(486 days)
Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.
The Medicinal Leech is a laboratory-raised bloodsucking annelid (segmented worm) that inhabits fresh water. The leech has a cylindrical body, is slightly flattened, and has around 32 segments. It has a disc-shaped sucker at the head end and a tail sucker at the caudal end.
This document is a 510(k) summary for a medical device called "Medicinal Leech" (K140907). It outlines the substantial equivalence determination for marketing the device.
Based on the provided text, the device is a Medicinal Leech, classified as Unclassified with product code NRN.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
This document describes a medical device, a Medicinal Leech, which is a biological entity. The FDA's substantial equivalence review for such a device does not typically involve traditional "acceptance criteria" based on quantitative performance metrics like sensitivity, specificity, or accuracy, as would be seen for an AI/software device. Instead, the review focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device.
The "performance" of the medicinal leech is described in terms of its function and therapeutic benefits, rather than specific numerical acceptance criteria.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as described) |
|---|---|
| Safety and Effectiveness (Equivalent to predicates) | The Medicinal Leech (Hirudo verbana or Hirudo medicinalis) is presented as identical to predicate devices (K040187, K132958). Its function is to facilitate prolonged localized bleeding when it attaches to the patient's skin for a blood meal. Therapeutic benefits include alleviating venous congestion and delayed healing, primarily through the release of up to 150 mL of blood over 10 or more hours following the bite. Controls are in place for handling, packaging, and storage to avoid contamination and maintain viability. |
| Indications for Use (Equivalent to predicates) | Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding. This is identical to the indications for use of the predicate devices. |
| Product Characteristics (Equivalent to predicates) | The device is a laboratory-raised bloodsucking annelid, cylindrical, slightly flattened, with around 32 segments, and disc-shaped suckers at both ends. It is stated to be identical to the predicate devices in its scientific name (Hirudo verbana or Hirudo medicinalis) and general characteristics. Facilities and handling procedures are described to ensure quality and prevent contamination. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical trials or performance studies with a specific sample size. The FDA review for this device is based on demonstrating substantial equivalence to existing legally marketed predicate devices. This typically involves comparing characteristics, indications for use, and safety/effectiveness profiles rather than presenting de novo clinical study data for acceptance criteria.
Therefore, there is no explicit test set sample size or data provenance described for this 510(k) submission. The "data" provenance would implicitly be from the history of use and the regulatory approvals of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there is no "test set" or ground truth established in the sense of a clinical or image-based diagnostic performance study for this type of device. The ground truth, if one could apply the term, would be the established medical consensus on the therapeutic utility and safety profile of medicinal leeches, which has been accumulated over centuries of use and recognized in prior regulatory approvals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no specific test set requiring adjudication in this regulatory submission.
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 a medicinal leech, a biological product, not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI/software performance, which is not relevant to a medicinal leech.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" is implicitly the established safety and effectiveness profile of legally marketed predicate medicinal leech devices, supported by historical medical use and scientific understanding of their physiological effects. This is a form of historical medical consensus and clinical experience, rather than a specific, newly generated type of ground truth data (like pathology or outcomes from a new clinical trial).
The study that proves the device meets the acceptance criteria (Substantial Equivalence):
The "study" here is not an experimental clinical trial, but rather a comparative analysis demonstrating substantial equivalence to predicate devices.
The document states:
- "Carolina Biological Supply Company (Carolina) will normally obtain and offer medicinal leeches that are identical to those approved under K132958, with scientific name Hirudo verbana."
- "If necessary, Carolina may obtain (from a registered source with an approved and registered device) and offer medicinal leeches with scientific name Hirudo medicinalis, as are approved under K040187."
- "Carolina's product is identical to predicate devices."
The listed predicate devices are:
- K040187: Ricarimpex SAS, Medicinal Leeches (Hirudo Medicinalis), Approved 06-21-04
- K132958: Biopharm (UK) Ltd, European Medicinal Leeches (Hirudo Verbena), Approved 02-19-14
Proof of Meeting Acceptance Criteria:
The core of the submission (and the "study" by regulatory standards here) is the assertion and demonstration that the characteristics, indications for use, and operational aspects (facilities, handling, packaging, storage, disposal) of the Carolina Biological Supply Company's Medicinal Leeches are substantially equivalent to those of these two legally marketed predicate devices. By proving they are "identical" in all relevant aspects to already-approved devices, the manufacturer demonstrates they meet the implicit safety and effectiveness "acceptance criteria" established by the predicates.
8. The sample size for the training set
Not applicable. This is not an AI/software device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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