EXPANDACELL INSTRUMENT WIPE

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 9, 2024 Shippert Medical Technologies Corporation Sarah Maxwell Lake Head of Regulatory Affairs 7002 South Revere Parkway, Suite 60 Englewood, Colorado 80112 Re: K960621 Trade/Device Name: EXPANDACELL™ Instrument Wipe Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: GEC Dear Sarah Maxwell Lake: 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 April 1, 1996. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code GEC. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, yu-chieh.chiu@fda.hhs.gov. Sincerely, Yu-chieh Chiu -S Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 1 1996 Ms. Sarah M. Lake Head of Regulatory Affairs Shippert Medical Technologies Corporation 7002 South Revere Parkway, Suite 60 Englewood, Colorado 80112 Re: K960621 Trade Name: EXPANDACELL™ Instrument Wipe Regulatory Class: I Product Code: GER Dated: February 12, 1996 Received: February 13, 1996 Dear Ms. Lake: 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. {2} Page 2 - Ms. Sarah M. Lake This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. 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 at (301) 443-6597. Sincerely yours, Kimber C. Richter, M.D. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3} K960621 Page 1 of 1 510(k) Number (if known): K960621 Device Name: Expandacell Instrument Wipe Indications For Use: The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.  (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) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) {4} K960621 APR - 1 1996 # SECTION 14 SMDA SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the written requirements of SMDA 1990 and 21 CFR 807.92 ## SAFETY AND EFFECTIVENESS OF EXPANDACELL™ INSTRUMENT WIPE The Expandacell Instrument Wipe is identical to existing medical devices, K920355, K791736 and K891101. These Instrument Wipes, marketed by Ultracell, Xomed/Merocel and Smith and Nephew have a proven track record that establishes this product line as safe and effective for use in surgery. There is no modification in the proposed device and the predicate devices. The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate device stated. Signature: Sarah Maxwell Luke Date: February 12, 1996 filename: 510kWIPE.doc 34