(147 days)
The Well Lead All Silicone Foley Catheters With Temperature Sensor are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
The Well Lead all Silicone Foley Catheters with Temperature are two-way Foley Catheters which are used in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
This submission is for a medical device (Well Lead All Silicone Foley Catheter with Temperature Sensor), not an AI/ML device, so the requested information regarding AI-specific criteria (like MRMC studies, ground truth establishment for training sets, etc.) is not applicable. The provided document is a 510(k) summary for a medical device and describes its intended use and general performance testing for substantial equivalence to predicate devices, but does not detail AI/ML acceptance criteria or studies.
However, I can extract the relevant information about the non-AI device's performance testing and acceptance criteria as described in the summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from the context of substantial equivalence) |
|---|---|
| Safe and effective for intended use | Meets manufacturing materials, operating principles, and physical operational specifications equivalent to predicate devices. |
| Equivalent intended use to predicate devices | Intended use for urine drainage/collection and simultaneous body core temperature monitoring. |
| Biocompatibility | Biocompatibility testing was completed and submitted (Section 14). |
| Performance of Foley Catheter component | All appropriate testing for Foley Catheters was completed and submitted in previously cleared submission K082815, using the same materials. |
| Performance of Temperature Sensor component | Testing for the Temperature Sensor can be found in Section 11 (Performance Testing). |
| Manufacturing quality | Subject to general controls provisions of the Act including good manufacturing practices (21 CFR Part 820). |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size or data provenance in the context of device performance studies. It refers to testing previously conducted for predicate devices and testing for the current device's components.
- For Foley Catheter components: "All of the appropriate testing for the Foley Catheters was completed and submitted in the previously cleared submission K082815 all the materials are the same as the Foley Catheters in this submission." This implies reliance on prior testing, the details of which are not within this summary.
- For Temperature Sensor: "The testing for the Temperature Sensor can be found in Section 11 the Performance Testing section and in Section 14 Biocompatibility Testing." Specific details about sample size or provenance for this testing are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar tasks.
4. Adjudication method for the test set
This section is not applicable for the same reasons as above. Device performance is typically assessed through engineering tests, material compatibility tests, and functional evaluations against specifications, not through expert adjudication in the traditional sense.
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 section is not applicable as the device is a physical medical device, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used
For physical medical devices like this, "ground truth" typically refers to established engineering standards, material specifications, physiological measurement accuracy (for the temperature sensor), and successful performance in functional tests. The summary implies that the ground truth for performance is established by demonstrating compliance with these standards and equivalence to legally marketed predicate devices.
8. The sample size for the training set
This section is not applicable as the device is a physical medical device and does not involve AI/ML training sets.
9. How the ground truth for the training set was established
This section is not applicable as the device is a physical medical device and does not involve AI/ML training sets.
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510(k) SUMMARY - K091516 (as required by 807.92(c))
.
:
OCT】62009
| Regulatory Correspondent: | Regulatory and Marketing Services, Inc962 Allegro LaneApollo Beach, FL 33572Arthur WardAwconsltng@aol.com813-645-2855813-645-2856 |
|---|---|
| Submitter of 510(k): | Well Lead Medical Device Instruments Ltd.A4-1# Jinhu Industrial EstateHualong, PanyuGuangzhou City, China 511434Han Guang Yuaninfo@welllead.com.cn |
| Date of Summary: | 5/18/09 |
| Trade/Proprietary Name: | Well Lead all Silicone Foley Catheter withTemperature Sensor |
| Classification Name: | Urological Catheter and Accessories |
| Product Code: | EZL |
| Intended Use: | The Well Lead all Silicone Foley Catheters withTemperature Sensor are intended for use in thedrainage/collection of urine from the urinarybladder and simultaneous monitoring of the bodycore temperature during surgical or post-surgicalintervals. |
| Device Description: | The Well Lead all Silicone Foley Catheters withTemperature are two-way Foley Catheters whichare used in the drainage/collection of urine from theurinary bladder and simultaneous monitoring of thebody core temperature during surgical or post-surgical intervals. |
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K873448 -- Smiths Foley Catheter Temperature Predicate Device: Sensor K082815 - Well Lead Silicone and Latex Foley Catheters Well Lead Medical Instruments claims the proposed Substantial Equivalence: devices to be substantially equivalent to the devices previously cleared by FDA in K873448 and K082815. Well Lead Medical Products claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principals and physical operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate device has been identified and explained on the comparison chart which has been included in section 9 of this submission. All of the appropriate testing for the Foley Catheters Performance Testing: was completed and submitted in the previously cleared submission K082815 all the materials are the same as the Foley Catheters in this submission. The testing for the Temperature Sensor can be found in Section 11 the Performance Testing section and in Section 14 Biocompatibility Testing.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
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
Well Lead Medical Co., Ltd. % Mr. Arthur Ward President Regulatory and Marketing Services, Inc. 962 Allegro Lane APOLLO BEACH FL 33572
OCT 1 6 2009
Re: K091516
Trade/Device Name: Well Lead All Silicone Foley Catheters with Temperature Sensor Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: September 1, 2009 Received: September 11, 2009
Dear Mr. Ward:
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 (reporting of medical
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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/CDRH/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kog15/6
Indications for Use
091516 510(k) Number (if known):
Device Name: Well Lead All Silicone Foley Catheters With Temperature Sensor
Indication for use:
The Well Lead All Silicone Foley Catheters With Temperature Sensor are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
x Over-The-Counter Use Prescription Use AND/OR (21CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulda Ruma
(Division Sign Off) (Division Sign-On)
Division of Reproductive, Abdominal, Division ological Devices 510(k) Number_
Traditional 510(k) for Well Lead All Silicone Foley Catheter With Temperature Sensor
§ 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.