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FD-1L/U-1 Hot Biopsy Forceps: This instrument has been designed to be used with Olympus endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
FD-410LR Single Use Electrosurgical Hemostatic Forceps: This instrument has been designed to be used with Olympus endoscopes to cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

The FD-1L/U-1 has been 510(k) cleared in K955052 for collecting tissue in the digestive tract. The subject FD-1L/U-1 has identical specification as the predicate cleared in K955052. This 510(k) submission is for the purpose of adding coagulation and hemostasis to the intended use. The FD-410LR is intended to be used for coagulation and hemostasis only. Although its cup shape is different from that of the FD-1L/U-1, coagulation and hemostasis abilities are the same.

The provided text is a 510(k) summary for Electrosurgical Hemostatic Forceps Series (K062517). This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving those criteria are met.

The document discusses:

• Device Identification: Electrosurgical Hemostatic Forceps Series (FD-1L/U-1 Hot Biopsy Forceps and FD-410LR Single Use Electrosurgical Hemostatic Forceps).
• Intended Use: For FD-1L/U-1, it's for collecting tissue, cauterizing, coagulating, and performing hemostasis with Olympus endoscopes in the digestive tract. For FD-410LR, it's for cauterizing, coagulating, and performing hemostasis with Olympus endoscopes in the digestive tract. The main purpose of this 510(k) for the FD-1L/U-1 is to add coagulation and hemostasis to its intended use.
• Predicate Devices: FD-1L/U-1 Hot Biopsy Forceps (K955052) and LSVP International Hot Biopsy Forceps (K971204).
• Conclusion: The devices (FD-1L/U-1 and FD-410LR) are substantially equivalent to the predicate device and do not incorporate significant changes that could affect safety or effectiveness.

Key takeaway for your request: This is a premarket notification for substantial equivalence, which primarily relies on comparing the new device's characteristics to a legally marketed predicate. It does not typically include detailed performance study data against specific acceptance criteria in the way you've outlined for clinical studies. The FDA letter confirms substantial equivalence but does not describe a clinical study validating performance parameters.

Therefore, for your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided in this document.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided.
4. Adjudication method: Not applicable/provided.
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 device is not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable/provided for this type of submission.
8. The sample size for the training set: Not applicable/provided.
9. How the ground truth for the training set was established: Not applicable/provided.

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