(87 days)
K#8211501, K#830473, K#812736
Not Found
No
The device description and intended use are for simple absorbent sponges, and there is no mention of AI, ML, image processing, or any computational analysis.
Yes
The intended use states that the device is "to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate," which describes a therapeutic action for medical purposes.
No
Explanation: The device description and intended use clearly state that these sponges are for absorbing fluids from wounds or burns, which is a treatment/management function, not a diagnostic one. There is no mention of analysis, measurement, or diagnosis of a condition.
No
The device description clearly states it consists of non-woven materials, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate. This is a direct interaction with the patient's body for a therapeutic or protective purpose.
- Device Description: The device is a physical sponge designed for absorption from the patient's skin.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not involve any such testing of specimens.
- Performance Studies: The performance studies focus on physical properties and biocompatibility, not on the analysis of biological samples.
This device falls under the category of a wound dressing or absorbent medical sponge, which are external medical devices used for patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.
Product codes
EFQ
Device Description
The Crosstex Non-Woven Sponges consist of non-woven materials quarter folded into:
- 2 X 2" (light) 4-Ply
- 2 X 2" (light)
- 3 X 3" (Premium) 4-Ply
- 4 X 4" (Premium) 4-Ply
sponges used for the absorption of liquids from the patient's skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's wound or burn
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
Non-Clinical Tests: Biocompatibility testing and physical testing including thickness, tensile strength, elongation, bending length, absorption time and absorption capacity, per ERT and EP standards, met relevent testing requirements.
Clinical Tests: Non-Applicable
Key Metrics
Not Found
Predicate Device(s)
K#8211501, K#830473, K#812736
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
EXHIBIT #1 PAGE 1 OF 2
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:_49841.87
1. Submitter's Identification:
Crosstex® International 10 Ranick Road Hauppauge, NY 11788 Contact: Mr. Richard Allen
Date Summary Prepared:
November 19, 1998
2. Name of the Device:
Crosstex Non-Woven Sponges
3. Predicate Device Information:
- Use Sponges, Johnson & Johnson, General a) Nu Gauze K#8211501
- The Nova Gauze External Sponge, American Threshold, b) K#830473
- Versalon, Kendall, K#812736 C)
4. Device Description:
The Crosstex Non-Woven Sponges consist of non-woven materials quarter folded into:
- 2 X 2" (light) 4-Ply
2 X 2" (light) ● 3 X 3" (Premium) 4-Ply - 4 X 4" (Premium) 4-Ply
sponges used for the absorption of liquids from the patient's skin.
1
5. Intended Use:
Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.
6. Comparison to Predicate Devices:
All of the predicate device non-woven sponges are made from hydroentanqled spunlace substrates. The Crosstex Non-woven Sponge is similar to the J&J Nu-Gauze with a 65/35 Rayon/Polyester composition, similar unit weight, similar single ply thickness, similar absorption time and similar absorption capacity.
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
Biocompatibility testing and physical testing including thickness, tensile strength, elongation, bending length, absorption time and absorption capacity, per ERT and EP standards, met relevent testing requirements.
8. Discussion of Clinical Tests Performed:
Non-Applicable
9. Conclusions:
We have demonstrated that the Crosstex Non-Woven Sponges are substantially equivalent to the predicate devices. We have tested the sponges and they meet applicable voluntary standards. There are no safety or effectiveness issues.
- 2 -
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Ms. Susan D. Goldstein-Falk Crosstex® International c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K984187
Trade Name: Crosstex Non-Woven Sponges Regulatory Class: Unclassified Product Code: EFQ Dated: November 19, 1998 Received: November 23, 1998
Dear Ms. Goldstein-Falk:
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 (Act). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
3
Page 2 - Ms. Susan D.Goldstein-Falk
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
4
EXHIBIT B Page 1 of 1
984187 ・・・・ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:____Crosstex Non-Woven Sponges
Indications For Use:
Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.
(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ✓ |
| (Optional Format 1-2-96) | ||
| scollifo | ||
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K984187 |