← Product Code [FBK](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBK) · K990996 # GENYX MEDICAL INJECTION NEEDLE (K990996) _Genyx Medical, Inc. · FBK · Jun 18, 1999 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBK/K990996 ## Device Facts - **Applicant:** Genyx Medical, Inc. - **Product Code:** [FBK](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBK.md) - **Decision Date:** Jun 18, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure. ## Device Story Genyx Injection Needle is an endoscopic accessory designed for the delivery of injectable materials into tissue. The device consists of a stainless steel shaft and a luer lock hub, allowing attachment to a standard syringe. It is used by clinicians during endoscopic procedures to inject materials through the needle lumen into the target tissue. The device functions similarly to existing endoscopic injection needles, providing a mechanical conduit for material delivery. It is intended for prescription use. ## Clinical Evidence Bench testing only. The device was evaluated for injection performance and compared to the Richard Wolf Aspiration/Injection Needle, demonstrating equivalent performance. ## Technological Characteristics Stainless steel shaft; luer lock hub; manual operation; compatible with standard syringes and existing endoscopes; non-powered. ## Regulatory 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. ## Predicate Devices - Injection Needle ([K982890](/device/K982890.md)) - Aspiration/ Injection Needle (Pre-Amendment) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ JUN 18 1999 Genyx Medical, Inc. Genyx Injection Needle K490994 March 24, 1999 Premarket Notification # SECTION 14 # SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ## Submitter's name, address, telephone number, contact person, and date summary 1. prepared: - Genyx Medical, Inc. a. 36 Argonaut, Suite 100 Aliso Viejo, CA 92656 - Contact Person: b. Judy F. Gordon, D.V.M. Vice President, Clinical & Regulatory Affairs - Date Summary Prepared: February 5, 1999 C. 2. Name of device, including trade name and classification name: - a. Trade/Proprietary Name: Genyx Injection Needle - b. Classification Name: Endoscope Needle ### 3. Identification of the predicate devices or legally marketed devices or devices to which substantial equivalence is being claimed: | Company: | Advanced UroScience | Richard Wolf Medical
Instruments | |---------------|---------------------|-------------------------------------| | Device: | Injection Needle | Aspiration/ Injection Needle | | 510(k): | K982890 | Pre-Amendment | | Date Cleared: | 10/26/98 | N/A | - 4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties): {1}------------------------------------------------ N'10444 Genyx Medical, Inc. Genyx Injection Needle March 24, 1999 Premarket Notification The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure. The Genyx Injection Needle materials are similar to those used in the predicate device. #### ട. Statement of intended use: The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure. ### Statement of how the technological characteristics of the device compare to those 6. of the predicate or legally marketed device. The Genyx Injection Needle is substantially equivalent to both predicate devices in that they all contain a stainless steel shaft and a luer lock hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue. #### 7. Brief summary of nonclinical tests and results: The Genyx Injection Needle has been designed and will be tested to applicable safety standards. In addition, the Genyx Injection Needle was found to perform equivalently to the predicate device, the Richard Wolf Aspiration/ Injection Needle with respect to injection performance. Thus, the technological changes in the Genyx Injection Needle do not raise any new issues of safety, effectiveness or performance of the product. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 18 1999 Ms. Judy F. Gordon, D.V.M. Vice President, Clinical & Regulatory Affairs Genvx Medical, Inc. 36 Argonaut, Suite 100 Aliso Vieio, CA 92656 Re: K990996 Genyx Medical Injection Needle Dated: March 24, 1999 Received: March 25, 1999 Regulatory Class: Il 21 CFR §876.1500/Procode: 78 FBK Dear Dr. Gordon: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations, 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 requlation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compilance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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. CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Genyx Injection Needle Device Name:_ Indications for Use: The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure. PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Gind A. Slegman (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_ --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBK/K990996](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBK/K990996) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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