(151 days)
Not Found
No
The device description and performance studies focus on mechanical functionality and equivalence to a predicate device, with no mention of AI or ML.
No.
The device is an applicator system used to apply fluids or solutions to a treatment site, rather than providing a direct therapeutic effect itself.
No
The device is an applicator system designed to apply fluids/solutions to a treatment site, not to diagnose a condition. Its function is to facilitate the delivery of substances during a procedure.
No
The device description clearly outlines physical hardware components including an air regulator, foot pedal, spray head, and tubing. It is a hardware-based system for applying fluids.
Based on the provided information, the Haemacure HemaMyst Surgical Applicator System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "application of two non-homogeneous fluids or solutions to the treatment site." This describes a device used on or in the body during a surgical procedure, not a device used to test samples outside the body (in vitro).
- Device Description: The description details a system for applying fluids, including an air regulator, foot pedal, and spray head. This aligns with a surgical application device.
- Anatomical Site: The device is used at the "treatment site," which is a location on or within a patient's body.
- Care Setting: The device is used in the "operating suite," a setting for surgical procedures.
IVD devices are used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. The Haemacure HemaMyst Surgical Applicator System does not perform this function. It is a surgical tool for applying substances during a procedure.
N/A
Intended Use / Indications for Use
Application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be used for the application of two non-homogeneous fluids to the surgical site.
Haemacure HemaMyst Surgical Applicator System is indicated for the application of two non-homogeneous fluids or solutions to the treatment site.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Haemacure HemaMyst Surgical Applicator System consists of an air regulator that can be coupled with compressed gasses present in the operating suite, a foot pedal to control air flow; and a spray head that can be coupled to currently available dual syringe applicators with a filtered air line to connect the base unit to the applicator spray head.
The base unit with the regulator and foot pedal is provided non-sterile and sold as a reusable device.
The spray head and filtered gas tubing is ethylene oxide (EtO) sterilized and sold as a sterile, single-use device.
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)
Performance (functionality) testing shows that the Haemacure HemaMyst Surgical Applicator System (HSAS) is substantiantialy equivalent in performance to the Biosurgical, Corp. Multi Chamber Suction Syringe (Sealouette) at comparable air pressure.
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.
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
Pre-market Notification Haemacure HemaMysf™ Surgical Applicator System
Attachment A
SMDA Summary of Safety and Effectiveness Information
In compliance with requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of the safety and effectiveness information for this 510(k) premarket notification.
- Applicant: Haemacure Corporation Two North Tamiami Trail Suite 802 Sarasota Florida 34236
Product: Haemacure HemaMyst Surgical Applicator System
Description: The Haemacure HemaMyst Surgical Applicator System consists of an air regulator that can be coupled with compressed gasses present in the operating suite, a foot pedal to control air flow; and a spray head that can be coupled to currently available dual syringe applicators with a filtered air line to connect the base unit to the applicator spray head.
The base unit with the regulator and foot pedal is provided non-sterile and sold as a reusable device.
The spray head and filtered gas tubing is ethylene oxide (EtO) sterilized and sold as a sterile, single-use device.
Predicate Device Identification: A claim of substantial equivalence of the Haemacure HemaMyst Surgical Applicator System is made to the following predicate device:
Biosurgical, Corp. Multi Chamber Suction Syringe; 510(k) Number K964597. (Also marketed as the Biosurgical Sealouette System)
Marketed by: BioSurgical Corporation 5990 Stoneridge Drive Suite 112 Pleasanton, California 94588 Phone: (925) 737-1851 Fax: (925) 737-1859
1
Summary of Performance Testing of the Haemacure HemaMyst Surgical Applicator System:
Performance (functionality) testing shows that the Haemacure HemaMyst Surgical Applicator System (HSAS) is substantiantialy equivalent in performance to the Biosurgical, Corp. Multi Chamber Suction Syringe (Sealouette) at comparable air pressure.
Summary of Characteristic Comparison of the Haemacure HemaMyst Surgical Applicator System (HSAS) to the Biosurgical, Corp. Multi Chamber Suction Syringe (Sealouette):
| Characteristic | Haemacure | Biosurgical, Corp. |
|---|---|---|
| Model | HemaMyst | |
| Applicator | ||
| (HSAS) | ||
| Surgical | ||
| System | Multi Chamber Suction | |
| Syringe (Sealouette) | ||
| Fluid Applicator Tip | Separate aerosol head that | |
| attaches to a dual syringe | ||
| applicator | Same | |
| Compressed Air Source | Compressed air or | |
| nitrogen from the | ||
| operating theater | Same | |
| Gas Tubing Line | 1/8" PVC with luer fitting | Same |
| Indications for Use | Application of FDA | |
| approved fluids to | ||
| wounds, the delivery of | ||
| antibiotics, and other | ||
| wound treatment fluids. It | ||
| can also be used for the | ||
| application of two non- | ||
| homogeneous fluids to the | ||
| surgical site | Same | |
| Sterilization of Disposable | EtO | Unknown |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2000
Ms. Elaine Whitmore Vice President, Regulatory Affairs Haemacure Corporation One Sarasota Tower, Suite 802 Two North Tamiami Trail Sarasota, Florida 34236
Re: K994023 Haemacure HemaMyst Surgical Applicator Trade Name: System Regulatory Class: II FMF Product Code: Dated: March 8, 2000 Received: March 14, 2000
Dear Ms. Whitmore:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਬੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
3
Page 2 -Ms. Whitmore
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Pre-market Notification Haemacure HemaMyst™ Surgical Applicator System
Attachment B
Indications for Use Statement
510(k) Number (if known): K 994023
Device Name: Haemacure HemaMyst Surgical Applicator System
Indications for Use:
Haemacure HemaMyst Surgical Applicator System is indicated for the application of two non-homogeneous fluids or solutions to the treatment site.
(PLFASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Per 21 CFT 801.109) OR
Over-the-Counter
Patrizia Civerati
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________