(265 days)
No
The device description and intended use describe a simple tubing set for fluid infusion and irrigation, with no mention of any computational or analytical capabilities that would suggest AI/ML.
No.
The device facilitates the infusion of fluids forbladder evacuation and irrigation during medical procedures but does not inherently provide therapy itself.
No
Explanation: The device is described as an "Irrigation Set" intended for the "infusion of fluids to evacuate the bladder" or for "continuous bladder irrigation." Its function is to deliver fluids, not to diagnose medical conditions.
No
The device description clearly outlines physical components such as tubing, spikes, a drip chamber, and a roller clamp, 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 the "infusion of fluids to evacuate the bladder" and for "continuous bladder irrigation" during procedures like cystoscopies and transurethral resections. This describes a device used in vivo (within the body) for therapeutic or procedural purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details tubing, spikes, a catheter adapter, drip chamber, and roller clamp. These are components of a system designed to deliver fluids into the bladder, not to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample collection, or any other elements typically associated with in vitro diagnostic devices.
Therefore, the AMSure® Bladder Irrigation Set is a medical device used for irrigation and fluid delivery within the body, not an IVD.
N/A
Intended Use / Indications for Use
The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.
Product codes
LJH
Device Description
The AMSure™ Bladder Irrigation Set is comprised of tubing with a catheter adapter at one end and “spikes” with protectors on the other end. The device is available in a single-lead (single spike), or multiple-lead (2 or 4 spikes) configuration. All configurations have a drip chamber and directly below the drip chamber is a roller clamp. There is a flexible, non-latex, synthetic rubber connecting tube, attached to the catheter adapter.
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
Non-Clinical Testing: Performance and biocompatibility testing have demonstrated that the AMSure® Bladder Irrigation System is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Medline Y-Type TUR/Bladder Irrigation Set (K970946)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K070873
AMSINO
Bladder Irrigation Set 510K Submission
510(K) Summary of Safety and Effectiveness
| Company: | Amsino International, Inc.
855 Towne Center Drive
Pomona, CA 91767
(909) 626-5888 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ching Ching Seah, Ph.D.
Director of Regulatory Affairs |
| Date Prepared: | March 27, 2007 |
| | DEC 1 9 2007 |
| Classification Name: | System, Urological, Irrigation
Common/Usual Name: Bladder Irrigation Set, TUR Irrigation Set
Proprietary Name: AMSure® Bladder Irrigation System
Product Code: LJH
Medical Specialty: Gastroenterology/Urology
Device Class: Unclassified (510K) |
| Predicate Devices: | Medline Y-Type TUR/Bladder Irrigation Set (K970946) |
| Device Description: | The AMSure™ Bladder Irrigation Set is comprised of tubing with a
catheter adapter at one end and “spikes” with protectors on the other
end. The device is available in a single-lead (single spike), or
multiple-lead (2 or 4 spikes) configuration. All configurations have a
drip chamber and directly below the drip chamber is a roller clamp.
There is a flexible, non-latex, synthetic rubber connecting tube,
attached to the catheter adapter. |
| Intended Use: | The AMSure® Bladder Irrigation Set is intended for the infusion of
fluids to evacuate the bladder. It is also indicated for use in such
procedures as cystoscopies and transurethral-resections as a means of
continuous bladder irrigation. |
| Comparison to Predicate: | The AMSure® Bladder Irrigation System is equivalent to the predicate
device in operational principle, materials, configuration, technical
characteristics and intended use. Any existing differences do not
affect safety and effectiveness of the device. |
| Non-Clinical Testing: | Performance and biocompatibility testing have demonstrated that the
AMSure® Bladder Irrigation System is safe and effective for its
intended use. |
:
. 1
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird with three parallel lines forming its body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2007
Yi Chen, Ph.D., RAC Vice President, Regulatory Affairs and Quality Assurance Amsino International, Inc. 855 Towne Center Drive POMONA CA 91767
Re: K070873
Trade/Device Name: AMSure® Bladder Irrigation Set Regulation Number: None Regulatory Class: Unclassified Product Code: LJH Dated: December 4, 2007 Received: December 11, 2007
Dear Dr. Chen:
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.
2
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 (QS) 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy Crogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K07 08 73
AMSINO
Bladder Irrigation Set 510K Submission
| 510(k) Number:
| (if known) | |
|---|---|
| Device Name: | AMSure ® Bladder Irrigation Set |
| Indications for Use: | The AMSure ® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation. |
Indications for Use Statement
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801. 109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Rauiological Devices
| 510(k) Number | B0P873 |
|---|---|
| --------------- | -------- |
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