(113 days)
No
The device description and performance studies focus on the material properties and hemostatic efficacy of the dressing, with no mention of AI or ML.
Yes
The device is described as a hemostatic dressing intended for the "temporary control of severely bleeding wounds," which directly addresses a health condition (bleeding) and provides a therapeutic effect (hemostasis).
No
Explanation: The D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds. It does not analyze or interpret medical data to identify a disease, condition, or risk.
No
The device description clearly states it is a physical dressing composed of kaolin and gauze, not software.
Based on the provided information, the D2 Hemostatic Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- D2 Hemostatic Dressing Function: The D2 Hemostatic Dressing is a topical dressing applied directly to a wound to control bleeding. It works by physically interacting with the blood at the wound site to promote clotting.
- Lack of In Vitro Testing: The description focuses on the dressing's application to the wound and its performance in controlling bleeding in vivo (in living organisms, specifically swine models). There is no mention of testing samples in vitro (outside the body).
Therefore, the D2 Hemostatic Dressing is a medical device used for wound management and hemostasis, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Product codes (comma separated list FDA assigned to the subject device)
FRO, QSY
Device Description
The D2 Hemostatic Dressing is composed of kaolin (hemostatic agent) bound to a non-woven gauze (polyester-rayon substrate). D2 Hemostatic Dressing is provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing: performed in accordance with the International Standards Organization (ISO) 10993 Guidelines, FDA General Program Memorandum No. G95-1 and the Office of Device Evaluation (ODE) Bluebook Memorandum G95-1 "Use of ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
- Cytotoxicity: Non-cytotoxic
- Irritation: Non-irritating
- Sensitization: Non-sensitizing
- Systemic Injection (intraperitoneal and intravenous injection): Non-toxic
- Genotoxicity: Non- mutagenic
- Subcutaneous implantation: Non-toxic
Efficacy testing: In vivo testing evaluated the efficacy of the D2 Hemostatic Dressing.
- Comparison Testing of D2 Hemostatic Dressing in Swine Model.
- DESCRIPTION: The hemostatic efficacy of the D2 Hemostatic Dressing was compared to legally marketed hemostatic dressings, QuikClot eX (K072474) and HemCon GuardaCareTM XR Surgical (K103641), when used to control bleeding in wounds such as superficial and subcutaneous injuries, injuries/ lacerations to spleen, mesentery and liver.
- RESULT: The performance of D2 Hemostatic Dressing was similar to the predicate devices.
- Conclusion: D2 Hemostatic Dressing is effective in controlling bleeding from wounds.
- Comparison Testing of D2 Hemostatic Dressing in Swine Femoral Artery Punch Injury Model.
- DESCRIPTION: The efficacy of D2 hemostatic dressings in controlling bleeding in Yorkshire Swine femoral artery punch injury model in comparison with predicate dressings (GuardaCare®).
- RESULT: The performance of D2 Hemostatic Dressing was similar to the predicate devices.
- Conclusion: D2 Hemostatic Dressing is effective in controlling bleeding from severe traumatic injury.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2023
Z-Medica, LLC Sheila K. Wallin Vice President of Clinical & U.S. Regulatory Affairs 4 Fairfield Blvd. Wallingford, Connecticut 06492
Re: K140757 Trade/Device Name: D2 Hemostantic Dressing Regulatory Class: Unclassified Product Code: QSY
Dear Sheila K. Wallin:
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 July 17, 2014. 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.
Image /page/0/Picture/7 description: The image shows the text "Sincerely, Julie A. Morabito - S". The text appears to be a signature. The font is a serif font, and the text is black. The image is a close-up of the text.
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
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
July 17, 2014
Z-Medica, LLC Ms. Sheila K. Wallin Vice President of Clinical & U.S. Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492
Rc: K140757
Trade/Device Name: D2 Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 29, 2014 Received: May 1, 2014
Dear Ms. Wallin:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. 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 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.
2
Page 2 - Ms. Sheila K. Wallin
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/ResourcesforYou/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/ReportalProblem/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
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
KI40757
Device Name
| D2 Hemostatic Dressing |
|---|
| ------------------------ |
Indications for Use (Describe)
D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Jiyoung Dang -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
·Do Not send your completed form to the Pra Staff EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the The buroen this of this Golloulen of internations in the maintain the data needed and complete tifie to review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
4
510(k) Summary for Z-Medica, LLC D2 Hemostatic Dressing
JUL 1 7 2014 K140757
SUBMITTER/510(K) HOLDER 1.
Z-Medica, LLC 4 Fairfield Blvd. Wallingford, CT 06492 Contact Person: Sheila K Wallin Telephone: 203-294-0000 x 308
Date Prepared: March 24, 2014
2. DEVICE NAME
Proprietary Name: D2 Hemostatic Dressing Common/Usual Name: Dressing, Wound, Drug Unclassified Classification: Dressing Classification Name: FRO Product Code:
PREDICATE DEVICE 3.
- K103641 HemCon GuardaCare™ XR Surgical .
4. DEVICE DESCRIPTION
The D2 Hemostatic Dressing is composed of kaolin (hemostatic agent) bound to a non-woven gauze (polyester-rayon substrate). D2 Hemostatic Dressing is provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound.
The proposed indications for use are substantially equivalent to the predicate device (HemCon GuardaCare™ XR Surgical K103641 cleared June 16, 2011, for surgical wounds and traumatic injuries). D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.
In vivo testing evaluated the efficacy of the D2 Hemostatic Dressing versus predicate (GuardaCare XR Surgical) to control bleeding in traumatic and surgical The data supports the effectiveness of D2 Hemostatic Dressing in wounds. achieving hemostasis in both traumatic and surgical wounds.
5
ട. INTENDED USE
D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE Q.
The D2 Hemostatic Dressing is substantially equivalent to the predicate device (HemCon GuardaCare™ XR Surgical - K103641) in that it has the same intended use and instructions for use, and similar design (hemostatic agent bound to a nonwoven polyester/rayon substrate with an x-ray detectable thread). Data included in this submission demonstrate that the device is as safe and as effective as the legally marketed predicate, and none of the differences between the D2 Hemostatic Dressing and the predicate device raise different questions of safety and effectiveness than the predicate device.
The D2 Hemostatic Dressing and the predicate device are substantially equivalent in that they contain a hemostatic agent that functions to control bleeding. Their mechanisms of action are also similar: in D2 Hemostatic Dressing the hemostatic agent is kaolin, a mineral, which triggers an electrostatic interaction when in contact with blood to promote clotting. GuardaCare XR Surgical uses a different hemostatic agent, chitosan, which is a polymer that also works by electrostatic interaction to promote clotting. Although the hemostatic components of these two products are different, their mechanism of action and outcome is substantially equivalent.
Additionally, the D2 Hemostatic Dressing is similar to Z-Medica's legally marketed kaolin-based hemostatic dressings (QuikClot eX, also marketed as Combat Gauze - K072474 and QuikClot Hemostatic Dressing - K123387) in that it has the same hemostatic agent (kaolin), and similar design and processing. The only difference in the existing products and the D2 Hemostatic Dressings is that calcium alginate is used instead of glycerin to bind the kaolin to the nonwoven gauze substrate. Calcium alginate was chosen because it was found that calcium alginate binds kaolin effectively to the gauze resulting in a de minimis release.
The D2 Hemostatic Dressing is offered in several configurations ranging from 1" x 1" x 1 ply to 4" x 12ft x 2 ply, packed individually or as a multipack.
6
7. PERFORMANCE TESTING
Biocompatibility testing for the intended application of the D2 Hemostatic Dressing was performed in accordance with the International Standards Organization (ISO) 10993 Guidelines, FDA General Program Memorandum No. G95-1 and the Office of Device Evaluation (ODE) Bluebook Memorandum G95-1 "Use of ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Per these guidance documents biological evaluation testing was categorized as limited contact duration, external communicating device, tissue/bone/dentin communicating.
See Appendix 15 for complete protocols and reports of the testing.
| Test | Description | Conclusion |
|---|---|---|
| Cytotoxicity | L929 Neutral Red Uptake according to ISO 10993-5:2009, | |
| 'Biological Evaluation of Medical Devices, Part 5: Tests for In | ||
| Vitro Cytotoxicity' | Non-cytotoxic | |
| Irritation | ISO 10993-10:2010, 'Biological Evaluation of Medical | |
| Devices, Part 10; Tests for Irritation and Skin Sensitization' | Non-irritating | |
| Sensitization | ISO 10993-10:2010, 'Biological Evaluation of Medical | |
| Devices, Part 10; Tests for Irritation and Skin Sensitization' | Non-sensitizing | |
| Systemic | ||
| Injection | ||
| (intraperitoneal | ||
| and intravenous | ||
| injection) | ISO 10993-11:2006, 'Biological Evaluation of Medical | |
| Devices, Part 11: Tests for Systemic Toxicity' | Non-toxic | |
| Genotoxicity | ISO 10993-3:2003, 'Biological evaluation of medical devices | |
| Part 3: Tests for genotoxicity, carcinogenicity and reproductive | ||
| toxicity' | Non- mutagenic | |
| Subcutaneous | ||
| implantation | ISO 10993-6, 2007, Biological Evaluation of Medical Devices |
- Part 6: Tests for Local Effects After Implantation | Non-toxic |
8. SAFETY AND EFFICACY
In vivo testing evaluated the efficacy of the D2 Hemostatic Dressing. The results of bench and safety testing indicated that the new device is as safe and as effective as the predicate device. The D2 Hemostatic Dressing and the predicate device have similar safety and performance results.
Protocols and test reports of the in vivo testing can be found in Section 19 of this submission.
| Test | Description | Conclusion |
|---|---|---|
| Comparison | ||
| Testing of D2 | ||
| Hemostatic | ||
| Dressing in Swine | ||
| Model | DESCRIPTION: The hemostatic efficacy of the D2 Hemostatic | |
| Dressing was compared to legally marketed hemostatic | ||
| dressings, QuikClot ex (K072474) and HemCon GuardaCareTM | ||
| XR Surgical (K103641), when used to control bleeding in | ||
| wounds such as superficial and subcutaneous injuries, injuries/ | D2 Hemostatic | |
| Dressing is | ||
| effective in | ||
| controlling | ||
| bleeding from |
7
| lacerations to spleen, mesentery and liver. | wounds | |
|---|---|---|
| RESULT: | ||
| The performance of D2 Hemostatic Dressing was similar to the | ||
| predicate devices. | ||
| Comparison | ||
| Testing of D2 | ||
| Hemostatic | ||
| Dressing in Swine | ||
| Femoral Artery | ||
| Punch Injury | ||
| Model | DESCRIPTION: | |
| The efficacy of D2 hemostatic dressings in controlling | ||
| bleeding in Yorkshire Swine femoral artery punch injury | ||
| model in comparison with predicate dressings (GuardaCare®). | ||
| RESULT: | ||
| The performance of D2 Hemostatic Dressing was similar to the | ||
| predicate devices. | D2 Hemostatic | |
| Dressing is | ||
| effective in | ||
| controlling | ||
| bleeding from | ||
| severe traumatic | ||
| injury |
9. CONCLUSION
Z-Medica believes that based on the indications for use, technological characteristics, and comparison to predicate device, the D2 Hemostatic Dressing has been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.