(115 days)
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.
The CryoSeal® FS Applicator System is composed of a thermoplastic polystyrene applicator handle, and two types of dispensing tips with a Y-body manifolds for application of the fibrin sealant: line/drop tips (5 and 10 cm lengths) and spray tips (3 configurations).
The provided text is a 510(k) summary for the CryoSeal® FS Applicator System. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, study details, or performance data to prove the device meets such criteria.
The document primarily focuses on the regulatory submission process, including:
- Applicant and contact information
- Device trade name, classification, and product code
- Predicate devices
- Statement of intended use
- Device description
- Comparison to predicate devices
- The FDA's decision letter confirming substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided text.
The 510(k) summary states that "This device, with respect to material composition, device characteristics, principles of operation, and intended use, is substantially equivalent to the predicate devices." This implies that the device's performance is considered equivalent to already approved devices, but specific performance criteria and the studies demonstrating them are not detailed here.
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510 (k) SUMMARY- CryoSeal® FS Applicator System
| Submitter Name: | ThermoGenesis Corp. |
|---|---|
| Submitter Address: | 2711 Citrus RoadRancho Cordova, CA 95742 |
| AUG 16 2007 | |
| Contact Person: | John Chapman PhDVP, 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, K014088Baxter Healthcare Corp., Duploject Easy-Prep System, K020666 |
| Statement of Intended Use: | The CryoSeal® FS Applicator System is intended for thesimultaneous application of the two components of CryoSeal FS(fibrin sealant) onto the incised liver surface in patientsundergoing liver resection. |
| Device Description: | The CryoSeal® FS Applicator System is composed of athermoplastic polystyrene applicator handle, and two types ofdispensing tips with a Y-body manifolds for application of thefibrin sealant: line/drop tips (5 and 10 cm lengths) and spray tips(3 configurations). |
| Comparison to the Predicate Devices: | This device, with respect to material composition, devicecharacteristics, principles of operation, and intended use, issubstantially 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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):
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)
and hand
Jivision Sign-Off) )ivision of Anesthesiology, General Hospital ifection Control, Dental Devices
ን(k) Number:_
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).