(29 days)
The SorbaFix Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair. The PermaFix Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
The proposed SorbaFix Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic absorbable fasteners. The fasteners are dyed with D & C Violet No. 2 in accordance with 21 CFR 74.1602. The shaft of the SorbaFix Absorbable Fixation System is 36 cm in length, including a piloting tip. The fasteners are 6.7 mm in length and are manufactured from Poly (D, L)-lactide. The fixation instrument shafts have an outer diameter of 5 mm, and may be used in open procedures or with most 5 mm trocars in laparoscopic procedures. The device includes a fastener gauge located on the back of the handpiece for user convenience only. The gauge will move right to left as the fasteners are deployed and indicates the approximate level of fasteners remaining in the device. The proposed PermaFix Fixation System is a sterile single use device that delivers fasteners manufactured from a non-absorbable acetal copolymer material. The other patient contacting components in the delivery system are all made from the same stainless steel as that of the predicates.
This 510(k) summary is for the SorbaFix™ Absorbable Fixation System and PermaFix™ Fixation System, which are implantable staples used for soft tissue approximation and surgical mesh fixation. The application focuses on demonstrating substantial equivalence to previously cleared predicate devices (SorbaFix K082396 and PermaFix K092483).
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical acceptance criteria for specific performance metrics (e.g., tensile strength, deployment force). Instead, it relies on demonstrating that the proposed devices meet the requirements set up in the product performance specifications for their respective predicate devices. The overall "acceptance criterion" is thus substantial equivalence to the predicates, which is shown through design verification and validation testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices (K082396, K092483) | - Devices have the same implantable fastener design and similar delivery system design. |
- Devices have the same materials as the predicate devices.
- Devices have the same shelf life.
- Devices use the same sterilization method.
- Devices are packaged and sterilized using the same materials and processes. |
| Biocompatibility with intended use | Full biocompatibility testing was conducted on the predicate SorbaFix and PermaFix fasteners (long term implants) in accordance with ISO 10993 series requirements. The results of these tests were submitted under K082396 and K092483. No further testing was necessary for the proposed devices as they incorporate the same materials. |
| Functional performance (e.g., fastener deployment, device operation) | "Design verification and validation testing were conducted and demonstrated that the proposed SorbaFix and PermaFix met the requirements set up in the product performance specifications for their respective predicate devices." (Summary of activities in Section 18.0, not provided here). |
| Adherence to intended use statement | The proposed devices are indicated for approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair, which aligns with the predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the design verification and validation testing. It mentions "design verification and validation testing were conducted," but details on the number of devices or components tested are not provided within this summary.
The data provenance is not specified in terms of country of origin. Given it's a 510(k) submission to the US FDA, it can be inferred that the testing and validation were conducted in a manner compliant with US regulatory standards. The testing appears to be retrospective in the sense that it evaluates the performance of the modified devices against established specifications of prior cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the evaluation of mechanical medical devices like fixation systems. The "ground truth" for these devices is typically established through engineering specifications, material properties, and functional performance testing, rather than expert interpretation of data like in diagnostic imaging. Therefore, no number of experts for ground truth establishment is mentioned within this summary.
4. Adjudication Method for the Test Set
Not applicable. The evaluation is based on engineering and material testing, not human-read interpretations requiring adjudication.
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 a medical device submission for a physical fixation system, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device submission for a physical fixation system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the test set is established by:
- Engineering Specifications: Defined performance requirements for mechanical properties, material integrity, and functionality established for the predicate devices.
- Material Properties: Chemical and physical characteristics of the materials used.
- Biocompatibility Standards: Adherence to ISO 10993 series requirements for long-term implants.
8. The Sample Size for the Training Set
Not applicable. This is a medical device submission for a physical fixation system, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.