(44 days)
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.
Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad treated with cross-linked dextran for the purpose of promoting rapid hemostasis.
I am sorry, but the provided text from the FDA 510(k) letters for the Bloxx™ Rapid Clotting Agent (K061722) does not contain the specific details required to complete your request. The document is an FDA letter confirming substantial equivalence and provides a summary of the device, its indications for use, and mentions that "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." However, it does not elaborate on:
- Specific acceptance criteria and reported device performance metrics.
- Sample sizes used for test sets, data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone (algorithm-only) performance.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a regulatory clearance letter, not a detailed study report. Therefore, I cannot generate the requested table and information based solely on the input provided.
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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
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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.
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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
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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
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Kat 1722
CrossLink-D. Inc. a Beach Barren and Constitue
.
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | CrossLink-D, Inc.3480 Industrial Blvd.Ste. 105West Sacramento, CA 95691 | AUG 02 2006 |
|---|---|---|
| CONTACT PERSON | Louis J. MazzareseConsultant to CrossLink-D, Inc. | |
| DATE PREPARED | August 1, 2006 | |
| CLASSIFICATION | Dressing; FROClass: Unclassified | |
| COMMON NAME | Surgical bandage | |
| PROPRIETARY NAME | Bloxx™ Rapid Clotting Agent | |
| PREDICATE DEVICE | Traumadex™/Bleed-X™ containing Hemadex™ ClottingBeadsMedafor, Inc. (Minneapolis, MN)K013225 (Dec. 26, 2001) | |
| DEVICE DESCRIPTION | Bloxx™ Rapid Clotting Agent is a hemostatic gauze padtreated with cross-linked dextran for the purpose of promotingrapid hemostasis. | |
| TESTING | Laboratory and animal testing using rabbit and porcine modelsconfirms the safety and efficacy of Bloxx™ Rapid ClottingAgent for the local management of bleeding wounds. | |
| INDICATIONS FOR USE | Bloxx™ Rapid Clotting Agent is a hemostatic gauze padintended for use as a topical dressing for local management ofbleeding wounds such as cuts, lacerations and abrasions.It may also be used for the temporary treatment of severelybleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.), and traumaticinjuries. |
CrossLink-D, Inc.
8/1/06 Replacing 6/15/06
N/A