SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

K031553 · Arcadia Medical Corporation · BTO · Nov 18, 2003 · Anesthesiology

Device Facts

• Record ID: K031553
• Device Name: SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Applicant: Arcadia Medical Corporation
• Product Code: BTO · Anesthesiology
• Decision Date: Nov 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.

Device Story

Silicone tracheostomy tubes provide direct tracheal access for airway management. Available in cuffless, foam cuff, and air cuff configurations; includes neonatal, pediatric, and adult sizes. Devices feature radiopaque silicone construction, 15mm connectors, and neck flanges. Some models include wire reinforcement or above-the-cuff suction/vocalization ports. Used in clinical settings by healthcare professionals. Tubes are inserted into the trachea to maintain airway patency. Benefits include secure airway access and ventilation support. Accessories include obturators, twill tape, and disconnect wedges.

Clinical Evidence

Bench testing only. Compliance with ASTM F 1666-95 and ASTM F 1627-95 standards demonstrated through comparative analysis of physical characteristics, materials, and design specifications against predicate devices.

Technological Characteristics

Materials: Silicone. Radiopaque. 15mm connector. Sterilization: ETO. Packaging: PETG tray with Tyvek lid or Tyvek pouch. Compliance: ASTM F 1666-95 (Adult), ASTM F 1627-95 (Pediatric). Configurations: Cuffless, Foam Cuff, Air Cuff, Wire Reinforced. Features: Adjustable neck flanges, above-the-cuff suction/vocalization ports.

Indications for Use

Indicated for patients requiring direct tracheal access for airway management. Suitable for neonatal, pediatric, and adult populations.

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

• Bivona Medical Technologies Fome-Cuf (K862267)
• Bivona Medical Technologies Aire Cuf (K862267)
• Bivona Medical Technologies Aire Cuf Adjustable (K894614)
• Bivona Medical Technologies Pediatric Trach Tube (K912469)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the date November 18, 2003. The month is abbreviated to NOV. The day is 18 and the year is 2003. The text is in a bold, sans-serif font.

Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a code or identifier. The text is "K031553" and is written in a slightly slanted manner. The handwriting is bold and clear, making the characters easily distinguishable against the white background.

### 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | Arcadia Medical Corporation<br>1450 East American Lane, Suite 1400<br>Schaumburg, IL 60173<br>USA | | | | | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------|---------------------|--------------|----------------------|---------|
| | | | | | | | |
| | <table><tr><th>Phone:</th><td>847-330-4447</td></tr><tr><th>Fax:</th><td>847-438-4693</td></tr></table> | Phone: | 847-330-4447 | Fax: | 847-438-4693 | | |
| Phone: | 847-330-4447 | | | | | | |
| Fax: | 847-438-4693 | | | | | | |
| Contact Person: | Mr. James Mondschean | | | | | | |
| Date of Summary: | May 15, 2003 | | | | | | |
| Trade Name: | Silicone Foam Cuff Tracheostomy Tubes, Silicone<br>Cuffless Neonatal and Pediatric Tracheostomy Tubes,<br>Silicone Cuffless Adult Tracheostomy Tubes, Silicone Air<br>Cuff and Air Cuff Adjustable Neck Flange Tracheostomy<br>Tubes | | | | | | |
| Classification Name: | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) | | | | | | |
| Predicate Device: | Bivona Medical Technologies – Fome-Cuf and Aire Cuf<br><table><tr><td>Tracheostomy Tubes</td><td>K862267</td></tr><tr><td>Aire Cuf Adjustable</td><td>K894614</td></tr><tr><td>Pediatric Trach Tube</td><td>K912469</td></tr></table> | Tracheostomy Tubes | K862267 | Aire Cuf Adjustable | K894614 | Pediatric Trach Tube | K912469 |
| Tracheostomy Tubes | K862267 | | | | | | |
| Aire Cuf Adjustable | K894614 | | | | | | |
| Pediatric Trach Tube | K912469 | | | | | | |

#### Intended Use:

Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.

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## Product Type: Arcadia Medical Adult Cuffless Tracheostomy Tubes

| Characteristic | Arcadia Medical | Bivona Medical (Predicate Device) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------------------------------------------------------|
| Size Range: 6.0mm, 7.0mm, 8.0mm, 9.0mm, 9.5mm (5 Sizes) | Yes | Yes- plus 5.0mm (6 sizes) |
| Length: 6.0=51mm, 7.0=67mm, 8.0=78mm, 9.0=91mm, 9.5=95mm | Yes | 5.0=60mm, 6.0=70mm, 7.0=80mm<br>8.0=88mm, 9.0=98mm, 9.5=98mm |
| Neck Flange with OD/ID, Name & Model Type | Yes | Yes |
| Material: Silicone | Yes | Yes |
| Radiopaque | Yes | Yes |
| Color: White | Yes | Yes |
| 15mm Connector | Yes | Yes |
| Cuff Style: Cuffless | Yes | Yes |
| Obturator | Yes | Yes |
| Packaging: PETG Tray with Tyvek Lid | Yes | Yes |
| Packaged with Accessories: Twill Tape and Disconnect Wedge | Yes | Yes |
| Sterilization Method: ETO | Yes | Yes |
| Label contains the following information: Product Name, product style (Cuffless), size, Part Number,<br>ID, OD, Length, Lot Number, Manufacturer's Name, Quantity, Sterile-ETO, Expiration Date | Yes | Yes |
| Complies with ASTM F 1666-95: Standard Specification for Adult Tracheostomy Tubes | Yes | Yes |

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#### Tracheostomy Tube Pred. .e Device Comparison Chart

## Product Type: Arcadia Medical Pediatric Cuffless Tracheostomy Tubes

| Characteristic | Arcadia Medical | Bivona Medical<br>(Predicate Device) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------------------------------|
| Size Range: 2.5mm, 3.0mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm (7 Sizes) | Yes | Yes |
| Length: 2.5=38mm, 3.0=39mm, 3.5=40mm, 4.0=41mm, 4.5=42mm, 5.0=44mm, 5.5=46mm | Yes | Yes |
| Neck Flange with OD/ID, Name & Model Type | Yes | Yes |
| Material: Silicone | Yes | Yes |
| Radiopaque | Yes | Yes |
| Wire Reinforced | Yes | Yes |
| Color: White | Yes | Yes |
| 15mm Connector | Yes | Yes |
| Cuff Style: Cuffless | Yes | Yes |
| Obturator | Yes | Yes |
| Packaging: PETG Tray with Tyvek Lid | Yes | Yes |
| Packaged with Accessories: Twill Tape and Disconnect Wedge | Yes | Yes |
| Sterilization Method: ETO | Yes | Yes |
| Label contains the following information: Product Name, product style (Cuffless), size, Part Number, ID, OD,<br>Length, Lot Number, Manufacturer's Name, Quantity, Sterile-ETO, Expiration Date | Yes | Yes |
| Complies with ASTM F 1627-95: Standard Specification for Pediatric Tracheostomy Tubes | Yes | Yes |

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# Product Type: Arcadia Medical Neonatal Cuffless Tracheostomy Tubes

| Characteristic | Arcadia Medical | Bivona Medical<br>(Predicate Device) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-------------------------------------------------------------------|
| Size Range: 2.5mm, 3.0mm, 3.5mm, 4.0mm, (4 Sizes) | Yes | Yes |
| Length: 2.5=30mm, 3.0=32mm, 3.5=34mm, 4.0=36mm | Yes | Yes |
| Neck Flange with OD/ID, Name & Model Type | Yes | Yes |
| Material: Silicone | Yes | Yes |
| Radiopaque | Yes | Yes |
| Wire Reinforced | Yes | Yes |
| Color: White | Yes | Yes |
| 15mm Connector | Yes | Yes |
| Cuff Style: Cuffless | Yes | Yes |
| Obturator | Yes | Yes |
| Packaging: PETG Tray with Tyvek Lid | Yes | Yes |
| Packaged with Accessories: Twill Tape and Disconnect Wedge | Yes | Yes |
| Sterilization Method: ETO | Yes | Yes |
| Label contains the following information: Product Name, product style (Cuffless), size, Part Number, ID, OD, Length, Lot Number, Manufacturer's Name, Quantity, Sterile-ETO, Expiration Date | Yes | Yes |
| Complies with ASTM F 1627-95: Standard Specification for Pediatric Tracheostomy Tubes | Yes | Yes |
| Characteristic | Arcadia Medical | Bivona Medical (Predicate Device) |
| Size Range: 6.0mm, 7.0mm, 8.0mm, 9.0mm, 9.5mm (5 Sizes) | Yes | Yes- plus 5.0mm (6 sizes) |
| Length: 6.0=51mm, 7.0=67mm, 8.0=78mm, 9.0=91mm, 9.5=95mm | Yes | 5.0=60mm, 6.0=70mm, 7.0=80mm<br>8.0=88mm, 9.0=98mm, 9.5=98mm |
| Neck Flange with OD/ID, Name & Model Type | Yes | Yes |
| Material: Silicone | Yes | Yes |
| Radiopaque | Yes | Yes |
| Color: White | Yes | Yes |
| 15mm Connector | Yes | Yes |
| Cuff Style: Foam Cuff with Pilot Port and attached plug | Yes | Yes |
| Obturator | Yes | Yes |
| Packaging: PETG Tray with Tyvek Lid | Yes | Yes |
| Packaged with Accessories: Twill Tape and Disconnect Wedge | Yes | Yes |
| Sterilization Method: ETO | Yes | Yes |
| Label contains the following information: Product Name, product style (Foam Cuff), size, Part Number, ID, OD, Length, Lot Number, Manufacturer's Name, Quantity, Sterile-ETO, Expiration Date | Yes | Yes |
| Complies with ASTM F 1666-95: Standard Specification for Adult Tracheostomy Tubes | Yes | Yes |
| Characteristic | Arcadia Medical | Bivona Medical (Predicate Device) |
| Size Range: 6.0mm, 7.0mm, 8.0mm, 9.0mm, 9.5mm (5 Sizes) | Yes | Yes- plus 5.0mm (6 sizes) |
| Length: 6.0=51mm, 7.0=67mm, 8.0=78mm, 9.0=91mm, 9.5=95mm | Yes | 5.0=60mm, 6.0=70mm, 7.0=80mm<br>8.0=88mm, 9.0=98mm, 9.5=98mm |
| Neck Flange with OD/ID, Name & Model Type | Yes | Yes |
| Material: Silicone | Yes | Yes |
| Radiopaque | Yes | Yes |
| Color: White | Yes | Yes |
| 15mm Connector | Yes | Yes |
| Cuff Style: Air Cuff with Pilot Balloon, Inflation Valve and Inflation Line | Yes | Yes |
| Obturator | Yes | Yes |
| Packaging: PETG Tray with Tyvek Lid | Yes | Yes |
| Packaged with Accessories: Twill Tape and Disconnect Wedge | Yes | Yes |
| Sterilization Method: ETO | Yes | Yes |
| Label contains the following information: Product Name, product style (Air Cuff), size, Part Number, ID, OD, Length, Lot Number, Manufacturer's Name, Quantity, Sterile-ETO, Expiration Date | Yes | Yes |
| Complies with ASTM F 1666-95: Standard Specification for Adult Tracheostomy Tubes | Yes | Yes |
| Characteristic | Arcadia Medical | Bivona Medical (Predicate Device) |
| Size Range: 6.0mm, 7.0mm, 8.0mm, 9.0mm (4 Sizes) | Yes | Yes |
| Usable Length: 6.0=110mm, 7.0=120mm, 8.0=130mm, 9.0=140mm | Yes | Yes |
| Adjustable Neck Flange with OD/ID, Name & Model Type | Yes | Yes |
| Material: Silicone | Yes | Yes |
| Radiopaque | Yes | Yes |
| Wire Reinforced | Yes | Yes |
| Color: Clear | Yes | Yes |
| 15mm Connector | Yes | Yes |
| Cuff Style: Air Cuff with Pilot Balloon, Inflation Valve and Inflation Line | Yes | Yes |
| Above the Cuff Access Port for Suctioning and Vocalization | Yes | Not Available on this Model<br>(Available on other Bivona Models) |
| Introducer/Obturator | Yes | Yes |
| Packaging: Tyvek Pouch | Yes | Yes |
| Packaged with Accessories: Twill Tape and Disconnect Wedge | Yes | Yes |
| Sterilization Method: ETO | Yes | Yes |
| Label contains the following information: Product Name, product style (Air Cuff), size, Part Number, ID, OD, Length, Lot Number, Manufacturer's Name, Quantity, Sterile-ETO, Expiration Date | Yes | Yes |
| Complies with ASTM F 1666-95: Standard Specification for Adult Tracheostomy Tubes | Yes | Yes |

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### Product Type: Arcadia Medical Adult Foam Cuff Tracheostomy Tubes

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#### Tracheostomy Tube Pred e Device Comparison Chart

# Product Type: Arcadia Medical Adult Air Cuff Tracheostomy Tubes

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#### Tracheostomy Tube Pred e Device Comparison Chart

Product Type: Arcadia Medical Adult Air Cuff Adjustable Neck Flange Tracheostomy Tubes

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Public Health Service

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or forms, arranged in a row.

NOV 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arcardia Medical Corporation c/o Mr. Arthur Ward RMS 962 Allegro Lane Apollo Beach, FL 33572

Re: K031553

Trade/Device Name: Silicone Tracheostomy Tubes Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tubes (W/Wo Connector) Regulatory Class: II Product Code: BTO Dated: September 26, 2003 Received: October 2, 2003

Dear Mr. Ward:

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 your 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.

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Page 2 – Mr. Arthur Ward

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Quris

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __ |<03|553

Arcadia Medical Tracheostomy tubes Device Name:

#### Indications For Use:

Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) of Anesthesiology, General Hospital. Infection Control, Denta 510(k) Number: OR Over-The-Counter Use ------------Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)