(123 days)
Not Found
No
The device description details a mechanical tracheostomy tube and its components, with no mention of software, algorithms, or any features indicative of AI/ML.
Yes
The device is intended for "airway management of tracheostomized patients," which directly addresses a physiological need or provides supportive care, fitting the definition of a therapeutic device.
No
The device description clearly states it is for "airway management of tracheostomized patients," which is a treatment or management function, not a diagnostic one.
No
The device description clearly outlines physical components made of PVC, Nylon, and polyethylene, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Rüsch Crystal Clear Tracheostomy Sets are used for airway management by being inserted into the trachea of a patient. They are a physical device used directly on the patient, not for analyzing samples taken from the patient.
- Intended Use: The intended use clearly states "airway management of tracheostomized patients," which is a therapeutic and supportive function, not a diagnostic one based on in vitro analysis.
The provided information describes a medical device used for direct patient care, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.
Product codes (comma separated list FDA assigned to the subject device)
73 JOH
Device Description
TracheoFix Sets will be offered in two (2) versions - Cuffed and Uncuffed. Descriptions are as follows:
The Rüsch Crystal Clear Tracheostomy Sets will be offered in two (2) versions - Cuffed and Cuffless. Descriptions are:
Rüsch Crystal Clear Tracheostomy Set, Cuffed:
The Rüsch Crystal Clear Tracheostomy Set, Cuffed consists of a polyvinylchloride (PVC) tracheostomy tube with high volume/low pressure cuff, pilot balloon and tapered tip to facilitate insertion, a PVC flexible neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.
Rüsch Crystal Clear Tracheostomy Set, Cuffless:
The Rüsch Crystal Clear Tracheostomy Set, Cuffless consists of a polyvinylchloride (PVC) tracheostomy tube with a tapered tip to facilitate insertion, a PVC flexible flange with a PVC turn lock fastener neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.
Each Rüsch Crystal Clear Tracheostomy Set, Cuffed and Cuffless will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, inside a protective inner pouch in a blister pack sheet with a Tyvek paper seal to provide a sterility barrier. Each pack will be individually labeled. The device will then be packaged, five units per carton, in a labeled outer cardboard carton. The inner cannulae will be marketed separately as accessories under separate part numbers.
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.
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
MAR 2 8 2003
Image /page/0/Picture/1 description: The image shows the logo for RUSCH International Group Regulatory Affairs. The word "RUSCH" is in large, bold, black letters at the top of the image. Below that, in smaller letters, is "INTERNATIONAL Group Regulatory Affairs". At the bottom of the image, it says "A Subsidiary of Teleflex Incorporated (USA)".
Tall Pines Park affrey, NH 03452 603) 532-7706 FAX (603) 532-8211 or 6108
510 (k) Summary
- Submitter Name, Address, and Date of Submission: 1.
Rick Lykins Group RA Manager - US Rüsch International Tall Pines Park Jaffrey, NH 03452 Telephone Number: (603) 532-0204 Fax Number: (603) 532-6179
rlykins@tfx.com E-Mail:
Same as above Contact:
- Name of the Device, Common, Proprietary (if known), and 2. Classification:
Classification Name: Tube, Tracheostomy (W/WO Connector)
Common Name: Tracheostomy Tube
Rüsch Crystal Clear Tracheostomy Proprietary Name: Set, Cuffed Rüsch Crystal Clear Tracheostomy Set, Cuffless
3. Identification of the legally marketed device to which the submitter claims equivalence:
Rüsch Crystal Clear Tracheostomy Sets are substantially The equivalent in design and materials to:
Rüsch Crystal Tracheostomy Set - K972546
1
Page 2
4 . Description of the Device:
TracheoFix Sets will be offered in two (2) versions - Cuffed and Uncuffed. Descriptions are as follows:
The Rüsch Crystal Clear Tracheostomy Sets will be offered in two (2) versions - Cuffed and Cuffless. Descriptions are:
Rüsch Crystal Clear Tracheostomy Set, Cuffed:
The Rüsch Crystal Clear Tracheostomy Set, Cuffed consists of a polyvinylchloride (PVC) tracheostomy tube with high volume/low pressure cuff, pilot balloon and tapered tip to facilitate insertion, a PVC flexible neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.
Rüsch Crystal Clear Tracheostomy Set, Cuffless:
The Rüsch Crystal Clear Tracheostomy Set, Cuffless consists of a polyvinylchloride (PVC) tracheostomy tube with a tapered tip to facilitate insertion, a PVC flexible flange with a PVC turn lock fastener neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.
2
Page 3
Each Rüsch Crystal Clear Tracheostomy Set, Cuffed and Cuffless provided sterile, by either Gamma Irradiation or will be Ethylene Oxide, inside a protective inner pouch in a blister pack sheet with a Tyvek paper seal to provide a sterility Each pack will be individually labeled. The device barrier. will then be packaged, five units per carton, in a labeled outer cardboard carton. The inner cannulae will be marketed separately as accessories under separate part numbers.
Intended Use of the Device: 5.
The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.
୧ . Summary of Technological Characteristics:
Rüsch Crystal Clear Tracheostomy Sets are identical The in materials and sizes to the 510(k) # K972546, Rüsch Crystal Tracheostomy Set, which was determined to be substantially equivalent on April 14, 1998. The 3.0mm and 11.0mm sizes indicated in K972546 have been removed from the current product line.
3
Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Mr. Rick Lykins Group RA Manager Rüsch International 50 Plantation Drive Jaffrey, New Hampshire 03452
Re: K023918
Trade/Device Name: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: 73 JOH Dated: November 21, 2002 Received: November 25, 2002
Dear Mr. Lykins:
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.
4
Page 2 - Mr. Lykins
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 (OS) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page of 1
510(k) Number (if known): ¥023918
Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Device Name: Cuffless
Indications for Use:
The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless intended for airway management of tracheostomized are patients.
(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)
Susan Ransor
(Division Sign-Off) Division of Anesthesiolo Infection Control. De
510(k) Number: