(27 days)
The AMSelf TM Closed Catheterization System is intended for use in the drainage of urine from the bladder.
The AMSelf TM Closed Catheterization System is a single-use patient device, compromising a PVC urological catheter and a drainage bag assembled in a closed-system configuration.
This 510(k) submission (K082831) for the AMSelf™ Closed Catheterization System is a premarket notification for a Class II medical device. The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, the AMSure™ Urethral Catheterization Tray (K030712), rather than presenting a study to prove performance against specific acceptance criteria for a novel device.
The provided information indicates that "Performance and biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." However, it does not explicitly detail the acceptance criteria, the specific results of these tests, or how these results "prove" the device meets the criteria. The submission is a standard FDA 510(k) filing, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate device). Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance endpoints is not present in this document.
Given the nature of the document, most of the requested information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth data for training sets is not applicable or explicitly stated.
Here's an attempt to address your prompts based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. The "performance" assessment is covered by the statement: "Performance and biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." This implies that the device successfully met internal or regulatory performance standards for a catheterization system. The implicit acceptance criterion is that the device performs equivalently to the predicate device, K030712, in terms of safety and effectiveness for urine drainage.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and effectiveness for intended use (drainage of urine from the bladder), equivalent to predicate device K030712. | "Performance and biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." The FDA's substantial equivalence determination (K082831) confirms that the device is considered as safe and effective as a legally marketed predicate device (K030712) for the stated indications for use. This implies the device passed necessary tests (e.g., sterility, material compatibility, functional integrity for fluid drainage, leak testing, ease of use for catheter insertion and removal, packaging integrity) to be deemed safe and effective for its purpose, aligning with the performance of the predicate. Specific quantitative results are not provided in this summary. |
| Biocompatibility with human tissues (for a device in contact with mucous membranes and internal body fluids). | "Biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." This indicates the materials used in the system are suitable for human contact without adverse reactions, typically confirmed through ISO 10993 series testing (though specific tests aren't listed). |
| Maintains sterile barrier and integrity of the closed system for urine drainage. | Implied through "performance and biocompatibility testing." A closed catheterization system specifically aims to reduce infection risk, so maintaining sterility and integrity during use would be a key performance aspect. |
| Functional performance in draining urine from the bladder, including flow rate and prevention of reflux/leakage (standard for such devices). | Implied through "performance testing." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for performance or biocompatibility testing, nor does it specify the provenance of any data (e.g., country of origin, retrospective or prospective). Such details are typically found in the full 510(k) submission, which this summary does not include.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The submission is for a physical medical device, not an interpretative AI/image analysis product where "ground truth" is established by experts. Performance and biocompatibility testing for such devices are typically conducted in laboratories following established standards and protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed for this physical device.
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
This information is not applicable and not provided. MRMC studies are generally performed for diagnostic imaging devices or AI-assisted diagnostic tools, not for a physical device like a catheterization system. There is no AI component mentioned in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical catheterization system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided in the context of "ground truth" as typically discussed for diagnostic or AI-driven systems. For a physical device, testing involves objective measures of criteria like sterility, material strength, flow rates, biocompatibility, and leak integrity. The "ground truth" or reference standards are typically established through recognized laboratory testing standards and methods (e.g., ISO standards, ASTM standards, USP monographs), with results empirically measured against these standards, rather than expert consensus on a diagnosis.
8. The sample size for the training set
This information is not applicable and not provided. Since this is a physical medical device and not an AI or machine learning algorithm, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" for this physical medical device.
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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 DrivePomona, 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 aclosed-system configuration. |
| Intended Use: | The AMSelf ™ Closed Catheterization System is intended for use in thedrainage of urine from the bladder. |
| Comparison to Predicate: | The AMSelf ™ Closed Catheterization System is a configuration andassembly 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 theAMSelf ™ Closed Catheterization System is safe and effective for itsintended use. |
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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 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.
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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
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| 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___________________________________________________________________________________________________________________________________________________________________________
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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 |
§ 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.