← Product Code [HCA](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA) · K992796 # ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 (K992796) _Image-Guided Neurologics, Inc. · HCA · Oct 25, 1999 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K992796 ## Device Facts - **Applicant:** Image-Guided Neurologics, Inc. - **Product Code:** [HCA](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA.md) - **Decision Date:** Oct 25, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4100 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use For the Aspiration or Irrigation of fluids during Intracranial procedures. This device is not intended for implant ## Device Story Aspiration/Irrigation Catheter used during intracranial procedures; facilitates removal or delivery of fluids. Operated by neurosurgeons in clinical/OR settings. Device provides mechanical access for fluid management; aids in maintaining surgical field visibility or therapeutic delivery. Benefits patient by enabling precise fluid control during neurosurgical intervention. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Catheter-based device for fluid aspiration/irrigation. Non-implantable. Class II device (Product Code: HCA). ## Regulatory Identification A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 5 1999 Mr. Michael Renner Vice President Image-Guided Neurologics 2290 Eau Gallie Boulevard Melbourne, Florida 32935 Re: K992796 > Trade Name: Aspiration/Irrigation Catheter Regulatory Class: II Product Code: HCA Dated: August 18, 1999 Received: August 19, 1999 Dear Mr. Renner: 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 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 II (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 requirement, 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 regulations. {1}------------------------------------------------ ## Page 2 – Mr. Michael Renner 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ of 510(k) NUMBER (IF KNOWN) : K 992720 9b Aspiration/Irrigation Catheter DEVICE NAME: INDICATIONS FOR USE: For the Aspiration or Irrigation of fluids This device during Intracranial procedures. is not intended for implant (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) X OR Over-The-Counter-Use (Optional Format 1-2-96) (Division Sign-Off) Division of General Restorative Devices L992796 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K992796](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K992796) **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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