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510(k) Data Aggregation
(449 days)
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
The Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube is intended to provide short-term enteral access for delivery of nutrition and/or medications to the small bowel in patients older than 12 years old.
The Tiger 2" Self-Advancing Nasal Jejunal Feeding Tube consists of a 14 Fr polyether-urethane tube manufactured with a length of 153 cm. It has 5 sideports on the distal end for the purpose of delivering nutrition and/or medication. The shaft of the Tiger 2" Self-Advancing Nasal Jejunal Feeding Tube includes 26-28 flaps cut into the tubing over the distal 40 cm segment of the device. These flaps provide a means for the catheter to be advanced by the natural peristaltic action of the gastrointestinal tract. The most distal flap is placed at approximately 2 cm from the distal tip of the catheter. Markings are placed along the shaft of the Tiger 2" Self-Advancing Nasal Jejunal Feeding Tube in 5 cm increments (labeled at 10 cm increments). The proximal end of the shaft is attached to a red feeding adapter marked with the text "ENTERAL FEED/MED." The Tiger 2 " Self-Advancing Nasal Jejunal Feeding Tube will be supplied sterile and is intended for one-time use.
The provided text describes a 510(k) summary for the "Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube". This document focuses on demonstrating substantial equivalence to a predicate device through various tests.
Based on the information provided, here's a breakdown of the acceptance criteria and the study details:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria (Explicitly Stated or Implied) | Reported Device Performance |
|---|---|---|
| Tensile Strength | The objective is that the device should not break or crack during proper clinical use. (Implied: The device must withstand forces encountered during insertion and use without structural integrity compromise). The "predetermined acceptance criteria" were met. | "The results showed that the predetermined acceptance criteria were met." The device is expected to not break or crack during proper clinical use. |
| Liquid Leakage | The objective is that the device should not leak during proper clinical use. (Implied: The device must maintain its integrity to ensure accurate delivery of nutrition/medication without leakage). The "predetermined acceptance criteria" were met. | "The results showed that the predetermined acceptance criteria were met." The device is expected to not leak during proper clinical use. |
| Misconnection | The connector should not provide a secure connection when forcefully assembled to any surface of the components of, and should easily disengage from, each connector of every other application category specified in ISO 80369-1:2010. OR, if a connection does engage, then greater than 75% of the infusate should leak from the misconnection between the connector and the reference connector. (This criterion aims to prevent unintended misconnections with other medical devices). | "All test results are considered acceptable." |
| Biocompatibility | The device must conform to biocompatibility requirements based on its intended use, as per ISO 10993-1 and FDA guidance. This includes demonstrating acceptable results for cytotoxicity, sensitization, intracutaneous irritation, pyrogen, subchronic toxicity, subacute toxicity, and acute systemic toxicity. (This ensures the device does not cause harmful biological reactions when it comes into contact with the body). | "Biocompatibility Testing demonstrated that the subject device conforms to the biocompatibility requirements based on its intended use. Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, pyrogen, subchronic toxicity, subacute toxicity, and acute systemic toxicity demonstrated the biocompatibility of the subject devices. All test results are considered acceptable." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for any of these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these engineering and biocompatibility tests. These types of tests are typically conducted in a laboratory setting, not with patient data.
3. 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 document describes performance testing of a physical medical device (feeding tube), not a diagnostic algorithm that requires expert ground truth. Therefore, this question is not applicable. The "ground truth" for these tests are the physical and chemical properties measured against predefined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the document describes performance testing of a physical medical device, not a diagnostic algorithm.
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
This question is not applicable as the document describes performance testing of a physical medical device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the document describes performance testing of a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For Tensile Strength, Liquid Leakage, and Misconnection tests, the "ground truth" is defined by the predetermined acceptance criteria and relevant industry standards (e.g., ISO 80369-1:2010 for misconnection). These are objective, measurable physical parameters.
For Biocompatibility Testing, the "ground truth" is established by adherence to ISO 10993-1 and FDA guidance, which includes standardized toxicology and biological evaluation methods. The results are compared against these established safety thresholds.
8. The sample size for the training set
This question is not applicable as the document describes performance testing of a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This question is not applicable as the document describes performance testing of a physical medical device, not a machine learning model.
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