(245 days)
No
The device description focuses on the material composition and physical properties of the wound dressing, with no mention of AI or ML technologies.
Yes.
The device is indicated for use in the management of various types of wounds, including pressure ulcers, venous stasis ulcers, and diabetic ulcers, which are conditions that require therapeutic intervention for healing and management. Its function involves covering and protecting wounds, absorbing exudate, and maintaining a moist wound environment, which are all therapeutic actions.
No
Explanation: The device description states its intended use is for "management of wounds to cover and protect the wound, absorb wound exudate, and provide and maintain a moist wound environment." This describes a treatment or management device, not one that identifies or diagnoses a condition.
No
The device description clearly states that Apis is a "conformable solid sheet" comprised of physical materials (collagen derivative, Manuka honey, and hydroxyapatite). It is a physical wound dressing, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as the "management of wounds," including covering and protecting the wound, absorbing exudate, and maintaining a moist wound environment. This is a therapeutic and protective function applied directly to the wound, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical dressing made of collagen, honey, and hydroxyapatite. It describes its physical properties and how it interacts with the wound environment. This aligns with a wound care product, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a disease state.
- Performance Studies: The performance studies focus on physical properties, biocompatibility, and comparison to predicate wound dressings, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
In summary, the device's function and description clearly place it in the category of a wound care product, not an in vitro diagnostic device.
N/A
Intended Use / 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
- abrasion
- surface wounds
- traumatic wounds (healing by secondary intention)
- donor site wounds
- surgical wounds
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
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. However, for some sizes, there is a restriction: "25 x 25 mm (not for use on children) 50 x 50 mm (not for use on children)".
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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.
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.
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.
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
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
6. Device Description
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.
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) | Substantial Equivalence | |
|---|---|---|---|---|
| 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 Honey | ||
| Wound 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 secondary | ||||
| intention) donor sites wounds surgical wounds | pressure ulcers | |||
| (stages I-IV) venous stasis ulcers diabetic ulcers abrasions surface wounds traumatic wounds | ||||
| (healing by | ||||
| secondary intention) donor sites wounds surgical wounds | ||||
| Single Use | Yes | Yes | Equivalent | |
| Comparison to | ||||
| predicate device shows | ||||
| no new questions of | ||||
| safety or effectiveness, | ||||
| and no change to | ||||
| intended use compared | ||||
| to predicate or | ||||
| reference device | ||||
| Sizes | 16 x 16 mm | |||
| 25 x 25 mm (not for use | ||||
| on children) | ||||
| 50 x 50 mm (not for use | ||||
| on children) | Supplied in many sizes, | |||
| for example 2x3", 4x4", | ||||
| 6x8" and possibly other | ||||
| additional shapes and | ||||
| sizes. | ||||
| Materials | ||||
| Materials of | ||||
| Construction | Manuka Honey | |||
| Crosslinked highly | ||||
| purified collagen | ||||
| derivative (gelatin) from | ||||
| porcine skin | Manuka Honey | |||
| Insoluble crosslinked | ||||
| polyacrylamide polymer | Equivalent | |||
| Comparison to | ||||
| reference device shows | ||||
| no new questions of | ||||
| safety or effectiveness, | ||||
| and no change to | ||||
| intended use compared | ||||
| to predicate or | ||||
| reference device | ||||
| Hydroxyapatite | Glycerin | Based on the function | ||
| of the hydroxyapatite, | ||||
| the intended use of the | ||||
| device is not changed | ||||
| compared to the | ||||
| predicate. Additionally, | ||||
| Apis in vivo animal data | ||||
| shows that there are no | ||||
| new questions of safety | ||||
| or effectiveness | ||||
| Features | Apis | Elasto-Gel™ Manuka Honey | ||
| Wound Dressing (sheet) | Substantial Equivalence | |||
| Subject Device | Primary Predicate Device | |||
| Absorbency | A relatively high | |||
| capacity for absorption | ||||
| of the wound fluid | A relatively high capacity | |||
| for absorption of the | ||||
| wound fluid | Equivalent | |||
| Absorbable | Fully absorbable | Partially absorbable | Comparison to | |
| predicate device shows | ||||
| no new questions of | ||||
| safety or effectiveness, | ||||
| and no change to | ||||
| intended use compared | ||||
| to predicate or | ||||
| reference device | ||||
| Moist environment | Maintains moist wound | |||
| environment | Maintains moist wound | |||
| environment | Equivalent | |||
| Wound protection | 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. | Protect the wound from | |||
| shear, friction and | ||||
| pressure, suitable as a | ||||
| protective padding and | ||||
| cushioning device as well | ||||
| as functioning as a | ||||
| dressing. | Equivalent | |||
| Performance | ||||
| Sterility | Yes, gamma sterilization | Yes, gamma sterilization | Equivalent |
5
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.
6
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.