INFUSASLEEVE IIA (IS-2A)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The seal features an abstract design with lines and curves. February 3, 2022 LocalMed, Inc. Ed Lee Director, Regulatory Affairs/quality Assurance 1820 Embarcadero Rd. Palo Alto, California 94303 Re: K972175 Trade/Device Name: InfusaSleeve IIa (IS-2a) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA Dear Ed Lee: 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 August 28, 1997. 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, Image /page/0/Picture/9 description: The image shows a digital signature. The signature is from Gregory W. O'connell. The date of the signature is 2022.02.03, and the time is 14:35:39 -05'00'. 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/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 body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Mr. Ed Lee Director, Requlatory Affairs and Quality Assurance LocalMed 1820 Embarcadero Road - -Palo Alto, California 94303 AUG 28 1997 Re: K972175 Kaplan-Simpson InfusaSleeve™ IIa Requlatory Class: II (two) Product Code: KRA Dated: June 6, 1997 Received: June 9, 1997 Dear Mr. Lee: 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 Reqister. 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}------------------------------------------------ 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 (21 Crk Farc our and dadreronary %07.10 10-12-200 at 13:00 am devices), please contact the Office of Cómpliance at (301) 594-4648. 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, Thomas J. Callehan 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): K972175 Device Name: InfusaSleeve IIa (IS-2a) Indications for Use:…… ------------------------------------------------------------------------------------------------------------------------------------------------------- The InfusaSleeve IIa 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. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (Division Sign-Off) | | | Division of Cardiovascular, Respiratory, and Neurological Devices | | | 510(k) Number | ____________________________________ | | Prescription Use (Per 21 CFR 801.109) | <span> <svg class="bi bi-check-lg" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M13.854 2.146a.5.5 0 0 1 0 .708l-7 7a.5.5 0 0 1-.708 0l-3.5-3.5a.5.5 0 1 1 .708-.708L6.5 9.793l6.646-6.647a.5.5 0 0 1 .708 0z" fill-rule="evenodd"></path> </svg> </span> | | | OR | | Over-The-Counter Use | ____________________________________ | | | (Optional Format 1-2-96) | {4}------------------------------------------------ K972175 510(K) SUMMARY AUG 2 8 | SUBMITTER'S NAME AND ADDRESS: | LocalMed, Inc.<br>1820 Embarcadero Road<br>Palo Alto, CA 94303 | |-------------------------------------|----------------------------------------------------------------| | PHONE: | (415) 843-6770<br>(415) 843-6771 fax | | CONTACT PERSON: | Edwin Lee | | DATE SUMMARY PREPARED: | June 6, 1997 | | DEVICE TRADE NAME: | Kaplan-Simpson InfusaSleeve ^TM IIa | | DEVICE COMMON NAME: | Catheter, infusion | | DEVICE CLASSIFICATION NAME: | Catheter, continuous flush | | SUBSTANTIALLY EQUIVALENT DEVICE(S): | InfusaSleeve ^TM II | ### DEVICE DESCRIPTION AND FUNCTION: The Kaplan-Simpson InfusaSleeve™ IIa is a multi-lumen catheter consisting of a proximal infusion port, a proximal shaft, and a main catheter shaft with a distal infusion region. An entry port for balloon and guide wire access is located at the proximal end of the main shaft which is proximal to the infusion region. See Figure 1. Image /page/4/Figure/6 description: This image shows a medical device with labels pointing to its different parts. The device includes a proximal infusion port, proximal shaft, main catheter shaft, shaft transition marker, balloon/wire entry port, radiopaque markers, tip, and flushing tool. There is also a detailed view of the infusion region, highlighting 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 equival infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve IIa is designed to track over standard dilatation catheters. #### INTENDED USE: The InfusaSleeve IIa 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 {5}------------------------------------------------ with a commercially available dilatation catheter to facilitate selective access and regional infusion. - | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: | | | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | | InfusaSleeve II | InfusaSleeve IIa (premarket notification) | | General indications: | General intravascular use, delivery of<br>therapeutic solutions. Selective and sub-<br>selective controlled infusion of solutions. | General intravascular use, delivery of<br>therapeutic solutions. Selective and sub-<br>selective controlled infusion of solutions. | | Usage: | Single use, disposable | Single use, disposable | | How supplied: | Sterile, non-pyrogenic | Sterile, non-pyrogenic | | Sterilization method: | 100% EtO sterilized | 100% EtO sterilized | | Materials: | | | | Infusion port: | Polycarbonate | Polycarbonate | | Proximal shaft: | Stainless Steel, Nylon | Stainless Steel, Nylon | | Main shaft & Tip: | Nylon | Nylon | | Lubricious<br>coating: | Silicone | Silicone | | Radiopaque<br>marker: | Gold/Stainless steel | Gold/Stainless steel | | Support elements: | Stainless steel | Stainless steel | | Design &<br>Construction: | | | | Catheter<br>configuration: | Introduced coaxially over a dilatation<br>device. Infusion through peripheral<br>lumens. | Introduced coaxially over a dilatation<br>device. Infusion through peripheral<br>lumens. | | Shaft<br>configuration: | Multi-lumen device. Central lumen<br>accommodates dilatation device. Four<br>opposing peripheral infusion lumens. | Multi-lumen device. Central lumen<br>accommodates dilatation device. Four<br>opposing peripheral infusion lumens. | | Distal infusion<br>region: | Nine delivery sideholes per peripheral<br>lumen. 0.04 mm sidehole diameters. | Nine delivery sideholes per peripheral<br>lumen. 0.028 mm sidehole diameters. | | Mode of operation: | | | | Solution delivery<br>mode: | Solution delivery via the peripheral lumen<br>sideholes into the vasculature. | Solution delivery via the peripheral lumen<br>sideholes into the vasculature. | | Maximum<br>proximal infusion<br>pressures: | 50 psig | 50 psig | | Vascular access: | Percutaneous | Percutaneous | | Tracking<br>mechanism: | Over-the-balloon | Over-the-balloon | | Size: | | | | Total length: | 1.4 m | 1.4 m | | Working length: | 1.3 m | 1.3 m | | | InfusaSleeve II | InfusaSleeve IIa (premarket notification) | | Infusion region<br>length: | 2 cm | 2 cm | | Outer diameter: | 1.5 - 2.1 mm | 1.5 - 2.1 mm | | Inner diameter: | 0.9 - 1.5 mm | 0.9 - 1.5 mm | | Compatibility: | | | | Max balloon<br>diameter | 3.5 mm | 4.0 mm | | Max balloon<br>catheter shaft size: | 3.5 Fr | 3.8 Fr | | Guiding catheter: | Standard | Standard | | Infusion port<br>fitting: | ISO 594 luer conical fitting | ISO 594 luer conical fitting | | Radiopacity: | via Radiopaque distal markers | via Radiopaque distal markers | # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 1 {6}------------------------------------------------ ### NONCLINICAL TESTS: Material biocompatibility, bond joint tensile strengths, infusion pathway fatigue, burst pressure, infusate flow, torque strength, histology, and in-vivo animal evaluations. ## TEST CONCLUSIONS: The test results verified that the InfusaSleeve IIa performance is equivalent to, or exceeds the InfusaSleeve II device performance.