(280 days)
No
The device description and performance studies focus on the physical characteristics and bench testing of a standard tracheostomy tube, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, a tracheostomy tube, is for airway management and mechanical support, not for treating a disease or condition itself.
No
Explanation: The device is a tracheostomy tube set used for airway management, which is a therapeutic intervention, not a diagnostic one. Its function is to facilitate breathing, not to identify or monitor a medical condition.
No
The device description clearly outlines physical components made of polyvinyl chloride and low density polyethylene, indicating it is a hardware device, not software-only.
Based on the provided information, the Rusch Single Use Crystal Tracheostomy Tube Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "airway management of tracheostomized patients." This is a direct medical intervention on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical tube inserted into the airway, a cuff for inflation, and inner cannulas. These are all components for managing the airway directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Rusch Single Use Crystal Tracheostomy Tube is indicated for airway management of tracheostomized patients. The Rusch Single Use Crystal Tracheostomy Tube Set is indicated for airway management of tracheostomized patients.
Product codes
73 JOH
Device Description
The Rusch Single Use Crystal Tracheostomy Tube set consists of a polyvinyl chloride tube with a radiopaque stripe, terminated with a flange and connector. The tube is fitted with a high volume cuff inflated through a luer-activated valve, pilot balloon, inflation tube and a lumen in the wall of the main tube.
Inner cannulas made of low density polyethylene and specifically designed for use with this tube are individually sterile packed. These cannulas may be boxed with the tracheostomy tube and will be available separately.
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
Laboratory bench testing has been completed to demonstrate compliance with appropriate sections of ISO 5366.
Key Metrics
Not Found
Predicate Device(s)
Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465, Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 a sequence of handwritten alphanumeric characters, specifically 'K972546'. The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The writing appears to be done with a dark ink or marker on a light background, providing good contrast and readability.
RUSCH.
INTERNATIONAL
Group Regulatory Affairs
A Subsidiary of Teleflex Incorporated (USA)
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
510 (k) SUMARY
APR 1 4 1998
[As required by 21 CFR 807.92]
1. Submitter and Contact Person
James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, NH 03452 Tel: (603)532 7706 Fax: (603)532 8211
- Device set Name
Trade Name:
Rüsch Single Use Crystal Tracheostomy Tube set
Common Name:
Tracheostomy Tube
Classification Name:
Tube, Tracheostomy, and Tube Cuff 73 JOH; 21 CFR 868.5800; Class II medical device
3. Comparison Devices
Rüsch (Warne Surgical Products) Crystal Tracheostomy Tube -Preamendment
Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465
Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088
1
4. Description of Device Set
The Rusch Single Use Crystal Tracheostomy Tube set consists of a polyvinyl chloride tube with a radiopaque stripe, terminated with a flange and connector. The tube is fitted with a high volume cuff inflated through a luer-activated valve, pilot balloon, inflation tube and a lumen in the wall of the main tube.
Inner cannulas made of low density polyethylene and specifically designed for use with this tube are individually sterile packed. These cannulas may be boxed with the tracheostomy tube and will be available separately.
5. Intended Use
The Rusch Single Use Crystal Tracheostomy Tube is indicated for airway management of tracheostomized patients.
Summary of Technological Characteristics 6.
The Rüsch Single Use Crystal Tracheostomy Tube Set has been developed from the Rüsch (formerly Warne Surgical Products) Crystal Tracheostomy Tube, which was in interstate commerce prior to May 28, 1976. The cumulative effect of developments, including modifications introduced to comply with the voluntary ISO 5366 standard, is thought to warrant this premarket notification.
The Rüsch Single Use Crystal Tracheostomy Tube Set will be available with and without an inner cannula, like the Smiths Industries (Portex) product and sizes from 3.0 to 11.0 mm.
7. Summary of Performance Data
Laboratory bench testing has been completed to demonstrate compliance with appropriate sections of ISO 5366.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1998
Mr. James R. Whitney Rüsch International Tall Pines Park Jaffrey, NH 03452
Re : K972546 Rüsch Crystal Tracheostomy Tube Requlatory Class: II (two) Product Code: 73 JOH Dated: November 25, 1997 Received: January 15, 1998
Dear Mr. Whitney: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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, 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.
3
Page 2 - Mr. James R. Whitney
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/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification "Indications for Use" Statement
510(k) Number (if known):
K 972546
Device set Name:
Rüsch Single Use Crystal Tracheostomy Tube Set
Indications for Use:
The Rusch Single Use Crystal Tracheostomy Tube Set is indicated for airway management of tracheostomized patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
ﺳ
Thomas J. Callahor
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 6972546
510(k) Number.
Prescription Use
(Per 21 CFR 801.109) /
子
Over-the-Counter Use