(83 days)
Not Found
No
The summary describes a wound dressing and does not mention any AI or ML components or functionalities.
No
The device is a dressing used in wound management, which supports healing but does not actively provide therapy in the way a therapeutic device might (e.g., drug delivery, physical therapy, or diagnostic function). It absorbs exudate and protects the wound.
No
Explanation: The device is a wound dressing used for managing exudating wounds. It does not perform any diagnostic functions.
No
The device description clearly states it is a physical dressing made of absorbent materials cast onto a net, and it is supplied in different sizes and sterilized. This indicates it is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds (leg ulcers and pressure sores). This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a dressing designed to absorb exudate from wounds. This is a physical barrier and absorbent material, not a reagent or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Comfeel® Seasorb Dressing is indicated for use (under the guidance of a health care professional) in management of moderate to heavily exudating wounds, partial and full thickness wounds, including leg ulcers and pressure sores.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
The revised Comfeel® Seasorb Dressing consists of an absorbent calcium sodium alginate/sodium carboxymethy/ceilulose xerogel cast onto a high density polyethylene net. The dressing is supplied in three sizes: 4 x 6 cm (3705), and 10 x 10 cm (3710) and 15 x 15 cm (3715). The dressings are packaged in individual pouches and sterilized by ethylene oxlde.
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
health care professional
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)
The revised Comfeel® Seasorb Dressing has been tested and shown no accumulative irritation effects, no evidence of delayed hypersensitivity and is non-cytotoxic (cytotoxicity grade
§ 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
DEC 310 1998
510(k) Summary Comfeel® Seasorb Dressing
Coloplast Corporation 1955 West Oak Circle Marietta. Georgia 30062-2249 Date: 10/05/98
1. Contact Person
Ms. Sydney Lilly. (770) 281-8260
2. Name of the Medical Device
| Proposed Classification name: | Hydrophylic Wound and Burn
Dressing |
|-------------------------------|----------------------------------------|
| Common/usual name: | Topical Wound Dressing |
| Proprietary name: | Comfeel® Seasorb Dressing |
3. Device Classification
The Comfeel® Seasorb Dressing has been classified by the FDA under the proposed heading of Hydrophylic Wound and Burn Dressing as an unclassified device.
4. Statement of Substantial Equivalence
The revised Comfeel® Seasorb Dressing is equivalent to the original Comfeel® Alginate (Seasorb) Dressing, manufactured by Coloplast A/S and approved for market under 510(k) K953497, but with minor alterations.
5. Intended Use
The revised Comfeel® Seasorb Dressing is indicated (under the guidance of a health care professional) for use in management of moderate to heavily exudating wounds, partial and full thickness wounds, including leg ulcers and pressure sores.
6. Description of Device
The revised Comfeel® Seasorb Dressing consists of an absorbent calcium sodium alginate/sodium carboxymethy/ceilulose xerogel cast onto a high density polyethylene net. The dressing is supplied in three sizes: 4 x 6 cm (3705), and 10 x 10 cm (3710) and 15 x 15 cm (3715). The dressings are packaged in individual pouches and sterilized by ethylene oxlde.
K 983519
1
510(k) Summary Comfeel® Seasorb Dressing Page 2 of 3
The revised Comfeel® Seasorb Dressing is a modification of Comfeel® alginate (seasorb) dressing (K953497) which consists of 100% alginate. Through adjustment of the formula to 30% carboxymethylcullulose sodium and 70% alginate, the performance of the dressing has been improved measured on softness and absorption capacity.
The revised Comfeel® Seasorb Dressing has been tested and shown no accumulative irritation effects, no evidence of delayed hypersensitivity and is non-cytotoxic (cytotoxicity grade ≤ 2).
A comparison Matrix for the revised Comfeel® Alginate Dressing versus the original Comfeel® Alginate Dressing (K953497) is presented in Section 6.
7. Predicate Device
| | Comfeel® Seasorb Dressing | Comfeel® Alginate (Seasorb)
Dressing |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of
Identy | Seasorb Dressing is a sterile
Wound Dressing | Comfeel® Alginate (Seasorb) Dressing
is a sterile Wound dressing |
| Device description | The Seasorb Dressing is a highly
absorbent wound dressing
consisting of an calcium sodium
alginate/sodium
carboxymethylcellulose Xerogel
cast into a high density
polyethylene net. | The Comfeel® Alginate (Seasorb)
Dressing is a highly absorbent material
composed of a Xerogel of calcium
sodium alginate cast into a high density
polyethylene net. |
| Sizes | 4x6 cm, 10x10 cm, 15x15 cm | 4x6 cm, 10x10 cm, 15x15 cm |
| Use (single,
reusable
disposable) | Single | Single |
| Intended use | For management of moderate to
heavily exudating Stage I-IV
wounds, partial and full thickness
wounds, including leg ulcers,
pressure sores and burns etc. | For management of (under the
guidance of a health care professional)
moderate to heavily exudating wounds,
including leg ulcers and pressure
sores, etc. |
Comfeel®: Alginate (Seasorb) Dressing (Colopiast, Inc. K953497)
2
510(k) Summary Comfeel® Seasorb Dressing Page 2 of 3
| | Comfeel® Seasorb Dressing | Comfeel® Alginate (Seasorb)
Dressing |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precautions | May be used on patients with
systemic infections when the
infectious conditions are under
medical control. | Wounds which are solely or mainly
caused by arterial insufficiency or
complicated diabetic wounds (primarily
lower leg and foot) should be inspected
by a physician or nurse regularly. |
| | Seasorb Dressing must be
removed prior to radiation
treatment of long duration (X-rays,
ultrasonic treatment, diathermy
and micro waves). | A physician should be consulted before
using this product on wounds with a
high risk of infection, or on lesions
caused by syphilis, tuberculosis,
leprosy or cancer. |
| | Not recommended for use on dry
wounds. | Comfeel®Seasorb (Seasorb) Dressing
must be removed prior to the following
treatments: radiation, X-rays, ultrasonic
treatment, diathermy and micro waves. |
| | Do not use on patients with known
hypersensitivity to any of the
ingredients. | Wounds with signs of clinical infection,
fever and local symptoms such as pain
erythema (redness) or pus should have
a bacterial swab examination. Use of
this product may be continued at the
discretion of a physician. Current
systemic antibiotic treatment may be
given if indicated. |
| | | Not recommended for use on dry
wounds or third degree burns. |
| | | Do not use on patients with known
hypersensitivity to any of the
ingredients. |
| Sterilization | Sterile | Sterile |
| Packaging | Polyester pouches laminated
with peelable polyethylene prior
to sterilization | Polyester pouches laminated with
peelable polyethylene prior to
sterilization |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in black and white.
DEC 30 1998
M. Sidney Lilly Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062
Re: K983519 Trade Name: Comfeel Seasorb Dressing Regulatory Class: Unclassified Product Code: KMF Dated: October 5, 1998 Received: October 8, 1998
Dear Ms. Lilly:
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). 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 2. 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.
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.
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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4
Page 2 - Ms. M. Sidney Lilly
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,
Mark N Melburn
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
DEC. -18' 98(FRI) 13:51
P. 002
510(k) Number (if known): K983519
Device Name: Comfeel® Seasorb Dressing
Indications for Use:
The Comfeel® Seasorb Dressing is indicated for use (under the guidance of a health care professional) in management of moderate to heavily exudating wounds, partial and full thickness wounds, including leg ulcers and pressure sores.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark n Millenn
(Division Sign of General Res 510(k) Number
| Prescription Use
| (Per 21 CFR 801.109 | |
|---|---|
| OR Over-The-Counter Use | X |
(Optional Format 1-2-96)