(36 days)
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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510(k) Summary
1. Product name and description
الموالي الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الم
| a) Scientific name: | Phaenicia sericata larvae (see Figure 1) |
|---|---|
| b) Common names: | Maggot dressings; green blow fly maggots; disinfected maggots; sterile maggots; therapeutic maggots; debriding maggots; maggot debridement therapy; MDT dressings |
| c) "Proprietary" name: | Medical Maggots; to be used with Creature Comforts or Creature Comforts II |
| d) Name and 510(k) number of legally marketed device: | Medical Maggots; K033391The dressings used to confine them on the wound are called "Creature Comforts." |
| e) Classification: | This is a pre-amendment device, still unclassified. Product Code: NQK |
2. Sponsor / Manufacturer identification:
Monarch Labs, LLC 17875 Sky Park Circle, Suite K Irvine, CA 92614 Phone: 949-679-3000 Fax: 949-679-3001 E-mail: rsherman@MonarchLabs.com Registration Number: 3005735989
3. Description of Modifications & Comparison to the cleared device
The proposed modified accessory is a pre-assembled version of the hydrocolloid-netting cage that is commonly assembled at the bedside by end-users.
The structure, function, technology and indications are the same as in the currently marketed product. The TIf sudetally, tulentify, tooliliers), and mails implication of the device, and consequently reduce the unferences rounding from this docessory from the parties and the opportunity for escaping maggots. There should be no change in efficacy as the underlying technology (debridement by medical grade larvae) remain unchanged.
4. Intended use of the device (Indications: unchanged)
The indications for using Medical Maggots and their confinement dressings remain unchanged: To debride 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.
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5. Discussion of Legally Marketed Device, including safety and efficacy data
Maggot therapy is essentially a controlled wound myiasis (maggot infestation). 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.
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(250-1,000 larvae in each vial), making an AE rate of about 0.95% of vials distributed. The vast majority (69%) of those complaints concerned transportation problems (late or lost shipments by FedEx), or viability problems resulting from extreme temperature exposure during delayed transportation. An additional concern has been identified by clients: Obtaining some of the dressing components locally has been difficult for some; and the substitutions they have made has resulted in dressings which break down at the bedside and could potentially lead to escaping maggots.
6. Proposed labeling
No changes are proposed for the labeling or package inserts on any of the currently manufactured and legally marketed items. A new label and package insert is proposed for the pre-assembled version of the confinement dressings (accessory: "Creature Comforts II"). As described in its labeling, this accessory has not changed the indicated use of the product.
7. Design & Manufacturing Information
Design and production controls are in place. Phaenicia sericata larvae are grown and harvested according to previously published methods (Sherman & Wyle; Am J Trop Med Hygeine, 1996), now the standard around the world. The species was specifically tested for safety and efficacy in laboratory and clinical trials 1990-1995, and has not been mixed with other genetic material, even from blowflies of the same species.
Creature Comfort dressings are constructed from polyester netting. Original Creature Comforts are simply cut to standard or custom sizes that match other commercially available components (i.e., hydrocolloid dressings indicated for wound care) with which they can be assembled. These pieces of fabric are assembled (with glues and tapes) by the end user at the bedside, along with other dressing components (most commonly they are affixed to a hydrocolloid pad) to create a confining "cage dressing." Creature Comforts II dual layered dressings are constructed by affixing the same polyester netting to one edge of a hydrocolloid pad (hinge-like), with an adhesive strip along the other three sides so that the fabric can be sealed completely to its matching hydrocolloid pad simply by removing the protective liner on the adhesive strip and pressing down on the netted polyester fabric.
Medical Maggots are chemically disinfected in-house, and each batch is tested. Components that can withstand autoclaving are also sterilized in-house, and each batch is tested. Creature Comforts II require chemical sterilization, which is done by a subcontractor, with validation & verification. Each batch is tested.
The disinfected fly eggs are placed in the sterile vials that provide air for the maggots but prevent microbial entry. Minimally nutritious fluid keeps the larvae alive during transportation but prevents them from maturing before they reach the bedside. 250-500 larvae are packed in each standard shipping vial; 500-1,000 in "large" sized vials. Vials are shipped in protective packaging to prevent damage and to maintain optimal temperature during transit.
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Medical Maggots should not be stored as they are highly perishable. They are sent out within 48 hours of production and should be used within 24 hours of arrival. Creature Comfort dressings can be stored for up to 6 months.
Medical Maggots are applied directly to the wound surface in a dose of 5-8 per square cm, and the confinement dressings are approading to the wound. The dressings are left in place on the wound for a "cycle" of 48 hours (24-72 hours). One to 3 cycles are applied weekly. Most wounds require 2-6 cycles for a "Cycle" of 46 flours (24-72 hours). One to 3-3 --- including application, removal, and disposal --- are described in detail in the Package Insert.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT & * 2007
Monarch Labs, LLC % Mr. Ronald S. Sherman Co-Founder and Laboratory Director 17875 Sky Park Circle, Suite K Irvine, California 92614
Re: K072438
Trade/Device Name: Medical Maggots and maggot confinement dressings Regulatory Class: Unclassified Product Code: NQK Dated: September 24, 2007 Received: September 29, 2007
Dear Mr. Sherman:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark McMulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND/PRSB D.O. f/t:CMD:kxl:10-3-07
OC Numbers:
and the comments of the comments of
:
.
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
:
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Statement of Indications for Use
072438
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Medical Maggots and maggot confinement dressings
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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Over-The-Counter Use (21 CFR 801 Subpart C)
t
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number
Page 8 of _39
8
N/A