MEDIFLY Maggots

{0} # 510(k) Summary # MEDIFLY Maggots # 1. Submitter Information Cuprina Pte. Ltd. 1090 Lower Delta Road, #06-08, Singapore 169201 Primary Contact Person: David Quek Telephone: +(65) 9829 8287 Secondary Contact Person: Belinda Seow Telephone: (b) (6) Date Prepared: 15 July 2025 # 2. Device Name Trade/Proprietary Name: MEDIFLY Maggots Common/Usual Name: Medicinal maggots / Medical grade fly Larvae Product Code: NQK Classification: Unclassified # 3. Predicate Device Trade/Proprietary Name: Medical Maggots™ 510(K) K033391 Product Code: NQK Classification Unclassified {1} #### **4. Device Description** MEDIFLY Maggots are single-use products containing approximately 250 *Lucilia cuprina* larvae, designed for use in maggot debridement therapy (MDT) to aid in the debridement of necrotic and sloughy wounds. The larvae are reared and disinfected in a controlled environment and are packaged in vials that allow air exchange but not microbial contamination, thereby maintaining their quality during transit. Each vial includes a minimally nutritious transportation medium to sustain the larvae while still delaying development until the maggots reach the patient. MEDIFLY Maggots are applied topically to non-healing wounds and covered by air-permeable and absorbent dressings (not provided). MEDIFLY Maggots are manufactured on demand, dispensed upon prescription, and applied under the supervision of trained healthcare professionals. #### **5. Intended Use/Indications for Use** MEDIFLY Maggots is indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds. #### **6. Summary of technological characteristics of the device compared to the predicate** Characteristics of the Cuprina MEDIFLY Maggots and the predicate device, Medical Maggots™ are substantially equivalent and include structural components, indications for use, technological characteristics, performance characteristics, and operational characteristics. {2} ## **7. Summary of non-clinical performance testing as basis for determination of substantial equivalence** Cuprina Pte Ltd MEDIFLY Maggots were tested to validate their function and to ensure that they consistently meet production specifications. A porcine MDT Debridement Assay Model (Blake et al, 2007) was used to demonstrate similar debridement efficacy compared to the predicate device. Additionally, no new safety concerns were identified. All testing was performed in laboratory settings by qualified technicians, and confirmed that the product meets the necessary performance requirements. ## **8. Summary of clinical tests performed to determine substantial equivalence** No clinical data were included in this 510(k) Premarket Notification. ## **9. Summary of other information** Additional information included in this 510(k) submission includes manufacturing details and data derived from the scientific literature. ## **10. Conclusions** MEDIFLY Maggots are substantially equivalent to the predicate device, Medical Maggots™, based on the information provided in this 510(k) Premarket Notification. The differences identified do not raise new safety and/or effectiveness concerns.