(183 days)
Not Found
No
The device description focuses on the material, physical characteristics, and accessories of tracheostomy tubes, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" states that tracheostomy tubes are "intended for use in providing direct tracheal access for airway management," which implies treating or managing a medical condition.
No
The device, a tracheostomy tube, is intended for direct tracheal access for airway management, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly outlines physical components made of silicone, packaging materials, and accessories, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "providing direct tracheal access for airway management." This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details a physical device used to maintain an airway. It doesn't mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. Tracheostomy tubes are used in vivo (inside the body) to facilitate breathing.
N/A
Intended Use / Indications for Use
Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.
Product codes (comma separated list FDA assigned to the subject device)
BTO
Device Description
The 510(k) summary describes several types of silicone tracheostomy tubes: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes, Silicone Cuffless Adult Tracheostomy Tubes, Silicone Air Cuff and Air Cuff Adjustable Neck Flange Tracheostomy Tubes. These devices are available in different size ranges (e.g., 6.0mm-9.5mm for adult, 2.5mm-5.5mm for pediatric, 2.5mm-4.0mm for neonatal) and lengths depending on the specific tube type. All tubes feature a neck flange with OD/ID, name & model type, are made of silicone, are radiopaque, and come with a 15mm connector and an obturator. The foam cuff style also has a pilot port and attached plug, while the air cuff styles have a pilot balloon, inflation valve, and inflation line. The adjustable neck flange type is wire-reinforced and has an above-the-cuff access port. All products are packaged in a PETG Tray with a Tyvek Lid (except for the adjustable neck flange type, which uses a Tyvek Pouch) and include twill tape and a disconnect wedge. Sterilization is performed using ETO. Labels contain product name, style, size, part number, ID, OD, length, lot number, manufacturer's name, quantity, sterilization method, and expiration date. The adult tubes comply with ASTM F 1666-95, and pediatric/neonatal tubes comply with ASTM F 1627-95.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal
Indicated Patient Age Range
Neonatal, Pediatric, Adult
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
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.(b)
Classification. Class II.
0
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
1450 East American Lane, Suite 1400
Schaumburg, IL 60173
USA | | | | | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------|---------------------|--------------|----------------------|---------|
| | | | | | | | |
| | Phone:847-330-4447Fax:847-438-4693 | 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
Cuffless Neonatal and Pediatric Tracheostomy Tubes,
Silicone Cuffless Adult Tracheostomy Tubes, Silicone Air
Cuff and Air Cuff Adjustable Neck Flange Tracheostomy
Tubes | | | | | | |
| Classification Name: | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) | | | | | | |
| Predicate Device: | Bivona Medical Technologies – Fome-Cuf and Aire Cuf
Tracheostomy TubesK862267Aire Cuf AdjustableK894614Pediatric Trach TubeK912469 | 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.
1
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 |
| 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, | ||
| 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 |
2
Tracheostomy Tube Pred. .e Device Comparison Chart
Product Type: Arcadia Medical Pediatric Cuffless Tracheostomy Tubes
| Characteristic | Arcadia Medical | Bivona Medical
(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,
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 |
3
Product Type: Arcadia Medical Neonatal Cuffless Tracheostomy Tubes
| Characteristic | Arcadia Medical | Bivona Medical
(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
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
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
(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 |
4
Product Type: Arcadia Medical Adult Foam Cuff Tracheostomy Tubes
5
Tracheostomy Tube Pred e Device Comparison Chart
Product Type: Arcadia Medical Adult Air Cuff Tracheostomy Tubes
6
Tracheostomy Tube Pred e Device Comparison Chart
Product Type: Arcadia Medical Adult Air Cuff Adjustable Neck Flange Tracheostomy Tubes
7
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.
8
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
9
510(k) Number (if known): __ |