KAPLAN-SIMPSON INFUSASLEEVE II

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that. February 3, 2022 LocalMed, Inc. Aaron Kaplan Chief Science Officer 1820 Embarcadero Rd. Palo Alto, California 94303 Re: K980957 Trade/Device Name: Kaplan-Simpson InfusaSleeve II Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA Dear Aaron Kaplan: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 10, 1998. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov. Sincerely, Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2022.02.03 Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three lines forming its body and head, symbolizing the department's mission to protect the health of all Americans. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". JUN 1 0 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Aaron Kaplan, MD Localmed, Inc. 1820 Embarcadero Road Palo Alto, CA 94303 Re: K980957 Kaplan-Simpson Infusasleeve II (100) or IS-2 (100) Trade Name: Regulatory Class: II Product Code: KRA Dated: March 11, 1998 Received: March 16, 1998 Dear Mr. Kaplan: 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 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance 895. 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 requlation may result in requlatory 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. {2}------------------------------------------------ #### Paqe 2 - Dr. Aaron Kaplan 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 Compliance at (301) 594-4618. 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, "Misbrandinq by reference to premarket notification" (21CFR 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, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510 (K) Number (if known): N/A Device Name: InfusaSleeve II (IS-2) Indications for Use: The InfusaSleeve II is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion. ## (PLESE 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) ్లో ప్ర OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ an (Division Sign-Off) (Optional Format 1-2-96) Division of Cardiovascular, Respiratory, and Neurological Devices K40095 510(k) Number {4}------------------------------------------------ JUN 10 1998 510(K) SUMMARY | SUBMITTER'S NAME AND ADDRESS: | LocalMed, Inc.,<br>1820 Embarcadero Road<br>Palo Alto, CA 94303 | |-------------------------------------|-----------------------------------------------------------------| | PHONE: | (650) 843-6770<br>(650) 843-6771 fax | | CONTACT PERSON: | Aaron Kaplan, MD | | DATE SUMMARY PREPARED: | March 11, 1998 | | DEVICE TRADE NAME: | Kaplan-Simpson InfusaSleeve™ II | | DEVICE COMMON NAME: | Catheter, infusion | | DEVICE CLASSIFICATION NAME: | Catheter, continuous flush | | SUBSTANTIALLY EQUIVALENT DEVICE(S): | InfusaSleeve™ IIa, InfusaSleeve™ II | DEVICE DESCRIPTION AND FUNCTION: The Kaplan-Simpson InfusaSleeve™ II is a multi-lumen catheter consisting of a proximal infusion port, a I he 'rapidi-omipon' intesselected with a distal infusion region. An entry port for balloon and guide wire proximal shart, and a main cancer shart which is proximal to the infusion region. See Figure 1. Image /page/4/Figure/6 description: The image shows a diagram of a medical device, specifically a catheter. The diagram labels different parts of the catheter, including the proximal infusion port, proximal shaft, main catheter shaft, shaft transition marker, balloon/wire entry port, infusion region, radiopaque markers, tip, and flushing tool. There is also a detailed view of the infusion region, showing expansion slits and sideholes. Figure 1 The infusion region consists of four separate infusion lumens each with multiple sideholes. Radiopaque markers are located within the infusion region. Infusion solution is delivered through the proximal infusion port, through the four infusion lumens and exits through the sideholes into the coronary vasculature. A standard luer adapter allows for attachment of a syringe with a manometer or equivalent to the proximal infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve II is designed to track over standard dilatation catheters. {5}------------------------------------------------ ### INTENDED USE: .............................................................................................................................................................................. The InfusaSleeve II is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urchinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation cather to facilitate selective and subselective access and regional infusion. # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: | | PREDICATE | | | | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------|--------| | | InfusaSleeve IIa | InfusaSleeve II | InfusaSleeve II | | | General indications: | General intravascular use, delivery<br>of therapeutic solutions. Selective<br>and sub-selective controlled infusion<br>of solutions. | same | same | | | Usage: | Single use, disposable | same | same | | | How supplied: | Sterile, non-pyrogenic | same | same | | | Sterilization method: | 100% Ethylene Oxide (EtO)<br>sterilized | same | same | | | Materials: | | | | | | Infusion port: | Polycarbonate | same | same | | | Proximal shaft: | Stainless Steel, Nylon | same | same | | | Main shaft & Tip: | Nylon | same | same | | | Lubricious coating: | Silicone | same | same | | | Radiopaque marker: | Gold/Stainless steel | same | same | | | Hard Stop: | Pellethane | same | same | | | Transition marker | Stainless steel | - | same | | | Support elements: | Stainless steel | same | same | | | Design & Construction: | | | | | | Catheter<br>configuration: | Introduced co-axially over a<br>dilatation device. Infusion through<br>peripheral lumens. | same | same | | | Shaft configuration: | Multi-lumen device. Central lumen<br>accommodates dilatation device.<br>Four opposing peripheral infusion<br>lumens. | same | same | | | Infusion region: | Nine-delivery side holes per<br>peripheral lumen. | same | same | | | Infusion side hole<br>diameter: | 28μm | 40μm | 40μm | | | Mode of operation: | | | | | | Solution delivery<br>mode: | Solution delivery via the peripheral<br>lumen side holes into the<br>vasculature. | same | same | | | Maximum proximal<br>infusion pressures: | 50 psig | 50 psig | 100 psig | | | PREDICATE | | | | | | | InfusaSleeve IIa | InfusaSleeve II | InfusaSleeve II | | | | Infusion Pressure (psig) | Flow Rate (mL/min) | | | | | 5 | 5 | 3 | | | | 15 | 10 | 7 | | | | 30 | 15 | 13 | | | | 40 | 17 | 17 | | | | 50 | 20 | 20 | | | | 60 | - | 24 | | | | 70 | - | 27 | | | | 80 | - | 31 | | | | 90 | - | 34 | | | | 100 | - | 38 | | | | Vascular access: | Percutaneous | same | same | | | Tracking mechanism: | Over-the-balloon | same | same | | Size: | | | | | | | Total length: | 1.4 m | same | same | | | Working length: | 1.3 m | same | same | | | Infusion region length: | 2 cm | same | same | | | Outer diameter: | 1.5 - 2.1 mm | same | same | | | Inner diameter: | 0.9 - 1.5 mm | same | same | | Compatibility: | | | | | | | Max balloon diameter | 4.0 mm | 3.5 mm | 4.0 mm | | | Max balloon catheter shaft size: | 3.8 Fr | 3.5 Fr | 3.8 Fr | | | Guiding catheter: | Standard | same | same | | | Infusion port fitting: | ISO 594 luer conical fitting | same | same | | Radiopacity: | | via Radiopaque distal markers | same | same | {6}------------------------------------------------ # NONCLINICAL TESTS: Material biocompatibility, bond joint tensile strengths, infinited fatige, burst pressure, flexural Material biocompatibility, bond joint tensite strellguls, intusion patings, tip expansion resistance, and invivo animal evaluations. # TEST CONCLUSIONS: The test results verified that the InfusaSleeve II performance is equivalent to, or exceeds the predicate InfusaSleeve II device performance.