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Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches may be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.

The device is a European Medicinal Leech (Hirudo verbana). It is a greenish segmented worm of the Annelida worm classification. The animal is a bloodsucking animal living in freshwater.

This document is a 510(k) summary for Biopharm (UK) Ltd.'s Medicinal Leeches (Hirudo verbana). The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device (K040187, also for Medicinal Leeches, but classified as Hirudo medicinalis).

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets specific performance criteria in the way one would expect for a diagnostic or therapeutic medical device with measurable outcomes. This is because Medicinal Leeches are a "Preamendment Device - Unclassified." This means they were marketed prior to May 28, 1976 (the enactment date of the Medical Device Amendments) and as such, they are not subject to the same regulatory requirements for performance testing, clinical trials, or established acceptance criteria as newly developed devices.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)."

Instead of performance criteria and a study to meet them, the submission focuses on:

• Intended Use: Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches can be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.
• Mechanism of Action: The saliva of the leech contains an anticoagulant (Hirudin) which is responsible for the prolonged bleeding that occurs after the leech has detached. This prolonged bleeding is used in instances where blood has become congested.
• Substantial Equivalence: The key "study" here is the comparison to a predicate device. The document states: "Our device and its predicate share the same characteristics, they are both European Medicinal Leeches... The only difference is that our device is scientifically categorized as the species Hirudo verbana (Southern European Medicinal Leeches) and the predicate is classified as Hirudo medicinalis (Northern European Medicinal Leeches). ... There are no known differences in the activity spectrums of the two European variants. The two medicinal leech species are used as exact equivalents for use in overcoming problems with venous congestion."

Therefore, I cannot provide the requested table and study details as they do not exist in the context of this 510(k) submission for a preamendment, unclassified device. The "acceptance criteria" were effectively met by demonstrating substantial equivalence to an existing legally marketed device and its accepted indications for use, without the need for a rigorous performance study with numerical targets.

If new performance data were required for this type of device, it would indicate a reclassification or a new regulatory pathway, which is not the case here.

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An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to when problems of venous congestion by creating prolonged localized bleeding.

Medicinal Leeches, a blood sucking aquatic animal living in fresh water and subject to regulation by the U.S. Fish and Wildlife Service, are a preamendment, unclassified device which, by nature of their historical use and documented value in various post surgical situations.

This 510(k) premarket notification for Medicinal Leeches (Hirudo Medicinalis) primarily establishes substantial equivalence based on the device's historical use and documented value as a "preamendment device" rather than presenting a traditional study with acceptance criteria and performance metrics against a newer, classified predicate.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, training set details) are not applicable or not provided in the given document.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document highlights their use since ancient Egypt and their re-adoption in modern surgery to restore venous blood circulation, producing anticoagulant and vasodilator substances that allow continued bleeding and improve venous circulation. |

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable/Not provided. The submission does not describe a "test set" in the conventional sense of evaluating a new device against a specific set of data.
• Data Provenance: The document refers to the historical use of medicinal leeches as far back as ancient Egypt and their revival in modern surgical practice. This suggests a reliance on retrospective, long-standing clinical experience and historical documentation rather than a specific prospective study with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. The submission focuses on the historical use and established value of leeches, which does not involve establishing ground truth for a discrete test set by a panel of experts in the context of a new device evaluation.

4. Adjudication method for the test set

• Not applicable/Not provided. No test set requiring expert adjudication is described.

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 is not an AI/software device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a biological device (medicinal leeches), not an algorithm or software. Its performance is inherently "standalone" in the sense that the leeches act directly, but not in the context of a computational algorithm.

7. The type of ground truth used

• The "ground truth" for the efficacy and safety of medicinal leeches in this context is based on historical clinical use, documented medical practice over centuries, and established physiological effects (anticoagulant and vasodilator properties, prolonged localized bleeding). This is essentially outcomes data and expert consensus accumulated over extended historical periods, rather than a singular, prospectively established ground truth for a specific study.

8. The sample size for the training set

• Not applicable/Not provided. There is no machine learning component to this device, and thus no "training set" in the computational sense. The "training" here refers to centuries of human experience and medical observation.

9. How the ground truth for the training set was established

• Not applicable/Not provided. As above, there is no computational training set. The effectiveness is derived from historical and ongoing clinical observation and medical understanding of their biological mechanisms.

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