GERM TRAPPER SUCTION TUBE HOLDER

K972372 · Rzv Medical Specialties, Inc. · JOL · Dec 11, 1997 · General Hospital

Device Facts

• Record ID: K972372
• Device Name: GERM TRAPPER SUCTION TUBE HOLDER
• Applicant: Rzv Medical Specialties, Inc.
• Product Code: JOL · General Hospital
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2

Intended Use

The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.

Device Story

Secretion Trapper TM Suction Tube Holder is a single-patient-use, disposable receptacle; designed to store suction tubes and attached hoses during oral suctioning procedures. Device secures suction hose to eliminate noise (hissing); provides storage for contaminated disposables post-procedure to facilitate safe clean-up. Used in clinical environments (anesthesia, ICU, ER, nursing homes); operated by healthcare personnel. Benefits include improved infection control by containing blood and body secretions (e.g., saliva) and enhanced workflow efficiency during patient care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-patient-use disposable receptacle. Form factor designed to hold suction tubes and hoses. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring oral suctioning in clinical settings including anesthesia, nursing homes, ambulatory care, ICU, respiratory care, and ER. Used to store suction tubes/hoses and contaminated disposables to manage blood and body secretions.

Regulatory Classification

Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda K. Ruvo RSV Medical Specialties, Incorporated 34 Thorncrest Drive Pittsburgh, Pennsylvania 15235

DEC I I 1997

K972372 Re : Germ Trapper Suction Tube Holder Trade Name: Regulatory Class: II Product Code: JOL November 25, 1997 Dated: Received: November 25, 1997

Dear Ms. Ruvo:

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 regulation may result in regulatory 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 anv 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.

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Page 2 - Ms. Ruvo

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 regulation (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 qeneral 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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510(k) Number: K972372

## Device Name: Secretion Trapper TM Suction Tube Holder

Indications for use:

The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Bvaluation (ODE)

Patricia Crescenti
(Division Sign-Off)

Division of Dental Infection Control, and General Hospital Devices

510(k) Number .

V Prescription Use (Per 21 CFR 801.109)

. . . .

OR

Over-the-counter Use

Optional Format 1-2-96