(186 days)
Hemogrip™ Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.
The Hemogrip™ Patch Hemostasis Pad is a non-invasive topical bandage intended to promote hemostasis when in contact with a bleeding wound. Hemogrip™ Patch is composed of a soft, sterile, palmitoyl-N-acetylglucomasine substrate/backing coated with a freeze-dried layer of poly N-acetylglucosamine (chitosan). The environment of use for the Hemogrip™ Patch is at a healthcare facility/hospital under the direction of a healthcare professional.
The Hemogrip™ Patch Hemostasis Pad promotes the control of bleeding wounds in patients. This is achieved by applying proximal pressure to the puncture site and placing a Hemogrip™ Patch over the puncture site using a sterile folded gauze. Firm compression is applied over the puncture site until hemostasis is achieved. Proximal pressure can be released after 2 to 3 minutes. Once hemostasis is achieved, pressure is released and a dry gauze is placed over the Hemogrip" Patch. The site is then covered with an appropriate dressing. Within 24 hours, Hemogrip™ Patch should be soaked with water and gently removed.
The Hemogrip™ Patch is sterilized via y-irradiation and is for single use only.
The provided document is a 510(k) summary for the Hemogrip™ Patch, a topical hemostasis pad. It focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.
Therefore, the information requested, particularly regarding acceptance criteria, specific performance metrics (like sensitivity, specificity, or AUC), sample sizes for test/training sets, expert adjudication details, and MRMC studies, is not available in this document. The document describes a non-clinical animal study to demonstrate performance similarity, and biocompatibility testing.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria in terms of quantitative performance metrics for human use, such as time to hemostasis, success rates in a clinical population, or statistical thresholds. Instead, the performance evaluation is based on demonstrating similarity to a predicate device in an animal model and meeting biocompatibility standards.
| Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|
| Hemostasis Performance: No statistically reliable difference compared to the predicate device in ability to promote hemostasis in an acute splenic hemorrhage swine model. | "Analysis of the results indicated no statistically reliable difference in the performance of the Syvek Patch and Hemogrip™ Patch in their ability to promote hemostasis. In all instances, the Hemogrip™ Patch functioned as intended and the control of bleeding observed was as expected." |
| Biocompatibility: Meet requirements of ISO 10993 standards (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity). | "Hemogrip™ Patch met the requirements of biocompatibility for each of these tests." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a number of animals. The study refers to "a controlled acute swine model," implying multiple animals were used, but the exact count is not provided.
- Data Provenance: The study was an "animal study... in a controlled acute swine model of splenic hemorrhage." The location of the study (e.g., country of origin) is not specified. It is a prospective animal study as it involved conducting tests for the purpose of this submission.
- No human data (retrospective or prospective) for a "test set" is mentioned for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was an animal study evaluating hemostasis, not a study requiring human expert assessment of images or clinical outcomes that would typically establish ground truth for a diagnostic device. The "ground truth" here would be the observed hemostatic outcome in the animal model.
4. Adjudication method for the test set
- Not applicable. See point 3.
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. This is a physical medical device (hemostasis patch), not an AI/software medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device. Performance relates to its physical interaction with wounds, not an algorithm.
7. The type of ground truth used
- The ground truth for the hemostasis performance study was the observed hemostatic outcome in the acute splenic hemorrhage swine model.
- For biocompatibility, the ground truth was meeting the criteria specified by ISO 10993 standards (e.g., absence of cytotoxicity, irritation, sensitization, or acute systemic toxicity).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 21, 2023
Remedium Technologies, Inc. John Gustin, Ph.D. Regulatory Affairs Coordinator 387 Technology Dr., Suite 3110B College Park, Maryland 20742
Re: K143466 Trade/Device Name: Hemogrip™ Patch Regulatory Class: Unclassified Product Code: QSY
Dear John Gustin, 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 June 8, 2015. 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2015
Remedium Technologies Incorporated John Gustin, Ph. D. Regulatory Affairs Coordinator 387 Technology Drive, Suite 3110B College Park, Maryland 20742
Re: K143466
Trade/Device Name: Hemogrip Patch Regulatory Class: Unclassified Product Code: FRO Dated: May 6, 2015 Received: May 6, 2015
Dear Dr. Gustin:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - John Gustin, Ph. D.
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143466
Device Name Hemogrip Patch
Indications for Use (Describe)
Hemogrip Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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HEMOGRIP™ PATCH 510(k) Summary
Traditional 510(k) Summary
| A. Name and Address of Applicant : | Remedium Technologies, Inc.387 Technology Dr., Suite 3110BCollege Park, MD 20742 | |
|---|---|---|
| B. Contact Person: | John Gustin, Ph.D.Regulatory Affairs CoordinatorPhone: (301) 405-3585Fax: (301) 314-9592 | |
| C. Date Prepared: | June 4, 2015 | |
| D. Device Trade Name: | Hemogrip™ Patch | |
| E. Device Common Name: | Topical Hemostasis Pad | |
| F. Device Classification: | Unclassified Device | |
| G. Classification Name: | Dressing, Wound, Drug | |
| H. Product Code: | FRO | |
| I. Predicate Device: | Marine Polymer Technologies Syvek Patch®(K984177) |
-
J. Indications for Use:
Hemogrip™ Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. -
K. Device Description:
The Hemogrip™ Patch Hemostasis Pad is a non-invasive topical bandage intended to promote hemostasis when in contact with a bleeding wound. Hemogrip™ Patch is composed of a soft, sterile, palmitoyl-N-acetylglucomasine substrate/backing coated with a freeze-dried layer of poly N-acetylglucosamine (chitosan). The environment of use for the Hemogrip™ Patch is at a healthcare facility/hospital under the direction of a healthcare professional.
The Hemogrip™ Patch Hemostasis Pad promotes the control of bleeding wounds in patients. This is achieved by applying proximal pressure to the puncture site and placing a Hemogrip™ Patch over the puncture site using a sterile folded gauze. Firm
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compression is applied over the puncture site until hemostasis is achieved. Proximal pressure can be released after 2 to 3 minutes. Once hemostasis is achieved, pressure is released and a dry gauze is placed over the Hemogrip" Patch. The site is then covered with an appropriate dressing. Within 24 hours, Hemogrip™ Patch should be soaked with water and gently removed.
The Hemogrip™ Patch is sterilized via y-irradiation and is for single use only.
L. Performance Data
An animal study was conducted in a controlled acute swine model of splenic hemorrhage to evaluate the chitosan materials of both the Syvek Patch and the Hemogrip Patch. The swine model was selected based on published comparisons evaluating the effectiveness of hemostatic agents. Analysis of the results indicated no statistically reliable difference in the performance of the Syvek Patch and Hemogrip™ Patch in their ability to promote hemostasis. In all instances, the Hemogrip TM Patch functioned as intended and the control of bleeding observed was as expected.
Extensive biological testing to verify the biocompatibility of Hemogrip™ Patch was conducted. The biological tests required to establish biocompatibility are identified in FDA Blue Book Memorandum G95-1, "Use of International Stanard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Hemogrip™ Patch is a topical chitosan-based pad that remains in contact with a breached or compromised external surface on human skin for less than 24 hours. Hence, the device was tested via ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation), ISO 10993-10 (Sensitization) and ISO 10993-11 (Acute Systemic Toxicity). Hemogrip™ Patch met the requirements of biocompatibility for each of these tests.
- M. Summary of Substantial Equivalence:
Remedium Technologies has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the Hemogrip 100 Patch is substantially equivalent to the currently marketed predicate device. See Table 1 (below) for a tabulated summary of substantial equivalence.
Hemogrip 110 Patch has essentially the same intended use as the predicate device. Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse events noted.
In conclusion, Hemogrip™ Patch has been shown to be substantially equivalent to the Class II predicate on which the device is based.
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| Marine Polymer Technologies | Remedium Technologies | |||
|---|---|---|---|---|
| Syvek Patch® (K984177) | Hemogrip™ Patch | |||
| Indications for Use | SyvekPatch is indicated for use under | Hemogrip™ Patch is indicated for | ||
| the direction of a healthcare | use, under the direction of a healthcare | |||
| professional. SyvekPatch promotes | professional, in the management of | |||
| the rapid control of bleeding in | bleeding wounds such as vascular | |||
| patients on hemodialysis and in | access sites and percutaneous catheters | |||
| patients on anticoagulation therapy. | or tubes. | |||
| SyvekPatch is indicated for use in the | ||||
| management of bleeding wounds | ||||
| such as vascular access sites and | ||||
| percutaneous catheters or tubes. | ||||
| Target Population/ | Diagnostic or interventional | Diagnostic or interventional | ||
| Anatomical Sites | catheterization procedures. | catheterization procedures. | ||
| Where Used | Bleeding wounds under the care of a | Bleeding wounds under the care of a | ||
| physician or licensed practitioner. | physician or licensed practitioner. | |||
| Material | SyvekPatch is a soft, white, sterile | Hemogrip™ Patch is a soft, sterile, | ||
| non-woven pad of cellulosic polymer, | non-woven palmitoyl-N- | |||
| poly-N-acetylglucosamine (chitosan). | acetylglucosamine coated with N- | |||
| acetylglucosamine (chitosan), a | ||||
| cellulosic polymer. | ||||
| Sizes | 2 cm x 2 cm | 3 cm x 3 cm | 2.5 cm x 2.5 cm | 4 cm x 4 cm |
| Weight | 0.01 g | 0.03 g | 0.5 g | 0.8 g |
| Biocompatibility | Biocompatibility has been established | Biocompatibility has been established | ||
| via ISO 10993. | via ISO 10993 | |||
| Sterility | Sterilized with gamma radiation, for | Sterilized with gamma radiation, for | ||
| single use only. | single use only. | |||
| Function/performance | Similar performance to other topical | Similar performance to other topical | ||
| bandages intended to promote | bandages intended to promote | |||
| hemostasis in an acute splenic | hemostasis in an acute splenic | |||
| hemorrhage model in swine. | hemorrhage model in swine. |
Table 1. Tabulated Summary of Substantial Equivalence
N/A