SMOKE EVACUATION HOSES/TUBING

K020510 · Dm Medical, Inc. · FYD · May 3, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020510
• Device Name: SMOKE EVACUATION HOSES/TUBING
• Applicant: Dm Medical, Inc.
• Product Code: FYD · General, Plastic Surgery
• Decision Date: May 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

Intended Use

The smoke evacuation hoses are intended for the removal of smoke and particles generated from the point of surgical activity during a medical procedure that uses an electrosurgical pencil or laser for cutting and/or cauterizing. The are to be connected to a smoke evacuation unit securely on one end and the other end is to be held at the surgical site no farther than 2" from the point of lasering or cauterizing of tissue. They are a single use item, considered a bio-hazardous item after use in surgery, and must be disposed of after each case in a bio-hazardous bag (a red bag).

Device Story

Device consists of plastic smooth-bore corrugated tubing with polyethylene adapters; available in various lengths/diameters; sterile or non-sterile. Operates as accessory to surgical exhaust apparatus; connects to vacuum/suction unit to aspirate smoke/particles from surgical site. Used in clinical surgical settings by medical staff; positioned within 2 inches of electrosurgical/laser activity. Single-use; disposed of as bio-hazardous waste post-procedure. Benefits patient/staff by clearing surgical smoke/particulates from operative field.

Clinical Evidence

Bench testing only. Performance testing confirmed capability to maintain adequate airflow for smoke aspiration. Biocompatibility testing performed on materials.

Technological Characteristics

Plastic smooth-bore corrugated tubing with polyethylene adapters. Dimensions vary by length/diameter. Energy source: external vacuum/suction apparatus. Sterilization: gamma radiation.

Indications for Use

Indicated for removal of smoke and particles from surgical sites during procedures involving electrosurgical pencils or lasers for cutting/cauterizing. Intended for single-use in clinical surgical settings.

Regulatory Classification

Identification

Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Smoke evacuation hoses/tubing (LASE, INC.) (K922555)

Submission Summary (Full Text)

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MAY 0-3 2002

DM Medical Inc 10865 Millington Ct Cincinnati, Ohio 45242 Ph 800.884.6414 Fax [phone]

# Koros70 510(k) Summary Smoke Evacuation Hoses/Tubing

Manufacturer

DM Medical Inc. 10865 Millington Ct. Cincinnati, Ohio 45242

Manufacturing Location

Same

Contract Sterilizer -- For Gamma Radiation Sterilization

IBA SteriGenics International 305 Enterprise Dr. Westerville, Ohio 43081

Manufacturer Telephone/Email/Fax

Telephone [phone] Fax [phone] [e-mail] Email

Contact Person

Robert W. Mays

Device Trade Name

Smoke Evacuation Hoses/Tubing

Common Name

o

Smoke Evacuation Hoses/Tubing

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### Classification Name

Accessory to surgical exhaust apparatus

ProCode

FYD

Predicate Device

Smoke evacuation hoses/tubing manufactured and sold by LASE, INC. Originally submitted by LASE, INC. under 510(k) number K922555.

Description

A plastic smooth bore corrugated tubing with polyethylene adapters. Supplied in a variety of diameters and lengths. Also supplied in Sterile and Non-Sterile.

## Intended Use

Intended for removing smoke and particles from the point of surgical activity during medical procedures that use an electrosurgical pencil or laser for cutting and/or cauterizing.

### Physical/Technical Comparison

Both the device and the predicate are made from the same material, are of the same general size and shape, and have the same intended use. Both devices require and use the same attachments to a vacuum or suction apparatus in order to aspirate smoke from the surgical site.

### Performance Summary

All smoke evacuation hoses are capable of maintaining adequate air flow to allow for adequate aspiration of smoke found at the site of surgical activity.

Biocompatibility Testing

The materials used for the manufacture of the smoke evacuation hoses have undergone biocompatibility testing and have been found to be non-irritating, non-cvtotoxic, non-sensitizing.

# Sterility and Shelf Life

The device is sterile processed using gamma radiation. They are considered sterile until the package has been opened or damaged.

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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 3 2002

Mr. Robert W. Mays President DM Medical Incorporated 10865 Millington Court Cincinnati, Ohio 45242

Re: K020510

Trade/Device Name: Smoke Evacuation Hoses/Tubing Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: FYD Dated: February 9, 2002 Received: February 15, 2002

# Dear Mr. Mays:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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# Page 2 - Mr. Robert W. Mays

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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) 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/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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# K020510

Statement of Indications for Use:

The smoke evacuation hoses are intended for the removal of smoke and particles generated from the point of surgical activity during a medical procedure that uses an electrosurgical pencil or laser for cutting and/or cauterizing. The are to be connected to a smoke evacuation unit securely on one end and the other end is to be held at the surgical site no farther than 2" from the point of lasering or cauterizing of tissue. They are a single use item, considered a bio-hazardous item after use in surgery, and must be disposed of after each case in a bio-hazardous bag (a red bag).

Olia S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _