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.

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).

AI/ML Overview

The provided document is a 510(k) summary for a medical device (BioMonde Larval Debridement Therapy Products - BioBag). This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study that involves human readers or AI in a clinical setting. Therefore, many of the requested elements are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Non-Clinical)	Reported Device Performance
First Criterion: Clearly observable differences between the wet and dry mass consumed (in grams) for the loose and bagged larvae test samples when compared to a control group of BioBags with no larvae.	Analysis of the mean values of both dry and wet mass consumed 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 (empty bags). The results for the bagged larvae were "much closer" to that of the loose larvae than the control. The document implies this "clearly observable difference" was demonstrated as mass consumed by larvae (bagged and loose) was significantly higher than the control where no larvae were present.
Second Criterion: Both the BioBag (modified device) and loose larvae (predicate device) product consume at least 30g of wet tissue over a 48-hour experiment per Blake et al., 2007 (equivalent to at least 5.53g of dry tissue).	Wet Weight: - BioBag (modified device): 36.01g - Loose larvae (predicate device): 46.11g Both values are greater than the 30g wet tissue target. Dry Weight: - BioBag (modified device): 7.89g - Loose larvae (predicate device): 12.38g Both values are greater than the 5.53g dry tissue target.

Acceptance Criterion (Non-Clinical)

Reported Device Performance

First Criterion: Clearly observable differences between the wet and dry mass consumed (in grams) for the loose and bagged larvae test samples when compared to a control group of BioBags with no larvae.

Analysis of the mean values of both dry and wet mass consumed 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 (empty bags). The results for the bagged larvae were "much closer" to that of the loose larvae than the control. The document implies this "clearly observable difference" was demonstrated as mass consumed by larvae (bagged and loose) was significantly higher than the control where no larvae were present.

Second Criterion: Both the BioBag (modified device) and loose larvae (predicate device) product consume at least 30g of wet tissue over a 48-hour experiment per Blake et al., 2007 (equivalent to at least 5.53g of dry tissue).

Wet Weight: - BioBag (modified device): 36.01g - Loose larvae (predicate device): 46.11g Both values are greater than the 30g wet tissue target. Dry Weight: - BioBag (modified device): 7.89g - Loose larvae (predicate device): 12.38g Both values are greater than the 5.53g dry tissue target.

2. Sample size used for the test set and the data provenance

Sample Size: The document states that samples of free-range Larvae300 (parent device), the BioBag100 (modified device), and empty bags (control) were tested "in triplicate." This means there were 3 samples for each of the three groups (loose larvae, bagged larvae, control), for a total of 9 test samples in the activity assay.
Data Provenance: The study was a non-clinical, in-vitro laboratory test performed by BioMonde. The location of the testing is not explicitly stated in this summary, but BioMonde's contact address is in the United Kingdom.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

Not applicable. This was a non-clinical performance test measuring tissue consumption by larvae, not a study involving human experts establishing ground truth for medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. There was no human expert adjudication of results in this non-clinical performance test. Performance was measured objectively (mass consumed).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a non-clinical performance study of larval debridement therapy, not an MRMC study comparing human reader performance with and without AI assistance.

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

Not applicable. This is not an algorithm or AI device. The "performance" being evaluated is the biological activity of live maggots.

7. The type of ground truth used

The ground truth for the non-clinical performance study was based on:

Objective measurement: The actual wet and dry mass of dead tissue consumed by the larvae.
Scientific literature: The 30g/5.53g consumption target for the second acceptance criterion was derived from Blake et al., 2007, which established a benchmark for maggot debridement activity.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires 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 model, no ground truth needed to be established for it.

Summary

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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 - BioBag50/100/200/300/400
Common/Usual Name:	Maggots
Classification Name:	Unclassified

3. PREDICATE DEVICE

BioMonde Larval Debridement Therapy Products - Larvac 100/200/300 (K123449)

4. DEVICE DESCRIPTION

. 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 .

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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

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 LarvalDebridementTherapy Product -BioBag50/100/200/300/400	BioMonde LarvalDebridementTherapy ProductK123449
Lucilia sericata/Phaenecia sericata from a closed, monitored colony	Yes	Yes
Oviposition takes place on liver obtained from an approved supplier ofanimal tissue. Eggs are carefully removed from the liver and weighed.	Yes	Yes
Collected eggs are separated using sodium sulfite solution andmechanical agitation prior to sieving to ensure only single eggs enterthe disinfection process.	Yes	Yes
Eggs are disinfected in a two stage process using 7.2% formaldehydesolution and 3.9% peracetic acid solution, after which they are rinsedwith sterile sodium chloride 0.9%.	Yes	Yes
Disinfected eggs are inoculated onto the surface of a defined growthmedium (Lucilia agar) contained in 90mm petri dishes. The petri dishesare placed into an incubator for 20-24 hours at 31-35℃ where the eggshatch 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

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Technological Characteristics	BioMonde LarvalDebridementTherapy Product –BioBag50/100/200/300/400	BioMonde LarvalDebridementTherapy ProductK123449
Available in containers of varying numbers of larvae	Yes	Yes
Larvae are removed from the growth medium using a loop or spoon andplaced 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 placedinto a pouch which is labeled and the pouch is placed into a labeledtransport 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).

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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.

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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

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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

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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

Regulation Number and Section

N/A