(56 days)
Not Found
No
The device description focuses on the physical characteristics and coatings of the catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are standard biocompatibility and functional tests for a physical medical device.
Yes.
The device is intended for bladder management including urine drainage, collection, and measurement, which are therapeutic interventions.
No
The text states the device is intended for "urine drainage, collection, and measurement" for bladder management, and it is a "catheter." These are functional purposes, not diagnostic ones.
No
The device description clearly describes a physical catheter with coatings and an insertion sleeve, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Magic3 Go® Function: The Magic3 Go® Intermittent Urinary Catheter is a device that is inserted into the body (specifically, the urethra and bladder) to drain urine. It is a therapeutic and management device, not a diagnostic one. It doesn't analyze a sample to provide diagnostic information.
The description clearly states its purpose is for "bladder management including urine drainage, collection, and measurement," which are all functions performed on the body, not on a sample taken from the body.
N/A
Intended Use / Indications for Use
The Magic3 Go® Intermittent Urinary Catheter is intended for urological use only. It is intended for use by adult and pediatric patients of all ages for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
Product codes
EZD
Device Description
The Magic3 Go® Intermittent Urinary Catheter is a ready-to-use silicone intermittent catheter with a self-hydrating over a hydrophilic coating. The device is provided sterile and is for single use.
The device consists of an all silicone single lumen catheter with a polyethylene insertion sleeve (Sure-Grip™) which is not made from natural rubber latex, DEHP and/or other phthalates. The catheter has four drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The catheter will be offered in multiple French sizes (6 – 20Fr), multiple lengths (10" & 16") and two tip designs (straight and coudé).
The outer surface of the catheter has two coatings. The first coating is a hydrophilic coating. Over the hydrophilic coating, a self-hydrating coating is applied. The additional coating does not require activation with water prior to use. The Sure-Grip™ insertion sleeve provides the user with an ergonomically designed area for a secure grip and notouch area with which to insert the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, urinary bladder
Indicated Patient Age Range
adult and pediatric patients of all ages
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
Biocompatibility: The biocompatibility evaluation of the subject device was conducted in accordance with Use of International Standard ISO 10993-1, Biological evaluation of medical devices and testing within a risk management process – July 21, 2016. The subject device is considered a mucosal contacting surface device with limited exposure. The battery of testing included Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Vaginal Mucosal Irritation (ISO 10993-10).
Non-clinical functional performance testing: Non-clinical functional performance testing of the subject device was performed in accordance with BS EN 1616:1997 + A1:1999, Sterile urethral catheters for single use. Coefficient of friction (CoF) testing was previously conducted on the cleared predicate device K150345. Since the subject device is identical to the predicate device K150345, in terms of catheter material and coatings, lubricity testing was not necessary on the subject device. The lubricity of the subject device is determined to be equivalent to the predicate device, K150345.
Key Metrics
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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2017
C.R. Bard, Inc. Nancy Underwood Regulatory Affairs Specialist 8195 Industrial Blvd Covington, GA 30014
K172247 Re:
Trade/Device Name: Magic3 Go® Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: July 25, 2017 Received: July 26, 2017
Dear Nancy Underwood:
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.
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 (reporting of medical 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Charles Viviano -S
Benjamin R. Fisher, Ph.D. For Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K172247
Device Name
Magic3 Go® Intermittent Urinary Catheter
Indications for Use (Describe)
The Magic3 Go® Intermittent Urinary Catheter is intended for urological use only. It is intended for use by adult and pediatric patients of all ages for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Page 1 of 1
Trade Secret | Confidential Information
Notify Bard Medical Division
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Magic3 Go® Intermittent Urinary Catheter 510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
Bard Medical Division C. R. Bard, Inc. 8195 Industrial Boulevard Covington GA 30014 Phone: 770-784-6284 Fax: 770-385-4706 Contact Person: Nancy Underwood, Regulatory Affairs Specialist Date of Submission: July 25, 2017
Subject Device Name:
| Name of Device: | Magic3 Go® Intermittent Urinary Catheter |
|---|---|
| Common or Usual | |
| Name: | Urological Catheter |
| Classification Name: | Urological catheter and accessories |
| FDA Pro Code: | EZD |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR §876.5130 |
| Predicate Devices: | |
| Primary Predicate | |
| Name of Device: | Magic3 Go® Intermittent Urinary Catheter, |
| K150345 | |
| Common or Usual | |
| Name: | Urological Catheter |
| Classification Name: | Urological catheter and accessories |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR §876.5130 |
| Name of Device: | Hydrophilic Personal Catheter®, K000723 |
| Common or Usual | |
| Name: | Urological Catheter |
| Classification Name: | Urological catheter and accessories |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR §876.5130 |
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Device Description:
The Magic3 Go® Intermittent Urinary Catheter is a ready-to-use silicone intermittent catheter with a self-hydrating over a hydrophilic coating. The device is provided sterile and is for single use.
The device consists of an all silicone single lumen catheter with a polyethylene insertion sleeve (Sure-Grip™) which is not made from natural rubber latex, DEHP and/or other phthalates. The catheter has four drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The catheter will be offered in multiple French sizes (6 – 20Fr), multiple lengths (10" & 16") and two tip designs (straight and coudé).
The outer surface of the catheter has two coatings. The first coating is a hydrophilic coating. Over the hydrophilic coating, a self-hydrating coating is applied. The additional coating does not require activation with water prior to use. The Sure-Grip™ insertion sleeve provides the user with an ergonomically designed area for a secure grip and notouch area with which to insert the catheter.
Indications for Use of Device:
The Magic3 Go® Intermittent Urinary Catheter is intended for urological use only. It is intended for use by adult and pediatric patients of all ages for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
Technological Comparison to Predicate Devices:
The Magic3 Go® Intermittent Urinary Catheter has similar technological characteristics as the predicate device, Magic3 Go® Intermittent Urinary Catheter previously cleared via K150345 and the Hydrophilic Personal Catheter® previously cleared via K000723. The subject and predicate devices are based on the following technological elements:
- Same intended use .
- . Similar indications for use
- Same drainage eye position
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- . Similar tip configurations
- Provided sterile for single-use .
- . Composed of biocompatible materials
- Same catheter materials
- . Same self-hydrating coating
- . Similar design features
- Similar product offerings
Performance Data:
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility
The biocompatibility evaluation of the subject device was conducted in accordance with Use of International Standard ISO 10993-1, Biological evaluation of medical devices and testing within a risk management process – July 21, 2016. The subject device is considered a mucosal contacting surface device with limited exposure. The battery of testing included the following:
- . Cytotoxicity (ISO 10993-5)
- . Sensitization (ISO 10993-10)
- . Vaginal Mucosal Irritation (ISO 10993-10)
Non-clinical functional performance testing
Non-clinical functional performance testing of the subject device was performed in accordance with BS EN 1616:1997 + A1:1999, Sterile urethral catheters for single use.
Coefficient of friction (CoF) testing was previously conducted on the cleared predicate device K150345. Since the subject device is identical to the predicate device K150345, in terms of catheter material and coatings, it has been determined that lubricity testing was not necessary on the subject device. The lubricity of the subject device is determined to be equivalent to the predicate device, K150345.
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Conclusions:
The Magic3 Go® Intermittent Urinary Catheter is substantially equivalent to the legally marketed predicate devices as demonstrated by the same intended use, similar indications for use, similar technological characteristics and performance data, and does not raise different questions of safety and effectiveness