(280 days)
- 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.
Envela™ is substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings.
The document provided is a 510(k) summary statement and a clearance letter for a medical device called Envela™ (Hydrohesive™ Occlusive Dressing). This type of document is for regulatory clearance to market a device, not for a clinical study proving performance against acceptance criteria in the way you've outlined for an AI/algorithm-driven device.
Here's why your request cannot be fully answered with the provided text, and what information can be extracted:
- This is a Class I device, subject to General Controls. Class I devices generally do not require extensive clinical studies or performance data like higher-risk devices, especially those involving AI/algorithms. Their clearance is often based on substantial equivalence to existing predicate devices, focusing on materials, dimensions, and known mechanisms of action.
- The document explicitly states "Performance Standards: Not applicable to Class I occlusive dressings; subject to General Controls." This means there are no specific quantitative performance metrics (like sensitivity, specificity, accuracy) defined or evaluated in a study for this type of device within this regulatory pathway.
- The "study" referenced for this type of clearance is primarily a comparison to predicate devices, not a clinical trial to establish efficacy or an AI performance study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, experts, adjudication methods, or MRMC studies, as these types of evaluations are not typically required or documented for a Class I occlusive dressing seeking 510(k) clearance via substantial equivalence.
However, I can extract information related to the device and its regulatory clearance as presented:
1. Table of Acceptance Criteria and the Reported Device Performance
- Acceptance Criteria (Implicit - Substantial Equivalence): The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to legally marketed predicate devices. This means the device must be as safe and effective as a legally marketed device that is not subject to premarket approval.
- Reported Device Performance (Implicit - Substantial Equivalence): The reported "performance" is that the device is "substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings." This statement serves as the basis for regulatory acceptance, rather than a specific numerical performance metric from a study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document does not describe a "test set" or a study with a sample size in the context of performance evaluation for an AI/algorithm. The clearance is based on comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. Ground truth establishment by experts is not described for this type of device clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are not described.
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
- No. This is not an AI-driven device, and no MRMC study was conducted or is relevant for this
510(k) clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-driven device, and no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No "ground truth" was established in the context of performance study for this device. The basis for clearance is comparison to predicate devices and their known clinical use.
8. The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not an AI/algorithm device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set or ground truth for it was established.
In summary, the provided document is a regulatory filing for a Class I medical device based on substantial equivalence to predicate devices, not a performance study for an AI or algorithm that would involve the criteria you listed.
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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) forits moisturizing and occlusive properties; CompeedPsoriasis Dressing and Hydrocolloid Dressing forPsoriasis for management of psoriasis and protectionof psoriatic plaques. |
| Sponsor/Establishment: | Teikoku Pharma USA, Inc1718 Ringwood AvenueSan Jose, CA 95131-1711 |
| Establishment Registration Number: | To be assigned. |
| Contact Person: | Andrew Korey, PhDChief Scientific Officer |
| Summary Date: | June 6, 2008 |
| Statement of Intended Use: | - For use in the management of psoriasis and theprotection of psoriatic plaques- As a protective dressing- For management of superficial, dry to lightlyexudating dermal wounds." |
| Comparison to Predicate Device: | Envela™ is substantially similar in terms of componentmaterials, shape, dimensions, and mode of action toexisting 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 beupdated if and when the Indications for Use have beencleared by FDA. Promotional literature and advertisingfor the device have not yet been prepared. |
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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 protectionof psoriatic plaques- As a protective dressing- For management of superficial, dry to lightly exudatingdermal 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)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
:
510(k) Number K072560
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§ 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.