(245 days)
The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. The THD Bandy is to be used for exclusive use by medical personnel trained in a proctology procedures.
The THD Bandy is an hemorthoidal ligator intended for pinching off hemorrhoidal nodule. The device is to be used in combination with a suction device, mounted on the basis of the THD Bandy. The THD Bandy consists of a ligation unit, a pusher and a cone. The ligation unit consists of a cylindrical housing connected with a trigger for the release of the elastic band or of the ligature. The hemorrhoidal nodule, trapped on the distal portion of the device, receive an elastic ring or a ligature in order to cut off the blood flow. The pusher and the cylindrical cone are provided in order to assist in the loading of the bands.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy) or comparative effectiveness. The available documents are a 510(k) summary and the FDA's clearance letter for the THD Bandy hemorrhoidal ligator.
Instead, the documents indicate that the device (THD Bandy) was determined to be "substantially equivalent" to predicate devices based on similarities in intended use, design characteristics, materials, and labeling information. The performance data section refers to compliance with international standards for biocompatibility (ISO 10993-1:2003), graphical symbols in labeling (CEN EN 980:1996+A1:1999+A2:2001), and risk management (ISO 14971:2007). These are general safety and procedural standards, not performance criteria for diagnostic or clinical effectiveness as one might expect for a study proving device performance in the sense of AI/reader studies.
Therefore, I cannot populate the requested table or provide information for points 2 through 9 based on the provided text. The device's "performance" in this context refers to its adherence to established safety and quality standards, and its equivalence to legally marketed predicate devices, rather than a clinical performance study with defined metrics.
Here's a breakdown of what can be extracted or deduced from the provided documents:
| # | Information Requested | Details from Document |
|---|---|---|
| 1 | Table of acceptance criteria and reported device performance | Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices and Standards Compliance): The device should have: |
- Same intended use as predicate devices.
- Similar design characteristics to predicate devices.
- Similar materials to predicate devices.
- Compliant labeling information.
- Adherence to biocompatibility standards (ISO 10993-1:2003).
- Adherence to graphical symbol standards for labeling (CEN EN 980:1996+A1:1999+A2:2001).
- Adherence to risk management standards (ISO 14971:2007).
Reported Device Performance (from K093497):
- "The THD Bandy is substantially equivalent to the predicate devices."
- "The intended use of THD Bandy is the same as Sapimed LEM (K070881)."
- "Both THD Bandy and Sapimed LEM (K070881) are manufacture in plastic material, are designed with similar dimensions and are single use devices."
- "The THD Bandy is equivalent to the Sapimed LEM (K070881) and to the Haemoband Multi Ligator Device (K091519) and to the THD Disposable Anoscope/Proctoscope (K080132) concerning the labeling information."
- The device has "been developed and tested according to the following international standards": ISO 10993-1:2003, CEN EN 980:1996+A1:1999+A2:2001, ISO 14971:2007. |
| 2 | Sample size used for the test set and data provenance | Not applicable. No "test set" in the context of clinical performance data is mentioned. The submission focuses on substantial equivalence and compliance with general standards. |
| 3 | Number of experts used to establish ground truth and qualifications | Not applicable. No clinical ground truth establishment or expert review process (outside of FDA's regulatory review) is described in relation to performance data. |
| 4 | Adjudication method for the test set | Not applicable. No test set requiring adjudication is mentioned. |
| 5 | MRMC comparative effectiveness study and effect size | Not applicable. No MRMC study or AI assistance is mentioned. This device is a mechanical ligator, not an AI or diagnostic tool. |
| 6 | Standalone (algorithm only) performance study | Not applicable. This is a medical device, not an algorithm. |
| 7 | Type of ground truth used | Not applicable in the context of clinical performance metrics. The "ground truth" for substantial equivalence is the characteristics of the predicate devices and the relevant international standards. |
| 8 | Sample size for the training set | Not applicable. No training set for an algorithm is mentioned. |
| 9 | How ground truth for training set was established | Not applicable. No training set for an algorithm is mentioned. |
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.