CRYOSEAL FS APPLICATOR SYSTEM

K071126 · Thermogenesis Corp. · FMF · Aug 16, 2007 · General Hospital

Device Facts

• Record ID: K071126
• Device Name: CRYOSEAL FS APPLICATOR SYSTEM
• Applicant: Thermogenesis Corp.
• Product Code: FMF · General Hospital
• Decision Date: Aug 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CryoSeal® FS Applicator System is intended for the simultaneous application of the two components of CryoSeal FS (fibrin sealant) onto the incised liver surface in patients undergoing liver resection.

Device Story

CryoSeal® FS Applicator System is a manual delivery device for fibrin sealant. It consists of a thermoplastic polystyrene applicator handle and two types of dispensing tips featuring Y-body manifolds: line/drop tips (5 and 10 cm lengths) and spray tips (3 configurations). The device is used in the operating room by surgeons to simultaneously apply two components of fibrin sealant onto incised liver surfaces during liver resection. By facilitating the controlled, simultaneous delivery of sealant components, the device assists in achieving hemostasis on the liver surface, potentially reducing blood loss and improving surgical outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Thermoplastic polystyrene applicator handle; Y-body manifold dispensing tips (line/drop and spray configurations); manual operation; non-powered; sterile.

Indications for Use

Indicated for patients undergoing liver resection requiring the application of fibrin sealant to the incised liver surface.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Baxter Healthcare Corp., DuploReach (K014088)
• Baxter Healthcare Corp., Duploject Easy-Prep System (K020666)

Submission Summary (Full Text)

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## 510 (k) SUMMARY- CryoSeal® FS Applicator System

| Submitter Name: | ThermoGenesis Corp. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 2711 Citrus Road<br>Rancho Cordova, CA 95742 |
| | AUG 16 2007 |
| Contact Person: | John Chapman PhD<br>VP, Scientific Affairs |
| Phone Number: | 916.858.5132 |
| Fax Number: | 916.858.5199 |
| Date Prepared: | April 19, 2007 |
| Device Trade Name: | CryoSeal® FS Applicator System |
| Classification Number: | 21 CFR 880.5860 |
| Classification Name: | Syringe. Piston |
| Product Code: | FMF |
| Predicate Devices: | Baxter Healthcare Corp., DuploReach, K014088<br>Baxter Healthcare Corp., Duploject Easy-Prep System, K020666 |
| Statement of Intended Use: | The CryoSeal® FS Applicator System is intended for the<br>simultaneous application of the two components of CryoSeal FS<br>(fibrin sealant) onto the incised liver surface in patients<br>undergoing liver resection. |
| Device Description: | The CryoSeal® FS Applicator System is composed of a<br>thermoplastic polystyrene applicator handle, and two types of<br>dispensing tips with a Y-body manifolds for application of the<br>fibrin sealant: line/drop tips (5 and 10 cm lengths) and spray tips<br>(3 configurations). |
| Comparison to the Predicate Devices: | This device, with respect to material composition, device<br>characteristics, principles of operation, and intended use, is<br>substantially equivalent to the predicate devices. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

John Chapman, Ph.D. Vice President, Scientific Affairs ThermoGenesis Corporation 2711 Citrus Road Rancho Cordova, California 95742

AUG 16 2007

Re: K071126

Trade/Device Name: CryoSeal® FS Applicator System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 27, 2007 Received: July 30, 2007

Dear Dr. Chapman:

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.

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Page 2 - Dr. Chapman

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 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 vours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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510(k) Number (if known):

K071126

Device Name:

CryoSeal® FS Applicator System

Indications for Use:

The CryoSeal® FS Applicator System is intended for the simultaneous application of the two components of CryoSeal FS (fibrin sealant) onto the incised liver surface in patients undergoing liver resection.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

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Jivision Sign-Off) )ivision of Anesthesiology, General Hospital ifection Control, Dental Devices

ን(k) Number:_