(43 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical aspects of the injection needle and do not mention any computational or data-driven features indicative of AI/ML.
No
The device is an injection needle; it is used to deliver therapeutic agents, but it is not a therapeutic agent itself, nor does it directly provide therapy. Its function is to facilitate the injection of therapeutic agents.
No
The device is used to inject therapeutic agents, not to diagnose a condition. The described function is therapeutic, not diagnostic.
No
The device description clearly describes a physical needle and sheath, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to inject therapeutic agents into the genitourinary system. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The device is a needle and sheath designed for delivering substances into the body. This aligns with a therapeutic or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the INJEKT™ Filiform Injection Needle is a medical device used for therapeutic purposes, not an IVD.
N/A
Intended Use / Indications for Use
Used to inject legally marketed therapeutic agents into the genitourinary system, most specifically for vesicoureteral reflux (VUR) in the pediatric population and for bladder neck injection for the population as a whole.
Product codes
FBK
Device Description
The INJEKT™ Filiform Injection Needle is used to inject legally marketed therapeutic agents into the genitourinary system, most specifically for vesicoureteral reflux (VUR) in the pediatric population and for bladder neck injection for the population as a whole. The INJEKT™ Filiform Injection Needle consists of a needle and an outer sheath with a filiform tip. Hash marks on the outside of the needle are used to assess proper depth of placement. The filiform tip of the needle acts as a landmark for easier access to precise injection. The needle exits the side of the device to allow precise injection and assures additional safety for the patient against inadvertent stick when the needle is retracted. The devices are provided sterile and are intended for one time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
genitourinary system, specifically for vesicoureteral reflux (VUR) and bladder neck
Indicated Patient Age Range
pediatric population and for the population as a whole.
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, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards. Testing data and information is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022484, K051905, K982890, 812057
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
INJEKT™ Filiform Injection Needle STED 510(k) submission Cook Urological, Incorporated June 23, 2008
510(k) SUMMARY
SEP 2 5 2008
K08 2319
Page 1 of 2
Submitted by:
Cindy Foote Regulatory Affairs Specialist Cook Urological, Incorporated 1100 West Morgan Street Spencer, IN 47460 February 29, 2008
INJEKT™ Filiform Injection Needle
Device:
Trade Name:
Proposed Classification Name:
Endoscopic Injection Needle, Gastroenterology-Urology 21 CFR Part 876.1500 Class II, FBK
Predicate Devices:
The INJEKT™ Filiform Injection Needle is similar with respect to indications for use and technology to existing predicate devices. Specifically, the INJEKT™ Filiform Injection Needle is similar to the Cook® Injection Needle (K022484), manufactured by Cook Urological, Incorporated, the Uroplasty Rigid Endoscopic Needle (K051905) manufactured by Uroplasty, Incorporated, the Advanced Uroscience Injection Needle (K982890), manufactured by Advanced Uroscience, Incorporated, and the Vance Cystoscopic Injection Needle (812057), manufactured by Cook® Urological. Incorporated. Please refer to Attachment C for marketing and FDA information regarding the predicate devices.
Device Description:
The INJEKT™ Filiform Injection Needle is used to inject legally marketed therapeutic agents into the genitourinary system, most specifically for vesicoureteral reflux (VUR) in the pediatric population and for bladder neck injection for the population as a whole. The INJEKT™ Filiform Injection Needle consists of a needle and an outer sheath with a filiform tip. Hash marks on the outside of the needle are used to assess proper depth of placement. The filiform tip of the needle acts as a landmark for easier access to precise injection. The needle exits the side of the device to allow precise injection and assures additional safety for the patient against inadvertent stick when the needle is retracted. The devices are provided sterile and are intended for one time use.
1
INJEKT™ Filiform Injection Needle STED 510(k) submission Cook Urological, Incorporated June 23, 2008
Page 2 of 2
Substantial Equivalence:
The Cook® Cervical Ripening Balloon is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards. Testing data and information is included in this submission.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2008
Ms. Cindy Footc Regulatory Affairs Specialist Cook Urological, Incorporated 1100 W. Morgan Street SPENCER IN 47460
Re: K082319
Trade/Device Name: INJEKT™ Filiform Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: August 11, 2008 Received: August 13, 2008
Dear Ms. Foote:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INJEKT™ Filiform Injection Needle STED 510{k} submission Cook Urological, Incorporated June 23, 2008
Indications for Use
| 510(k) Number (if known): | K082319 |
|---|---|
| Device Name: | INJEKT™ Filiform Injection Needle |
| Indications for Use: | Used to inject legally marketed therapeutic agents |
inject legally marketed therapeutic agents into the genitourinary system, most specifically for vesicoureteral reflux (VUR) in the pediatric population and for bladder neck injection for the population as a whole.
Prescription Use? X (Part 21 CFR 801 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)
Helena
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Company Confidential Cook Urological