HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 by HAEMACURE CORP.

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.

AI/ML Overview

The provided documentation is for a 510(k) premarket notification for the Haemacure HemaMyst Surgical Applicator System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove effectiveness or safety. Therefore, many of the typical acceptance criteria and study design elements for AI/ML-based medical devices are not present.

However, I can extract the information relevant to performance testing that was conducted to demonstrate equivalence.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence in performance to the predicate device.	Performance (functionality) testing shows that the Haemacure HemaMyst Surgical Applicator System (HSAS) is substantially equivalent in performance to the Biosurgical, Corp. Multi Chamber Suction Syringe (Sealouette) at comparable air pressure.
	Key characteristics (Fluid Applicator Tip, Compressed Air Source, Gas Tubing Line, Indications for Use) are the "Same" as the predicate device.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This means showing that the new device is as safe and effective as the predicate, or that any differences do not raise new questions of safety or effectiveness. The performance testing conducted here directly addresses this.

Regarding the other requested information, much of it is not applicable or not provided in the context of this 510(k) submission for a non-AI surgical applicator system:

Sample size used for the test set and the data provenance: Not applicable. Performance testing for this device would likely involve engineering bench testing, not a clinical "test set" with patient data. No details about sample sizes for such tests are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device does not involve a diagnostic or predictive algorithm that requires expert-established ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is a surgical applicator, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be engineering specifications and functional output, not clinical outcomes or pathology.
The sample size for the training set: Not applicable. This device does not use machine learning and therefore has no "training set."
How the ground truth for the training set was established: Not applicable.

In summary: The provided document describes a 510(k) submission for a surgical applicator system. The "study" mentioned is performance (functionality) testing, which aimed to demonstrate substantial equivalence to a predicate device. This is primarily bench testing to ensure the device performs as intended and similarly to its predicate. It does not involve clinical trials with "test sets," "ground truth" as typically defined for diagnostic devices, or AI/ML components.

Summary

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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

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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	HemaMystApplicator(HSAS)SurgicalSystem	Multi Chamber SuctionSyringe (Sealouette)
Fluid Applicator Tip	Separate aerosol head thatattaches to a dual syringeapplicator	Same
Compressed Air Source	Compressed air ornitrogen from theoperating theater	Same
Gas Tubing Line	1/8" PVC with luer fitting	Same
Indications for Use	Application of FDAapproved fluids towounds, the delivery ofantibiotics, and otherwound treatment fluids. Itcan also be used for theapplication of two non-homogeneous fluids to thesurgical site	Same
Sterilization of Disposable	EtO	Unknown

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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

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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.

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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 ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).