← Product Code [BSP](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP) · K050499 # PROBLOC, HN SERIES AND PROLONG, PL SERIES (K050499) _Life-Tech, Inc. · BSP · May 17, 2005 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K050499 ## Device Facts - **Applicant:** Life-Tech, Inc. - **Product Code:** [BSP](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP.md) - **Decision Date:** May 17, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5150 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use Prolong is used to administer a patient conduction, regional, or local anesthesia. ProBloc is used in performance of regional anesthesia block. ## Device Story ProBloc (HN Series) and Prolong (PL Series) are anesthesia conduction needles. Used by clinicians to deliver regional or local anesthesia. Devices facilitate regional anesthesia blocks. No complex electronics, software, or automated processing involved. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Anesthesia conduction needles. Class II device (21 CFR 868.5150). Product code BSP. ## Regulatory Identification An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia. ## 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 Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. ## MAY 1 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Jeff Kasoff Director of Regulatory Affairs Life-Tech, Incorporated 4235 Greenbriar Drive Stafford, Texas 77477-3995 Re: K050499 Trade/Device Name: ProBloc, HN Series and Prolong, PL Series Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: February 25, 2005 Received: March 1, 2005 Dear Mr. Kasoff: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your secure mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to do room Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 600; Drag, Drag, therefore, market the device, subject to the general approvin applicans of the Act. The general controls provisions of the Act include controls provided or 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 (1 WIT), it they of basyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ea. row roublish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Kasoff 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), r please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ U.S. Food and Drug Administration Image /page/2/Picture/1 description: The image shows the logo of the Department of Health and Human Services. The logo consists of a stylized eagle on the left and the text "Department of Health and Human Services" on the right. The text is stacked vertically, with "Department of" on the top, "Health and" in the middle, and "Human Services" on the bottom. KOENTER FOR DEVICES AND RADIO RADIO FO CICAL FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH ## Indications for Use 510(k) Number (if known): Unknown Device Name: Modified Prolong, ProBloc Indications for Use: Prolong is used to administer a patient conduction, regional, or local anesthesia. ProBloc is used in performance of regional anesthesia block. Quls (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number K050499 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K050499](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K050499) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com