K Number
K020510
Device Name
SMOKE EVACUATION HOSES/TUBING
Manufacturer
Date Cleared
2002-05-03

(77 days)

Product Code
Regulation Number
878.5070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

Not Found

No
The description focuses on the physical components and function of smoke evacuation hoses, with no mention of AI or ML.

No
The device is described as smoke evacuation hoses used for removing smoke and particles generated during surgical procedures. Its function is to clear the surgical field for visibility and safety, not to directly treat a medical condition or disease.

No
Explanation: This device is described as smoke evacuation hoses used for removing smoke and particles during surgical procedures. Its function is to clear the surgical field, not to diagnose medical conditions or provide diagnostic information.

No

The device description clearly states it is "plastic smooth bore corrugated tubing with polyethylene adapters," indicating it is a physical hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVDs are used to examine specimens from the human body. The intended use of this device is to remove smoke and particles generated during a surgical procedure, directly at the surgical site. It does not involve analyzing samples of blood, tissue, or other bodily fluids outside the body to diagnose a condition or monitor health.
  • The description focuses on physical function. The device description details the materials and construction of the tubing, and the performance study focuses on airflow. This aligns with a surgical accessory, not a diagnostic tool.
  • The intended use is for surgical smoke removal. This is a physical process to maintain a clear surgical field and protect personnel, not a diagnostic test.

Therefore, this device falls under the category of a surgical accessory or instrument, not an In Vitro Diagnostic device.

N/A

Intended Use / 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)."

Product codes

FYD

Device 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."

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

"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."

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K922555

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a)
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.(b)
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.

0

MAY 0-3 2002

DM Medical Inc 10865 Millington Ct Cincinnati, Ohio 45242 Ph 800.884.6414 Fax 513.936.6555

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 1-800-884-6414 Fax 1-513-936-6555 RMAYS@PREMEDCO.COM Email

Contact Person

Robert W. Mays

Device Trade Name

Smoke Evacuation Hoses/Tubing

Common Name

o

Smoke Evacuation Hoses/Tubing

1

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.

2

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.

3

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 (301) 594-4618. 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 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 (800) 638-2041 or (301) 443-6597 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

4

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 _