(122 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a hydrophilic intermittent catheter, with no mention of AI or ML technology.
No
The device is described as an intermittent catheter for draining urine from the bladder, which is a supportive rather than therapeutic function.
No
The device description clearly states its purpose is for drainage of urine from the bladder, not for diagnosing any medical condition.
No
The device is a physical catheter intended for urine drainage, not a software application.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the physical drainage of urine from the bladder through insertion into the urethra. This is a physical intervention, not a test performed on a sample outside of the body.
- Device Description: The description details a physical catheter designed for insertion and drainage. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like urine itself), detecting biomarkers, or providing diagnostic information based on the analysis of a sample.
IVDs are devices intended for use in the examination of specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
INTENDED USE: The AMSure® Hydrophilic Intermittent Catheter is inserted into the patient's bladder and indicated for intermittent use for the purpose of drainage of urine from the bladder. The catheter does not contain a balloon on its tip. An optional Water sachet is included to activate the hydrophilic-coated surface prior to use. The target populations for the subject device are Adults and Pediatrics.
Product codes
EZD
Device Description
The AMSure® Hydrophilic Intermittent Catheter is a urethral catheter intended to be passed through the urethra during urinary catheterization and into the bladder to drain urine. It is hydrophilic and lubricous coated flexible tube owns a hydrophilic polymer in the surface which makes the catheter highly lubricious and good adhesion upon contact with water, saline solution, body fluids. The catheter and gripper is manufactured with medical grade PVC, the surface is coated with a hydrophilic low-friction coating (polyvinyl pyrrolidone, or PVP), the water sachet is with USP grade sterile water. Each catheter is provided in sterile, single-use packages, intended to be used by adults and pediatrics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra
Indicated Patient Age Range
Adults and Pediatrics
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)
Nonclinical Testing:
- Biocompatibility Testing: Cytotoxicity, Sensitization and Irritation have been conducted per ISO 10993-5 and ISO 10993-10. The Biocompatibility testing demonstrated the biological safety of the proposed devices which may directly contact the patients.
- Performance Testing: Performance Testing of AMSure® Hydrophilic Intermittent Catheter was conducted as below:
- Packaging inspection
- Appearance inspection
- Leakage
- Kink resistance
- Strength test
- Connector security
- Flow test
- Friction value
- Chemical performance: Reducing matter
- Chemical performance: pH value
- Chemical performance: Metal ions
- Chemical performance: EO residue
- Biological performance: Sterility
- Physical performance: Water sachet
- Chemical performance: sterile water
- Aging (shelf life/stability testing)
- Human factor 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 1, 2018
Amsino International Inc. Zoe Wu RA Specialist 708 Corporate Center Drive Pomona, CA 91768
Re: K181445
Trade/Device Name: AMSure Hydrophilic Intermittent Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: August 15, 2018 Received: August 21, 2018
Dear Zoe Wu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181445
Device Name
AMSure® Hydrophilic Intermittent Catheter
Type of Use (Select one or hoth, as annlicable)
Indications for Use (Describe)
INTENDED USE:
The AMSure® Hydrophilic Intermittent Catheter is inserted into the patient's bladder and indicated for intermittent use for the purpose of drainage of urine from the bladder. The catheter does not contain a balloon on its tip. An optional Water sachet is included to activate the hydrophilic-coated surface prior to use. The target populations for the subject device are Adults and Pediatrics.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the AMSINO logo. The logo is blue and white, with the word "AMSINO" in large, bold letters. Below the word "AMSINO" is the phrase "Advancing Healthcare Worldwide" in smaller letters. The logo is simple and professional, and it conveys the company's mission of improving healthcare around the world.
Section 5: 510(k) Summary
| Submitter Information | 1 |
|---|---|
| Submitter: | Amsino International Inc. |
| 708 Corporate Center Drive, Pomona CA 91768, USA | |
| Contact Person: | Zoe Wu |
| RA Specialist | |
| Phone: | +86(21)-69117118 |
| Fax: | +86(21)-59148142 |
| E-mail: | Zoe_Wu@amsino.com |
Date Prepared: Sep 28, 2018
- വ Device Information
Trade Name: AMSure® Hydrophilic Intermittent Catheter Device Common Name: Urological Catheter and Accessories Regulation Name: Urological Catheter and Accessories Regulation Number: 21 CFR §876.5130 Product Code: EZD
Device Class: Class II
Review Panel: Gastroenterology/Urology
Table 5-1
| Product Code | Description |
|---|---|
| HG971610 | Hydrophilic Intermittent Catheter, 10Fr |
| HG971612 | Hydrophilic Intermittent Catheter, 12Fr |
| HG971614 | Hydrophilic Intermittent Catheter, 14Fr |
| HG971616 | Hydrophilic Intermittent Catheter, 16Fr |
| HG971610SS | Hydrophilic Intermittent Catheter with water sachet and sleeve, 10Fr |
| HG971612SS | Hydrophilic Intermittent Catheter with water sachet and sleeve, 12Fr |
| HG971614SS | Hydrophilic Intermittent Catheter with water sachet and sleeve, 14Fr |
| HG971616SS | Hydrophilic Intermittent Catheter with water sachet and sleeve, 16Fr |
4
Image /page/4/Picture/0 description: The image is a logo for AMSINO, a healthcare company. The logo is blue and white, with the word "AMSINO" in large, bold letters. Below the word "AMSINO" is the tagline "Advancing Healthcare Worldwide". The logo is simple and professional, and it conveys the company's mission of improving healthcare around the world.
- 3 Predicate Device Information
Device Description: ব
The AMSure® Hydrophilic Intermittent Catheter is a urethral catheter intended to be passed through the urethra during urinary catheterization and into the bladder to drain urine. It is hydrophilic and lubricous coated flexible tube owns a hydrophilic polymer in the surface which makes the catheter highly lubricious and good adhesion upon contact with water, saline solution, body fluids. The catheter and gripper is manufactured with medical grade PVC, the surface is coated with a hydrophilic lowfriction coating (polyvinyl pyrrolidone, or PVP), the water sachet is with USP grade sterile water. Each catheter is provided in sterile, single-use packages, intended to be used by adults and pediatrics.
- 5 Intended use
The AMSure® Hydrophilic Intermittent Catheter is inserted into the patient's bladder and indicated for intermittent use for the purpose of urine from the bladder. The catheter does not contain a balloon on its tip. An optional Water sachet is included to activate the hydrophilic-coated surface prior to use. The target populations for the subject device are Adults and Pediatrics.
6 Product Comparison Summary
The proposed AMSure® Hydrophilic Intermittent Catheter and the predicate devices are intended for patients who drain the urine from bladder. These products are urethral catheters that have the same technological characteristics and material for tubing and funnel, same intended use, similar indications for use, the same function, and the same general characteristics.
The design and materials of the proposed devices are identical to the predicate Cure CatheterTM Hydrophilic Coated (K132500) and AMSure® PVC Intermittent catheter (K091306).
5
Image /page/5/Picture/0 description: The image is a logo for AMSINO, a company that is advancing healthcare worldwide. The logo is blue and white, with the word "AMSINO" in large, bold letters. Below the company name is the slogan "Advancing Healthcare Worldwide" in a smaller font. The logo is simple and professional, and it conveys the company's mission to improve healthcare around the world.
- Nonclinical Testing 7
- � Biocompatibility Testing
Cytotoxicity, Sensitization and Irritation have been conducted per ISO 10993-5 and ISO 10993-10. The Biocompatibility testing demonstrated the biological safety of the proposed devices which may directly contact the patients.
- � Performance Testing
Performance Testing of AMSure® Hydrophilic Intermittent Catheter was conducted as below:
Table 5-2
| SN | Test items |
|---|---|
| 1 | Packaging inspection |
| 2 | Appearance inspection |
| 3 | Leakage |
| 4 | Kink resistance |
| 5 | Strength test |
| 6 | Connector security |
| 7 | Flow test |
| 8 | Friction value |
| 9 | Chemical performance: Reducing matter |
| 10 | Chemical performance: pH value |
| 11 | Chemical performance: Metal ions |
| 12 | Chemical performance: EO residue |
| 13 | Biological performance: Sterility |
| 14 | Physical performance: Water sachet |
| 15 | Chemical performance: sterile water |
| 16 | Aging (shelf life/stability testing) |
| 17 | Human factor testing |
ထ Conclusions
The information provided within this pre-market notification demonstrates that the AMSure® Hydrophilic Intermittent Catheter is substantially equivalent to the predicate devices.