(62 days)
Not Found
No
The device description focuses on mechanical components and physical function, with no mention of AI/ML or data processing.
No.
The device facilitates the introduction of other instruments into the urethra and protects the urethra, but it does not directly treat a disease or condition.
No
The device is intended to facilitate the introduction of catheters or instruments and act as a lubricious barrier, which are procedural functions, not diagnostic ones.
No
The device description clearly outlines physical components made of plastic and silicone, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the introduction of catheters or instruments into the urethra and act as a lubricious barrier. This is a surgical or procedural aid, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical device used for insertion into the body. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility and in vitro performance related to the device's function as a sheath and introducer. There are no studies related to diagnostic accuracy or analysis of biological samples.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
Product codes (comma separated list FDA assigned to the subject device)
KNY
Device Description
The Solace Guardian Urethral Sheath is an everting sleeve sheath with a backflow valve for the establishment of a protective tract to the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra. The sheath consists of a thin-walled rigid plastic tube, an obturator, and an everting sleeve that deploys from the obturator during insertion to reduce friction. Improvements from the Generation I sheath include a silicone disc to improve patient comfort at the external contact point, a single handed fluid management system, and independent fill and waste lines.
The Urethral Sheath is supplied sterile and is single use. The working channel is sized to accommodate instruments up to 19 French. The sheath outside size is 24 French with a working length of 4.7 cm.
The Sheath helps the patient by protecting the urethra and reducing abrasion or tenderness resulting from instruments passing through the urethra.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, 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)
Biocompatibility Testing
Biocompatibility tests were conducted on the Guardian Urethral Sheath according to the requirements of ISO 10993:2009. The following were completed:
- Cytotoxicity .
- . Sensitization
- . Irritation or Intracutaneous reactivity
In Vitro Performance Testing
In vitro performance tests were performed on the Guardian Urethral Sheath. The following were performed:
- Simulated Use Testing .
- Design Verification Testing .
- Process Validation Testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device ACT (SMDA) of 1990.
- l. Sponsor Name Submitter's Name: Solace Therapeutics Address: 135 Newbury St, Framingham, MA 01701 Phone: (508) 283-1200 Contact Person: William Gruber Date of Preparation: May 30, 2013
-
- Device Information Trade Name: Guardian Urethral Sheath Common Name: Urological catheter Class: Il Classification Name: Urological catheter (21 CFR 876.5130, Product Code KNY)
AUG 20 2013
-
- Predicate Devices Guardian Urethral Sheath K052298 (formerly CYSTOGLIDE INTRODUCER SHEATH)
-
- Device Description
The Solace Guardian Urethral Sheath is an everting sleeve sheath with a backflow valve for the establishment of a protective tract to the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra. The sheath consists of a thin-walled rigid plastic tube, an obturator, and an everting sleeve that deploys from the obturator during insertion to reduce friction. Improvements from the Generation I sheath include a silicone disc to improve patient comfort at the external contact point, a single handed fluid management system, and independent fill and waste lines.
The Urethral Sheath is supplied sterile and is single use. The working channel is sized to accommodate instruments up to 19 French. The sheath outside size is 24 French with a working length of 4.7 cm.
The Sheath helps the patient by protecting the urethra and reducing abrasion or tenderness resulting from instruments passing through the urethra.
-
- Intended Use
The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
- Intended Use
-
- Comparison of Technological Characteristics
1
The Generation 2 Guardian Urethral Sheath is substantially equivalent in material, design and function to the Generation 1 Guardian Urethral Sheath K052298 (formerly CYSTOGLIDE INTRODUCER SHEATH)
Improvements from the Generation 1 sheath include a silicone disc to improve patient comfort at the external contact point, a single handed fluid management system, and independent fill and waste lines.
-
- Performance Data
Biocompatibility Testing
- Performance Data
Biocompatibility tests were conducted on the Guardian Urethral Sheath according to the requirements of ISO 10993:2009. The following were completed:
- Cytotoxicity .
- . Sensitization
- . Irritation or Intracutaneous reactivity
In Vitro Performance Testing
In vitro performance tests were performed on the Guardian Urethral Sheath. The following were performed:
- Simulated Use Testing .
- Design Verification Testing .
- Process Validation Testing .
Conclusion
Based upon these biocompatibility and in vitro performance tests, the Guardian Urethral Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K052298.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6(19 Silver Spring, MD 20993-0002
August 20, 2013
Solace Therapeutics % William Gruber President 135 Newbury Street Framingham, MA 01701
Re: K131803
Trade/Device Name: Guardian Urethral Sheath Regulation Number: 21 CFR$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: July 23, 2013 Received: July 24, 2013
Dear William Gruber,
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 (sec 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 - William Gruber
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); 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
K131803 510(k) Number (if known):
Guardian Urethral Sheath Device Name:
Indications For Use:
The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
Prescription Use X (Per 21 CFR 801.109 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)
ﺴﺴ
Herbert P. Lerner -S
Page 1 of 1
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131803 510(k) Number _