(63 days)
The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System
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.
The provided 510(k) summary (K050495) for the EasySpray and Spray Set for TISSEEL (Fibrin Sealant) focuses on demonstrating substantial equivalence to a predicate device through minor design modifications. It does not include specific acceptance criteria or performance studies in the way one might expect for a diagnostic or AI-driven device. The submission primarily addresses the change in the gas on/off function's location from a foot pedal to a clip.
Therefore, the requested information elements related to performance studies (like sample size, ground truth, expert opinions, MRMC studies, and training set details) are not applicable or present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| 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. This is maintained as per the predicate device. |
| Fundamental Scientific Technology | The design modifications do not alter the fundamental scientific technology of the system. |
| Effect on TISSEEL Fibrin Sealant | No changes to TISSEEL Fibrin Sealant as a result of the device modifications. |
| Safety and Effectiveness (Implicit) | Substantial equivalence to the predicate device (TISSOMAT and Spray Set K981089) is claimed, implying that the modified device is equally safe and effective for its intended use, based on the minor nature of the design change. |
| Design Modification Specific | Accommodate a change in the location of the gas on/off function from a foot pedal to a clip that attaches to the back end of the DUPLOJECT. This functional change was successfully implemented. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission describes a design modification to a medical device's control mechanism, not a study evaluating performance against a test set of data (e.g., in diagnostics). The demonstration of substantial equivalence relies on the nature of the design change being minor and not affecting fundamental technology or intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There was no "test set" in the context of data requiring expert ground truth in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm; it is a mechanical accessory for applying fibrin sealant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There was no "ground truth" established from clinical data or expert consensus in this submission. The "truth" considered by the FDA in granting substantial equivalence was that the design modifications were minor and did not change the device's fundamental function, safety, or effectiveness compared to its predicate.
8. The sample size for the training set
Not applicable. There was no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. There was no training set and thus no ground truth established for it.
{0}------------------------------------------------
510(k) # K050495
510(k) SUMMARY EasySpray and Spray Set for TISSEEL (Fibrin Sealant)
| Date Prepared | February 25, 2005 |
|---|---|
| Submitter | Baxter HealthcareBaxter BioScienceOne Baxter WayWestlake Village, CA 91362 |
| Contact | Ron LagerquistSenior Manager, Regulatory Affairs |
| Device Name | Piston Syringe Accessories |
| Common/Usual/Classification Name | Piston Syringe Accessories80 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
§ 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).