(63 days)
No
The summary describes a mechanical device for applying fibrin sealant with a minor design modification related to gas flow control. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
This device is an applicator system for a fibrin sealant, which is a drug/biologic, not a therapeutic device itself.
No
Explanation: The device is intended for the application of a sealant and not for diagnosing any condition.
No
The device description clearly outlines physical components (EasySpray, Spray Set, clip) and modifications to hardware (moving a control from a foot pedal to a clip). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "simultaneous application of TISSEEL Two-Component Fibrin Sealant". This describes a device used in vivo (on or within a living organism) for applying a therapeutic substance.
- Device Description: The description focuses on the mechanical function of applying a sealant, specifically modifying the gas control mechanism. This is consistent with a device used during a medical procedure, not for testing samples in vitro (outside of a living organism).
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information, which are hallmarks of IVD devices.
Therefore, the EasySpray and Spray Set is a device used for applying a medical sealant during a procedure, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The EasySpray and Spray Set system represents minor design modifications to the TISSOMAT and Spray Set, 510(k) K981089. The purpose of the design modifications is to accommodate a change in the location of the gas on/off function of the system. The original TISSOMAT and Spray Set design includes a foot pedal to turn the gas flow on and off. The EasySpray and Spray Set system moves the control from a foot pedal, to a clip that attaches to the back end of the DUPLOJECT.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TISSOMAT and Spray Set K981089
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) # K050495
510(k) SUMMARY EasySpray and Spray Set for TISSEEL (Fibrin Sealant)
| Date Prepared | February 25, 2005 |
|---|---|
| Submitter | Baxter Healthcare |
| Baxter BioScience | |
| One Baxter Way | |
| Westlake Village, CA 91362 | |
| Contact | Ron Lagerquist |
| Senior Manager, Regulatory Affairs | |
| Device Name | Piston Syringe Accessories |
| Common/Usual/ | |
| Classification Name | Piston Syringe Accessories |
| 80 FMF | |
| Device Description | The EasySpray and Spray Set system represents minor design modifications to the TISSOMAT and Spray Set, 510(k) K981089. The purpose of the design modifications is to accommodate a change in the location of the gas on/off function of the system. The original TISSOMAT and Spray Set design includes a foot pedal to turn the gas flow on and off. The EasySpray and Spray Set system moves the control from a foot pedal, to a clip that attaches to the back end of the DUPLOJECT. |
| Intended Use | The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System |
| Predicate Device | TISSOMAT and Spray Set K981089 |
| Substantial Equivalence | The EasySpray and Spray Set represent minor design modifications to the TISSOMAT and Spray Set. The design modifications do not affect the intended use of the device or alter the fundamental scientific technology of the system. In addition, there have been no changes to TISSEEL Fibrin Sealant as a result of the device modifications described in this Pre-Market Notification. |
:
:
1
Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle or bird-like figure with three distinct wing or feather segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2005
Mr. Ronald F. Lagerquist, RAC Senior Manager, Regulatory Affairs Baxter Healthcare Corporation One Baxter Way Westlake Village, California 91362-3811
Re: K050495
Trade/Device Name: EasySpray and Spray Set Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 25, 2005 Received: April 6, 2005
Dear Mr. Lagerquist:
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 received a or 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 the Fouch a plication (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 writ), it hay ob of Federal Regulations, Title 21, Parts 800 to 898. In your device A may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Lagerquist
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DT 3 lestained on that your device complies with other requirements modi that I Drima made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statuse and squirements, including, but not limited to: registration r ou must comply war a 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CF RT art 007), labality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ijon 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) This letter will and in Jourse FDA finding of substantial equivalence of your device to a premarket notification. - The PDF minuts 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), II you desire specificatives for your de 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 may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Quetic f. Michael Dmd.
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
3
K050495
page 1 of 1
Indications for Use
171 510(k) Number (if known):
Device Name: EasySpray and Spray Set
Indications for Use:
The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page ੀ
Susan Rummo
- Asion Sign-Off) . Svision Sign-Off)
Wision of Anesthesiology, General Hospital, ്
· 11:3
10(k) Number