(36 days)
K911865/B
K911865/B
No
The device description and intended use describe a simple tube set for fluid delivery, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a tube set intended to provide a conduit for liquid to a bladder catheter during a Urodynamic Cystometry test. It is a delivery system for fluids, not a device that directly treats or diagnoses a medical condition.
No
The device is described as a tube set that connects a liquid reservoir to a bladder catheter for filling the bladder during a Urodynamic Cystometry test. It provides a means to perform a part of the test (bladder filling), but it does not perform any diagnostic function itself (e.g., measuring, analyzing, or interpreting data to diagnose a condition).
No
The device description explicitly details physical components like a vented spike, drip chamber, roller clamp, male luer lock connector, and polyurethane tubing, 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 to provide a conduit for fluid to fill the bladder during a Urodynamic Cystometry test. This is a procedure performed on the patient's body, not on a sample taken from the body.
- Device Description: The device is a tube set for fluid delivery, not for analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine or blood), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is purely for fluid delivery during a clinical procedure.
N/A
Intended Use / Indications for Use
The LuMax Cystometry Tube Set is intended to be used in the exact same manner as the previous tube sets manufactured by NASP and cleared by FDA under K911865/B. The intended use of these tube sets is to provide a conduit from a liquid resevoir to the infusion lumen of a bladder pressure catheter.
The LuMax Cystometry Tube Set is to be used to provide a conduit from a liguid reservoir to the infusion lumen of a bladder catheter whenever filling a bladder is required in conjunction with performing a Urodynamic Cystometry test .
Product codes
78 FEN
Device Description
The LuMax Cystometry Tube Set consists of a vented spike with a drip chamber for connection to the liquid reservoir, usually a one to three liter saline or DI water bag, a roller clamp for regulating fluid flow rates, and a male luer lock connector for connecting to the filling lumen of the bladder catheter. It is assembled with polyurethane tubing giving it an overall length of 72 inches.
The materials used in the manufacture of the tube set are used in similar tubing sets and in urologic catheters. The methods of packaging and sterilization are the same as MedAmicus uses in its Fiberoptic Catheter line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
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
Sample devices will be subjected to physical bench testing. Tests will include visual examination for workmanship, tensile strength testing and pressure withstand testing. All samples will meet the required specifications. Test descriptions and specifications are contained in Attachment H.
Key Metrics
Not Found
Predicate Device(s)
K911865/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1620 Urodynamics measurement system.
(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
JUN - 3 1997
PAGE I OF 3
510(k) Summary
LuMax Cystometry Tube Set
General Information
Classification Class II
| Trade Name | LuMax Cystometry Tube Set |
|---|---|
| Submitter | MedAmicus, Inc. |
| 15301 Highway 55 West | |
| Minneapolis, MN 55447 | |
| Contact | Dennis S. Madison |
| Vice President of Administration and regulatory Affairs | |
| (612) 559-2613 |
Predicate Devices
Administration tube set from North American Sterilization and Packaging Company (NASP).
Device Description Information
Intended Use
The LuMax Cystometry Tube Set is intended to be used in the exact same manner as the previous tube sets manufactured by NASP and cleared by FDA under K911865/B. The intended use of these tube sets is to provide a conduit from a liquid resevoir to the infusion lumen of a bladder pressure catheter.
Device Description
The LuMax Cystometry Tube Set consists of a vented spike with a drip chamber for connection to the liquid reservoir, usually a one to three liter saline or DI water bag, a roller clamp for regulating fluid flow rates, and a male luer lock connector for connecting to the filling lumen of the bladder catheter. It is assembled with polyurethane tubing giving it an overall length of 72 inches.
1
The materials used in the manufacture of the tube set are used in similar tubing sets and in urologic catheters. The methods of packaging and sterilization are the same as MedAmicus uses in its Fiberoptic Catheter line.
PAGE ZOF 3
100 100 100 100 100 100
Device Performance / Product Testing
Sample devices will be subjected to physical bench testing. Tests will include visual examination for workmanship, tensile strength testing and pressure withstand testing. All samples will meet the required specifications. Test descriptions and specifications are contained in Attachment H.
Sterilization Information
The sterilization cycle for the LuMax Cystometry Tube Set will be identical to the cycle for the Urodynamic Fiberoptic Catheters.The ETO sterilization cycle for these products was validated using the AAMI method of three half cycles and one full cycle.
Validation tests were performed with spore strips (one million spores of Bacillus var niger) placed in sample product and sterilized at one half the regular cycle. The results showed a complete kill which proves a Sterility Assurance Level (SAL) of better than 10°. See Attachment D for further information.
Packaging
The packaging materials for the package are identical to the MedAmicus Urodynamic Fiberoptic Pressure Catheter products. The product is placed within a sealed Tyvek Pouch. The sterile product, with appropriated labeling, is then placed in a carton for shipping.
Substantial Equivalence
The LuMax Cystometry Tube Set is intended to provide a conduit from a saline or DI resevoir and the infusion lumen of a bladder pressure catheter. The basic design, methods of manufacturing, and materials used are identical to existing administration tube sets cleared by the FDA. Our application of this device is substantially equivalent to the aforementioned standard medical devices already approved for use. The clinical indications for use remain unchanged. MedAmicus believes the LuMax
2
Cystometry Tube Set is substantially equivalent to currently marketed medical administration tube sets employing the same technology.
Conclusion
In conclusion, MedAmicus believes the LuMax Cystometry Tube Set is substantially equivalent to the predicate administration tube sets. The intended use, materials, sterilization, packaging, labeling, and method of operation and manufacturing methods are substantially equivalent.
3
Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Mr. Dennis S. Madison Vice President of Administration and Regulatory Affairs MedAmicus, Inc. 15301 Highway 55 West Plymouth, Minnesota 55447
Re: K971911
LuMax Cystometry Tube Set .... Dated: April 24, 1997 Received: April 28, 1997 Regulatory Class: II 21 CFR 876.1620/Procode: 78 FEN
Dear Mr. Madison:
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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 the Electronic Product 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) 594-4616. 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,
William 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
4
S10(k) Number (if known): K9719 ||
ADMINISTRATION TOBINE SET Device Name: Cystomersey
Indications For Use:
The LuMax Cystometry Tube Set is to be used to provide a conduit from a liguid reservoir to the infusion lumen of a bladder catheter whenever filling a bladder is required in conjunction with performing a Urodynamic Cystometry test .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter R. Sutherg
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number 719
Prescription Use (Per 21 CFR. 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)