CHITO-SEAL

K021062 · Abbott Vascular, Inc. · QSY · Aug 23, 2002 · SU

Device Facts

• Record ID: K021062
• Device Name: CHITO-SEAL
• Applicant: Abbott Vascular, Inc.
• Product Code: QSY · SU
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.

Device Story

Chito-Seal is a topical hemostasis pad/bandage; promotes rapid bleeding control upon contact with bleeding wounds. Used for vascular access sites and percutaneous catheters/tubes; specifically targets patients on hemodialysis or anticoagulation therapy. Device functions as a topical dressing to facilitate hemostasis. Applied by healthcare providers in clinical settings. Benefits include rapid control of bleeding at access sites.

Clinical Evidence

Clinical evidence supported safety and performance. Non-clinical testing and animal studies were conducted to simulate clinical conditions; no adverse effects were noted.

Technological Characteristics

Topical hemostasis pad/dressing. Biocompatible materials. Principle of operation involves topical application to promote hemostasis at bleeding sites.

Indications for Use

Indicated for management of bleeding wounds, including vascular access sites and percutaneous catheters or tubes. Specifically indicated for rapid bleeding control in patients undergoing hemodialysis or receiving anticoagulation therapy.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Marine Polymer Technologies SyvekPatch® (K984177)

Submission Summary (Full Text)

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June 11, 2023

Perclose Sevrina Ciucci Regulatory Affairs Coordinator 400 Saginaw Drive Redwood City, California 94063

Re: K021062 Trade/Device Name: Chito-Seal™ Regulatory Class: Unclassified Product Code: QSY

Dear Sevrina Ciucci:

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 23, 2002. 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug. Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2002

Ms. Sevrina Ciucci Regulatory Affairs Coordinator Perclose 400 Saginaw Drive Redwood City, California 94063

Re: K021062 Trade/Device Name: Chito-Seal™ Product Code: FRO Dated: July 9, 2002 Received: July 11, 2002

Dear Ms. Ciucci:

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.

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Page 2 - Ms. Sevrina Ciucci

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

R. Mark N. Mulkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

# VII. STATEMENT OF INDICATIONS FOR USE

510(k) Number:

K021062

Chito-Seal™

Device Name:

Indications for Use:

Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.

Mark n. Mulkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KO21062 510(k) Number _

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Perclose, 510(k) K021062 Chito-Seal™ Amendment 02 Confidential

| 510(k) SUMMARY | | AUG 2 3 2002 |
|----------------|----------------------|-------------------------------------------------------------------------------------------------------|
| A. | Sponsor/Submitter: | Perclose<br>400 Saginaw Drive<br>Redwood City, CA 94063<br>Tel: [phone]<br>Fax: [phone] |
| B. | Contact Person: | Sevrina Ciucci<br>Regulatory Affairs Coordinator<br>[phone] |
| C. | Date of Submission: | July 9, 2002 |
| D. | Trade (Brand) Name: | Chito-Seal™ |
| E. | Common Name: | Topical Hemostasis Pad |
| F. | Classification: | Unclassified Device |
| G. | Classification Name: | Dressing |
| H. | Product Code: | 79FRO |
| I. | Predicate Device: | Marine Polymer Technologies SyvekPatch® (K984177) |

#### J. Intended Use:

II.

Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.

## K. Device Description:

.

Chito-Seal is a topical bandage intended to promote hemostasis when in contact with a bleeding wound.

## L. Summary of Substantial Equivalence:

Perclose has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that Chito-Seal is substantially equivalent to currently marketed predicate device.

Chito-Seal has essentially the same intended use as the predicate device. Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted. Clinical evidence further supported the safety and performance of Chito-Seal.

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In conclusion, Chito-Seal has been shown to be substantially equivalent to the Class I predicate on which the device is based.

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