(109 days)
Not Found
No
The summary describes a simple, single-use catheter made of PVC tubing and a funnel, with no mention of AI, ML, image processing, or any computational capabilities.
Yes
The device is intended for the drainage of urine from the bladder, which is a therapeutic action.
No
This device is described as an intermittent catheter intended for the drainage of urine, which is a therapeutic or management function, not a diagnostic one. The document focuses on its performance for drainage and biocompatibility, not on diagnosing a condition.
No
The device description explicitly states it is a "PVC tubing and funnel," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "drainage of urine from the bladder." This is a direct intervention on the body for therapeutic or diagnostic purposes, not for examining specimens in vitro (outside the body).
- Device Description: The device is a "PVC tubing and funnel," designed for physical insertion and drainage. This is consistent with a medical device used for a procedure, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine itself), using reagents, or performing tests in vitro.
IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to physically drain urine, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The AMSure™ PVC Intermittent Catheter is intended for use in the drainage of urine from the bladder.
Product codes (comma separated list FDA assigned to the subject device)
FCM, EZD
Device Description
The AMSure™ PVC Intermittent Catheter is a sterile, single-use patient device, compromising a PVC tubing and funnel.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and biocompatibility testing has demonstrated the safety and effectiveness of the AMSure™ PVC Intermittent Catheter for its intended use.
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
§ 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
AMSINO
Special 510(k) Submission ----------------------------------------------------------------------------------------------------------------------------------------------------
K09/306
510(K) Summary of Safety and Effectiveness AMSelf™ PVC Intermittent Catheter
| Company: | Amsino International, Inc.
855 Towne Center Drive
Pomona,CA 91767
(909)626-5888 | AUG 21 2009 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Holiven Ji
Manager of Regulatory Affairs | |
| Date Prepared: | April 22, 2009 | |
| Classification Name: | Tray, Catheterization, Sterile Urethral, with or without Catheter
(876.5130) | |
| Common Name: | Urethral Catheter | |
| Proprietary Name: | AMSure ™ PVC Intermittent Catheter | |
| Product Code: | FCM | |
| Medical Specialty: | Gastroenterology/Urology | |
| Device Class: | Class II | |
| Unmodified Device: | AMSure ™ Urethral Catheterization Tray (K030712) | |
| Device Description: | The AMSure ™ PVC Intermittent Catheter is a sterile, single-
use patient device, compromising a PVC tubing and funnel. | |
| Intended Use: | The AMSure ™ PVC Intermittent Catheter is intended for use in
the drainage of urine from the bladder. | |
| Comparison to Predicate: | The AMSure ™ PVC Intermittent Catheter is a configuration
and label modification of the AMSure ™ Urethral
Catheterization Tray (K030712) and is intended for the same
use. | |
| Non-Clinical Testing: | Performance and biocompatibility testing has demonstrated
the safety and effectiveness of the AMSure ™ PVC
Intermittent Catheter for its intended use. | |
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Image /page/1/Picture/0 description: The image shows a logo and the word "DEPARTMENT". The logo is a stylized image of an eagle with three lines representing its wings. The word "DEPARTMENT" is in a bold, sans-serif font and is underlined. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 1 2009
Mr. Holiven Ji Manager of International Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive POMONA CA 91767
Re: K091306
Trade/Device Name: AMSure" PVC Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 20, 2009 Received: July 28, 2009
Dear Mr, Ji:
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 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.
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); medical device reporting of medical
2
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Lammy M. Mouck
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number:
K091/306
(if known)
:
510(k) Number --
Device Name: AMSure PVC Intermittent Catheter
Indications The AMSure PVC Intermittent Catheter is intended for use in for Use: the drainage of urine from the bladder.
Prescription Use √ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | K091306 |
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