The Williams Cystoscopic Injection Needle is used for cystoscopic injection into the urethra, bladder neck, and bladder wall.
Device Story
Semi-rigid injection needle; used for cystoscopic delivery of injectable materials into urethra, bladder neck, and bladder wall. Device consists of polyurethane catheter (35 or 45 cm length; 3.7 or 5.0 French) with stainless steel beveled tip cannula (7 or 8 mm length; 20-25 gauge). Features grip wing hub. Operated by clinicians during cystoscopic procedures. Single-use; EtO sterilized. Provides targeted tissue injection to facilitate therapeutic or diagnostic interventions.
Clinical Evidence
Bench testing only. Evaluated via biocompatibility (ISO 10993-1), shelf life (accelerated aging), functional verification, and dimension verification. All tests met predetermined acceptance criteria.
Technological Characteristics
Materials: Polyurethane catheter, stainless steel cannula. Dimensions: 3.7/5.0 French, 35/45 cm length, 7/8 mm tip, 20-25 gauge. Sterilization: EtO. Single-use. No software or electronic components.
Indications for Use
Indicated for patients requiring cystoscopic injection into the urethra, bladder neck, or bladder wall.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
{0}------------------------------------------------
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2017
Cook Incorporated Rebecca Odulio (Li-Chun Liu) Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K171602
Trade/Device Name: Williams Cystoscopic Injection Needle Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: May 31, 2017 Received: June 1, 2017
Dear Rebecca Odulio (Li-Chun Liu):
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 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)
#### K171602
#### Device Name Williams Cystoscopic Injection Needle
Indications for Use (Describe)
The Williams Cystoscopic Injection Needle is used for cystoscopic into the urethra, bladder wall.
X 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}------------------------------------------------
## 2.0 510(k) Summary
# Williams Cystoscopic Injection Needle 21 CFR §807.92 Date Prepared: May 31, 2017
#### Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|--------------------|---------------------------------------------------------------|
| Applicant: | Cook Incorporated |
| Contact: | Rebecca Odulio (Li-chun Liu) |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact Phone: | (812) 339-2235 x104673 |
| Contact Fax: | (812) 332-0281 |
#### Device Information:
| Trade Name: | Williams Cystoscopic Injection Needle |
|------------------------------------|-------------------------------------------------------|
| Common Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
| Classification Name: | Endoscope and Accessories |
| Classification Regulation: | 21 CFR §876.1500, Product Code FBK |
| Device Class/Classification Panel: | Class II, Gastroenterology/Urology |
#### Predicate Device:
Cook Injection Needles (Cook Urological Inc., K022484) is the predicate device for the Williams Cystoscopic Injection Needle.
#### Device Description:
The Williams Cystoscopic Injection Needle is a semi-rigid injection needle. It is provided in 3.7 or 5.0 French sizes with 35 or 45 centimeters long polyurethane catheter, which ends with a 7 or 8 millimeter length stainless steel beveled tip cannula that is available in 20 to 25 needle gages. The subject device is sterilized with EtO and is intended for one-time use.
{4}------------------------------------------------
#### Indications for Use:
The Williams Cystoscopic Injection Needle is used for cystoscopic injection into the urethra, bladder neck, and bladder wall.
#### Comparison to Predicate Device:
The Williams Cystoscopic Injection Needle has similar methods of operation, materials, and fundamental technological characteristics as the predicate device. Differences between the subject device and the predicate device include minor dimensional variations that fall within the range of the predicate device and an additional feature of a grip wing hub. Characteristics of the subject device that differ from the predicate device are supported by testing to demonstrate that the subject device met the design input requirements for the instruction for use. The change for which this device is submitted is the more specific indications for use.
| | Indications for Use |
|------------------|----------------------------------------------------------------------------------------|
| | To deliver a variety of injectable material into tissues during laparoscopic, |
| | hysteroscopy, cystoscopic, endoscopic, transurethral procedures and open surgical |
| Predicate device | procedures. The type of material to be injected will be dependent on the nature of the |
| | procedure, but such materials may include for example, saline, contrast media, |
| | collagen, silicone, Teflon, local anesthetics, etc. |
| Subject device | Used for cystoscopic injection into the urethra, bladder neck, and bladder wall. |
#### Performance Data:
The following testing were performed to demonstrate that the subject Williams Cystoscopic Injection Needle met applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO international standards.
- Biocompatibility Biological risks have been evaluated in accordance with ISO . 10993-1 and FDA's Guidance on ISO 10993-1 and determined to be acceptable for the intended uses of the subject devices.
- Shelf Life A three-year shelf life is supported by device performance testing after . accelerated aging to the equivalence of three years. All predetermined acceptance criteria were met.
- . Functional Verification - Testing demonstrated that the subject device functions as intended. The results showed that acceptance criteria were met.
- . Dimension Verification - Testing demonstrated that the subject device functions as intended. The results showed that acceptance criteria were met.
{5}------------------------------------------------
# Conclusion:
The results of these tests provide reasonable assurance that the subject Williams Cystoscopic Injection Needle functions as intended and does not raise new questions of safety or effectiveness as compared to the predicate device.
{6}------------------------------------------------
# 2.0 510(k) Summary
# Williams Cystoscopic Injection Needle 21 CFR §807.92 Date Prepared: May 31, 2017
#### Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|--------------------|---------------------------------------------------------------|
| Applicant: | Cook Incorporated |
| Contact: | Rebecca Odulio (Li-chun Liu) |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact Phone: | (812) 339-2235 x104673 |
| Contact Fax: | (812) 332-0281 |
#### Device Information:
| Trade Name: | Williams Cystoscopic Injection Needle |
|------------------------------------|-------------------------------------------------------|
| Common Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
| Classification Name: | Endoscope and Accessories |
| Classification Regulation: | 21 CFR §876.1500, Product Code FBK |
| Device Class/Classification Panel: | Class II, Gastroenterology/Urology |
#### Predicate Device:
Cook Injection Needles (Cook Urological Inc., K022484) is the predicate device for the Williams Cystoscopic Injection Needle.
#### Device Description:
The Williams Cystoscopic Injection Needle is a semi-rigid injection needle. It is provided in 3.7 or 5.0 French sizes with 35 or 45 centimeters long polyurethane catheter, which ends with a 7 or 8 millimeter length stainless steel beveled tip cannula that is available in 20 to 25 needle gages. The subject device is sterilized with EtO and is intended for one-time use.
{7}------------------------------------------------
# Indications for Use:
The Williams Cystoscopic Injection Needle is used for cystoscopic injection into the urethra, bladder neck, and bladder wall.
# Comparison to Predicate Device:
The Williams Cystoscopic Injection Needle has similar methods of operation, materials, and fundamental technological characteristics as the predicate device. Differences between the subject device and the predicate device include minor dimensional variations that fall within the range of the predicate device and an additional feature of a grip wing hub. Characteristics of the subject device that differ from the predicate device are supported by testing to demonstrate that the subject device met the design input requirements for the instruction for use. The change for which this device is submitted is the more specific indications for use.
| | Indications for Use |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate device | To deliver a variety of injectable material into tissues during laparoscopic, hysteroscopy, cystoscopic, endoscopic, transurethral procedures and open surgical procedures. The type of material to be injected will be dependent on the nature of the procedure, but such materials may include for example, saline, contrast media, collagen, silicone, Teflon, local anesthetics, etc. |
| Subject device | Used for cystoscopic injection into the urethra, bladder neck, and bladder wall. |
## Performance Data:
The following testing were performed to demonstrate that the subject Williams Cystoscopic Injection Needle met applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO international standards.
- . Biocompatibility - Biological risks have been evaluated in accordance with ISO 10993-1 and FDA's Guidance on ISO 10993-1 and determined to be acceptable for the intended uses of the subject devices.
- . Shelf Life - A three-year shelf life is supported by device performance testing after accelerated aging to the equivalence of three years. All predetermined acceptance criteria were met.
- . Functional Verification - Testing demonstrated that the subject device functions as intended. The results showed that acceptance criteria were met.
- . Dimension Verification - Testing demonstrated that the subject device functions as intended. The results showed that acceptance criteria were met.
{8}------------------------------------------------
# Conclusion:
The results of these tests provide reasonable assurance that the subject Williams Cystoscopic Injection Needle functions as intended and does not raise new questions of safety or effectiveness as compared to the predicate device.
