(120 days)
Not Found
No
The device description and performance studies focus on the biological action of live larvae for debridement, with no mention of AI or ML technologies.
Yes
The device is indicated for "debridement of non-healing necrotic skin and soft tissue wounds," which is a therapeutic intervention.
No
This device is indicated for debridement of wounds, which is a therapeutic treatment. It does not perform any diagnostic function.
No
The device is described as live larvae within a sterile bag, which are physical, biological components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "debridement of non-healing necrotic skin and soft tissue wounds." This is a therapeutic action performed directly on the patient's wound, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device consists of live larvae applied to a wound. This is a biological therapy, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, tissue, etc.) to diagnose a condition or provide information about a patient's health status. The larvae are performing a physical function (debridement).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 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.
Product codes (comma separated list FDA assigned to the subject device)
NQK
Device Description
The BioMonde BioBag 50/100/200/300/400 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata, provided within a sterile bag. They are manufactured in five (5) configurations:
- BioBag 50: at least 50 larvae per container
- BioBag 100: at least 100 larvae per container.
- BioBag 200: at least 200 larvae per container
- BioBag 300: at least 300 larvae per container
- BioBag 400: at least 400 larvae per container .
The larvae are derived from disinfected fly eggs. The BioBags are open mesh polyester bags that come in a variety of sizes based on the dose (number) of larvae to be used. The bags are used to constrain the larvae, preventing them from migrating from the wound. The bags also contain sterile PVA foam cubes that serve as spacers' in the BioBags to allow free movement of the larvae within the mesh bag. Larvae are transferred under controlled manufacturing conditions into sterilized bags after which they are placed into sterile transport tubes which are additionally pouched and boxed for transport. Upon arrival at the treatment location, the BioBags are applied to the wound and covered with permeable and absorbent dressings (not provided).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and soft tissue wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical performance testing (comparative testing)
Sample Size: Not specified for each test, but involved triplicate testing for BioMonde BioBag, parent BioMonde Larvae 100/200/300, and empty bags.
Key Results:
- Testing utilized the BioMonde Larval Activity Assay, measuring consumption of dead tissue by larvae.
- First acceptance criterion: clearly observable differences between the wet and dry mass consumed for loose and bagged larvae test samples compared to a control group of BioBags with no larvae.
- Second acceptance criterion: both BioBag and loose larvae product consume at least 30g of tissue over a 48-hour experiment.
- Analysis showed that the average mass consumed per 100 larvae for both loose and BioBag larvae product configurations was much greater than that of the control group.
- The results for the bagged larvae were much closer to that of the loose larvae than the control.
- Both the loose and the BioBag product configurations met the second acceptance criterion (46.11 and 36.01g respectively for wet weight, and 12.38 and 7.89g respectively for dry weight, against a 5.53g target).
- The study concluded that while there is a difference in overall consumption between loose larvae and BioBag configurations, this difference does not raise new issues of safety or effectiveness and is covered by the product labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BioMonde Larval Debridement Therapy Products - Larvac 100/200/300 (K123449)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
REVISED 510(K) SUMMARY BIOMONDE LARVAL DEBRIDEMENT THERAPY PRODUCTS -BIOBAC 50/100/200/300/400 (PER 21CFR 807.92(C))
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 |
|---|---|
| Telephone: | Office (UK): +44 (0)845 230 1810; |
| Office (Germany): +49 (0)40 6710 570 | |
| AUG 2 8 2013 |
Date Prepared: July 23, 2013
2. DEVICE NAME
| Proprietary Name: | Larval Debridement Therapy Products - BioBag
50/100/200/300/400 |
|----------------------|--------------------------------------------------------------------|
| Common/Usual Name: | Maggots |
| Classification Name: | Unclassified |
3. PREDICATE DEVICE
BioMonde Larval Debridement Therapy Products - Larvac 100/200/300 (K123449)
4. DEVICE DESCRIPTION
The BioMonde BioBag 50/100/200/300/400 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata, provided within a sterile bag. They are manufactured in five (5) configurations:
- . BioBag 50: at least 50 larvae per container
- BioBag 100: at least 100 larvae per container .
- . BioBag 200: at least 200 larvae per container
- . BioBag 300: at least 300 larvae per container
- BioBag 400: at least 400 larvae per container .
1
The larvae are derived from disinfected fly eggs. The BioBags are open mesh polyester bags that come in a variety of sizes based on the dose (number) of larvae to be used. The bags are used to constrain the larvae, preventing them from migrating from the wound. The bags also contain sterile PVA foam cubes that serve as spacers' in the BioBags to allow free movement of the larvae within the mesh bag.
Larvae are transferred under controlled manufacturing conditions into sterilized bags after which they are placed into sterile transport tubes which are additionally pouched and boxed for transport. Upon arrival at the treatment location, the BioBags 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 - BioBag 50/100/200/300/400 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.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S
Technological characteristics shared by the BioMonde BioBag 50/100/200/300/400 and the parent BioMonde Larvae 100/300/300 are summarized in the Table below.
| Technological Characteristics | BioMonde Larval
Debridement
Therapy Product -
BioBag
50/100/200/300/400 | BioMonde Larval
Debridement
Therapy Product
K123449 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Lucilia sericata/Phaenecia sericata from a closed, monitored colony | Yes | Yes |
| Oviposition takes place on liver obtained from an approved supplier of
animal tissue. Eggs are carefully removed from the liver and weighed. | Yes | Yes |
| Collected eggs are separated using sodium sulfite solution and
mechanical agitation prior to sieving to ensure only single eggs enter
the disinfection process. | Yes | Yes |
| Eggs are disinfected in a two stage process using 7.2% formaldehyde
solution and 3.9% peracetic acid solution, after which they are rinsed
with sterile sodium chloride 0.9%. | Yes | Yes |
| Disinfected eggs are inoculated onto the surface of a defined growth
medium (Lucilia agar) contained in 90mm petri dishes. The petri dishes
are placed into an incubator for 20-24 hours at 31-35℃ where the eggs
hatch and the larvae reach 2-6mm in size. | Yes | Yes |
Side-by-Side Comparison of the Technological Characteristics of the BioBag 50/100/200/300/400 with the Parent Device, Larvae 100/200/300
BioMonde, Response to RTA Notification K131221 July 23, 2013 BioMonde Larval Debridement Therapy Products -BioBag 50/100/200/300/400
Revised 510(k) Summary
2
| Technological Characteristics | BioMonde Larval
Debridement
Therapy Product –
BioBag
50/100/200/300/400 | BioMonde Larval
Debridement
Therapy Product
K123449 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Available in containers of varying numbers of larvae | Yes | Yes |
| Larvae are removed from the growth medium using a loop or spoon and
placed into containers marked with fill heights for the dosage required. | | |
| The correct dosage of larvae is transferred to a sterile transport tube. | No* | Yes |
| The transport tubes containing the larvae are labeled, the tube is placed
into a pouch which is labeled and the pouch is placed into a labeled
transport box with the instructions for use. | Yes | Yes |
The sole difference between the technological characteristics of the new and cleared product is that larvae are provided within the BioBag rather than as loose larvae. Comparative testing of the two products demonstrates that the application as free larvae as compared to application in constraining netting does not raise new questions of safety and effectiveness.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
presents non clinical testing that includes l`his premarket notification biocompatibility testing per ISO10993-1 and stability/shelf life testing. In addition, comparative testing that demonstrates that the product fulfills design and performance specifications is also provided. Side-by side-testing of the performance of the BioMonde BioBag, the parent BioMonde Larvae 100/200/300, and a control demonstrates substantial equivalence in performance. Testing utilized the BioMonde Larval Activity Assay, a method developed and validated by BioMonde to measure the consumption of dead tissue by a certain number of larvae under standardized conditions that are typical of chronic wounds. To mimic clinical conditions. the products were tested after overnight delivery to the test location. Samples of free range Larvae300 (parent device), the BioBag100 (modified device), and empty bags (identical to the BioBag product but without larvae) were tested in triplicate. The first acceptance criterion for this study was that clearly observable differences between the wet and dry mass consumed (in grams) for the loose and bagged larvae test samples were required when compared to a control group of BioBags with no larvae. The second acceptance criterion for this study was that both the BioBag and loose larvae product consume at least 30g of tissue over the 48 hour experiment per Blake et al., 2007 who showed that a single maggot was capable of debriding approximately 0.15g of dead tissue per day in a wound model (equating to 30g over a 2 dav period).
3
Testing was performed in compliance with prospectively defined procedures. Analysis of the mean values of both dry and wet mass consumed show that the average mass consumed per 100 larvae for both loose and BioBag larvae product configurations is much greater than that of the control group and the results for the bagged larvae are much closer to that of the loose larvae than the control. The second acceptance criterion was met by both the loose and the BioBag product configurations (46.11 and 36.01g respectively) with the dry weight target being 5.53g, again achieved by both loose and bagged larvae (12.38 and 7.89g respectively).
Based on the results, BioMonde concluded that while there is a difference in the overall consumption by loose larvae (cleared product) and BioBag configurations (modified product) under the conditions of this test, the difference does not raise new issues of safety or effectiveness. This difference in overall performance is covered by the labelling (instructions for use) for the product.
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 BioMonde BioBag 50/100/200/300/400 and the parent BioMonde Larvae 100/300/300 are substantially equivalent, that differences are minor, and do not raise new safety and effectiveness questions.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 28, 2013
BioMonde % Antiv Solutions Rosina Robinson, RN, MED, RAC 62 Forest Street, Suite 300 Marlborough. Massachusetts 01752
Re: K131221
Trade/Device Name: BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 Regulatory Class: Unclassified Product Code: NQK Dated: July 23, 2013 Received: July 24, 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 cither 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
5
Page 2 - Rosina Robinson, RN, MED, RAC
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/CDRH/CDRHOffices/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/Industrv/default.htm.
Sincerely yours,
FOR Peter D. Rümm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
4. INDICATIONS FOR USE
510(k) Number (if known): K131221
BioMonde Larval Debridement Therapy Products - BioBag Device Name: 50/100/200/300/400
Indications for Use:
The BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 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.
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 OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131221
BioMonde. Response to RTA Notification K131221 July 23, 2013 BioMonde Larval Debridement Therapy Products -BioBag 50/100/200/300/400
Revised Indications for Use
ATTACHMENT 12 - Page 1 of 1