(137 days)
The ciSNaP® Closed Incision System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudate from surgical incisions that continue to drain following sutured or stapled closure.
The ciSNaP® Closed Incision System ("ciSNaP System") is a new addition to Spiracur Inc.'s ("Spiracur") family of negative pressure wound management devices. The ciSNaP System is a portable, non-powered, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management through the removal of small amounts of exudate from surgically closed incisions. The ciSNaP System utilizes the concept of forced expansion of volume to produce negative pressure at the closed incision. The ciSNaP System can be applied in the sterile field. The ciSNaP System has no electrically powered parts and is disposable after use. Additionally, it is capable of delivering negative pressure wound therapy at a near-constant pressure level over several days without any required adjustments by the patient or clinician. The dressing component of the ciSNaP System incorporates an antimicrobial interface.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the ciSNaP® Closed Incision System.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Appropriate design characteristics | Verification testing performed, demonstrates appropriate design characteristics for intended use. |
| Biocompatibility | Biocompatibility testing according to ISO 10993-1 standards performed, results demonstrate device is biocompatible. |
| Packaging and shelf life | Packaging and shelf life testing performed, results demonstrate conformance to product specifications. |
| Ion release rate (silver ion availability) | Ion release rate testing performed, results demonstrate antimicrobial characteristics are not significantly different after aging during continuous use period. |
| Antimicrobial Log Reduction (Day 1) | >4.3 for Staphylococcus aureus |
4.3 for MRSA
4.5 for VRE
4.4 for Escherichia coli
4.1 for Pseudomonas aeruginosa
4.3 for Klebsiella pneumoniae
4.3 for Candida albicans
3.2 for Aspergillus brasiliensis |
| Antimicrobial Log Reduction (Day 3) | >4.4 for Staphylococcus aureus
4.3 for MRSA
4.6 for VRE
4.4 for Escherichia coli
4.1 for Pseudomonas aeruginosa
4.2 for Klebsiella pneumoniae
4.2 for Candida albicans
3.2 for Aspergillus brasiliensis |
| Antimicrobial Log Reduction (Day 7) | >4.1 for Staphylococcus aureus
4.2 for MRSA
4.6 for VRE
4.3 for Escherichia coli
4.4 for Pseudomonas aeruginosa
4.4 for Klebsiella pneumoniae
4.1 for Candida albicans
3.6 for Aspergillus brasiliensis |
| Equivalence to predicate devices (intended use and technology) | Nonclinical performance test results demonstrate the ciSNaP System performs equivalently to predicate devices and is as safe and effective. |
| No new issues of safety or effectiveness | Differences in technological characteristics do not raise any new issues of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not specify sample sizes for human subjects or clinical data in the "test set" as the studies described are nonclinical, bench testing. The antimicrobial log reduction tests were conducted on "samples of the silverplated skin interface layer" and "silverplated samples" (of the ciSNaP® Controlled Tension Relief Layer). The exact number of samples tested for each organism or time point is not provided.
The provenance (country of origin, retrospective/prospective) is not applicable or provided as these are in vitro laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the provided document. The studies described are nonclinical, bench tests, and in vitro antimicrobial log reduction tests. These types of tests do not typically involve human experts establishing ground truth in the way a clinical study or imaging study would. The 'ground truth' for these tests would be the measured physical, chemical, or biological properties and performance against established standards (e.g., ISO 10993-1 for biocompatibility, or microbial counts for antimicrobial efficacy).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the provided document. As mentioned above, the studies are nonclinical bench tests and in vitro antimicrobial tests, which do not typically involve adjudication methods for human interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The document solely describes nonclinical bench testing and in vitro antimicrobial tests. There is no mention of human readers, AI assistance, or clinical comparative effectiveness studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (negative pressure wound therapy system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The in vitro antimicrobial tests represent the standalone performance of the silver-plated material's antimicrobial properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the nonclinical tests was based on:
- Design specifications and verification testing: For appropriate design characteristics.
- ISO 10993-1 standards: For biocompatibility.
- Product specifications: For packaging and shelf life.
- Measured silver ion availability: For ion release rate.
- Microbial counts of control samples: For antimicrobial log reduction tests (comparing silver-plated samples to unplated controls).
8. The sample size for the training set
This information is not applicable. The document describes nonclinical testing and does not mention any machine learning or AI models with training sets.
9. How the ground truth for the training set was established
This information is not applicable, as there is no mention of a training set for machine learning or AI models.
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
(a)
Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.