(152 days)
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.
N/A