(90 days)
Not Found
Not Found
No
The device description and intended use focus on the physical properties and materials of the endotracheal tube for laser resistance, with no mention of AI or ML capabilities.
No
The device is an endotracheal tube used during surgical procedures involving lasers to administer anesthesia gases or overcome airway obstruction. It is not designed to treat, cure, mitigate, or prevent disease.
No.
The device description and intended use indicate that the Laser-Shield II is an endotracheal tube designed for administering anesthesia gases and protecting against laser energy during surgery. It does not mention any function related to diagnosing a disease, condition, or state of health.
No
The device description clearly states it is an endotracheal tube made of physical materials (silicone elastomer, aluminum, fluoroplastic) and includes a physical cuff and inflation assembly. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for endotracheal intubation during surgical procedures involving lasers. This is a direct medical intervention on a patient's airway.
- Device Description: The device is an endotracheal tube designed to be inserted into the trachea. It's a physical device used for a medical procedure.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, the Laser-Shield II is a medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Laser-Shield II is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10,60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthesia gases or to overcome emergency obstruction of an airway.
Product codes (comma separated list FDA assigned to the subject device)
73BTR
Device Description
Xomed Laser-Shield II is an endotracheal tube provided sterile with laser resistant overwraps of aluminum and fluoroplastic covering the silicone elastomer shaft. The tube is fitted with an inflatable cuff designed to provide tracheal seal. The inflation assembly/balloon contains dry methylene blue that mixes with a liquid inflation media (sterile normal saline) to provide visible detection of inadvertent cuff rupture by the laser. Sterile cottonoid patties are also provided for wetting and placement around the positioned and inflated cuff for additional heat sink.
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)
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.
Not Found
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
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
K
- 1.0 Date Prepared October 14, 1999
- 2.0 Submitter (Contact) Rov Berens Xomed Surgical Products Jacksonville, FL Telephone: 904-296-645
3.0 Device Name
Proprietary Name: Laser-Shield® II Tracheal Tube, Endotracheal Tube Common Name(s): Classification Name: Tracheal Tube
4.0 Device Classification
Product Code 73BTR Class II Tier II Tracheal Tube 21 CFR 868.5730
5.0 Device Description
Xomed Laser-Shield II is an endotracheal tube provided sterile with laser resistant overwraps of aluminum and fluoroplastic covering the silicone elastomer shaft. The tube is fitted with an inflatable cuff designed to provide tracheal seal. The inflation assembly/balloon contains dry methylene blue that mixes with a liquid inflation media (sterile normal saline) to provide visible detection of inadvertent cuff rupture by the laser. Sterile cottonoid patties are also provided for wetting and placement around the positioned and inflated cuff for additional heat sink.
6.0 Intended Use
Xomed Laser-Shield II is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns) or KTP (532 mm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthesia gases or to overcome emergency obstruction of an airway.
7.0 Substantial Equivalence
The modified Xomed Laser-Shield II is identical to the current device with the exception of the extension of the aluminum wrap under a portion of the cuff and covering of this extension with a flexible silicone sleeve. The intended use and claims for the modified device remains unchanged and no new materials are being used.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 0 2000
Mr. Roy Berens Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216-0980
Re: K993582 Modification to Laser-Shield® II Endotracheal Tube Requlatory Class: II (two) Product Code: 73 BTR October 20, 1999 Dated: October 22, 1999 Received:
Dear Mr. Berens:
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 leqally 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, Druq, 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 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 (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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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.
2
Page 2 - Mr. Roy Berens
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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Joanna VA Westerhausen for,
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification [510(k)] for Modification to Laser-Shield® II
Intended Use Statement
993582 510(k) Number (if known): K
Device Name: Modification to Laser-Shield II
Indications for Use: Laser-Shield II is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10,60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthesia gases or to overcome emergency obstruction of an airway.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Or
Over-the-Counter Use
(Optional Format 1-2-96)
io.Aulestschen
51 : Kki Numt