(87 days)
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.
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.
The provided document describes a 510(k) submission for "Crosstex Non-Woven Sponges," which are medical sponges used for absorbing fluids. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing novel performance criteria through a study with specific acceptance criteria as would be typical for a device with a more complex functional output (e.g., an AI-powered diagnostic tool).
Therefore, many of the requested categories in your prompt are not applicable to this type of device and submission. This is a basic medical device (a sponge) where "performance" is primarily assessed through physical and biocompatibility testing against established standards and comparison to similar predicate devices.
Here's an analysis based on the provided text, indicating where information is not applicable (N/A) for this specific submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from predicate comparison) | Reported Device Performance (as compared to J&J Nu-Gauze K#8211501) |
|---|---|
| Biocompatibility testing requirements (per ERT and EP standards) | Met relevant testing requirements |
| Physical testing requirements (thickness, tensile strength, elongation, bending length, absorption time, absorption capacity, per ERT and EP standards) | Met relevant testing requirements |
| Similar Rayon/Polyester composition | 65/35 Rayon/Polyester composition (similar) |
| Similar unit weight | Similar unit weight |
| Similar single ply thickness | Similar single ply thickness |
| Similar absorption time | Similar absorption time |
| Similar absorption capacity | Similar absorption capacity |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The document refers to "testing" performed for biocompatibility and physical properties, but does not provide details on the number of sponges tested.
- Data Provenance: Not specified. Testing would typically be conducted in a laboratory setting. No country of origin for "data" is relevant in the context of a physical product's performance testing.
- Retrospective or Prospective: N/A. This is for product testing, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This device does not involve subjective interpretation or ground truth establishment by medical experts in the way a diagnostic device would. Performance is measured objectively through standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for subjective assessments (e.g., expert reads) which are not part of this device's performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is a non-AI, non-diagnostic physical product. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a non-AI physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is objective measurement against established physical and chemical standards and comparison to a legally marketed predicate device's characteristics. No clinical outcomes data or expert consensus on features is mentioned or needed for this type of device.
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. Not an AI/machine learning device.
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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.
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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.
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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.
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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
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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 |
N/A