HEMCON CHITOFLEX-SURGICAL DRESSING

K071519 · Hemcon, Inc. · QSY · Aug 6, 2007 · SU

Device Facts

• Record ID: K071519
• Device Name: HEMCON CHITOFLEX-SURGICAL DRESSING
• Applicant: Hemcon, Inc.
• Product Code: QSY · SU
• Decision Date: Aug 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

HemCon ChitoFilex™ Surgical is 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 temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries.

Device Story

HemCon ChitoFlex™-Surgical Dressing is a sterile, chitosan-based topical dressing. Designed for local management of bleeding wounds; used for cuts, lacerations, abrasions, and temporary treatment of severe surgical or traumatic bleeding. Applied by clinicians or patients to wound sites to facilitate hemostasis. Device functions as a physical dressing; chitosan material interacts with blood to assist clotting. Benefits include rapid control of bleeding in surgical and traumatic contexts.

Technological Characteristics

Sterile, chitosan-based topical dressing. Form factor is a flexible dressing. No electronic components, software, or energy sources.

Indications for Use

Indicated for local management of bleeding wounds including cuts, lacerations, abrasions, and temporary treatment of severely bleeding wounds such as surgical (operative, postoperative, dermatological) and traumatic injuries.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• HemCon® Bandage (K043050)
• Bloxx Rapid Clotting Agent (K061722)

Submission Summary (Full Text)

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HemCon, Medical Technologies, Inc. c/o Kevin Hawkins Director, Quality & Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

June 11, 2023

Re: K071519 Trade/Device Name: HemCon ChitoFlex™ -Surgical Dressing Regulatory Class: Unclassified Product Code: QSY

Dear Kevin Hawkins:

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 6, 2007. 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].

Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is the Assistant Director at DHT4B: Division of Infection Control and Plastic Surgery Devices. It also lists OHT4: Office of Surgical and Infection Control Devices. The signature block concludes with Office of Product Evaluation and Quality Center for Devices and Radiological Health.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HemCon Medical Technologies, Inc. % Mr. Kevin Hawkins Director, Quality & Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

AUG - 6 2007

Re: K071519

Trade/Device Name: HemCon ChitoFlex™ -Surgical Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 31, 2007 Received: June 5, 2007

Dear Mr. Hawkins:

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 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); 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.

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

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Page 2 - Mr. Kevin Hawkins

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,

Mark M. Milliken

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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### 4. SECTION 4- INDICATIONS FOR USE STATEMENT

Applicant: HemCon, Inc.

510(k) Number (if known): Not Yet Assigned Device Name: HemCon ChitoFlex™-Surgical Dressing

Indications for Use:

HemCon ChitoFilex™ Surgical is 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 temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Melkman

and Neurologi

**510(k) Number** K

Page of

(Posted November 13, 2003)

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HemCon Medical Technologies, Inc. ChitoFlex™ Surgical™ 510(k)

Mav 31, 2007

AUG -6 2007

# HemCon ChitoFlex™ -Surgical 510(k) Notification

## 5. SECTION 5 - 510(K) SUMMARY

Name and Address of Sponsor:

Device Name:

HemCon Medical Technologies, Inc. 10575 SW Cascade Avenue, Suite 103 Portland, OR 97223

Proprietary Name: HemCon ChitoFlexTM-Surgical Dressing

Common Name: Traumatic Wound Dressing Classification Name: Dressing Product Code: FRO

### Establishment Registration Number:

9053189

General Description:

The HemCon ChitoFlex™-Surgical Dressing is a sterile chitosan based dressing 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 temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatalogical, etc.) and traumatic injuries.

The HemCon ChitoFlex™ Surgical Dressing is nearly identical to the legally marketed HemCon® Bandage (K043050, cleared June 3, 2005) in composition, design and processing; the chly major difference is the size and the modification of the intended use for temporary treatment of severely bleeding wounds such as surgical wounds. In this respect, the indications for use are identical to the Bloxx Rapid Clotting Agent (K061722, cleared August 2, 2006).

#### Indication for Use:

HemCon ChiteFlex™ Surgical is 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 temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatalogical, etc.) and traumatic injuries.

Contact Person(s) and Phone Number: Kevin Hawkins Director - Quality & Regulatory Phone [phone] x114 Fax [phone]