INNOVASA STAT*SEAL TOPICAL HEMOSTAT

K071225 · Innovasa, Inc. · DXC · Aug 31, 2007 · Cardiovascular

Device Facts

• Record ID: K071225
• Device Name: INNOVASA STAT*SEAL TOPICAL HEMOSTAT
• Applicant: Innovasa, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Aug 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stat-Seal is indicated for use following femoral vascular catheterization procedures to assist in obtaining hemostasis.

Device Story

Stat*Seal Topical Hemostat is a device used to assist in achieving hemostasis following femoral vascular catheterization procedures. It is applied topically to the puncture site by a clinician. The device functions as a hemostatic agent to promote blood clotting at the access site, thereby reducing the time required to achieve hemostasis and potentially improving patient comfort and recovery post-procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Topical hemostatic agent; form factor designed for application to femoral vascular catheterization sites. No specific materials or software components described.

Indications for Use

Indicated for patients undergoing femoral vascular catheterization procedures to assist in achieving hemostasis.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2007

Innovasa Corporation Ms. Roberta Hines 16625 Redmond Way PMB M-316 Redmond WA 98052

Re: K071225

Trade/Device Name: Stat*Seal Topical Hemostat Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 1, 2007 Received: August 2, 2007

Dear Ms. Hines:

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

{1}------------------------------------------------

## Page 2 - Ms. Hines

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours,

Daune R. Holmes

Bram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K071225

Device Name: Trade Name, Stat*Seal Topical Hemostat

## Indications for Use

Stat-Seal is indicated for use following femoral vascular catheterization procedures to assist in obtaining hemostasis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (Part 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)

Dana R. Vachner

(Division Sign..?)
Division

Storal Devices

51: K071225