(450 days)
Not Found
No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for managing wounds, including various types of ulcers, abrasions, cuts, and burns, which are conditions that require therapeutic intervention.
No
The device description clearly states its purpose is for "management of wounds... to cover and protect the wound, absorb wound exudate, and provide and maintain a moist wound environment." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a sterile, single-use, conformable solid sheet comprised of physical materials (collagen derivative, Manuka honey, hydroxyapatite) intended to cover and protect wounds, absorb exudate, and maintain a moist environment. This is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds by covering, protecting, absorbing exudate, and maintaining a moist environment. This is a direct interaction with the wound itself, not the analysis of a sample taken from the body.
- Device Description: The device is a physical sheet applied to the wound. Its function is based on its physical properties (conformability, absorption, biodegradability) and the components it contains (collagen derivative, honey, hydroxyapatite) that interact with the wound environment.
- Lack of Diagnostic Activity: There is no mention of the device being used to diagnose a condition, analyze a biological sample (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is therapeutic and protective for the wound itself.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional. APIS® / VERIS™ Wound Management Devices are 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
For over-the-counter use, APIS® OTC / VERISTM OTC Wound Management Devices may be used for:
- minor abrasions
- · lacerations
- minor cuts
- · minor scalds and burns
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device for the management of wounds, are sterile, single-use devices. APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device are conformable solid sheets that are biodegradable and absorbable. APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device in its final form, is comprised of a highly purified collagen derivative from porcine skin (gelatin), Manuka honey, and hydroxyapatite (HAp).
The intended use of APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device 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® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device 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.
There is no difference between the APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device except APIS® Wound Management Device and APIS® OTC Wound Management Devices have a thickness of 0.03cm and is the compressed form of VERIS™ Wound Management Device and VERIS™ OTC Wound Management Devices which has a thickness of 0.6cm. In other words, VERIS™ Wound Management Devices and VERIS™ OTC Wound Management Devices are 20 times thicker than the APIS® Wound Management Devices and APIS® OTC Wound Management Devices (dressings).
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 for use in infant patients or children under 10kg / 22lbs. This applies to both the prescription and OTC uses.
Intended User / Care Setting
Under the supervision of a healthcare professional (for Rx Use). Over-the-Counter Use (for OTC Use).
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 APIS® / VERIS™ Wound Management Devices and APIS® OTC/ VERIS™ OTC Wound Management Devices are as safe and effective as the legally marketed predicate devices, including fluid uptake, and conformability. Sterilization validation, distribution testing and shelf-life testing have been completed. Biocompatibility testing and literature demonstrate that APIS® / VERIS™ Wound Management Devices and APIS® OTC/ VERIS™ OTC Wound Management Devices are safe for its intended use. Endotoxin, cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity, genotoxicity, and implantation testing were performed. Chemical characterization and toxicological risk assessment were performed to address the chronic toxicity, 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.
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
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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 13, 2023
SweetBio, Inc % Carolyn Guthrie VP of Regulatory Kapstone Medical 520 Elliot Street Charlotte, North Carolina 28202
Re: K222143
Trade/Device Name: APIS® Wound Management Device, VERIS™ Wound Management Device APIS® OTC Wound Management Device, VERIS™ OTC Wound Management Device Regulatory Class: Unclassified Product Code: FRO. KGN Dated: July 19, 2022 Received: July 20, 2022
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control
2
and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222143
Device Name
APIS® Wound Management Device, VERIS™ Wound Management Device
APIS® OTC Wound Management Device, VERIS™ OTC Wound Management Device
Indications for Use (Describe)
Under the supervision of a healthcare professional. APIS® / VERIS™ Wound Management Devices are 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
For over-the-counter use, APIS® OTC / VERISTM OTC Wound Management Devices may be used for:
- minor abrasions
- · lacerations
- minor cuts
- · minor scalds and burns
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K222143 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Name, Address, Phone, and Fax Number of Applicant
SweetBio, Inc. Address: 460 South Highland Street Floor 2, Memphis, TN 38111 Phone: (888)-323-2015
B. Contact Person
Carolyn Guthrie Regulatory Affairs Consultant Kapstone Medical, LLC
C. Date Prepared
October 12, 2023
D. Device Name and Classification
| Trade Name: | APIS® Wound Management Device
VERIS™ Wound Management Device
APIS® OTC Wound Management Device
VERIS™ OTC Wound Management Device |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dressing, Wound, Drug |
| Panel: | General and Plastic Surgery |
| Regulation Number: | Unclassified |
| Classification: | Unclassified |
| Product Code: | FRO |
5
E. Predicate Device
APIS® Wound Management Device and VERIS™ Wound Management Device are substantially equivalent to the Rx Only predicate device shown in Table 1. APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device are substantially equivalent to the OTC predicate device shown in Table 1.
| Predicate | 510(k) Number | Device | Manufacturer |
|---|---|---|---|
| Primary – Rx | |||
| Only | K182725 | APIS® Wound Management Device | SweetBio, Inc |
| Primary - OTC | K110546 | MediHoney Hydrogel Sheet Dressings with | |
| Leptospermum Honey (non-adhesive) | Derma Sciences, Inc |
Table 1: Predicate devices
ட் Device Description
APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device for the management of wounds, are sterile, single-use devices. APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device are conformable solid sheets that are biodegradable and absorbable. APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device in its final form, is comprised of a highly purified collagen derivative from porcine skin (gelatin), Manuka honey, and hydroxyapatite (HAp).
The intended use of APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device 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® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device 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.
6
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.
There is no difference between the APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device except APIS® Wound Management Device and APIS® OTC Wound Management Devices have a thickness of 0.03cm and is the compressed form of VERIS™ Wound Management Device and VERIS™ OTC Wound Management Devices which has a thickness of 0.6cm. In other words, VERIS™ Wound Management Devices and VERIS™ OTC Wound Management Devices are 20 times thicker than the APIS® Wound Management Devices and APIS® OTC Wound Management Devices (dressings).
G. Indications for Use
Under the supervision of a healthcare professional, APIS® / VERIS™ Wound Management Devices are 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
For over-the-counter use, APIS®OTC/ VERIS™ OTC Wound Management Devices may be used for:
- . minor abrasions
- lacerations
- . minor cuts
- . minor scalds and burns
7
H. Technological Comparison – Prescription Use Only
| Features | APIS® / VERIS™ Wound
Management Device | APIS® Wound
Management Device | 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
• pressure ulcers
(stages I-IV)
• venous stasis ulcers
• diabetic ulcers
• abrasions
• surface wounds
• traumatic wounds
(healing by secondary
intention)
• donor sites wounds
• surgical wounds
• Not for use in infant
patients or children
under 10kg / 22lbs | • 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 sites wounds
• surgical wounds
• Not for use in infant
patients
• Not for use on
children (2.5cm x
2.5cm, and 5.0cm x
5.0cm) | Equivalent
No new risks of safety or
effectiveness |
| Single Use | Yes | Yes | Equivalent |
| Sizes | APIS® Wound
Management Device:
1.6 x 1.6 cm x 0.03cm
2.5 x 2.5 cm x 0.03cm
5.0 x 5.0 cm x 0.03cm
Additional sizes up to
454cm² | APIS® Wound
Management Device:
1.6 x 1.6 cm x 0.03cm
2.5 x 2.5 cm x 0.03cm
5.0 x 5.0 cm x 0.03cm
VERISTM:
1.6 x 1.6 cm x 0.6cm | Equivalent |
| Features | APIS® / VERIST™ Wound
Management Device | APIS® Wound
Management Device | Substantial Equivalence |
| | Subject Device | Primary Predicate Device | |
| | VERIS Wound
Management Device | 5.0 x 5.0 cm x 0.6cm | |
| | 1.6 x 1.6 cm x 0.6cm | | |
| | 2.5 x 2.5 cm x 0.6cm | | |
| | 5.0 x 5.0 cm x 0.6cm | | |
| | Additional sizes up to
454cm² | | |
| Materials | | | |
| Materials of
Construction | Manuka Honey | Manuka Honey | Equivalent |
| | Crosslinked highly
purified collagen
derivative from porcine
skin | Crosslinked highly
purified collagen
derivative from porcine
skin | Equivalent |
| | Hydroxyapatite | Hydroxyapatite | Equivalent |
| Technological Characteristics | | | |
| Absorbency | A relatively high
capacity for absorption
of the wound fluid | A relatively high
capacity for absorption
of the wound fluid | Equivalent |
| Absorbable | Yes | Yes | Equivalent |
| 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 |
8
K222143
SweetBio - APIS® / VERIS™ Wound Management Device SweetBio - APIS® OTC / VERIS™ OTC Wound Management Device
9
| Features | APIS® OTC/ VERIST™ OTC
Wound Management
Device | MediHoney Hydrogel
Sheet Dressings with
Leptospermum Honey
(non-adhesive) | Substantial Equivalence |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate Device | |
| Indications for Use | | | |
| Intended Use | Management of
wounds | Management of
wounds | Equivalent |
| Type of Use | Over-the-Counter | Over-the-Counter | Equivalent |
| Indications | For over-the-counter
use, APIS® OTC/ VERIST™
OTC Wound
Management Device
may be used for:
• minor abrasions
• lacerations
• minor cuts
• minor scalds and
burns
Not for use in infant
patients or children
under 10kg / 22lbs | For over-the-counter
use, MediHoney
Hydrogel Sheet
Dressings with
Leptospermum Honey
may be used for:
• minor abrasions
• lacerations
• minor cuts
• minor scalds and
burns
N/A | Equivalent |
| Single Use | Yes | Yes | Equivalent |
| Size | APIS® OTC Wound
Management Device:
1.6 x 1.6 cm x 0.03cm
2.5 x 2.5 cm x 0.03cm
5.0 x 5.0 cm x 0.03cm
Additional sizes up to
$454cm^2$
VERIST™ OTC Wound
Management Device:
1.6 x 1.6 cm x 0.6cm
2.5 x 2.5 cm x 0.6cm | 6.1 x 6.1 cm
10.98 x 10.98 cm | No new risks of safety or
effectiveness per
toxicological risk
assessment |
| Features | APIS® OTC/ VERIST™ OTC
Wound Management
Device | MediHoney Hydrogel
Sheet Dressings with
Leptospermum Honey
(non-adhesive) | Substantial Equivalence |
| | Subject Device | Primary Predicate Device | |
| | Additional sizes up to
454cm² | | |
| Structure | Sheet | Sheet | Equivalent |
| Materials | | | |
| Materials of
Construction | Manuka Honey | Leptospernum
(Manuka) Honey | No increased risk in
safety or effectiveness. |
| | Crosslinked highly
purified collagen
derivative from porcine
skin | Polymer | Both devices are
available with Rx Only
indications with identical
materials of construction |
| | Hydroxyapatite | N/A | |
| Technological Characteristics | | | |
| Absorbency | A relatively high
capacity for absorption
of the wound fluid | A relatively high
capacity for absorption
of the wound fluid | Equivalent |
| Absorbable | Yes | Yes | Equivalent |
| 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. | 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. | Equivalent |
| Performance | | | |
| Sterility | Yes, gamma sterilization | Yes, gamma sterilization | Equivalent |
Technological Comparison – Over-the-Counter l.
10
K222143
SweetBio - APIS® / VERIS™ Wound Management Device SweetBio - APIS® OTC / VERIS™ OTC Wound Management Device
11
Performance Data J.
Nonclinical testing was performed to demonstrate that APIS® / VERIS™ Wound Management Devices and APIS® OTC/ VERIS™ OTC Wound Management Devices are as safe and effective as the legally marketed predicate devices, including fluid uptake, and conformability. Sterilization validation, distribution testing and shelf-life testing have been completed.
Biocompatibility testing and literature demonstrate that APIS® / VERIS™ Wound Management Devices and APIS® OTC/ VERIS™ OTC Wound Management Devices are safe for its intended use. Endotoxin, cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity, genotoxicity, and implantation testing were performed. Chemical characterization and toxicological risk assessment were performed to address the chronic toxicity, and carcinogenicity endpoints.
K. Basis for Substantial Equivalence
APIS® / VERIS™ Wound Management Devices (Rx Only)
The subject and predicate devices for prescription use only are identical with respect to materials, design, intended use, and procedural steps for application. The only difference is a change in the directions of use between the current instructions for use and the proposed instructions for use.
APIS® OTC/ VERIS™ OTC Wound Management Devices (Over-the-Counter)
The subject and predicate devices for over-the-counter use are equivalent with respect to intended use and indications for use. Technological differences do not result in new questions of safety or effectiveness.
L. Conclusion
APIS® / VERIS™ Wound Management Devices (Rx Only)
APIS® / VERIS™ Wound Management Devices are substantially equivalent to the predicate device, Apis Wound Management Device (K182725).
-
Both devices have the same intended use.
-
All the devices have similar technological characteristics in terms of primary constituent, raw material used, sterilization method, geometric specifications, and design of the device. Biocompatibility tests, stability test, and sterilization validation performed on the predicate device are applicable to the current device and hence no new questions on safety and effectiveness are raised.
12
Hence, a determination of substantial equivalence is supported.
APIS® / VERIS™ Wound Management Devices (Over-the-Counter)
APIS® OTC/ VERIS™ OTC Wound Management Devices are substantially equivalent to the predicate device, MediHoney Hydrogel Sheet Dressings with Leptospermum Honey (K110546).
-
Both devices have the same intended use.
-
Technological differences in materials of construction do not result in new questions of safety or effectiveness.
Hence, a determination of substantial equivalence is supported.