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Medical Maggots are indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.

The accessory maggot confinement dressings, Creature Comforts™, and LeFlap™ and LeSoc™, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.

Phaenicia sericata larvae (see Figure 1)
Common names: Maggot dressings; green blow fly maggots; disinfected maggots; sterile maggots; therapeutic maggots; debriding maggots; maggot debridement therapy. Accessories: MDT dressings; maggot confinement dressings; maggot cage dressings.
"Proprietary" name: Medical Maggots; to be used with Creature Comforts or LeSoc (the latter being the new accessory featured in this Special PMN)

Maggot therapy is essentially a controlled wound myiasis (maggot infessation). The maggots macerate their food with their mouth hooks, release their digestive enzymes into the local environment, and ingest the liquefying and semi-solid tissue. As they grow, they molt twice. When satiated, the maggots leave their food source, burry themselves in a suitably protected area, and pupate. Adult flies emerge (eclose) approximately 1-3 weeks later. Maggot therapy dressings contain the medical grade larvae on the wound during the period of debridement, and facilitate easy and controlled removal when the patient and therapist determine they have completed their work.

The proposed modified accessory ("LeSoc") has the same basic structure and use as the previously approved "Sterile Nylon Stocking," with the exception that we will make the stocking out of a different polyester fabric: the same polyester monofilament fabric that we currently use in the production of our approved Creature Comforts dressing (our flat, non-stocking dressing). This means that the stocking weave will be fixed, not free to move or stretch.

The structure, function, technology and indications are the same as in the currently marketed products. The only difference will be the offering of a hybrid dressing accessory to create a stocking-like dressing out of our currently used fixed-weave polyester net instead of the stretch-weave polyester of our Sterile Nylon Stockings.

The provided text is a 510(k) summary for a medical device (Medical Maggots and maggot confinement dressings), specifically addressing a modification to an accessory (the "LeSoc" dressing). The document largely focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study report with specific acceptance criteria and performance metrics in the typical format for AI/ML device evaluations.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not present or applicable in this submission. This is common for predicate device submissions, where the focus is on showing the new device is as safe and effective as devices already on the market, often through addressing minor modifications and validating that the change does not negatively impact performance or create new risks.

Here's an attempt to extract and interpret the information provided, while noting where details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide quantitative acceptance criteria (e.g., "X% of maggots should not escape") or specific numerical performance metrics. The statements are qualitative affirmations of successful validation.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The "Penetration & Durability Feasibility Study" is mentioned, but no sample size (e.g., number of dressing prototypes tested, number of maggots used) is given.
• Data Provenance: The studies appear to be internal validations performed by the manufacturer, Monarch Labs, LLC. There's no mention of external data or specific geographical origin beyond the company's location in Irvine, CA. The "Penetration & Durability Feasibility Study" and sterilization validation were performed by the manufacturer. Biocompatibility data was "supplied by manufacturer."
• Retrospective or Prospective: These appear to be prospective validation studies performed specifically for this 510(k) submission, confirming the performance of the modified accessory.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable/Not mentioned. This type of information (expert consensus for ground truth) is typically relevant for diagnostic imaging AI/ML devices. For a physical medical device like this maggot dressing, the "ground truth" for the penetration and durability study would likely be directly observed maggot escape, not expert interpretation.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. Adjudication methods (like 2+1) are for resolving discrepancies in expert interpretations, which is not relevant for the types of studies described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done. This type of study is primarily for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not relevant for this physical device.

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

• No, a standalone AI algorithm performance study was not done. This device does not incorporate an AI algorithm. The "device" itself is the physical maggot dressing and the biological maggots.

7. The Type of Ground Truth Used

• For Penitration & Durability: Direct observation of maggot escape (or lack thereof) from the dressing.
• For Sterilization Validation: Laboratory testing to confirm sterility parameters were met.
• For Biocompatibility: Results from standard biological evaluation tests (e.g., in vivo or in vitro tests using mice/cells) based on regulatory standards.

8. The Sample Size for the Training Set

• Not applicable/Not mentioned. This device does not involve a "training set" in the context of machine learning. The "training" for the maggots is their natural biological behavior, and the dressings are physical containment systems.

9. How the Ground Truth for the Training Set was Established

• Not applicable. See point 8.

Summary of Device and its Purpose based on the Text:

The device consists of "Medical Maggots" (Phaenicia sericata larvae) and associated confinement dressings. This submission focuses on a new dressing accessory called "LeSoc," which is a hybrid of existing approved dressings. The primary purpose of the maggots is debriding non-healing necrotic skin and soft tissue wounds. The dressings are to confine the maggots to the treatment area. The modification to the LeSoc dressing involves using a fixed-weave polyester fabric (similar to another approved dressing, "Creature Comforts") instead of a stretch-weave fabric (used in "Sterile Nylon Stockings") to prevent maggots from escaping. The studies described are validations of this material change, focusing on preventing maggot escape, ensuring proper sterilization, and confirming biocompatibility, to demonstrate substantial equivalence to previously cleared devices.

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Medical Maggots are indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and nonhealing traumatic or post surgical -wounds.

The accessory maggot confinement dressings, Creature Comforts and Creature Comforts II, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.

Phaenicia sericata larvae (Medical Maggots) and maggot confinement dressings (Creature Comforts and Creature Comforts II). The maggots are used for debridement of non-healing necrotic skin and soft tissue wounds. The dressings are used to confine the maggots on the wound. The modified accessory is a pre-assembled version of the hydrocolloid-netting cage.

This 510(k) submission describes a modification to an existing device, "Medical Maggots," which involves a pre-assembled version of their confinement dressing, "Creature Comforts II." As such, the submission does not contain extensive new clinical study data or detailed acceptance criteria for a novel device. Instead, it focuses on demonstrating substantial equivalence to the previously cleared device and ensuring the modification does not negatively impact safety or efficacy.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria in a table format, nor does it present detailed performance metrics for the modified device in comparison to such criteria. This is typical for a 510(k) modification where the fundamental product (the maggots) and its intended use remain unchanged. The core argument is substantial equivalence, not a new performance claim against defined thresholds.

Instead, the submission refers to:

• Safety and Efficacy Data (for the predicate device): "All complaints and adverse events are collected and reviewed (phase 4 post-marketing study), along with solicited and unsolicited client comments. Analysis of this data recently revealed that there were 43 complaints and adverse events (AE) reported over the prior 2 years in association with 4,506 vials of maggots... making an AE rate of about 0.95% of vials distributed."
• Improvement with "Creature Comforts II": The new dressing aims to "reduce the unferences rounding from this docessory from the parties and the opportunity for escaping maggots." This implies an acceptance criterion related to maggot containment and ease of use, though no specific metrics are given.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (for the modified accessory): The document does not describe a formal head-to-head clinical "test set" for the "Creature Comforts II" dressing with specific sample sizes. The modification is primarily a design change to address existing issues.
• Data Provenance (for the predicate device's post-market surveillance): The data on adverse events (43 complaints over 2 years for 4,506 vials) is from a retrospective, post-marketing study ("phase 4 post-marketing study") based on "all complaints and adverse events...along with solicited and unsolicited client comments." The country of origin is not explicitly stated, but given Monarch Labs is US-based and this is an FDA submission, the data is likely predominantly from the United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable to this submission. The submission does not describe a clinical study for the modified device that required expert consensus for ground truth. The adverse event data relies on client reports, not expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable to this submission. There is no described test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported for this device. This device is a medical product (larvae for debridement) and its associated dressing, not an imaging or diagnostic device typically evaluated with MRMC studies comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study (algorithm only) was not done. The device (Medical Maggots) is a biological product, and its effectiveness is inherently tied to its biological action on a wound, in conjunction with human application and monitoring. The "Creature Comforts II" is a physical dressing.

7. Type of Ground Truth Used

• For the predicate device's efficacy/safety: The original "Medical Maggots" were tested for safety and efficacy in "laboratory and clinical trials 1990-1995" (Section 7). The specific type of ground truth used in those original trials is not detailed in this 510(k) summary, but for wound debridement efficacy studies, it would typically involve clinical assessments (e.g., wound area reduction, necrotic tissue removal) potentially supported by photographic evidence or pathological examination if biopsies were taken.
• For the current modification: The "ground truth" for identifying issues with the original dressing leading to the modification was client complaints and adverse event reports related to transportation, viability, and challenges in local assembly leading to potential maggot escape (Section 5).

8. Sample Size for the Training Set

Not applicable. The submission does not describe a machine learning algorithm or an AI component that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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For debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.

Not Found

This document is a 510(k) clearance letter for "Medical Maggots" and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device for specific indications for use, but it does not detail any performance metrics or clinical study results.

Therefore, I cannot provide the requested information based on the provided text.

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