HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01

K041504 · Haemacure Corp. · FMF · Aug 6, 2004 · General Hospital

Device Facts

• Record ID: K041504
• Device Name: HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
• Applicant: Haemacure Corp.
• Product Code: FMF · General Hospital
• Decision Date: Aug 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

HemaMyst Surgical Applicator System is a sterile, single-use device for simultaneous spray delivery of two-component fibrin sealants (HEMASEEL APR or Tisseel VH) to surgical sites. System consists of a spray head attaching via Luer connectors to dual-syringe applicators (e.g., Duploject) and coupled to an air regulator base unit via sterile filtered air lines. Compressed gas enhances component mixing and spraying at the treatment site. Used in surgical settings by clinicians to apply sealant; device facilitates uniform coverage of non-homogeneous fluids. Benefits include improved delivery and mixing of fibrin sealant components compared to manual application.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by functionality testing demonstrating the system's ability to effectively mix and spray HEMASEEL APR or Tisseel VH fibrin sealants.

Technological Characteristics

Sterile, single-use piston syringe-based applicator system. Components include spray head, Luer connectors, and air regulator base unit. Uses compressed gas for component mixing and spray delivery. Compatible with dual-syringe applicators (e.g., Duploject).

Indications for Use

Indicated for the simultaneous application of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to a treatment site.

Regulatory Classification

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.

Predicate Devices

• Haemacure HemaMyst Surgical Applicator System (K994023)
• Tissomat and Spray Set (K981089)

Submission Summary (Full Text)

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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 [phone] ext. 28

Submission Contact: Elaine Whitmore SciVance Consulting [phone]

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 [phone]. 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 [phone] or [phone] 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

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510(k) Number: /< v 4 /S 4 y