(156 days)
The ReNew single patient use disposable scissor tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
This Traditional 510(k) Submission is being submitted for an update to the ReNew Disposable Scissor Tips. The current ReNew Disposable Scissor Hub Assembly is being updated in an effort to decrease assembly labor. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub. Due to this change an additional change needed to be made to the heat shrink on the scissor tip. An adhesive is needed to seal the heat shrink to the backhub to prevent moisture passing through and to prevent an electrical pathway.
This submission is also intended to "catch up" incremental modifications to the predicate device [510(k): K962119] that were incorporated over time.
The subject devices are made of ten (10) primary components which includes the following:
- Front Hub
- Overmolded Back Hub
- Disc Spring
- Yoke
- Yoke Pin
- Crimp Pin
- Short Blade
- Long Blade
- Surgislip Lubricant
- Heat Shrink with Adhesive Polymer
There are no medicinal substances associated with the subject devices. There is no use of animal tissue in manufacturing of the subject devices, and they are not made with Natural Rubber Latex, Bisphenol-A, Vinyl (PVC) or Phthalates.
The subject devices are supplied as sterile. In accordance to 21 CFR § 801.109, Subpart D, the labeling for the devices will indicate for prescription (Rx) use only.
The provided text describes a 510(k) submission for an updated medical device, the "ReNew Laparoscopic Instruments Disposable Scissor Tips." This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria based on AI/ML performance.
The document discusses mechanical and biocompatibility testing for the updated scissor tips, mainly to show that design changes (related to the hub assembly and heat shrink) do not adversely affect performance or safety compared to the predicate device.
Therefore, the requested information regarding AI/ML device performance, acceptance criteria, sample sizes for AI/ML test and training sets, expert ground truth establishment for AI/ML, MRMC studies, standalone AI performance, etc., cannot be extracted from this document as it is not an AI/ML medical device submission.
The document details the following:
1. Acceptance Criteria and Device Performance (Non-AI/ML):
The acceptance criteria are implicitly defined by the successful completion of various engineering and biological validation tests. The device performance is deemed acceptable if it meets these criteria, demonstrating equivalence to the predicate device and establishing safety and effectiveness.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Summary from text) |
|---|---|
| Bench Performance Testing | Met performance specifications criteria for Substantial Equivalence. No new risks or safety/effectiveness issues raised. |
| Cutting Equivalency | Demonstrated equivalency to the currently marketed device. |
| Assembly and Disassembly | Successfully assembled and disassembled to the ReNew Handpiece. |
| Heat-shrink printing adhesion | Successfully demonstrated adhesion. |
| Tissue Thermal Spread | Tested and performance met requirements. |
| Ethylene Oxide (EO) Sterilization Validation | Validated. |
| Electrical Safety and EMC (IEC 60601-1, -1-2, -2-2) | Met requirements. |
| Biocompatibility (ISO 10993-1, -5, -10, -11) | Successfully established no new risks; determined to be biologically safe for Cytotoxicity, Intracutaneous Reactivity, Delayed type Sensitivity, Acute Systemic Toxicity, and Pyrogenicity. |
| Animal (Coagulation Performance) | Met all design and predetermined performance specifications to demonstrate intended use. |
2. Sample Size and Data Provenance (Non-AI/ML context):
- Sample sizes for testing: Specific numbers are not provided in this summary. The tests were "bench performance testing" and "animal testing." These typically involve a statistically relevant number of units to demonstrate consistency and reliability, but the exact N is not disclosed here.
- Data Provenance: Not explicitly stated as "country of origin" for testing data. The animal study was conducted in compliance with FDA Good Laboratory Practice Regulations.
3. Number of Experts and Qualifications:
Not applicable for this type of device submission as it does not involve human interpretation of AI outputs or image reading. The testing is primarily engineering and biological.
4. Adjudication Method:
Not applicable, as there's no AI output to adjudicate.
5. MRMC Comparative Effectiveness Study:
Not applicable. This is not an AI/ML device.
6. Standalone Performance Study:
Not applicable for a surgical instrument. The performance testing is integral to the device's function.
7. Type of Ground Truth:
For this device:
- Bench Performance: Performance specifications and engineering standards define the "ground truth" (e.g., successful cut, proper assembly, specified thermal spread).
- Biocompatibility: Established biological safety standards (ISO 10993 series) define the "ground truth" for material safety.
- Animal Testing: Pre-determined performance specifications observed in animal models established the "ground truth" for coagulation performance.
8. Sample Size for Training Set:
Not applicable. This is not an AI/ML device.
9. How Ground Truth for Training Set was Established:
Not applicable. This is not an AI/ML device.
In summary, the provided document is a 510(k) summary for a mechanical/electrosurgical device modification, not an AI/ML device. Therefore, the specific criteria and study details requested for an AI/ML device performance evaluation are not present in this document.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.