass through a 0.106 mm aperture calibrated sieve (ASTM E11) when manually sieved.) |
| Intended Use | Same as predicate: To cover, protect, and provide a moist wound environment. | Same |
| Indications for Use | Same as predicate for specified wound types. | Same |
| Configuration | Same as predicate: Particles. | Same |
| Material Source | Same as predicate: Human umbilical cord (recovered per 21 CFR 1271). | Same |
| Components | Same as predicate: Collagen and associated ECM components (collagen I, collagen III, collagen V). | Same |
| Collagen (% total weight) | Same as predicate: 46% (Mean Value). | 46% (Mean Value) |
| Total Glycosaminoglycans (mg/g) | Same as predicate: 20.3 mg/g (Mean Value). | 20.3 mg/g (Mean Value) |
| Endotoxin (EU/device) | Same as predicate: |
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