← Product Code EFQ · K984187 # CROSSTEX NON-WOVEN SPONGES (K984187) _Crosstex Intl. · EFQ · Feb 18, 1999 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K984187 ## Device Facts - **Applicant:** Crosstex Intl. - **Product Code:** EFQ - **Decision Date:** Feb 18, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## 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. ## Device Story Crosstex Non-Woven Sponges are non-woven, quarter-folded sponges composed of a 65/35 rayon/polyester blend. Designed for medical use, these sponges are applied directly to patient wounds or burns to absorb excess body fluids or exudate. The device is available in various sizes (2x2", 3x3", 4x4") and ply configurations. It is intended for over-the-counter use. The device functions as a passive absorbent dressing; it does not involve electronic components, software, or active sensing. Clinical benefit is derived from the management of wound exudate to support patient care. ## Clinical Evidence No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility and physical performance metrics (thickness, tensile strength, elongation, bending length, absorption time, and absorption capacity) compared against established standards. ## Technological Characteristics Non-woven, hydroentangled spunlace substrate; 65/35 rayon/polyester composition. Available in 2x2", 3x3", and 4x4" sizes with 4-ply construction. Passive absorbent dressing. Testing performed per ERT and EP standards. ## Predicate Devices - Nu Gauze (K8211501) - Nova Gauze External Sponge ([K830473](/device/K830473.md)) - Versalon ([K812736](/device/K812736.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) | |
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| | | | | Division of General Restorative Devices | | | 510(k) Number | K984187 | | --- **Source:** [https://fda.innolitics.com/device/K984187](https://fda.innolitics.com/device/K984187) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com