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510(k) Data Aggregation
(60 days)
PENROSE DRAIN MODELS 6001 - 6007
Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.
Passive Wound Drain. Flat Silicone Drain. Dimensionally equivalent to the Davol Gravity Drain, except Davol offers both 12" and 18"; Sil-Med Corporation offers 18" only. Both have inner diameter teeth to prevent the drain from collapsing. Both devices have a Radiopaque stripe. Sil-Med Penrose Drains are sold sterile only.
The provided text describes a 510(k) summary for the Sil-Med Corporation's Penrose Drain, comparing it to a predicate device, the Davol Gravity Drain. The information focuses on a comparison of device characteristics and biocompatibility testing, not on clinical performance or diagnostic accuracy. Therefore, the questions related to AI/algorithm performance, ground truth, expert opinions, and reader studies are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria & Reported Performance for Sil-Med Penrose Drain
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Rabbit Pyrogen Test | Must be non-pyrogenic | Non-pyrogenic |
| Hemolysis-Rabbit Blood | Non-hemolytic at a certain % (implicitly low) | Non-hemolytic at 2.02% Hemolysis |
| Salmonella typhimurium Reverse Mutation Assay | Must be non-mutagenic | Non-mutagenic |
| Kligman Maximization Study (Cottonseed Oil Extract) | Low/weak allergenic potential (implicitly Grade I) | Grade I - weak allergenic potential (not considered significant) |
| Kligman Maximization Study (Sodium Chloride Extract) | Low/weak allergenic potential (implicitly Grade I) | Grade I - weak allergenic potential (not considered significant) |
| USP CLASS VI | Must satisfy requirements of USP XXII Biological Test for Plastics, Class VI-121°C | Satisfied the requirements of USP XXII Biological Test for Plastics, Class VI-121°C |
| Elution Test | Must be non-cytotoxic | Non-cytotoxic |
| USP Muscle Implantation Study in Rabbits with Histopathology (90 Days) | Must meet USP requirements | Met USP requirements |
| Dimensional Equivalence to Predicate Device (Davol Gravity Drain) | Equivalent dimensions to predicate device (except length options) | Inner diameter teeth to prevent collapsing; 18" length (Davol offers 12" and 18") |
| Radiopaque Stripe | Presence of radiopaque stripe | Both devices have a Radiopaque stripe |
| Sterility | Device offered as sterile (predicate offered sterile/non-sterile) | Sold sterile only |
| Intended Use | Equivalent to predicate device | Equivalent to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to various standard biocompatibility tests (e.g., Rabbit Pyrogen Test, Hemolysis-Rabbit Blood, Salmonella typhimurium REVERSE Mutation ASSAY, Kligman Maximization Study, USP CLASS VI, Elution Test, USP MUSCLE IMPLANTATION STUDY IN RABBITS WITH HISTOPATHOLOGY). The sample sizes are inherent to the standard protocols for these specific biological tests (e.g., number of rabbits for pyrogenicity or implantation, number of wells/bacteria for mutagenesis). The document does not explicitly state the specific number of samples or animals used beyond what is implied by the test names.
Data provenance (country of origin, retrospective/prospective) is not mentioned, as these are lab-based biological tests, not clinical studies involving patient data.
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)
Not applicable. This submission concerns biocompatibility and dimensional equivalence, not diagnostic performance or expert review of medical images/data. The "ground truth" here is established by the validated methods of the specified biological and physical tests and their established pass/fail criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving disagreements in expert readings of medical data. The tests described are objective biological and physical assessments.
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
Not applicable. This is not a submission for an AI/CAD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a submission for an AI/CAD device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is based on:
- Established Biomedical Standards: For tests like USP CLASS VI, the ground truth is defined by the requirements outlined in the United States Pharmacopeia.
- Standardized Laboratory Protocols: For tests like pyrogenicity, hemolysis, mutagenesis, and sensitization, the ground truth is determined by the specific, validated methods and endpoints of these universally accepted in vitro and in vivo biological assays.
- Physical Measurement Comparisons: For dimensional equivalence, the ground truth is direct measurement and comparison to the predicate device's specifications.
8. The sample size for the training set
Not applicable. There is no AI/machine learning model being developed, so no training set is relevant.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/machine learning model, there is no training set and therefore no ground truth establishment for it.
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