(52 days)
No
The summary describes a wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is described as an occlusive wound dressing intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process, which are therapeutic actions.
No
The device description states its purpose is to facilitate wound healing by providing a moist environment and allowing debridement, not to diagnose a condition.
No
The device description clearly states it is an "occlusive wound dressing," which is a physical, hardware-based medical device. There is no mention of software as the primary or sole component.
Based on the provided information, the DermaStream™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- DermaStream™ Function: The description clearly states that the DermaStream™ is an occlusive wound dressing used for applying topical treatments directly to a wound on the body. It facilitates wound healing on the body.
The intended use and device description focus on wound care and topical treatment delivery, which are not functions of an IVD device.
N/A
Intended Use / Indications for Use
The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and to allow debridement to facilitate the normal wound healing process.
Product codes
NAD
Device Description
The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments. It is provided as a sterile, single-use, disposable device.
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)
K020781, K973036, K901845, K021501
Reference Device(s)
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
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter's
Corporate
Address: | MedicSense, Ltd.
14 Imber
Kiriat Arie, Petach Tikva, Israel 49511
www.medicsense.com |
|--------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | EnzySurge, Ltd.
63 Ha ' Odem St. POB 1
Shoham, Israel 73142 |
| | Mfg. Phone: | 972-3-979-6344 |
| | Contact Person: | Dr. Allon Leibovitz, CEO |
| | Date: | January 4, 2006 |
| 2. | Device &
Classification
Name: | Dressing, wound and burn occlusive (Class 1), Product Code NAD,
21 CFR 878.4020- Trade-name of device: DermaStream™ |
| 3. | Predicate Device: | KCI Wound Cell Transparent Wound Dressing (K020781)
3M Tegaderm Transparent Dressing (K973036 & K901845)
KCI V.A.C. Instillamat (K021501) |
| 4. | Description: | The DermaStream™ is an occlusive wound dressing which permits the
introduction of topical wound treatments. It is provided as a sterile, single-
use, disposable device. |
| 5. | Intended Use: | The DermaStream™ is an occlusive wound dressing which permits the
introduction of other topical wound treatments such as irrigating solutions,
antimicrobial and enzymatic debriding solutions, suspensions, and other
solutions. It is intended to provide a moist healing environment and to allow
debridement to facilitate the normal wound healing process. |
| 6. | Comparison of
Technological
Characteristics: | With respect to technology, the DermaStream™ is substantially equivalent
to its predicate devices. This is because it is a combination of the
fundamental features and characteristics of its predicate devices. The
primary difference is the ability to provide a solution and drainage to the |
protected wound via gravity versus a vacuum provided by electrical power
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
FEB 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EnzySurge, Ltd. c/o Mr. George J. Hattub, RAC, CQE Senior Staff Consultant MedicSense, Ltd. 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K060046
Trade/Device Name: DermaSteam™ Regulation Number: 21 CFR 878.4020 Regulation Name: Occlusive wound dressing Regulatory Class: I Product Code: NAD Dated: January 4, 2006 Received: January 6, 2006
Dear Mr. Hattub:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your 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 for assossion in the Merced 1976, the enactment date of the Medical Device Amendments, or to conniner of the rear reclassified in accordance with the provisions of the Federal Food, Drug, de neces mat na vo been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dierefore, mains 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 your de subject to such additional controls. Existing major regulations affecting your device n may of sucject to Cool of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA ean or the mirther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of acrisou that i bring that your device complies with other requirements of the Act that I Dr Has/Intations and regulations administered by other Federal agencies. You must or any I vith 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 CI I rart 007), idoling (21 (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.
2
Page 2 - Mr. Hattub
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device to a legally premation fouriedion." - e 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 If you desire of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: DermaStream™
Indications For Use: The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of C Qffice of Device Evaluation (ODE) - son of General, Restorative. Page 1 of 1 nd Neurological Devices
510(k) Number