(280 days)
DuoDerm® Extra Thin (Extra Thin® CGF Dressing), Compeed Psoriasis Dressing and Hydrocolloid Dressing for Psoriasis
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as substantially similar to existing occlusive wound dressings with no mention of AI/ML capabilities.
Yes
The device is indicated for the management of psoriasis and dermal wounds, which are therapeutic applications.
No
The provided text describes Envela™ as an occlusive wound dressing for managing psoriasis and superficial wounds, similar to existing wound dressings. Its intended uses are protective and management, not diagnostic.
No
The device description explicitly states it is substantially similar to existing occlusive wound dressings in terms of component materials, shape, dimensions, and mode of action, indicating it is a physical dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for the management of psoriasis, protection of psoriatic plaques, and management of superficial dermal wounds. These are all related to the treatment and protection of the body's surface, not the examination of specimens taken from the body to provide information about a physiological state, health, or disease.
- Device Description: The description states it's an occlusive wound dressing, which is a topical device applied to the skin.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory tests.
Therefore, Envela™ is a medical device, specifically a wound dressing, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- For use in the management of psoriasis and the protection of psoriatic plaques
- As a protective dressing
- For management of superficial, dry to lightly exudating dermal wounds.”
Product codes (comma separated list FDA assigned to the subject device)
NAD
Device Description
Envela™ is substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound 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 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)
Not Found
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.
DuoDerm® Extra Thin (Extra Thin® CGF Dressing), Compeed Psoriasis Dressing and Hydrocolloid Dressing for Psoriasis
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
§ 878.4020 Occlusive wound dressing.
(a)
Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
0
JUN 1 7 2008
510(k) Summary Statement for Envela™ (Hydrohesive™ Occlusive Dressing)
| Device Classification Name: | Occlusive dressing |
|---|---|
| Common/Usual Name: | Occlusive dressing |
| Proprietary Name: | Envela™ (Hydrohesive™ Occlusive Dressing) |
| Classification: | Class I General Controls |
| (21 CFR 878.4020, 4022) | |
| Performance Standards: | Not Applicable |
| Predicate Devices: | DuoDerm® Extra Thin (Extra Thin® CGF Dressing) for |
| its moisturizing and occlusive properties; Compeed | |
| Psoriasis Dressing and Hydrocolloid Dressing for | |
| Psoriasis for management of psoriasis and protection | |
| of psoriatic plaques. | |
| Sponsor/Establishment: | Teikoku Pharma USA, Inc |
| 1718 Ringwood Avenue | |
| San Jose, CA 95131-1711 | |
| Establishment Registration Number: | To be assigned. |
| Contact Person: | Andrew Korey, PhD |
| Chief Scientific Officer | |
| Summary Date: | June 6, 2008 |
| Statement of Intended Use: | - For use in the management of psoriasis and the |
| protection of psoriatic plaques |
- As a protective dressing
- For management of superficial, dry to lightly
exudating dermal wounds." |
| Comparison to Predicate Device: | Envela™ is substantially similar in terms of component
materials, shape, dimensions, and mode of action to
existing occlusive wound dressings. |
| Performance Standards: | Not applicable to Class I occlusive dressings;
subject to General Controls. |
| Proposed Labeling: | The text for the individual foil envelope, carton label,
Package Insert (including Instructions for Use) will be
updated if and when the Indications for Use have been
cleared by FDA. Promotional literature and advertising
for the device have not yet been prepared. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its wings or feathers. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2008
Teikoku Pharma USA, Inc. % Margie Nemcik-Cruz, MA, RAC Regulatory Affairs Consultant 1718 Ringwood Avenue San Jose, California 95131-1711
Re: K072560
Trade/Device Name: Envela™ (Hydrohesive " Occlusive Dressing) Regulation Number: 21 CFR 878.4020 Regulation Name: Occlusive wound dressing Regulatory Class: I Product Code: NAD Dated: June 6, 2008 Received: June 9, 2008
Dear Ms. Nemcik-Cruz:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Margie Nemcik-Cruz, MA, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K07J60
Indications for Use Statement
(Food Drug and Cosmetic Act, Section 502(f)(1))
| 510(k) Number (if known): | To be assigned |
|---|---|
| Device Name: | EnvelaTM (HydrohesiveTM Occlusive Dressing) |
| Indications for Use: | - For use in the management of psoriasis and the protection |
| of psoriatic plaques |
-
As a protective dressing
-
For management of superficial, dry to lightly exudating
dermal wounds.” |
Prescription Use
OR
Over-the-Counter Use _ V
(21 CFR 801 SUBPART D)
(21 CFR 801 SUBPART C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
17 4 100 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
:
510(k) Number K072560
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