(88 days)
K#982890, K#960519, K#990996, K#983765, K#812057
Not Found
No
The description focuses on the physical components and intended use of a standard injection needle, with no mention of AI or ML capabilities.
No.
The device is an injection needle, which is used to deliver substances, but it does not directly provide therapy itself. It is a tool for administration.
No
Explanation: The device is an injection needle used to deliver materials into tissues, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to identify or monitor a disease or condition.
No
The device description clearly outlines physical components (Polyurethane Catheter, Stainless Steel Needle Tip, luer lock hub) and their dimensions, indicating it is a hardware medical device.
Based on the provided information, the Cook Injection Needles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the needles are used to "deliver a variety of injectable materials into tissues during laparoscopic, hysteroscopic, cystoscopic transurethral procedures and open surgical procedures." This describes a device used in vivo (within the body) for therapeutic or procedural purposes.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Cook Injection Needles do not perform this function.
- Device Description: The description details a physical needle and catheter designed for injection into tissues, not for analyzing biological samples.
Therefore, the Cook Injection Needles are a medical device used for surgical and procedural interventions, not an IVD.
N/A
Intended Use / Indications for Use
The Cook Injection Needles are used to deliver a variety of injectable materials into tissues during laparoscopic, hysteroscopic, cystoscopic transurethral procedures and open surgical procedures. The type of material to be injected will be dependent on the nature of the procedure. The needle is intended to be used with legally marketed drugs and devices.
Product codes
78 FBK
Device Description
The Cook Injection Needle will consist of a Polyurethane Catheter with a Stainless Steel Needle Tip and a luer lock hub. The Catheter sizes range from 3.7 French to 9 French and will be 15cm to 65cm's in length. The Stainless Steel Needle portion will be 16 Gage though 25 Gage. These Devices will be manufactured according to specified controls and a Ouality Assurance Program. The devices will undergo packaging similar to the devices currently marketed and distributed by Cook Urological.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tissues (during laparoscopic, hysteroscopic, cystoscopic transurethral procedures and open surgical procedures)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#982890, K#960519, K#990996, K#983765, K#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
K 022484
510(k) Premarket Notification Cook Iniection Needles Cook Urological, Inc.
510(k) SUMMARY I.
Submitted By:
Debbie Schmitt Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891
Date: July 26, 2002
Device
Cook Injection Needles Trade Name: Proposed Classification Name: Class II Needle, Endoscopic 78 FBK Specifically, the Cook Injection Needles are similar to The Predicate Devices: Advanced UroScience Injection Needles (K#982890), The Martech Endoscopic Needle (K#960519), The Genyx Medical Injection Needles (K#990996), The Tunis Transurethral Injection/Aspiration System Probe Devices (K#983765) and The Vance Cystoscopic Injection Needle (K#812057). The Cook Injection Needle will consist of a Polyurethane Device Description: Catheter with a Stainless Steel Needle Tip and a luer lock hub. The Catheter sizes range from 3.7 French to 9 French and will be 15cm to 65cm's in length. The Stainless Steel Needle portion will be 16 Gage though 25 Gage. These Devices will be manufactured according to specified Substantial Equivalence: controls and a Ouality Assurance Program. The devices will undergo packaging similar to the devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.
7
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles within the eagle's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2002
Ms. Debbie Schmitt Regulatory Affairs Manager Cook® Urological 1100 W. Morgan Street SPENCER IN 46460
Re: K022484
Trade/Device Name: Cook Injection Needles Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FBK Dated: July 26, 2002 Received: July 29, 2002
Dear Ms. Schmitt:
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 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); 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.
2
Page 2
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy Chrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known): 人 0 22 48 4
Device Name: Cook Injection Needles
Indications For Use: The Cook Injection Needles are used to deliver a variety of injectable materials into tissues during laparoscopic, hysteroscopic, cystoscopic transurethral procedures and open surgical procedures. The type of material to be injected will be dependent on the nature of the procedure. The needle is intended to be used with legally marketed drugs and devices.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L/
OR
Over-the-Counter______________________________________________________________________________________________________________________________________________________________
David A. Depson
(Division Sign-Off Division of Reproductiv and Radiological Devic 510(k) Number