(60 days)
No
The document describes a mechanical applicator system for fibrin sealant and does not mention any AI or ML components.
Yes
The device is used for the simultaneous application of fibrin sealant to a treatment site, which is a therapeutic intervention.
No
The device description states that the HemaMyst Surgical Applicator System is used for the "simultaneous delivery, by spraying, of the two components of fibrin sealant to the treatment site." This indicates a therapeutic or application function rather than a diagnostic one. There is no mention of the device being used to detect, identify, or monitor a medical condition.
No
The device description explicitly states it is a "sterile, single-use device consisting of a Head that attaches by Luer connectors to currently available dual syringe spray noals and is coupled to an air regulator base unit". This describes physical hardware components, not a software-only device.
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 application of fibrin sealant to a treatment site. This is a therapeutic or surgical application, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as an applicator system for spraying components onto a treatment site. This aligns with a surgical or therapeutic tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the HemaMyst Surgical Applicator System is a medical device used for a surgical/therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HemaMyst Surgical Applicator System is indicated for the simultaneous application of the two components of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
Product codes
FMF
Device Description
The HemaMyst Surgical Applicator System is a sterile, single-use device consisting of a Head that attaches by Luer connectors to currently available dual syringe spray noals and is coupled to an air regulator base unit by means of a sterile filtered air applicators, and is obablicator System allows simultaneous delivery, by spraying, of the two components of fibrin sealant to the treatment site.
The change from the predicate Haemacure HemaMyst Surgical Applicator System device is the indication for application of the two separate components of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant. (Note: HEMASEEL APR and Tisseel VH Fibrin Sealants are identical products.) The HemaMyst Surgical Applicator System is fibrin sealants are identical products:) - its > con-homogeneous fluids or solutions to the currently marcated toh the provisions of 510(k) No. K994023.
Like the Tissomat and Spray Set, the HemaMyst Surgical Applicator System is attached to a currently available dual syringe applicator, and separately delivers the two separate to a currently available dual syringes to a spray tip for application to the treatment fibrin sealain conforms from the Syray Set, the HemaMyst Surgical Applicator System uses compressed gas to enhance component mixing and spraying.
compressed gas to enhance component mining mith a dual syringe applicator, NOTE. The Duploject Dual Syringe Applicator, that has been determined by direct such as the Duploject Dual Dyringo Application the HemaMyst spray head and with the performanoo tosting to EEEL APR or Tisseel VH fibrin sealant.
Functionality testing shows that the HemaMyst Surgical Applicator System is Functionality testing shows that the nemal 3, 50 and 11, 2017 and and Spray of HEMASEEL APR or Tisseel VH fibrin sealant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
treatment site.
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)
Functionality testing shows that the HemaMyst Surgical Applicator System is Functionality testing shows that the nemal 3, 50 and 11, 2017 and and Spray of HEMASEEL APR or Tisseel VH fibrin sealant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG - 6 2004
Section 1
510(k) SUMMARY
Date Prepared: June 4, 2004
Submitter: Haemacure Corporation 2 North Tamiami Trail Sarasota, FL 342020
Haemacure Contact: Dr. Christian Hours (888) 621-8076 ext. 28
Submission Contact: Elaine Whitmore SciVance Consulting (941) 350-2631
Device Name: HemaMyst Surgical Applicator System
Common/Usual/Classification Name: Syringe, Piston
Predicate Device(s):
Haemacure HemaMyst Surgical Applicator System 510(k) No. K994023 Haemacure Corporation
Tissomat and Spray Set 510(k) No. K981089 Baxter Healthcare Corporation
Device Description:
The HemaMyst Surgical Applicator System is a sterile, single-use device consisting of a I he Head that attaches by Luer connectors to currently available dual syringe spray noals and is coupled to an air regulator base unit by means of a sterile filtered air applicators, and is obablicator System allows simultaneous delivery, by spraying, of the two components of fibrin sealant to the treatment site.
The change from the predicate Haemacure HemaMyst Surgical Applicator System device is the indication for application of the two separate components of HEMASEEL APR
1
Fibrin Sealant or Tisseel VH Fibrin Sealant. (Note: HEMASEEL APR and Tisseel VH Fibrin Sealants are identical products.) The HemaMyst Surgical Applicator System is fibrin sealants are identical products:) - its > con-homogeneous fluids or solutions to the currently marcated toh the provisions of 510(k) No. K994023.
Like the Tissomat and Spray Set, the HemaMyst Surgical Applicator System is attached to a currently available dual syringe applicator, and separately delivers the two separate to a currently available dual syringes to a spray tip for application to the treatment fibrin sealain conforms from the Syray Set, the HemaMyst Surgical Applicator System uses compressed gas to enhance component mixing and spraying.
compressed gas to enhance component mining mith a dual syringe applicator, NOTE. The Duploject Dual Syringe Applicator, that has been determined by direct such as the Duploject Dual Dyringo Application the HemaMyst spray head and with the performanoo tosting to EEEL APR or Tisseel VH fibrin sealant.
Functionality testing shows that the HemaMyst Surgical Applicator System is Functionality testing shows that the nemal 3, 50 and 11, 2017 and and Spray of HEMASEEL APR or Tisseel VH fibrin sealant.
Intended Use:
The HemaMyst Surgical Applicator System is indicated for the simultaneous application i he Hellawlyst Surgical Applicator Byteen is increation or Tisseel VH Fibrin Sealant to the treatment site.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, with three curved lines forming the body and head, and a wavy line below representing the legs or base.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
Haemacure Corporation C/O Dr. Elaine Whitmore SciVance Consulting 7113 River Club Boulevard Bradenton, Florida 34202
Re: K041504
Trade/Device Name: HemaMyst Surgical Applicator System Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 4, 2004 Received: June 7, 2004
Dear Dr. Whitmore:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your was determined the device is substantially equivalent (for the Itelerediced above and have actoringlosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to they we's reclassified in accordance with the provisions of Amendinents, or to de roos 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 approvisions of the Act. The general controls provisions of the Act include Controls provisions of the Fist. I'm , 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 If your device is classified (been additional controls. Existing major regulations affecting (1 MA), it may of subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round in further announcements concerning your device in the Federal Register.
3
Page 2 - Dr. Whitmore
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 mean that IDA has made a determinares and regulations administered by other Federal agencies. of the Act of ally I edelar statues and registerials, but not limited to: registration You must comply with an all the Piece brog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 667), labling systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality systems of the stations 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 anow you to obgin finding of substantial equivalence of your device to a premits in the motive to in minute 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), If you desire speofite at 700 to your and (301) 594-4618. Aso, 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 obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
4
Indications for Use
510(k) Number (if known): _K041504
Device Name: HemaMyst Surgical Applicator System
Indications For Use:
The HemaMyst Surgical Applicator System is indicated for the simultaneous The ThemalWySt Surgiour Npk.coms of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
and the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the states of the states of the states of the stat
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cather D. h.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of _1
510(k) Number: /