← Product Code [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB) · K062145 # MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 (K062145) _Acumen Medical, Inc. · DYB · Aug 23, 2006 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K062145 ## Device Facts - **Applicant:** Acumen Medical, Inc. - **Product Code:** [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB.md) - **Decision Date:** Aug 23, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1340 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters .. ## Device Story Modified Acumen Lead Delivery Sheath is a single-use percutaneous catheter; features guidewire lumen and lead introduction lumen. Used by clinicians to facilitate placement of pacing or defibrillator leads and catheters. Device provides a pathway for lead delivery; assists in cardiovascular procedures. Benefits include simplified lead introduction. ## Clinical Evidence Bench testing only; all components and subassemblies met required specifications. ## Technological Characteristics Single-use percutaneous catheter; includes guidewire lumen and lead introduction lumen. Materials are biocompatible and consistent with previously cleared products. No energy source or software. ## Regulatory Identification A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. ## Predicate Devices - Acumen Lead Delivery Sheath ([K051515](/device/K051515.md)) ## 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}------------------------------------------------ # AUG 2 3 2006 K062145 #### 5. 510(k) Summary General Information Date Compiled Classification Trade Name Submitter July 26, 2006 Class II Orion 11 Modified Acumen Lead Delivery Sheath Models: LDS-10-57, LDS-10-64, LDS-10-57-90, and LDS-10-64-90 Acumen Medical, Inc. 275 Santa Ana Court Sunnyvale, CA 94085 Tel: 408-530-1810 Fax: 408-530-1811 Contact Marybeth Gamber Director, Regulatory Affairs ### Intended Use The Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters .. Predicate Devices Acumen Lead Delivery Sheath Manufactured by Acumen Medical, Inc. K051515 #### Device Description The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads. #### Matcrials All materials used in the manufacture of the Modified Acumen LDS are suitable for this use and have been used in numerous previously cleared products. Testing Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. ### Summary of Substantial Equivalence Acumen Medical, Inc. believes the Modified Acumen Lead Delivery Sheath is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are cither identical or substantially equivalent to existing legally marketed predicate product. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 3 2006 Acumen Medical, Inc. c/o Ms. Marybeth Gamber Director, Regulatory Affairs 275 Santa Ana Court Sunnyvale, CA 94085 Re: K062145 Trade/Device Name: Modified Acumen Lead Delivery Sheath Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 26, 2006 Received: July 27, 2006 Dear Ms. Marybeth Gamber: 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 such 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. {2}------------------------------------------------ Page 2 - Ms. Marybeth Gamber 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), 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, B/Summner for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use Statement 4. This application 510(k) Number (if known): Device Namc: Modified Acumen Lead Delivery Sheath Indications for Use: . The Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters. Prescription Use _X (Pcr 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Pcr 21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Blummina (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number k060145 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K062145](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K062145) **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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