(44 days)
Not Found
No
The summary describes a hemostatic gauze pad with a chemical treatment (cross-linked dextran) and does not mention any computational or algorithmic components indicative of AI/ML.
Yes
The device is described as a hemostatic gauze pad for the local management and temporary treatment of bleeding wounds, including surgical and traumatic injuries, which are therapeutic applications.
No
The device is a hemostatic gauze pad used for the local management and temporary treatment of bleeding wounds, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "hemostatic gauze pad," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "topical dressing for local management of bleeding wounds" and for "temporary treatment of severely bleeding wounds." This describes a device applied externally to the body to control bleeding, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description confirms it's a "hemostatic gauze pad treated with cross-linked dextran." This is a physical device for wound care.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Bloxx™ Rapid Clotting Agent does not fit this description.
N/A
Intended Use / Indications for Use
Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, post operative, donor sites, dermatological, etc.), and traumatic injuries.
Product codes (comma separated list FDA assigned to the subject device)
OSY, FRO
Device Description
Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad treated with cross-linked dextran for the purpose of promoting rapid hemostasis.
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)
Laboratory and animal testing using rabbit and porcine models confirms the safety and efficacy of Bloxx™ Rapid Clotting Agent for the local management of bleeding wounds.
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.
Not Found
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logos are displayed against a white background.
June 11, 2023
CrossLink-D, Inc. c/o Louis J. Mazzarese 150 Aran Hill Road Fairfield, Connecticut 06824-1712
Re: K061722 Trade/Device Name: Bloxx™ Rapid Clotting Agent Regulatory Class: Unclassified Product Code: OSY
Dear Louis J. Mazzarese:
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 2, 2006. 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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around the perimeter. Inside the circle, there is a stylized image of four human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 2 2006
CrossLink-D, Inc. % Mr. Louis J. Mazzarese 150 Aran Hill Road Fairfield, Connecticut 06824-1712
Re: K061722
Trade/Device Name: Bloxx ** Rapid Clotting Agent Regulatory Class: Unclassified Product Code: FRO Dated: June 15, 2006 Received: June 19, 2006
Dear Mr. Mazzarese:
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 mean that FDA has made a determination that your device complies with other requirements of the 201 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Louis J. Mazzarese
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 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), 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Heeler Lemon
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT FOR INDICATIONS FOR USE
510(k) Number: K061722
Device Name: Bloxx™ Rapid Clotting Agent
Indications for Use:
Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, post operative, donor sites, dermatological, etc.), and traumatic injuries.
Prescription Use: Yes
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Herbert Lerner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061722
4
Kat 1722
CrossLink-D. Inc. a Beach Barren and Constitue
.
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | CrossLink-D, Inc.
3480 Industrial Blvd.
Ste. 105
West Sacramento, CA 95691 | AUG 02 2006 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON | Louis J. Mazzarese
Consultant to CrossLink-D, Inc. | |
| DATE PREPARED | August 1, 2006 | |
| CLASSIFICATION | Dressing; FRO
Class: Unclassified | |
| COMMON NAME | Surgical bandage | |
| PROPRIETARY NAME | Bloxx™ Rapid Clotting Agent | |
| PREDICATE DEVICE | Traumadex™/Bleed-X™ containing Hemadex™ Clotting
Beads
Medafor, Inc. (Minneapolis, MN)
K013225 (Dec. 26, 2001) | |
| DEVICE DESCRIPTION | Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad
treated with cross-linked dextran for the purpose of promoting
rapid hemostasis. | |
| TESTING | Laboratory and animal testing using rabbit and porcine models
confirms the safety and efficacy of Bloxx™ Rapid Clotting
Agent for the local management of bleeding wounds. | |
| INDICATIONS FOR USE | Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad
intended for use as a topical dressing for local management of
bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for the temporary treatment of severely
bleeding wounds such as surgical wounds (operative, post
operative, donor sites, dermatological, etc.), and traumatic
injuries. | |
CrossLink-D, Inc.
8/1/06 Replacing 6/15/06