BLOXX RAPID CLOTTING AGENT

K061722 · Crosslink-D, Inc. · QSY · Aug 2, 2006 · SU

Device Facts

• Record ID: K061722
• Device Name: BLOXX RAPID CLOTTING AGENT
• Applicant: Crosslink-D, Inc.
• Product Code: QSY · SU
• Decision Date: Aug 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad treated with cross-linked dextran; designed to promote rapid hemostasis. Applied topically to bleeding wounds; acts as a dressing to manage local bleeding from cuts, lacerations, abrasions, surgical sites, and traumatic injuries. Used in clinical or emergency settings to assist in blood coagulation; benefits patient by accelerating clot formation and reducing blood loss.

Clinical Evidence

Bench testing and animal studies (rabbit and porcine models) were conducted to confirm safety and efficacy for local management of bleeding wounds. No human clinical trial data provided.

Technological Characteristics

Hemostatic gauze pad treated with cross-linked dextran. Mechanical hemostatic agent. Non-electronic, non-software device.

Indications for Use

Indicated for local management of bleeding wounds (cuts, lacerations, abrasions) and temporary treatment of severely bleeding wounds (surgical, traumatic) in patients requiring topical hemostasis.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Traumadex™/Bleed-X™ containing Hemadex™ Clotting Beads (K013225)

Submission Summary (Full Text)

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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, [e-mail].

> 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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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 [phone]. 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 [phone] or [phone] 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

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## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| SUBMITTER | CrossLink-D, Inc.<br>3480 Industrial Blvd.<br>Ste. 105<br>West Sacramento, CA 95691 | AUG 02 2006 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON | Louis J. Mazzarese<br>Consultant to CrossLink-D, Inc. | |
| DATE PREPARED | August 1, 2006 | |
| CLASSIFICATION | Dressing; FRO<br>Class: Unclassified | |
| COMMON NAME | Surgical bandage | |
| PROPRIETARY NAME | Bloxx™ Rapid Clotting Agent | |
| PREDICATE DEVICE | Traumadex™/Bleed-X™ containing Hemadex™ Clotting<br>Beads<br>Medafor, Inc. (Minneapolis, MN)<br>K013225 (Dec. 26, 2001) | |
| DEVICE DESCRIPTION | Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad<br>treated with cross-linked dextran for the purpose of promoting<br>rapid hemostasis. | |
| TESTING | Laboratory and animal testing using rabbit and porcine models<br>confirms the safety and efficacy of Bloxx™ Rapid Clotting<br>Agent for the local management of bleeding wounds. | |
| INDICATIONS FOR USE | Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad<br>intended for use as a topical dressing for local management of<br>bleeding wounds such as cuts, lacerations and abrasions.<br>It may also be used for the temporary treatment of severely<br>bleeding wounds such as surgical wounds (operative, post<br>operative, donor sites, dermatological, etc.), and traumatic<br>injuries. | |

CrossLink-D, Inc.

8/1/06 Replacing 6/15/06