(67 days)
This device is used to inject legally marketed injectable therapeutic agents into the lower urinary tract through the working channel of a cystoscope.
This device is a flexible, sheath covered injection needle The device consists of a device handle, flexible outer sheath, and needle assembly. The device has an outer diameter of 6Fr, a working length of 70 cm and a 23 ga needle for injection of legally marketed therapeutic agents into the lower urinary tract through the working channel of a cystoscope.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the "Injekt™ Cysto Flexible Injection Needle," primarily focused on establishing substantial equivalence to a legally marketed predicate device (Cook Injection Needles, K022484) and outlining the device's indications for use.
Therefore, I cannot populate the requested table or answer the specific questions about a study, sample sizes, ground truth, or expert involvement. The document explicitly states:
"Performance standards under Section 514 of the Federal ~Food, Drug and Cosmetic Act applicable to Injekt™ Cysto Flexible Injection Needle have not been established by the Food and Drug Administration."
This indicates that formal performance standards or acceptance criteria, as typically defined by the FDA for certain device types, were not established for this device at the time of this 510(k) submission. The substantial equivalence argument relies on comparison of characteristics and addressing risks through their Design Control Process.
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Attachment E - 510(k) Summary
FEB 1 4 2012
| Name: | Cook Ireland Ltd |
|---|---|
| Address: | O'Halloran RoadNational Technology ParkLimerick, Ireland |
| Phone: | +353 61 334440 |
| Fax: | +353 61239293 |
| Contact Persons: | Laura Guinane, Regulatory Affairs SpecialistEmmett Devereux, Director of Quality & Regulatory Affairs |
| Phone: | +353 61 334440 |
| Fax: | +353 61 239293 |
| Date: | December 7, 2011 |
| Trade Name: | InjektTM Cysto Flexible Injection Needle |
| Common Name: | Flexible Injection Needle |
| Classification Name: | Endoscopic Injection Needle,Gastroenterology-Urology (21 CFR 876.1500, Product Code: FBK) |
| Legally Marketed Devices: | Cook Injection Needles |
| Description of the Device: | This device is a flexible, sheath covered injection needle The device consists of a device handle, flexible outer sheath, and needle assembly. The device has an outer diameter of 6Fr, a working length of 70 cm and a 23 ga needle for injection of legally marketed therapeutic agents into the lower urinary tract through the working channel of |
Indications for use:
This device is used to inject legally
a cystoscope.
{1}------------------------------------------------
Comparison of Characteristics:
Performance Data:
marketed injectable therapeutic agents into the lower urinary tract through the working channel of a cystoscope.
The modified device is substantially equivalent to the currently marketed device, the Cook Injection Needles, as cleared by K022484.
The risks associated with the modifications to our subject device have been adequately addressed through our Design Control Process. Performance standards under Section 514 of the Federal ~Food, Drug and Cosmetic Act applicable to Injekt™ Cysto Flexible Injection Needle have not been established by the Food and Drug Administration.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Laura Guinane Regulatory Affairs Specialist Cook Ireland Ltd. O'Halloran Road, National Technology Park LIMERICK IRELAND
FEB 1 4 2012
Re: K113634
Trade/Device Name: Injekt™ Cysto Flexible Injection Needle Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: January 19, 2012 Received: January 23, 2012
Dear Ms. Guinane:
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, ac nees mar have been 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drinas intacted and regulations administered by other Federal agencies. You must of any I edolul battatob and requirements, including, but not limited to: registration and listing Comply with an the 110 110 110 112 11 Part 801); medical device reporting (reporting of medical
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· Page 2 -
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/Resourcesfor You/Industry/default.htm.
Sincerély yours,
Sincerely yours,
Benjamin K. Evans
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
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Attachment A - Indications for Use
Device Name: Injekt™ Cysto Flexible Injection Needle
Indications for Use:
This device is used to inject legally marketed injectable therapeutic agents into the lower urinary tract through the working channel of a cystoscope.
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF)
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Leuu
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, d
Urological Devices
510(k) Number K 113634
Page 1 of 1
§ 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.