(128 days)
The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads.
The Percutaneous Introducer Set is a single use device allowing for introduction, manipulation, and removal of stimulation leads after percutaneous entry is gained with a needle. The sheath is made of HDPE (High Density Polyethylene) with a HDPE hub. It is slightly tapered at the distal end to make a smooth transition to the dilator. The dilator is made of 304 stainless steel tubing tapered at the distal end for smooth insertion. It has a molded HDPE hub. The guidewire directional guide is made of 304 stainless steel wire with radiuses at each end. It has depth markings etched into the surface along the distal end.
This document, K013120, is a 510(k) summary for a Percutaneous Introducer Set. The device is intended for the introduction, manipulation, and removal of stimulation leads.
The document indicates that the device's substantial equivalence is based on its similarity to a predicate device, the MedAmicus Epidural Introducer (K994097), in terms of intended use, basic design, manufacturing methods, and materials.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document
does NOT list specific acceptance criteria with quantifiable metrics, nor does it provide a detailed table of reported device performance against such criteria.
Instead, it offers a general statement: "Performance data indicates that the Percutaneous Introducer Set meets the functional requirements and specifications for this device."
To infer potential "acceptance criteria" based on the provided information, we can consider the aspects of similarity to the predicate device and relevant material properties:
| Acceptance Criterion (Inferred from document) | Reported Device Performance (as stated in document) |
|---|---|
| Intended Use Equivalence: Percutaneous introduction, manipulation, and removal of stimulation leads. | "The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads." "The intended use... are similar to the predicate device..." |
| Basic Design Equivalence: Physical structure and components (sheath, dilator, guidewire). | "The basic design... are similar to the predicate device..." Detailed description of components: HDPE sheath, HDPE hub, 304 stainless steel dilator, 304 SS guidewire, platinum iridium marker band. |
| Manufacturing Methods Equivalence: Processes used to produce the device. | "The methods of manufacturing... are similar to the predicate device..." "The sheath materials and manufacturing processes for the Percutaneous Introducer Set are equivalent to those used on the predicate MedAmicus device..." |
| Material Equivalence: Composition of parts that come into contact with the patient or leads. | "The materials are similar to the predicate device..." "Materials used in the Percutaneous Introducer Set are identical to materials previously approved/cleared for market release." (Specific examples: HDPE identical to K990705, 304 SS identical to P970004, Platinum Iridium identical to P970004). |
| Biocompatibility: Safety for contact with tissue. | "Applications referred to below are for Externally Communicating - Blood Path Indirect - Limited Exposure which includes all the testing required above." "Since the materials are identical to those previously approved/cleared, there are no new issues involving safety and effectiveness." |
| Sterility: Assurance of being free from viable microorganisms. | "Present sterilization cycle assures a Sterility Assurance Level (SAL) of >10-6." |
| Packaging Equivalence: Maintenance of sterility and physical integrity. | "The packaging materials for the Percutaneous Introducer Set are equivalent to the predicate MedAmicus Epidural Introducer. These materials consist of a double sterile barrier using Tyvek/Mylar pouches." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a specific "test set" with a defined sample size or data provenance (e.g., country of origin, retrospective or prospective). The submission relies on establishing substantial equivalence to a predicate device, and the "performance data" mentioned is a general statement, not a detailed study report.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The submission focuses on device equivalence rather than a study requiring expert-established ground truth for a test set.
4. Adjudication Method
This information is not provided in the document. As no specific test set or expert ground truth establishment is described, neither is an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this 510(k) submission. The document aims for substantial equivalence based on physical and functional characteristics, not on the impact of the device on human readers' performance with or without AI assistance.
6. Standalone Performance Study
A standalone (algorithm-only without human-in-the-loop performance) study was not performed or reported in this 510(k) submission. This is a medical device, not an AI/algorithm-based diagnostic tool. The "performance data" mentioned is a general statement about meeting functional requirements.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in the context of diagnostic performance studies (e.g., expert consensus, pathology, outcomes data) does not apply directly to this 510(k) submission. The "truth" for this submission is based on the demonstration of substantial equivalence to a legally marketed predicate device and the "identicality" of materials to those previously approved.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As there is no training set for an AI/machine learning model, there is no ground truth establishment for such a set.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).