K Number
K071225
Device Name
INNOVASA STAT*SEAL TOPICAL HEMOSTAT
Manufacturer
Date Cleared
2007-08-31

(121 days)

Product Code
Regulation Number
870.4450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Stat-Seal is indicated for use following femoral vascular catheterization procedures to assist in obtaining hemostasis.
Device Description
Trade Name, Stat*Seal Topical Hemostat
More Information

Not Found

Not Found

No
The summary describes a topical hemostat and does not mention any AI or ML components or functionalities.

Yes

Explanation: The device is used to assist in obtaining hemostasis after femoral vascular catheterization procedures, which is a therapeutic intervention.

No
Explanation: The device, Stat-Seal Topical Hemostat, is indicated for assisting in obtaining hemostasis after femoral vascular catheterization, which is a treatment-oriented function, not a diagnostic one.

No

The device description "Stat*Seal Topical Hemostat" strongly suggests a physical product applied topically, not a software-only device. The lack of any mention of software, algorithms, or digital processing further supports this conclusion.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "assist in obtaining hemostasis following femoral vascular catheterization procedures." This describes a device used on the patient's body to control bleeding, not a test performed on a sample taken from the body to diagnose a condition.
  • Device Description: The description "Topical Hemostat" further reinforces that it's a device applied externally or locally to stop bleeding.
  • Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing diagnostic information about a disease or condition
    • Using reagents or assays

Therefore, Stat-Seal is a medical device used for hemostasis, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes

DXC

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral vascular

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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