(52 days)
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.
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.
The provided text describes a 510(k) summary for a medical device (DermaStream™ occlusive wound dressing) but does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document focuses on:
- Device Identification: Name, classification, manufacturer, contact.
- Predicate Devices: Identifying similar legally marketed devices (KCI Wound Cell Transparent Wound Dressing, 3M Tegaderm Transparent Dressing, KCI V.A.C. Instillamat).
- Device Description: An occlusive wound dressing permitting topical wound treatment introduction, sterile, single-use, disposable.
- Intended Use: To provide a moist healing environment and allow debridement to facilitate normal wound healing.
- Technological Characteristics Comparison: Stating it is substantially equivalent to predicate devices, being a combination of their features, with the primary difference being solution/drainage provision via gravity vs. vacuum.
- FDA Correspondence: Confirming the substantial equivalence determination.
Therefore, I cannot provide the requested table or elaborations on the study details because the necessary information is not present in the provided text. The document is essentially a regulatory submission summary, not a performance study report.
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510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter'sCorporateAddress: | MedicSense, Ltd.14 ImberKiriat Arie, Petach Tikva, Israel 49511www.medicsense.com |
|---|---|---|
| 1. (b) | ManufacturerAddress: | EnzySurge, Ltd.63 Ha ' Odem St. POB 1Shoham, Israel 73142 |
| Mfg. Phone: | 972-3-979-6344 | |
| Contact Person: | Dr. Allon Leibovitz, CEO | |
| Date: | January 4, 2006 | |
| 2. | Device &ClassificationName: | 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 theintroduction 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 theintroduction of other topical wound treatments such as irrigating solutions,antimicrobial and enzymatic debriding solutions, suspensions, and othersolutions. It is intended to provide a moist healing environment and to allowdebridement to facilitate the normal wound healing process. |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology, the DermaStream™ is substantially equivalentto its predicate devices. This is because it is a combination of thefundamental features and characteristics of its predicate devices. Theprimary difference is the ability to provide a solution and drainage to the |
protected wound via gravity versus a vacuum provided by electrical power
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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.
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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
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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
§ 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.