CRICOTHYROTOMY TUBE

K983000 · Polamedco, Inc. · BTO · Oct 27, 1999 · Anesthesiology

Device Facts

• Record ID: K983000
• Device Name: CRICOTHYROTOMY TUBE
• Applicant: Polamedco, Inc.
• Product Code: BTO · Anesthesiology
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of this device is to permit conventional ventilation, suctioning, and spontaneous ventilation on the part of an adult patient after insertion of the device in an incision at the cricothyriod space.

Device Story

Flexible medical-grade PVC tracheostomy tube designed for emergency cricothyrotomy; used by EMTs, paramedics, ER physicians, anesthesiologists, and RNs. Device features beveled rounded tip to minimize trauma, full radiopaque line for depth visualization, and 15 mm connector. Longer length than comparable tracheostomy tubes. Sterile, single-use, latex-free, and heavy-metal-free. Inserted into cricothyroid space incision to facilitate conventional ventilation, suctioning, and spontaneous ventilation. Benefits include rapid airway establishment in emergency settings.

Clinical Evidence

Bench testing only. Evidence includes in-house inflation/deflation testing, functional manufacturing testing, and sterilization validation per ISO 11135 and ISO 11737 standards.

Technological Characteristics

Flexible medical-grade PVC construction; heavy-metal-free. Features 15 mm connector, beveled tip, and radiopaque line. Available in 5.5 mm, 6.0 mm, and 6.5 mm ID sizes. Sterilized via Ethylene Oxide (ETO) per ANSI/AAMI/ISO 11135. Compliant with ISO 10993-7 for residual limits.

Indications for Use

Indicated for emergency surgical cricothyrotomy in adult patients and children above 8 years of age requiring airway establishment.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Predicate Devices

• Kendall Argyle Tracheostomy tube (K831720)

Submission Summary (Full Text)

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OCT 27 1999

POLAMEDCO, INC. 4054 GLENCOE AVENUE MARINA DEL REY, CA 90592-5608 PHONE: [phone] [phone] FAX: [phone]

Page 1 of 2 510 (K) Summary

### 510 (K) SUMMARY POLAMEDCO Tracheostomy Tube for Emergency Cricothyrotomy

| Date: | June 25,1999 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/Operator: | Polamedco, Inc.<br>4054 Glencoe Avenue<br>Marina del Rey, CA 90292<br>Registration # 2020839 |
| Device Trade Name: | Tracheostomy Tube for Emergency Cricothyrotomy |
| Common Name: | Tracheostomy Tube for Emergency Cricothyrotomy |
| Classification Name: | Class 2 |
| Regulatory Reference: | K 983000 |
| Predicate Device: | Kendall Argyle Tracheostomy tube "substantially equivalent to<br>devices introduced into interstate commerce prior to<br>May 28, 1976", Ref:K 831720 |

#### Description:

- · Polamedco's Tracheostomy Tube for Emergency Cricothyrotomy is designed for use by EMT's, Paramedics, E.R. Physicians, Anesthesiologists and R.N.'s
- · The length of the device is longer than a tracheostomy tube with comparable internal diameter/outside diameter
- · The device features a beveled smooth rounded tip that minimizes trauma
- · The device is made of flexible medical grade PVC
- · Features full radiopaque line for tube depth visualization
- · Packaged Sterile and single use
- · Latex Free
- · The device is made with heavy metal free materials that are safe incinerate and autoclave
- · Available in: 5.5 mm., 6.0 mm and 6.5 mm. ID sizes

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## Intended Use:

· The intended use of this device is to permit conventional ventilation, suctioning, and spontaneous ventilation on the part of an adult patient after insertion of the device in an incision at the cricothyriod space.

# Physical/Technical Comparison:

# Similarities:

- · have the same intended use which is to establish ventilation or airway
- · both devices are for use on adult patients and children above 8 years of age
- are both latex free
- · are both safe to incinerate and or autoclave
- · both are preconnected to 15 mm connectors
- · the POLAMEDCO device has a full radiopaque line for tube depth visualization; the Arglye device is radiopaque.
- · both packaged sterile and disposable for single use
- · the devices feature a beveled smooth rounded tip that minimizes trauma
- both devices are for use in children and adults
- · both devices do not include or require stylets for use
- · both are flexible
- · both are unshortened

# DIFFERENCES:

• The length of the device is longer than a tracheostomy tube with comparable internal diameter/ outside diameter

# Performance Summary:

The following tests are to assure safety and effectiveness of Polamedco, Inc. Tracheostomy Tube for Emergency Cricothyrotomy:

- In-house inflation and deflation test ●
- Functional test during manufacturing .
- Sterilization validation ●
- Other applicable qualifying tests .

# Reference Standards:

- · Federal Register 43June 1978 Proposed Residual Limits for ETO, ECH and ETG.
- · Sterilization Exposed to sub process Treatment, ISO 11737-97 Appendix 1-4
- · 21 CFR 821 June 23,1978 and ANSI/AAMI/ISO 10993-7: 1995
- · ANSI/AAMI/ISO 11135: 1994 Guideline for Industrial Ethylene Oxide Sterilization Medical Devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### OCT 27 1999

Gerald S. Linder, M.D. Polamedco, Inc. 4054 Glencoe Avenue Marina Del Rey, CA 90292-5608

Re : K983000 Cricothyrotomy Tube Regulatory Class: II (two) Product Code: 73 BTO Dated: July 1, 1999 Received: August 26, 1999

Dear Dr. Linder:

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 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 any 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.

Image /page/2/Picture/9 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird or abstract human figure.

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Page 2 - Gerald S. Linder, M.D.

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 (301) 594–4648. 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" (21 CFR 807.97). 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/dsma/dsmamain.html".

Sincerely yours,

farmer H. Westerhausen for,

Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### POLAMEDCO, INC 4054 GLENCOE AVENUE MARINA DEL REY, CA 90292-5608 PHONE: [phone] [phone] FAX: FAX: 1

Indication For Use

510 (k) Number K983000

Indication For Use:

The Tracheony Tube for Emergency Cricothyrotomy is intended for emergency surgical crioothyrotomy. :

Prescription use per 21 CFR 601.109

.OR

Oversthe-Counter Use

(PERSEN NEEDED)

Concurrunge of CDRH Office of Device Evaluation (ODE)

(Division Siga-m
Division of Cardiovascutar. Respiratory,
and Ne

510(k) Number: K983000

: