Apis, for the management of wounds, is a sterile, single-use device. Apis is a conformable solid sheet that is biodegradable and absorbable. Apis, in its final form, is comprised of a highly purified collagen derivative (gelatin) from porcine skin, Manuka honey, and hydroxyapatite (HAp).

The intended use of Apis in the management of wounds is to cover and protect the wound, absorb wound exudate, and provide and maintain a moist wound environment. The structural reinforcement of Apis is achieved through the incorporation of hydroxyapatite into the crosslinked collagen derivative structure. The absorption and moisture-retaining properties are based on the manufacturing process and incorporation of honey into the crosslinked structure.

The device is biodegradable and absorbs into the surrounding tissue. The degradation occurs through natural processes such as enzymatic breakdown, hydrolysis and other chemical/biological reactions depending on wound type and level of exudation.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "Apis," a wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a rigorous clinical study with AI components.

Therefore, the information requested in your prompt related to AI performance, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," and "sample size for the training set," cannot be found or inferred from this document. This document is a regulatory submission for a wound dressing, not an AI-powered diagnostic device.

However, I can extract information related to the device's technical characteristics and the non-clinical testing performed to demonstrate its safety and effectiveness relative to predicate devices.

Here's the information that can be extracted or inferred from the provided text, adapted to the closest relevant categories of your request:

1. A table of (acceptance criteria) and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of quantitative thresholds for the Apis device's performance. Instead, it aims to demonstrate substantial equivalence to predicate devices by comparing their technological characteristics and intended use. The "performance" is described as meeting the same functional goals as the predicate, supported by non-clinical testing.

Table: Comparison of Apis to Predicate Device (Elasto-Gel™ Manuka Honey Wound Dressing)

Feature	"Acceptance Criteria" (Implicit for Substantial Equivalence to Predicate)	Reported Apis Performance
Indications for Use	Same as predicate (management of wounds: full/partial thickness, pressure ulcers I-IV, venous stasis, diabetic, abrasions, surface, traumatic, donor site, surgical wounds)	Management of wounds: full/partial thickness, pressure ulcers I-IV, venous stasis, diabetic, abrasions, surface, traumatic, donor site, surgical wounds
Intended Use	Management of wounds	Management of wounds
Type of Use	Prescription Use	Prescription Use
Single Use	Yes	Yes
Absorbency	A relatively high capacity for absorption of wound fluid	A relatively high capacity for absorption of the wound fluid
Absorbable	Partially absorbable (as per predicate) or absorbable overall	Fully absorbable (Note: This is a difference from the direct predicate comparison, but the document claims "Comparison to predicate device shows no new questions of safety or effectiveness").
Moist Environment	Maintains moist wound environment	Maintains moist wound environment
Wound Protection	Protects the wound from shear, friction, and pressure; suitable as protective padding/cushioning and dressing.	Protects the wound from shear, friction and pressure and is suitable as a protective padding and cushioning device as well as functioning as a dressing.
Sterility	Yes, gamma sterilization	Yes, gamma sterilization

Nonclinical Testing Performed (Functioning as "Performance Data"):

Fluid uptake
Conformability
Porosity testing
Mechanical testing
Endotoxin level testing
Chemical composition testing
Sterilization testing
Distribution testing
Shelf-life testing

Biocompatibility Testing:

Cytotoxicity
Sensitization
Irritation
Acute systemic toxicity
Material-mediated pyrogenicity
Subchronic toxicity
Implantation testing
Chemical characterization and toxicological risk assessment (for chronic toxicity, genotoxicity, carcinogenicity)

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

This document primarily describes non-clinical testing (e.g., fluid uptake, mechanical testing, biocompatibility). It does not mention a "test set" in the context of human data or AI model validation. Therefore, there's no information on sample size for a test set of data provenance in that sense. The "sample" here refers to the physical device samples used for laboratory testing.

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

Not applicable. This is a medical device (wound dressing) submission, not an AI diagnostic submission. Ground truth would relate to the specific non-clinical tests performed (e.g., measurements of fluid uptake, mechanical strength, chemical composition), which are established by standard laboratory methods and equipment, not human experts for ground truth labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no human reading or adjudication process described for the performance evaluation of this wound dressing.

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 is not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests mentioned (e.g., fluid uptake, mechanical testing, chemical composition), the "ground truth" is established through standardized laboratory testing procedures and measurements using calibrated equipment. For biocompatibility, established ISO standards and chemical characterization methods define the "truth" regarding material safety. The document does not describe the use of human expert consensus, pathology, or outcomes data to establish ground truth for the device's characteristics.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI device, so there is no "training set" or corresponding ground truth establishment process.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

May 31, 2019

SweetBio, Inc % Carolyn Guthrie Director of Quality/Regulatory Kapstone Medical, LLC PO Box 969 Leicester, North Carolina 28748

Re: K182725

Trade/Device Name: Apis Regulatory Class: Unclassified Product Code: FRO Dated: April 26, 2019 Received: April 29, 2019

Dear Carolyn Guthrie:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

David Krause Acting Division Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182725

Device Name

Apis

Indications for Use (Describe)

Apis is indicated for use in management of wounds, including
· full and partial thickness wounds
· pressure ulcers (stages I-IV)
venous stasis ulcers
· diabetic ulcers
abrasion
· surface wounds
· traumatic wounds (healing by secondary intention)
· donor site wounds
· surgical wounds

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR 807.92, the following summary of information is provided.

1. Date of Preparation:

28 May 2019

2. Applicant

SweetBio, Inc 20 Dudley Street, Suite 900 Memphis, TN 38103

3. Official Correspondent

Kapstone Medical LLC 5960 Fairview Rd, #400 Charlotte NC 28210

Contact Person:

Carolyn Guthrie Email: cguthrie@kapstonemedical.com

4. Device Name

Trade Name: Apis Common/Usual Name: Dressing, Wound, Drug Classification: Unclassified Regulation Number: Unclassified Product Code: FRO Panel: General and Plastic Surgery

5. Predicate Devices

Apis is substantially equivalent to the predicate devices shown in Table 1-1.

Predicate	510(k) Number	Device	Manufacturer
Primary	K083334	Elasto-Gel Manuka Honey Wound Dressing	Southwest Technologies, Inc
Reference	K112580	Collagen Wound Dressing	Dalim Tissen Co., Ltd

Table 1-1: Predicate devices

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6. Device Description

7. Indications for Use

Apis is indicated for use in management of wounds, including:

Full and partial thickness wounds ●
. pressure ulcers (stages I -IV)
venous stasis ulcers
diabetic ulcers
abrasions
surface wounds
. traumatic wounds (healing by secondary intention)
donor site wounds
. surgical wounds

8. Technological Characteristics

The subject device was shown to be substantially equivalent and have the same intended use and similar technological characteristics to its predicate devices through comparison in areas including design, material composition, function and sterilization method.

Features	Apis		Elasto-Gel™ Manuka Honey Wound Dressing (sheet)
	Subject Device	Primary Predicate Device
Indications for Use
Intended Use	Management of wounds	Management of wounds	Equivalent
Type of Use	Prescription Use	Prescription Use	Equivalent
Indications	• full and partial thickness wounds	• full and partial thickness wounds	Equivalent
Features	Apis	Elasto-Gel™ Manuka HoneyWound Dressing (sheet)	Substantial Equivalence
	Subject Device	Primary Predicate Device
	pressure ulcers(stages I-IV) venous stasis ulcers diabetic ulcers abrasions surface wounds traumatic wounds(healing by secondaryintention) donor sites wounds surgical wounds	pressure ulcers(stages I-IV) venous stasis ulcers diabetic ulcers abrasions surface wounds traumatic wounds(healing bysecondary intention) donor sites wounds surgical wounds
Single Use	Yes	Yes	EquivalentComparison topredicate device showsno new questions ofsafety or effectiveness,and no change tointended use comparedto predicate orreference device
Sizes	16 x 16 mm25 x 25 mm (not for useon children)50 x 50 mm (not for useon children)	Supplied in many sizes,for example 2x3", 4x4",6x8" and possibly otheradditional shapes andsizes.
Materials
Materials ofConstruction	Manuka HoneyCrosslinked highlypurified collagenderivative (gelatin) fromporcine skin	Manuka HoneyInsoluble crosslinkedpolyacrylamide polymer	EquivalentComparison toreference device showsno new questions ofsafety or effectiveness,and no change tointended use comparedto predicate orreference device
	Hydroxyapatite	Glycerin	Based on the functionof the hydroxyapatite,the intended use of thedevice is not changedcompared to thepredicate. Additionally,Apis in vivo animal datashows that there are nonew questions of safetyor effectiveness
Features	Apis	Elasto-Gel™ Manuka HoneyWound Dressing (sheet)	Substantial Equivalence
	Subject Device	Primary Predicate Device
Absorbency	A relatively highcapacity for absorptionof the wound fluid	A relatively high capacityfor absorption of thewound fluid	Equivalent
Absorbable	Fully absorbable	Partially absorbable	Comparison topredicate device showsno new questions ofsafety or effectiveness,and no change tointended use comparedto predicate orreference device
Moist environment	Maintains moist woundenvironment	Maintains moist woundenvironment	Equivalent
Wound protection	Protects the woundfrom shear, friction andpressure and is suitableas a protective paddingand cushioning deviceas well as functioning asa dressing.	Protect the wound fromshear, friction andpressure, suitable as aprotective padding andcushioning device as wellas functioning as adressing.	Equivalent
Performance
Sterility	Yes, gamma sterilization	Yes, gamma sterilization	Equivalent

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Image /page/5/Picture/1 description: The image shows the logo for Sweetbio. The word "sweet" is in gray, and the word "bio" is in yellow. To the right of the word "bio" is a yellow honeycomb.

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Image /page/6/Picture/1 description: The image shows the logo for "sweetbio". The word "sweet" is in gray, and the "bi" is in yellow. To the right of the word "sweetbio" is a yellow honeycomb design.

9. Performance Data

Nonclinical testing was performed to demonstrate that the subject device, Apis, is as safe and effective as the legally marketed predicate device, including fluid uptake, conformability, porosity testing, mechanical testing, endotoxin level testing, and chemical composition testing. Sterilization, distribution testing and shelf-life testing have been completed.

Biocompatibility testing and literature demonstrated that Apis is intended use. Cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity, and implantation testing were performed. Chemical characterization and toxicological risk assessment were performed to address the chronic toxicity, genotoxicity, and carcinogenicity endpoints.

10.Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, Apis has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

N/A