(57 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a mechanical injection needle, with no mention of AI or ML.
No
The device is an injection needle, which is used to deliver a substance (likely medication) into a specific anatomical site. While the substance delivered might be therapeutic, the device itself is a tool for delivery rather than providing a therapeutic effect directly (e.g., by treating or curing a disease or condition).
No
The device description indicates it is an injection needle used for delivering substances into the body, not for observing, measuring, or analyzing medical conditions.
No
The device description clearly outlines physical components like a polyurethane catheter and a stainless steel beveled tip cannula, indicating it is a hardware device.
Based on the provided information, the Williams Cystoscopic Injection Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "cystoscopic injection into the urethra, bladder neck, and bladder wall." This describes a procedure performed directly on a patient's body for therapeutic or diagnostic purposes (in this case, likely for injecting substances).
- Device Description: The description details a physical needle and catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVD devices are typically used for tests and analyses performed on samples.
Therefore, the Williams Cystoscopic Injection Needle is a medical device used for a procedure performed in vivo (within the body), not an IVD device.
N/A
Intended Use / Indications for Use
The Williams Cystoscopic Injection Needle is used for cystoscopic injection into the urethra, bladder wall.
Product codes (comma separated list FDA assigned to the subject device)
FBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra, bladder wall, bladder neck
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 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.
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
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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)
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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 |
| 750 Daniels Way | |
| 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 |
| 750 Daniels Way | |
| 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.