(318 days)
Not Found
Not Found
No
The device description focuses on the physical properties and function of a wound dressing, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a "wound dressing" for the "management of exudating wounds" including various types of ulcers, burns, and incisions, indicating its use in treating and healing conditions, thus making it a therapeutic device.
No
Explanation: The device description clearly states its function is to absorb wound exudate and manage wounds. It does not mention any capabilities for identifying, examining, or evaluating a patient's condition or disease, which are the characteristics of a diagnostic device.
No
The device description clearly describes a physical wound dressing made of polymer granules encased in a mesh fabric, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of exudating wounds by absorbing wound fluid. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the dressing and its ability to absorb exudate. There is no mention of analyzing biological samples or providing information about a patient's health status.
- Lack of Diagnostic Elements: An IVD device would typically involve testing a sample (like blood, urine, or tissue) to detect or measure something that provides diagnostic information. This device does not perform any such testing.
This device is a wound dressing, which falls under the category of medical devices used for treatment and management, not diagnosis.
N/A
Intended Use / Indications for Use
A highly absorptive pillow dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
Product codes
KMF
Device Description
Osmo/PCA Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb up to 20 times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the Osmo/PCA Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels.
Osmo/PCA Pillow Wound Dressing contains a highly absorptive polymer able to absorb up to 20 times its weight in wound exudate.
Osmo/PCA Pillow Wound Dressing contains highly absorptive polymer granules able to absorb up to 20 times their weigh in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
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)
Biocompatibility testing has been performed as recommended in the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1." These tests support the safe use of Osmo/PCA Pillow Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OsmoCyte™ Pillow Wound Dressing, lamin® Hydrating Gel
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
4 7 1 6 1 2
MAR 1 6 1998
11.2 510(k) Summary 11.2 -
Submitter's Name and Address:
ProCyte Corporation 12040 115th Ave NE #210 Kirkland, Washington 98034-6900
Contact person and telephone number:
Paul Ketteridge Regulatory Affairs Officer Telephone: (206) 820-4548 Fax: (206) 820-7611
Date summary was prepared: April 29, 1997
Name of the Device:
| Proprietary name: | Osmo/PCA Pillow Wound Dressing |
|---|---|
| Common name: | Wound Dressing |
| Classification name: | Wound and Burn Dressing |
ldentification of Predicate Devices to which Substantial Equivalence is Being Claimed:
Osmo/PCA Pillow Wound Dressing is substantially equivalent in function and intended use to the following non-classified commercially available or 510(k) cleared non-interactive wound and burn dressings:
- OsmoCyte™ Pillow Wound Dressing .
- lamin® Hydrating Gel .
1
K971 K=1 R
A Pillow Wound Dressing
Device Description:
Explanation of how the device functions: Osmo/PCA Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb up to 20 times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the Osmo/PCA Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels.
Basic scientific concepts that form the basis for the device: Osmo/PCA Pillow Wound Dressing contains a highly absorptive polymer able to absorb up to 20 times its weight in wound exudate.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: Osmo/PCA Pillow Wound Dressing contains highly absorptive polymer granules able to absorb up to 20 times their weigh in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
2
Image /page/2/Picture/0 description: The image shows a series of characters or symbols, possibly letters, arranged horizontally. The characters are drawn in a dark color against a light background, giving them a distinct contrast. The style of the characters appears somewhat stylized or handwritten, with varying line thicknesses and shapes. The overall impression is that of a sequence of symbols or letters, potentially forming a word or code.
PCA Pillow Wound Dressing oril 30, 1997 Page 3 of 3
Statement of the Intended Use of the Device, Including General Description of the Conditions the Device Will Mitigate and the Patient Population for which the Device Is Intended:
A highly absorptive pillow dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
These indication statements are not different from the predicate devices identified above.
Statement of how the Technological Characteristics of the Device Compare to those of the Predicate Device:
The technological characteristics of the device are similar to the predicate devices. The ability to absorb large amounts of wound exudate, coupled with the ability to be used safely in deep cavity or tunnel wounds is comparable to several the predicate devices. In addition, Osmo/PCA Pillow Wound Dressing has the advantage, by using an inert LDPE mesh, containing the absorbent granules, to assuring its complete removal from the wound.
Assessment of Performance Data:
Biocompatibility testing has been performed as recommended in the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1." These tests support the safe use of Osmo/PCA Pillow Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 1998
Mr. Paul Ketteridge Regulatory Affairs Officer Procyte Corporation 12040 115th Avenue NE, Suite 210 Kirkland, Washington 98034-6900
Re: K971612 Trade Name: OSMO/PCA Pillow Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: January 12, 1998 Received: January 16, 1998
Dear Mr. Ketteridge:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic).skin---------------------------------------------------------------------------------------------------------------------------------------------
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
4
Page 2 - Mr. Ketteridge
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
Page 1 of 1
| 510(k) Number (if known): | K971612 |
|---|---|
| Device Name: | OSMO/PCA Pillow Wound Dressings |
Indications For Use:
Indications:
.. "
mulcations.
Exudating wounds, including pressure ulcers, venus stasis ulcers, arena injurise or Exudating wounds, including probodro alsore, alsole attive incisions, trauma injuries or incisions.
(Please Do Not Write Below This Line-Continue On Another Page If Needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K971612 |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |