The HemaMyst Surgical Applicator System is indicated for the simultaneous application of the two separate components of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the HemaMyst Surgical Applicator System. However, it does not contain information about acceptance criteria, device performance, a specific study proving acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

Device Description: A sterile, single-use device for simultaneous delivery of two components of fibrin sealant.
Changes from Predicate: The key change is the indication for application of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant.
Functionality Testing: States that functionality testing shows the device is "function[al] with 3, 50 and 11, 2017 [sic] and and Spray of HEMASEEL APR or Tisseel VH fibrin sealant." This is a very brief and incomplete statement regarding testing and doesn't provide detailed performance metrics or acceptance criteria.
Intended Use/Indications for Use: Simultaneous application of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
Substantial Equivalence: The FDA's letter confirming substantial equivalence to predicate devices (K994023 and K981089).

Therefore, based solely on the provided text, I cannot complete the requested tables and information.

Here's an attempt to fill in what can be inferred or directly stated, and to explicitly highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from "Functionality Testing")	Reported Device Performance (From "Functionality Testing")
Device functions for spraying fibrin sealant.	"Functionality testing shows that the HemaMyst Surgical Applicator System is Function[al] with 3, 50 and 11, 2017 [sic] and and Spray of HEMASEEL APR or Tisseel VH fibrin sealant."
Specific quantitative performance metrics (e.g., spray pattern, flow rate, consistency, delivery accuracy, seal strength)	Not provided in the text.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The phrase "function[al] with 3, 50 and 11, 2017" is unclear. It might refer to three specific tests, or some other parameters, but it's not a clear sample size.
Data Provenance (country of origin, retrospective/prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is mechanical. The concept of "ground truth" and "experts" as in diagnostic AI studies typically doesn't apply to this kind of functionality testing in the same way. The assessment would likely be based on engineering specifications and direct measurement, not expert consensus on an image or medical condition.
Number of experts: Not applicable/Not specified.
Qualifications of experts: Not applicable/Not specified.

4. Adjudication method for the test set

Not applicable/Not specified, as this refers to a diagnostic assessment process. For a mechanical device, performance is typically measured against specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This is a mechanical device, not a diagnostic algorithm involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, implicitly. The "Functionality testing" refers to the device's performance. Since it's a mechanical applicator for fibrin sealant, its performance would inherently be evaluated in a standalone manner, separate from a human operator's skill, to ensure it delivers the sealant correctly. However, a specific study detailed as "standalone performance" is not described.

7. The type of ground truth used

The "ground truth" for a mechanical device's functionality would be its adherence to engineering specifications and proper delivery of the fibrin sealant. The text does not detail these specifications or measurement methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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K041504

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

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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.

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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.

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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

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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: /< v 4 /S 4 y

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).