(309 days)
SteBar Instr. Corp. Schroeder Oral/Nasal Stylette, Vision-Sciences EndoSheath, AMERICAN OPTICAL Flexible Brochoscope FBS-1, Karl Storz Intubation Fiberscope
No reference devices were found in the text.
No
The description focuses on the mechanical and optical components of a standard endoscope and introducer sheath, with no mention of AI/ML features or image processing capabilities beyond basic visualization.
No
The device is described as an Intubation Endoscope and Introducer Sheath used for direct visualization during fiberoptically assisted intubation and airway management, which is a diagnostic or procedural aid rather than a device that provides therapy.
No
The device is described as being used for "direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management." This primarily describes a functional tool for performing a medical procedure, not for identifying a disease or condition. While visualization can be part of diagnosis, the primary intended use stated is procedural assistance.
No
The device description clearly outlines physical components like a malleable sheath, channels, a deflecting mechanism, lenses, and a connection for a light cable, indicating 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 "direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management." This describes a procedure performed directly on the patient's body for diagnostic or therapeutic purposes, not a test performed on a sample taken from the body.
- Device Description: The device description details an endoscope and introducer sheath used for visualization and manipulation within the airway. This is consistent with a medical device used for direct patient care, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Intubation Endoscope and Introducer Sheath are used in the direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.
The Intubation Endoscope is used for direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.
Product codes (comma separated list FDA assigned to the subject device)
77 EOO
Device Description
UROHEALTH Intubation Endoscope Introducer Sheath is a device that consists a malleable or nonmalleable introducer sheath that houses a channel for insufflation of oxygen or fluid delivery, a deflecting mechanism for the distal tip, a channel for scope insertion, and a distal window. The reusable fiber optic imaging and illumination system consists of a focusing ocular lens, a distal objective lens, and a connection for a fiber optic light cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fiberoptic
Anatomical Site
trachea and lungs
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)
The Intubation Endoscope and Introducer Sheath will be tested to ensure integrity of the sterile barrier under normal usage conditions. All bonded joints will tested according to the appropriate ASTM procedure.
Biocompatibility testing will be conducted on both component level and finished devices (sterile, if applicable). This testing will include but is not limited to cytotoxicity, sensitization, and irritation. The device is considered body contact surface of mucosal membranes for a limited (less than 24 hours) contact duration. This testing is in accordance with EN 30993 for medical devices.
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.
SteBar Instr. Corp. Schroeder Oral/Nasal Stylette, Vision-Sciences EndoSheath, AMERICAN OPTICAL Flexible Brochoscope FBS-1, Karl Storz Intubation Fiberscope
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
510(k) SUMMARY
In accordance with the requirements of SMDA 1990 and 21 CFR 807.92 this in accordanos with the required Effectiveness is submitted with the Premarket Submission.
| Company Name: | UROHEALTH Systems, Inc.
3050 Redhill Ave.
Costa Mesa, CA 92626 | NOV 18 1997 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person:
Telephone Number: | Ronald Bergeson
714.708.7748, ext. 248 | |
| Device Name: | Bronchoscope | |
| Proprietary Device Name: | Intubation Endoscope and
Introducer Sheath | |
| Classification Name: | Bronchoscope (flexible or rigid) and
accessories | |
| Predicate Devices: | SteBar Instr. Corp. Schroeder Oral/Nasal
Stylette™ | |
| | Vision-Sciences EndoSheath® | |
| | AMERICAN OPTICAL Flexible
Brochoscope FBS-1 | |
| | Karl Storz Intubation Fiberscope | |
| Device Description: | UROHEALTH Intubation Endoscope Introducer
Sheath is a device that consists a malleable or
nonmalleable introducer sheath that houses a
channel for insufflation of oxygen or fluid
delivery, a deflecting mechanism for the distal
tip, a channel for scope insertion, and a distal
window. The reusable fiber optic imaging and
illumination system consists of a focusing
ocular lens, a distal objective lens, and a
connection for a fiber optic light cable. | |
Image /page/0/Picture/4 description: The image shows a sequence of numbers. The numbers are 000048. The first four numbers are zeros, followed by the numbers four and eight.
1
| Intended Use: | The Intubation Endoscope and Introducer
Sheath are used in the direct visualization in
the trachea and lungs during fiberoptically
assisted intubation and airway management. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing: | The Intubation Endoscope and Introducer
Sheath will be tested to ensure integrity of
the sterile barrier under normal usage
conditions. All bonded joints will tested
according to the appropriate ASTM
procedure. |
| Biocompatibility: | Biocompatibility testing will be conducted on
both component level and finished devices
(sterile, if applicable). This testing will include
but is not limited to cytotoxicity, sensitization,
and irritation. The device is considered body
contact surface of mucosal membranes for a
limited (less than 24 hours) contact duration.
This testing is in accordance with EN 30993 for
medical devices. |
| Substantial Equivalence: | Based on the indications for use, technological
characteristics, and safety and performance
testing to be completed, the UROHEALTH
Intubation Endoscope and Introducer Sheath
will be shown to be safe and effective for its
intended use. |
(
(
Image /page/1/Picture/1 description: The image shows a sequence of numbers: 000049. The numbers are printed in a bold, sans-serif font. The first four digits are zeros, followed by the numbers 4 and 9. The numbers appear to be slightly distressed, with some minor imperfections in the print.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1997
Ronald Bergeson Corporate Director, Regulatory Affairs Imagyn (formerly UroHealth) 5 Civic Plaza Suite 100 Newport, CA 92660
Re:
K970107 Intubation Endoscope and Introducer Sheath Dated: October 7. 1997 Received: October 8, 1997 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOO
Dear Mr. Bergeson:
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, 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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/dsmamain.html".
Sincerely yours,
W. Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
| (if known): | K970107 |
|---|---|
| ------------- | --------- |
Intubation Endoscope and Introducer Sheath Device Name:
Indications for Use:
510 (k) Number (if
The Intubation Endoscope is used for direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.
(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 801.1091 OR
Over-The-Counter Use
(Optional Format 1-2-96)
Olin L. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deviçes 0107 510(k) Number .