(245 days)
Not Found
No
The device description and performance studies focus on the physical properties and functional performance of a silicone catheter with a hydrophilic coating, with no mention of AI or ML.
No
The device is a catheter used for bladder management, including drainage, collection, and measurement of urine. It serves a supportive or diagnostic function rather than directly treating a disease or condition.
No
The device is described as a catheter for "urine drainage, collection and measurement" for bladder management, which are functions related to treatment or management of a condition, not diagnosis.
No
The device description clearly states it is a physical catheter made from silicone elastomer with a hydrophilic coating, including a handle and drainage eyes. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a urinary catheter used for bladder management, including urine drainage, collection, and measurement. It is a physical device inserted into the body.
- Lack of Diagnostic Testing: There is no mention of the device performing any tests on the urine sample itself to diagnose or monitor a condition. Its primary function is mechanical.
Therefore, this device falls under the category of a medical device used for therapeutic and management purposes, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.
Product codes
EZD
Device Description
The Hydrophilic Intermittent Urinary Catheter is made from silicone elastomer with a hydrophilic coating. The device is for urological use only. It is intended for use by patients for bladder management including urine drainage, collection, and measurement.
The device consists of an all silicone elastomer single lumen catheter and includes a silicone handle. The catheter has drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has a hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. The handle provides the patient-user an ergonomically designed area for a secure grip and notouch area when inserting the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary bladder, urethra
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)
Non-Clinical Performance Data
Design Qualification
- Hydrophilic Intermittent Catheter with a Handle VAL439, TR1691, This non-. clinical test data includes: dimensional analysis, appearance, and functional testing according to EN 1616. Lubricity testing was conducted according to modified ASTM D1894.
Long Term Stability/Shelf Life
- Hydrophilic Intermittent Catheter with a Handle LTS096. This non-clinical test . data includes: dimensional analysis, appearance, and functional testing according to EN 1616.
Biocompatibility
- ISO 10993-5, Cytotoxicity .
- ISO 10993-10, Sensitization GPMT (Klingman), 2 extracts .
- ISO 10993-10, Vaginal Irritation w/Histopathology, 2 extracts ●
Conclusion:
Substantial equivalence of the Hydrophilic Intermittent Urinary Catheter is supported by a comparison of the design and intended use compared to the predicate devices which received marketing clearance under Premarket Notification, as well as acceptable results from functional performance and 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.
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K122785 Page 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Rochester Medical. The logo consists of a circle on the left side, with a line extending from the circle to the right, forming a mountain-like shape. The text "Rochester" is written in a stylized font, with the word "MEDICAL" written in smaller letters below it.
MAY 1 4 2013
5.0 510(k) Summary
510(k) Submitter:
Rochester Medical Corporation One Rochester Medical Drive Stewartville, MN 55976 USA Phone: (507) 533-9600 Fax: (507) 533-9740
Contact Name:
Robert Anglin Rochester Medical Corporation One Rochester Medical Drive Stewartville, MN 55976 Phone: (507) 533-9613 Fax: (507) 533-9740
Date prepared:
August 28, 2012
Trade or Proprietary Name: HydroSil, Magic, Personal Catheter
Common or Usual Name:
Urological Catheter
Urological catheter and accessories (21 CFR 876.5130, Product Code EZD)
Predicate Device(s):
Classification Name:
K000723 Rochester Medical Corporation Personal® Catheter (Hydrophilic)
K072808 Coloplast Corp. SpeediCath Compact
Device Description:
The Hydrophilic Intermittent Urinary Catheter is made from silicone elastomer with a hydrophilic coating. The device is for urological use only. It is intended for use by patients for bladder management including urine drainage, collection, and measurement.
The device consists of an all silicone elastomer single lumen catheter and includes a silicone handle. The catheter has drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has a hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. The handle provides the patient-user an ergonomically designed area for a secure grip and notouch area when inserting the catheter.
1
Image /page/1/Picture/1 description: The image shows the logo for Rochester Medical. The logo features a stylized mountain range above the word "Rochester" in a bold, italicized font. Below "Rochester" is the word "MEDICAL" in a smaller, sans-serif font. To the left of the word "Rochester" is a circle with a line extending from the left side of the circle to the mountain range.
Intended Use of the Device:
For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.
Technological Characteristics:
The device described in the 510(k) is an all silicone single lumen drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The predicate devices are also made from similar materials such as silicone and polyurethane. The 510(k) device has an outer hydrophilic coating which is hydrated with sterile water. The predicate devices also have an outer hydrophilic coating, which is hydrated in the similar manner such as sterife water and saline solution. The 510(k) device has a handle designed to facilitate ease of catheter insertion. The predicate devices may also have a handle. All of the devices are supplied sterile for single use.
Non-Clinical Performance Data
The following non-clinical performance data demonstrates substantial equivalence of the 510(k) device to the predicate devices:
Design Oualification
- Hydrophilic Intermittent Catheter with a Handle VAL439, TR1691, This non-. clinical test data includes: dimensional analysis, appearance, and functional testing according to EN 1616. Lubricity testing was conducted according to modified ASTM D1894.
Long Term Stability/Shelf Life
- Hydrophilic Intermittent Catheter with a Handle LTS096. This non-clinical test . data includes: dimensional analysis, appearance, and functional testing according to EN 1616.
Biocompatibility
- ISO 10993-5, Cytotoxicity .
- ISO 10993-10, Sensitization GPMT (Klingman), 2 extracts .
- ISO 10993-10, Vaginal Irritation w/Histopathology, 2 extracts ●
Conclusion:
Substantial equivalence of the Hydrophilic Intermittent Urinary Catheter is supported by a comparison of the design and intended use compared to the predicate devices which received marketing clearance under Premarket Notification, as well as acceptable results from functional performance and biocompatibility testing.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2013
Rochester Medical Corporation % Mr. Robert Anglin Vice President of Quality and Regulatory One Rochester Medical Drive STEWARTVILLE MN 55976
Re: K122785
Trade/Device Name: Hydrophilic Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: April 11, 2013 Received: April 19, 2013
Dear Mr. Anglin:
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. 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.
3
Page 2 - Mr. Robert Anglin
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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 vours.
Herbert P. Lerner -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
4
4.0 INDICATIONS FOR USE STATEMENT
K122785 510(k) Number (if known):
Hydrophilic Intermittent Urinary Catheter DEVICE NAME:
INDICATIONS FOR USE:
For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert | Pagerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K122785