(77 days)
No
The summary describes a physical catheter device for access and visualization, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is used for access, visualization, drainage, and irrigation of the bladder, which are diagnostic or supportive functions, not directly treating a disease or condition.
Yes
The device description explicitly states, "The CystoSure® and CystoSure® Plus catheters are intended for use in the diagnostic visualization of the female bladder..." and that they are "used in both surgical and diagnostic procedures."
No
The device description clearly states it is a physical catheter made from silicone, which is a hardware component.
No, 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.
- CystoSure® Plus function: The description clearly states the device is a catheter used for:
- Providing access and visualization of the female urinary bladder.
- Urethral urinary catheterization.
- Postoperative bladder irrigation/lavage.
- Allowing passage of an endoscope for visualization.
- Draining the bladder.
These functions involve direct interaction with the body and are related to procedures and visualization, not the analysis of samples taken from the body. The device is a tool used within the body for diagnostic and therapeutic purposes, not a test performed on a sample.
N/A
Intended Use / Indications for Use
The CystoSure® Plus catheter provides access and visualization for the female urinary bladder.
The single-use CystoSure® Plus catheter provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of an endoscope. It is suitable for medium- to long-term use with a maximum patient indwelling time
§ 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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August 6, 2018
Emmy Medical, LLC. % Christine Santagate Director, Northeast Regional Operations R&O Solutions, LLC. 15 Standish Road Norfolk, MA 02056
Re: K181346
Trade/Device Name: CystoSure® Plus Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: July 5, 2018 Received: July 9, 2018
Dear Christine Santagate:
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 mav, 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 avare 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.
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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
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Indications for Use
510(k) Number (if known)
Device Name CystoSure® Plus Catheter
Indications for Use (Describe)
The CystoSure® Plus catheter provides access and visualization for the female urinary bladder.
The single-use CystoSure® Plus catheter provides urethral urinary catheterization and postoperative bladder inrigation/ lavage with the addition of a sealed port for passage of an endoscope. It is suitable for medium- to long-term use with a maximum patient indwelling time Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 8.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter Information
| Submitter's Name: | Ronald Adams |
|---|---|
| Address: | 18 Hillside Drive, Holliston, MA 01746 |
| Telephone: | 508-944-5166 |
| Fax: | 844-225-4600 |
| Contact Person: | Ronald Adams |
| Telephone : | 508-944-5166 |
| Fax : | 844-225-4600 |
| May 1, 2018 | |
| Prepared: | |
| ce Trade Name: | CystoSure® Plus Catheter |
| mon/Usual Name: | Catheter, Retention Type, Balloon |
| latory Information | |
| lation Name: | Urological catheter and accessories |
| II | |
| uct Code(s): | EZL |
| lation Number(s): | 21 CFR 876.5130 |
Date
Devic Comn
Regul Regul Class: Produ Regul Review Panel:
Gastroenterology/Urology
Predicate Device: K142194 CystoSure Urinary Access System
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Device Description & Comparison:
The CystoSure® and CystoSure® Plus catheters are intended for use in the diagnostic visualization of the female bladder with a port to allow for the insertion of an endoscope. They are made from silicone and they are used in both surgical and diagnostic procedures for draining the bladder and enabling the visualization of internal bladder surfaces.
The differences between Cystosure® Plus and the original Cystosure® catheter are tabulated in Table 1. Engineering drawings of the Predicate Cystosure® and Subject Cystosure® Plus catheters are provided in Attachment 1. The operational characteristics and performance criteria of the two devices are identical as both are flexible tubes used for drainage and bladder access in females.
The indications for use of the device are different by necessity, as reference to the catheter system and CystoSure® cystoscope have been removed. However, the intended use of the device remains unchanged.
Indications for Use:
Intended Use/Indications for Use: The CystoSure® Plus catheter provides access and visualization for the female urinary bladder.
The single-use CystoSure® Plus catheter provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of an endoscope. It is suitable for medium- to long-term use with a maximum patient indwelling time