(576 days)
Prescription use: ATD is intended for temporary external use to control traumatic bleeding. Over-The-Counter-Use: ATD is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
ATD is composed of an absorbent pad of carboxymethyl cellulose impregnated with ionic silver and then uniformly coated with silicon particles for the purpose of promoting rapid hemostasis. The hemostatic mechanism of silicon in ATD is through, contact pathway activation (intrinsic) of clot formation. The device is provided as a sterile 10 cm x 100 cm strip that is Z-folded and vacuum packed. The dressing is placed directly on the site of bleeding with applied pressure as long as necessary or until the time of definitive care.
The provided FDA 510(k) summary for the Advanced Trauma Dressing (ATD) mainly focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and explicitly proving device performance against them. The information provided is typical for a 510(k) submission, emphasizing comparison with existing cleared devices.
Therefore, many of the requested details about specific acceptance criteria and a detailed study proving performance against them, especially for AI/ML devices (which this is not), are not present in the provided text.
However, I can extract and infer some information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a medical device (a trauma dressing), the "acceptance criteria" are generally framed as demonstrating substantial equivalence to a predicate device. The performance is reported in comparison to the predicate devices.
| Acceptance Criteria (Inferred for 510(k)) | Reported Device Performance (ATD vs. Predicate) |
|---|---|
| Intended Use Equivalence: Same indications for use as predicate devices. | ATD has the "same intended use" as QuikClot®eX (K072474) and Aquacel® Ag (K080383). |
| Technological Characteristics Equivalence: Similar materials and mechanism of action. | ATD consists of the "same absorbent material (carboxymethyl cellulose) and contains the same concentration of silver ions as Aquacel® Ag." ATD is coated with an "equivalent hemostatic agent (slicon vs silicate based particles) that are in the same size regime as QuikClot®eX," resulting in an "identical mechanism of action." |
| Performance Equivalence: Comparable hemostatic properties and biocompatibility. | "Bench and animal testing has demonstrated equivalency of performance between ATD and the predicate devices." ATD showed "equivalent hemostatic properties to QuikClot-eX in bench top coagulation studies and in 3 separate injuries performed on swine." ATD also demonstrated "biocompatibility through the same four biocompatibility tests" as QuikClot-eX. |
| Sterilization Equivalence: Same sterilization method as predicate. | ATD is "provided sterile by gamma sterilization which is the same as the predicate." |
| Safety and Effectiveness: No new questions of safety or effectiveness raised compared to predicates. | "no new questions of safety or effectiveness have been raised." |
2. Sample size used for the test set and the data provenance
- Test Set Description: The performance data primarily comes from:
- Bench top coagulation studies.
- 3 separate in vivo porcine models of acute bleeding.
- Sample Size: The exact sample size for the bench studies and the number of animals used in the porcine models (e.g., how many pigs, how many injuries per pig) are not specified in the provided document.
- Data Provenance: The study was conducted by Nanosys, Inc. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but animal studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document as it's not relevant for a medical device 510(k) submission that relies on physical and biological performance testing rather than expert-derived ground truth (as might be the case for an AI/ML diagnostic device).
4. Adjudication method for the test set
This information is not provided. Given the nature of the in vivo and bench testing (e.g., measuring clotting time, bleeding volume), formal expert adjudication methods like 2+1 or 3+1 are typically not applicable. The assessment would likely be based on quantitative measurements.
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
No, an MRMC comparative effectiveness study was not done. This device is a trauma dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical trauma dressing, not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" for performance evaluation was established through:
- Quantitative measurements in bench top coagulation studies: This would involve objective metrics of clotting.
- Physiological outcomes in in vivo porcine models: This would involve direct observation and measurement of bleeding control in a live animal model (e.g., time to hemostasis, total blood loss).
8. The sample size for the training set
This question is not applicable. The device is a physical trauma dressing and does not involve a training set as an AI/ML algorithm would.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
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July 28, 2023
Nanosys, Inc. c/o Hugh Daniels, Ph.D. 2625 Hanover Street Palo Alto, California 94304
Re: K101257 Trade/Device Name: Advanced Trauma Dressing (ATD) Regulatory Class: Unclassified Product Code: OSY
Dear Hugh Daniels, Ph.D .:
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 December 1, 2011. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
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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Image /page/1/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized birds in flight, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 1 2011
Nanosys, Inc. % Hugh Daniels, Ph.D. 2625 Hanover Street Palo Alto, California 94304
Re: K101257
Trade/Device Name: Advanced Trauma Dressing (ATD) Regulatory Class: Unclassified Product Code: FRO Dated: November 14, 2011 Received: November 15, 2011
Dear Dr. Daniels:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 mean 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); medical device reporting (reporting of medical
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Page 2 - Hugh Daniels, Ph.D.
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain 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) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K101257
Device Name: Advanced Trauma Dressing (ATD)
INDICATIONS FOR USE:
Prescription use:
ATD is intended for temporary external use to control traumatic bleeding.
Over-The-Counter-Use:
ATD is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Prescription Use x (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101257
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510(K) SUMMARY
DEC. - 1 2011
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.
| APPLICANT | Nanosys, Inc.2625 Hanover StreetPalo Alto, CA. 94304USA |
|---|---|
| CONTACT PERSON | Hugh Daniels, PhDDirector of Life Sciences R&DPhone: (650) 331-2100, ext 2108Fax: (650) 331-2101e-mail: hdaniels@nanosysinc.com |
| TRADE NAME: | ATD - Advanced Trauma Dressing |
| COMMON NAME: | Trauma Dressing |
| CLASSIFICATIONNAME: | Dressing, Wound |
| DEVICECLASSIFICATION: | Unclassified |
| PRODUCT CODE | FRO |
| PREDICATEDEVICES: | Convatec Aquacel® Ag.(K080383)Z-Medica QuikClot®eX (K072474) |
| DATE PREPARED: | April 30, 2010 |
Description of Device:
ATD is composed of an absorbent pad of carboxymethyl cellulose impregnated with ionic silver and then uniformly coated with silicon particles for the purpose of promoting rapid hemostasis. The hemostatic mechanism of silicon in ATD is through, contact pathway activation (intrinsic) of clot formation.
The device is provided as a sterile 10 cm x 100 cm strip that is Z-folded and vacuum packed. The dressing is placed directly on the site of bleeding with applied pressure as long as necessary or until the time of definitive care.
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K 101257
page 2 of 2
Indications for Use:
Prescription Use:
ATD is intended for temporary external use to control traumatic bleeding.
Over-The-Counter-Use:
ATD is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Description of Substantial Equivalence:
ATD has the same intended use and technological characteristics as the predicate devices QuikClot@eX (K072474) and Aquacel® Ag (K080383) and therefore is substantially equivalent to the predicates.
ATD consists of the same absorbent material (carboxymethyl cellulose) and contains the same concentration of silver ions as Aquacel® Ag. ATD is coated with an equivalent hemostatic agent (silicon vs silicate based particles) that are in the same size regime as QuikClot@eX. This results in ATD having an identical mechanism of action, namely contact pathway activation (intrinsic) of clot formation as the predicate.
Performance Data:
Bench and animal testing has demonstrated equivalency of performance between ATD and the predicate devices. Performance testing included a comparison of material properties in bench testing and hemostatic performance in three in vivo porcine models of acute bleeding. ATD was shown to have equivalent hemostatic properties to QuikClot-eX in bench top coagulation studies and in 3 separate injuries performed on swine. In addition, ATD has demonstrated biocompatibility through the same four biocompatibility tests that the predicate device (QuikClot-eX) was subjected to and is provided sterile by gamma sterilization which is the same as the predicate.
Conclusion:
In summary, ATD and the predicate devices have the same intended use, design, material, and performance characteristics and no new questions of safety or effectiveness ' have been raised. Nanosys Inc. considers ATD to be substantially equivalent to the legally marketed predicate devices QuikClot@eX (K072474) and Aquacel® Ag (K080383), for the purpose of this 510(k) submission.
N/A