(305 days)
Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.
SILVERSEAL® Wound Packing Strip with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
The provided text is a 510(k) summary for the SILVERSEAL® Wound Packing Strips with X-Static®. This type of document is for clearance of a medical device, and therefore focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study with numerical thresholds.
As such, many of the requested categories for a rigorous study design (e.g., sample size for test set, number of experts, adjudication methods, multi-reader multi-case studies, effect size, training set details) are not applicable or not present in this type of submission. The primary "study" for a 510(k) is a comparison to a legally marketed predicate device.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission focused on substantial equivalence, there are no explicit numerical acceptance criteria described in the same way one might find in a clinical trial protocol (e.g., "sensitivity must be >90%"). Instead, the "acceptance criteria" are implied by demonstrating that the new device shares fundamental technological characteristics, intended use, and similar performance to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Design (Similar to predicates) | Flexible, non-adherent, protective dressing. Consists of nylon fibers with a metallic silver surface. |
| Performance (Similar to predicates) | Designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Silver provides effective protection of the dressing against microbial contamination. |
| Intended Use (Similar to predicates) | Control of local wound bleeding and nasal hemorrhage; encourages draining by wicking fluids from a body cavity, infected area, or abscess; helps remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing. |
| Biocompatibility (Safe for intended use) | Passed standard in vivo biocompatibility tests: cytotoxicity, sensitization, and acute intracutaneous reactivity. Performed in accordance with ISO 10993. |
| Technological Characteristics | Flexible primary contact wound dressing, permeability to oxygen and fluids, and protection against microbial contamination of the dressing. Substantially equivalent to cited predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. There was no specific "test set" of cases or patients in the sense of a clinical performance study with statistical endpoints. The evaluation was primarily based on material characterization and in vivo biocompatibility testing.
- Data Provenance: The biocompatibility tests were in vivo studies, likely conducted in animal models, but specific details on the "country of origin" or "retrospective/prospective" nature of patient data (which is not applicable here) are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There was no "ground truth" established by experts for a test set of clinical cases. The evaluation involved laboratory testing and comparison to existing device classifications and intended uses.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method was used, as there was no clinical test set requiring expert review or consensus.
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
- Not applicable. This device is a wound packing strip, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" for the biocompatibility assessment was derived from standardized in vivo biological evaluations based on ISO 10993, rather than expert consensus, pathology, or outcomes data from human patients for performance claims.
- The "ground truth" for substantial equivalence relies on the established intended use, technological characteristics, and safety profile of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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June 11, 2023
Noble Fiber Technologies, Inc. c/o Patricia Davidson 300 Palm Street Scranton, Pennsylvania 18505
Re: K063190
Trade/Device Name: SILVERSEAL® Wound Packing Strips with X-Static® Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Patricia Davidson:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 21, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely, Julie A. Morabito -S Julie Morabito, Ph.D.
Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2007
Noble Fiber Technologies, Inc. % Ms. Patricia Davidson 300 Palm Street Scranton, Pennsylvania 18505
Re: K063190
Trade/Device Name: SILVERSEAL® Wound Packing Strips with X-Static® Regulatory Class: Unclassified Product Code: FRO Dated: July 27, 2007 Received: July 31, 2007
Dear Ms. Davidson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not tnean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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Page 2 - Ms. Patricia Davidson
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may oltain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO63190 510(k) Number (if known):
Device Name: SILVERSEAL® Wound Packing Strips with X-Static®
Indications For Use:
Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 663190
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October 17, 2006
| 10. 510(k) SUMMARY | K063190Page 1 of 2 | ||
|---|---|---|---|
| 10.1 | Summary Information | ||
| 10.1.1 | Submitter's Name and Address | ||
| Noble Fiber Technology300 Palm StreetScranton, PA 18505 | AUG 21 2007 | ||
| Contact Person and telephone number: | |||
| William McNallyTelephone: 877-978-2842Telefax: 877-978-2842 | |||
| Date Summary was Prepared | |||
| October 17, 2006 | |||
| 10.1.2 | Name of Device | ||
| Trade Name: | SILVERSEAL® Wound Packing Stripwith X-Static® | ||
| Common Name:Classification Name: | Silver-nylon packing strip dressingWound dressing |
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
FRO
SILVERSEAL® Wound Packing Strip with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is substantially equivalent to Silverlon Wound Packing Strip (K984210), Dynarex Iodoform Packing Strip (K012816), Medline Wound Packing Strip (K052720) ; SILVERSEAL® Contact Wound Dressing with X-Static® (K033587) , Silverseal® Burn Dressing with X-Static (K050649), with respect to functional design, performance, and intended use as these presently distributed devices
10.1.4 Device Description
Classification:
Explanation of how the device functions: SILVERSEAL® Wound Packing Strip with X-Static® are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination.
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Basic scientific concepts that form the basis for the device: The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Wound Packing Strip with X-Static® consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination.
Significant physical and performance characteristics of the device design, materials used, and physical device such as SILVERSEAL® Wound Packing Strip with X-Static are properties: made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
10.1.5 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
Silverseal® Wound Packing Strip with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.
10.1.16 Statement of how the technological characteristics of the device compare to those of the predicate device
The technological characteristics of the device, such as flexible primary contact wound dressing, permeability to oxygen and fluids, and protection against microbial contamination of the dressing that are substantially equivalent to the predicate devices cited.
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10.2 Assessment of Performance Data
SILVERSEAL® Wound Packing Strip with X-Static® were subjected to standard in vivo biocompatibility tests including cytotoxicity, sensitization, and acute intracutaneous reactivity. All tests were performed in accordance with Part-10993 of the International Standard Organization (ISQ) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA). The studies indicated that SILVERSEAL® Wound Packing Strip with X-Static® are safe for their intended use.
N/A