(147 days)
No
The summary describes a standard medical device (Foley catheter with temperature sensor) and makes no mention of AI or ML capabilities, data processing, or algorithms.
No.
The device is primarily used for drainage/collection of urine and temperature monitoring, which are diagnostic and supportive functions rather than direct therapeutic treatment of a disease or condition.
No.
The device is used for drainage/collection of urine and simultaneous monitoring of body core temperature, which are management activities rather than diagnostic ones.
No
The device description clearly states it is a "Foley Catheter with Temperature Sensor," which is a physical medical device, 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 for the drainage/collection of urine and simultaneous monitoring of body core temperature. This is a direct interaction with the patient's body for therapeutic (drainage) and monitoring purposes.
- Device Description: The description reinforces the function of draining urine and monitoring temperature, which are in-vivo (within the living body) activities.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of a specimen outside the body.
Therefore, the Well Lead All Silicone Foley Catheters With Temperature Sensor is a medical device used in vivo for drainage and monitoring, not an IVD.
N/A
Intended Use / Indications 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.
Product codes
EZL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY - K091516 (as required by 807.92(c))
.
:
OCT】62009
| Regulatory Correspondent: | Regulatory and Marketing Services, Inc
962 Allegro Lane
Apollo Beach, FL 33572
Arthur Ward
Awconsltng@aol.com
813-645-2855
813-645-2856 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Well Lead Medical Device Instruments Ltd.
A4-1# Jinhu Industrial Estate
Hualong, Panyu
Guangzhou City, China 511434
Han Guang Yuan
info@welllead.com.cn |
| Date of Summary: | 5/18/09 |
| Trade/Proprietary Name: | Well Lead all Silicone Foley Catheter with
Temperature Sensor |
| Classification Name: | Urological Catheter and Accessories |
| Product Code: | EZL |
| Intended 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. |
| Device Description: | 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. |
1
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.
2
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
3
Page 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/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
4
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