(191 days)
Not Found
No
The summary describes a mechanical device (sheath) and its intended use for facilitating instrument insertion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on physical properties and sterilization, not algorithmic performance.
No
The device is described as facilitating the introduction of other instruments and serving as a protective barrier, not as directly treating a condition or disease.
No.
The document describes the device's purpose as facilitating the introduction of catheters or instruments and providing a lubricious barrier, not for diagnosing conditions.
No
The device description explicitly details physical components (Visual Obturator, Sheath, Single-Use Sterile Seal) and mentions sterilization and in vitro performance testing on these physical components, indicating it is a hardware device.
Based on the provided information, the Vesair Cystoscopic Sheath is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for facilitating the introduction of catheters or instruments into the urethra and acting as a guide and lubricious barrier. This is a direct interaction with the patient's anatomy for a procedural purpose.
- Device Description: The description reinforces its use in visualizing and establishing a protective tract within the urethra and bladder.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The device is used in vivo (within the body).
- Performance Studies: The performance studies mentioned are related to the physical performance and sterilization of the device, not diagnostic accuracy based on analyzing biological samples.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. The Vesair Cystoscopic Sheath does not fit this description.
N/A
Intended Use / Indications for Use
The Vesair Cystoscopic Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Vesair Cystoscopic 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
KNY
Device Description
The Vesair Cystoscopic Sheath is intended for use in visualizing the urethra and bladder as well as the establishment of a protective tract into the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra.
The Vesair Cystoscopic Sheath Assembly includes a Visual Obturator, Sheath and the Vesair Single-Use Sterile Seal. The Sheath is provided non-sterile and requires cleaning and steam sterilization prior to use.
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
Prescription Use
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
In Vitro Performance Testing
In vitro performance tests were performed on the Vesair Cystoscopic Sheath. The following were performed:
- Design Verification Testing / Simulated Use Testing
- Ship Testing
- Repeat Steam Sterilization Testing
- Accelerated Aging
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Solace Therapeutics, Inc. William Gruber President and CEO 135 Newbury Street Framingham, MA 01701
Re: K162356
Trade/Device Name: Vesair Cystoscopic Sheath Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KNY Dated: February 7, 2017 Received: February 8, 2017
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 (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. 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
1
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 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 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
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
Indications for Use
510(k) Number (if known) K162356
Device Name Vesair Cystoscopic Sheath
Indications for Use (Describe)
The Vesair Cystoscopic Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Vesair Cystoscopic 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.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
1. Sponsor Name
| Submitter's Name: | Solace Therapeutics |
|---|---|
| Address: | 135 Newbury St, Framingham, MA 01701 |
| Phone: | (508) 283-1200 |
| Fax: | (508) 283-1199 |
| Contact Person: | William Gruber |
| Date of Preparation: | August 22, 2016 |
2. Device Information
| Trade Name: | Vesair Cystoscopic Sheath |
|---|---|
| Common Name: | Urological catheter |
| Class: | II |
| Classification Name: | Urological catheter |
| (21 CFR 876.5130, Product Code KNY) |
3. Predicate Devices
Guardian Urethral Sheath (K141252)
4. Device Description
The Vesair Cystoscopic Sheath is intended for use in visualizing the urethra and bladder as well as the establishment of a protective tract into the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra.
The Vesair Cystoscopic Sheath Assembly includes a Visual Obturator, Sheath and the Vesair Single-Use Sterile Seal. The Sheath is provided non-sterile and requires cleaning and steam sterilization prior to use.
5. Intended Use
The Vesair Cystoscopic Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Vesair Cystoscopic 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.
4
6. Comparison of Technological Characteristics
The Vesair Cystoscopic Sheath is substantially equivalent in Guardian Urethral Sheath K141252. Improvements from the Guardian Urethral Sheath include modifications to the length, material, ID/OD, sterilization methodology, Obturator change, and Seal Assembly change.
| Feature/Specification | Guardian Urethral Sheath
(K141252) | Vesair Cystoscopic Sheath |
|-----------------------|---------------------------------------------|------------------------------------------|
| Working Length | 55 mm | 166 mm |
| Material | Polymer | Stainless Steel |
| Sterilization | Ethylene Oxide | Steam |
| Inner Diameter | 20 Fr | 19.5 Fr |
| Outer Diameter | 21 Fr | 22.5 Fr |
| Obturator Change | Blunt nose – no cystoscope
compatibility | Blunt nose with cystoscope compatibility |
| Seal Assembly | No assembly required | Seal to be replaced between uses by user |
Table 1 - Comparison of Proposed Vesair Cystoscopic Sheath to predicate Guardian Urethral Sheath
7. Performance Data
In Vitro Performance Testing
In vitro performance tests were performed on the Vesair Cystoscopic Sheath. The following were performed:
- Design Verification Testing / Simulated Use Testing ●
- Ship Testing ●
- Repeat Steam Sterilization Testing
- Accelerated Aging ●
8. Conclusion
Based upon the in vitro performance tests, the Vesair Cystoscopic Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K141252.