(22 days)
The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.
This Intended Use of the Modified Safety Needle with Introducer device is identical to the Modified TFX Medical Safety Needle with Introducer cleared by the FDA in K021034. In order to provide a more robust design, the material of construction has been changed from High Density Polyethylene to Polypropylene. An increase in the outer diameter has also been implemented to add additional rigidity to the cannula sheath.
The Modified TFX Medical Safety Needle with Introducer will continue to allow placement of guidewires ranging from 0.015" - 0.052". The variance in sizes and lengths is due to the specific procedure, physician preference and patient body type.
This product consists of the following two components:
- Safety Needle (Needle with Passive Sharps Protection)- The Safety Needle, has the 1. same blunter technology as the Bio-Plexus, Punctur-Guard Blood Collection needle (K895024).
- Sheath Introducer- The functionality of the peelable, splitable introducer is identical 2. to the existing introducer sold by TFX Medical, which was initially cleared under K920908 and subsequently cleared under K021034 to be used for guidewire introduction during gastrointestinal procedures.
The sheath will also be made available in a non-peelable configuration.
The provided text describes a 510(k) submission for a Modified TFX Medical Safety Needle with Introducer. This submission is for a medical device and not an AI/ML algorithm, therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
The submission relies on substantial equivalence to predicate devices, rather than establishing new performance criteria through clinical studies with acceptance criteria. The acceptance criteria for the material and design changes are inferred to be successful performance in the identified performance testing and conformance with voluntary performance standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Equivalence | The new material, Polypropylene, is in the same family (Olefins) as the previous High Density Polyethylene, indicating similar behavior under processing conditions (molding, sterilization, aging). |
| Design Equivalence (Sheath) | The non-peelable sheath configuration is identical to the peelable version, except for the lack of a skiving operation. |
| Performance Testing | Performance testing was conducted to support substantial equivalence. (Specific results are not detailed in this summary). |
| Conformance with Voluntary Standards | Conformance with ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices. |
| Intended Use | Identical to the Modified TFX Medical Safety Needle with Introducer cleared under K021034. |
| Guidewire Compatibility | Continues to allow placement of guidewires ranging from 0.015" - 0.052". |
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not mention the specific sample size used for performance testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective).
2. 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)
- This is not applicable as the submission is for a physical medical device, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth from a test set. Substantial equivalence is based on engineering and material characteristics, and conformance to standards.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable for a physical medical device submission of this nature.
4. 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
- This is not applicable. The device is a safety needle and introducer, not an imaging analysis or diagnostic AI tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The submission is for a physical medical device.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the material and design changes, the "ground truth" is based on established engineering principles, material science properties, and adherence to recognized performance standards (e.g., ISO 10993-1 for biocompatibility). The performance testing would have compared the device's characteristics against these established benchmarks or against the predicate device's measured performance. No clinical "outcomes data" or "expert consensus" for diagnostic accuracy are mentioned beyond the device's intended function.
7. The sample size for the training set
- This is not applicable. The submission does not involve an AI/ML algorithm or a "training set" in that context.
8. How the ground truth for the training set was established
- This is not applicable.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.