(265 days)
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.
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.
The provided 510(k) submission for the AMSure® Bladder Irrigation Set (K070873) describes a medical device and its non-clinical testing for safety and effectiveness. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to an AI/algorithm-driven device, nor does it detail a study that proves the device meets such criteria in the context of AI.
The information provided confirms that the AMSure® Bladder Irrigation Set is a urological irrigation system, and its submission indicates performance and biocompatibility testing were conducted. However, these tests are typical for a physical medical device and do not involve AI, machine learning, or software-driven diagnostic capabilities. Therefore, many of the questions regarding AI/algorithm performance, ground truth, expert review, and reader studies are not applicable to this submission.
Here's a breakdown of the requested information based on the provided document and why certain sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Performance and biocompatibility testing have demonstrated that the AMSure® Bladder Irrigation System is safe and effective for its intended use." However, it does not provide a table of specific acceptance criteria (e.g., fluid flow rates, pressure limits, material strength, sterility, etc.) or the quantitative results of these performance tests.
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical medical device, not an AI/algorithm. Performance testing would involve physical samples of the irrigation sets, not a "test set" of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI, refers to expert-validated labels for data. This device does not generate diagnostic outputs that require expert ground truth labeling.
4. Adjudication method for the test set
Not applicable. Adjudication methods are used in AI performance studies to resolve discrepancies in expert labeling or model outputs, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. There are no "human readers" interpreting data with or without AI assistance for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for this physical device that operates in a standalone capacity.
7. The type of ground truth used
Not applicable. As there's no AI/algorithm generating outputs to be evaluated against a ground truth, this concept doesn't apply. The "truth" for this device would be its physical properties and function meeting predefined engineering specifications and biological safety standards (e.g., non-toxic materials, sterile packaging).
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no "training set" in the AI sense.
9. How the ground truth for the training set was established
Not applicable. No AI training set.
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K070873
AMSINO
Bladder Irrigation Set 510K Submission
510(K) Summary of Safety and Effectiveness
| Company: | Amsino International, Inc.855 Towne Center DrivePomona, 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, IrrigationCommon/Usual Name: Bladder Irrigation Set, TUR Irrigation SetProprietary Name: AMSure® Bladder Irrigation SystemProduct Code: LJHMedical Specialty: Gastroenterology/UrologyDevice 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 acatheter adapter at one end and “spikes” with protectors on the otherend. The device is available in a single-lead (single spike), ormultiple-lead (2 or 4 spikes) configuration. All configurations have adrip 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 offluids to evacuate the bladder. It is also indicated for use in suchprocedures as cystoscopies and transurethral-resections as a means ofcontinuous bladder irrigation. |
| Comparison to Predicate: | The AMSure® Bladder Irrigation System is equivalent to the predicatedevice in operational principle, materials, configuration, technicalcharacteristics and intended use. Any existing differences do notaffect safety and effectiveness of the device. |
| Non-Clinical Testing: | Performance and biocompatibility testing have demonstrated that theAMSure® Bladder Irrigation System is safe and effective for itsintended use. |
:
. 1
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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.
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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
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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 |
|---|---|
| --------------- | -------- |
Page 4 of 14
§ 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.