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510(k) Data Aggregation
(41 days)
STONY BROOK SURGICAL INNOVATIONS, INC.
The Stony Brook Surgical Innovations' (SBSI) Sterna-Wire is a non-absorbable Stainless Steel Wire with an attached needle that is used during thoracic surgery to close and hold the sternum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.
Sterna-Wire is indicated for use in the Sternal Closure. Sterna-Wire is a non absorbable sterile surgical suture composed of 316L stainless steel. The wire material consists of 18" (45cm) 316L stainless steel surgical suture wire and the needle material is a 420 stainless steel sharp semi-circular needle, sterile, nonabsorbable, single use. The product will be packaged as 2 wires, 2 sterna-band and 4 wires, 4 sterna-band and 2 wires, and 2 sterna-band products.
The provided text describes a 510(k) summary for the Stony Brook Surgical Innovations Sterna-Wire, a non-absorbable stainless steel suture. The device is a Class II medical device, and this submission is for substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device is substantially equivalent to the predicate device, Ethi-Pack™ Surgical Stainless Steel Suture. The primary acceptance criteria appear to be compliance with specific non-clinical standards and the absence of new questions regarding safety or effectiveness compared to the predicate.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Material Composition | Identical wire material (18" 316L Stainless Steel Wire) to predicate | Meets: Device uses 18" 316L Stainless Steel Wire |
| Identical needle material (420 Stainless Steel Sharp Semi Circular Needle) to predicate | Meets: Device uses 420 Stainless Steel Sharp Semi Circular Needle | |
| Packaging | Consistent with predicate (cardboard sleeve and tyvek pouch) | Meets: Packaging consists of cardboard sleeve and tyvek pouch |
| Sterilization Method | Identical to predicate (ETO Sterilization) | Meets: Sterilization by ETO |
| Intended Use | Identical to predicate (median sternotomy closure) | Meets: Indicated for use in Sternal Closure (after median sternotomy) |
| Non-Clinical Testing | USP 21 Stainless Steel Suture Monographs, Modified | Bench testing performed and supplied with submission, demonstrating no differences in technological characteristics. |
| ASTM F899 Standard Designations | Bench testing performed and supplied with submission, demonstrating no differences in technological characteristics. | |
| AAMI/ANSI/ISO 11137 ETO Sterilization Requirements | Bench testing performed and supplied with submission, demonstrating no differences in technological characteristics. | |
| Safety and Effectiveness | No new questions of safety or effectiveness compared to predicate | Met: "non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: Not applicable. This submission relies on non-clinical (bench) testing and comparison to a predicate device, not a "test set" of clinical data for performance evaluation in the way a diagnostic device would.
- Data Provenance: Not applicable for clinical data. The "test set" in this context refers to the materials and manufacturing processes tested against established standards (USP, ASTM, AAMI/ANSI/ISO). The provenance of these tests would be the manufacturing facility or contract labs where the bench testing was conducted. The document does not specify country of origin for these non-clinical tests. The data is from "bench testing" which is inherently retrospective in nature relative to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. The "ground truth" for this type of device (a surgical suture) is established by adherence to recognized material and sterilization standards, and mechanical property testing, rather than expert consensus on diagnostic interpretations. The standards themselves are developed by expert bodies in their respective fields (e.g., USP for pharmacopeial standards, ASTM for materials, ISO for sterilization).
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication process as would be used for clinical diagnostic performance studies. The compliance with standards is typically a pass/fail determination based on established numerical limits.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not conducted and not applicable. This device is a surgical suture, not a diagnostic imaging or AI-based device that would involve human readers interpreting images.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This device is a physical medical device (suture), not a software algorithm.
7. Type of Ground Truth Used:
The ground truth used is primarily based on established industry standards and regulatory requirements for materials (e.g., 316L Stainless Steel, 420 Stainless Steel for needles), mechanical properties (implied by USP and ASTM standards for sutures), and sterilization efficacy (AAMI/ANSI/ISO). The substantial equivalence claim is also founded on direct comparison to a legally marketed predicate device with the same intended use and technological characteristics.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI/software device, there is no training set or associated ground truth establishment process.
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