(116 days)
Not Found
No
The device description and intended use clearly state that the product consists of live larvae for debridement. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The performance testing focuses on the biological function of the larvae.
Yes
The device is indicated for "debridement of non-healing necrotic skin and soft tissue wounds," which is a therapeutic intervention.
No
The device description and intended use clearly state that the BioMonde Larvae products are used for debridement of wounds, which is a therapeutic function, not a diagnostic one. They are applied to remove necrotic tissue, not to identify or characterize a medical condition.
No
The device description explicitly states the product is live larvae, which are biological organisms, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The BioMonde Larval Debridement Therapy Products are applied directly to a wound on the patient's body. Their function is to debride (remove dead tissue from) the wound, which is a therapeutic action performed in vivo (within the living organism).
- Intended Use: The intended use clearly states "debridement of non-healing necrotic skin and soft tissue wounds." This is a treatment, not a diagnostic test performed on a sample outside the body.
The device is a therapeutic device used for wound care, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The BioMonde Larval Debridement Therapy Products – Larvae 100/200/300 are indicated for debridement of 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.
Product codes
NQK
Device Description
The BioMonde Larvae 100/200/300 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata. They are manufactured in three (3) configurations:
- Larvae100: at least 100 larvae per container ●
- Larvae200: at least 200 larvae per container .
- Larvae300: at least 300 larvae per container .
The larvae are derived from disinfected fly eggs. Larvae are transferred under controlled manufacturing conditions into transport tubes which are additionally boxed for transport.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Upon arrival at the treatment location, they are applied to the wound and covered with permeable and absorbent dressings (not provided).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Testing that demonstrates that the product fulfills design and performance specifications. Side by side testing of the performance of the BioMonde product and the predicate demonstrates substantial equivalence in performance.
SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical data were included in this 510(k) Premarket Notification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(K) SUMMARY 5.
MAR 5 2013
BIOMONDE LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 (PER 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
BioMonde (a trading name of ZooBiotic Limited) Units 2-4 Dunraven Business Park Coychurch Road Bridgend CF31 3BG United Kingdom
Contact Person: Suzanne Morgan Office (UK): +44 (0)845 230 1810; Telephone: Office (Germany): +49 (0)40 6710 570
Date Prepared: October 18, 2012
2. DEVICE NAME
Larval Debridement Therapy Products – Larvae 100/200/300 Proprietary Name: Maggots Common/Usual Name: Unclassified Classification Name:
3. PREDICATE DEVICE
Medical Maggots (K033391; Procode: NQK)
4. DEVICE DESCRIPTION
The BioMonde Larvae 100/200/300 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata. They are manufactured in three (3) configurations:
- Larvae100: at least 100 larvae per container ●
- Larvae200: at least 200 larvae per container .
- Larvae300: at least 300 larvae per container .
The larvae are derived from disinfected fly eggs. Larvae are transferred under controlled manufacturing conditions into transport tubes which are additionally boxed for transport.
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Upon arrival at the treatment location, they are applied to the wound and covered with permeable and absorbent dressings (not provided).
5. INDICATION FOR USE/INTENDED USE
The BioMonde Larval Debridement Therapy Products - Larvae 100/200/300 are indicated for debridement of 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.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S
Characteristics shared by the BioMonde and the predicate device, the Monarch Labs Medical Maggots is based on intended use, indications for use, technological characteristics, performance characteristics, and operational characteristics.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Testing that demonstrates that the product fulfills design and performance specifications. Side by side testing of the performance of the BioMonde product and the predicate demonstrates substantial equivalence in performance.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical data were included in this 510(k) Premarket Notification.
9. SUMMARY OF OTHER INFORMATION
Other information provided in the 510(k) included manufacturing information and information from the scientific literature.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the information provided in this 510(k) Premarket Notification, BioMonde has determined that the Larval Debridement Therapy Products - Larvae 100/200/300 are substantially equivalent to the predicate device, Medical Maggots, and that differences do not raise new safety and effectiveness questions.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Letter dated: March 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center- WO66-G609 Silver Spring, MD 209930002
Biomonde (A Trading name of Zoobiotic Limited) % Aptiv Solutions Ms. Rosina Robinson RN, MED, RAC Affiliate Principle Regulatory Consultant 225 Turnpike Road Southborough, Massachusetts 01772
Re: K123449
Trade/Device Name: BioMonde Larval Debridement Therapy Products-Larvae 100/200/300 Regulation Class: Unclassified Product Code: NOK Dated: February 07, 2013 Received: February 14, 2013
Dear Ms. Robinson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm1.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ব INDICATIONS FOR USE
510(k) Number (if known):
BioMonde Larval Debridement Therapy Products - Larvae Device Name: 100/200/300
Indications for Use:
The BioMonde Larval Debridement Therapy Products – Larvae 100/200/300 are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and nonhealing traumatic or post-surgical wounds.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123449