HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01

K994023 · Haemacure Corp. · FMF · Apr 25, 2000 · General Hospital

Device Facts

• Record ID: K994023
• Device Name: HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
• Applicant: Haemacure Corp.
• Product Code: FMF · General Hospital
• Decision Date: Apr 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Haemacure HemaMyst Surgical Applicator System is indicated for the application of two non-homogeneous fluids or solutions to the treatment site.

Device Story

The Haemacure HemaMyst Surgical Applicator System is a surgical tool used to deliver fluids to a treatment site. It consists of a reusable base unit with an air regulator and foot pedal, and a sterile, single-use spray head with filtered gas tubing. The system connects to existing operating room compressed air or nitrogen sources and dual syringe applicators. The physician operates the foot pedal to control airflow, which aerosolizes and delivers fluids (such as antibiotics or other wound treatment fluids) to the surgical site. The device facilitates the application of two non-homogeneous fluids simultaneously. It is intended for use in an operating room setting to assist in surgical wound management.

Clinical Evidence

Bench testing only. Performance functionality testing demonstrated substantial equivalence to the predicate device at comparable air pressures.

Technological Characteristics

System includes a reusable air regulator, foot pedal, and sterile single-use spray head. Gas tubing is 1/8" PVC with luer fittings. Operates using compressed air or nitrogen from the operating theater. Sterilization of disposable components is via ethylene oxide (EtO).

Indications for Use

Indicated for the application of two non-homogeneous fluids or solutions to a surgical 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

• Biosurgical, Corp. Multi Chamber Suction Syringe (K964597)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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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 | HemaMyst<br>Applicator<br>(HSAS)<br>Surgical<br>System | Multi Chamber Suction<br>Syringe (Sealouette) |
| Fluid Applicator Tip | Separate aerosol head that<br>attaches to a dual syringe<br>applicator | Same |
| Compressed Air Source | Compressed air or<br>nitrogen from the<br>operating theater | Same |
| Gas Tubing Line | 1/8" PVC with luer fitting | Same |
| Indications for Use | Application of FDA<br>approved fluids to<br>wounds, the delivery of<br>antibiotics, and other<br>wound treatment fluids. It<br>can also be used for the<br>application of two non-<br>homogeneous fluids to the<br>surgical site | Same |
| Sterilization of Disposable | EtO | Unknown |

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 ________________________________________________________________________________________________________________________________________________________________