(27 days)
Not Found
No
The summary describes a simple mechanical device for urine drainage and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is intended for the drainage of urine, which is a supportive function and not a therapeutic intervention for a disease or condition.
No
The device is described as a "Closed Catheterization System" for "drainage of urine from the bladder," which indicates a therapeutic or management function rather than diagnosis.
No
The device description explicitly states it is a "single-use patient device, compromising a PVC urological catheter and a drainage bag assembled in a closed-system configuration," indicating it includes physical hardware components.
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 related to the function of the bladder, not for examining specimens in vitro (outside the body).
- Device Description: The device is a "urological catheter and a drainage bag." This is a medical device used for a physical procedure (catheterization), not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or any process that would be performed in vitro.
IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device is used to physically drain urine from the bladder.
N/A
Intended Use / Indications for Use
The AMSelf ™ Closed Catheterization System is intended for use in the drainage of urine from the bladder.
Product codes (comma separated list FDA assigned to the subject device)
FCM
Device Description
The AMSelf ™ Closed Catheterization System is a single-use patient device, compromising a PVC urological catheter and a drainage bag assembled in a closed-system configuration.
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 that the AMSelf ™ Closed Catheterization System is safe and effective 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.
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Page / KO82831
OCT 2 3 2008
510(K) Summary of Safety and Effectiveness AMSelf™ Closed Catheterization System
| 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: | September 24, 2008 |
| Classification Name: | Tray, Catheterization, Sterile Urethral, with or without Catheter (876.5130) |
| Common Name: | Catheterization Kit |
| Proprietary Name: | AMSelf ™ Closed Catheterization System |
| Product Code: | FCM |
| Medical Specialty: | Gastroenterology/Urology |
| Device Class: | Class II |
| Unmodified Device: | AMSure ™ Urethral Catheterization Tray (K030712) |
| Device Description: | The AMSelf ™ Closed Catheterization System is a single-use patient device,
compromising a PVC urological catheter and a drainage bag assembled in a
closed-system configuration. |
| Intended Use: | The AMSelf ™ Closed Catheterization System is intended for use in the
drainage of urine from the bladder. |
| Comparison to Predicate: | The AMSelf ™ Closed Catheterization System is a configuration and
assembly modification of the AMSure ™ Urethral Catheterization Tray
(K030712) and is intended for the same use. |
| Non-Clinical Testing: | Performance and biocompatibility testing has demonstrated that the
AMSelf ™ Closed Catheterization System is safe and effective for its
intended use. |
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 stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2008
Ching Ching Seah, Ph.D. Director of Research, Development and Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive POMONA CA 91767
Re: K082831
Trade/Device Name: AMSelfTM Closed Catheterization System Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: FCM Dated: September 24, 2008 Received: October 8, 2008
Dear Dr. Seah:
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
Page 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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,
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 4 of 6
| Indications for Use Statement | |
|---|---|
| 510(k) Number: (if known) | K082831 |
| Device Name: | AMSelf TM Closed Catheterization System |
| Indications for Use: | The AMSelf TM Closed Catheterization System is intended for use in the drainage of urine from the bladder. |
Prescription > Use (Per 21 CFR 801. 109)
. ... OR
Over-The-Counter Use___________________________________________________________________________________________________________________________________________________________________________
:
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K082831 |