Mic-Key* SF Over-the-Wire Stoma Measuring Device

{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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 26, 2018 Halyard Health, Inc. David M. Lee, JD Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, GA 30004 Re: K173955 > Trade/Device Name: MIC-KEY* SF Over-the-Wire Stoma Measuring Device Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: December 26, 2017 Received: December 28, 2017 Dear David M. Lee: 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Benjamin R. Fisher -S Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173955 Device Name MIC-KEY* SF Over-the-Wire Stoma Measuring Device Indications for Use (Describe) MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(K) SUMMARY- K173955 #### Date: January 20, 2018 #### Applicant's Name, Address, Telephone, Contact Person Halvard Health. Inc. 5405 Windward Parkway Alpharetta, Georgia 30004 Contact Name: David M. Lee, JD Associate Director, Requlatory Affairs Halvard Health 470 448 5182 (Phone) David.lee@hyh.com #### 1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME | Classification: | Class II, per 21 CFR 876.5980 | |----------------------|--------------------------------------------------| | Classification Name: | Gastrointestinal tube and accessories | | Common/Usual Name: | Stoma Measuring Device | | Product Code: | KNT | | Trade Name: | MIC-KEY* SF Over-the-Wire Stoma Measuring Device | #### 2. PREDICATE DEVICE MIC-KEY* SF Over the Wire Stoma Measuring Device cleared under the MIC-KEY*LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES-K122653. #### 3. INDICATIONS FOR USE MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube. #### 4. DESCRIPTION OF DEVICE MIC-KEY* SF Over-the-Wire Stoma Measuring Device is designed for measuring the length of a stoma prior to placement of a low profile feeding tube. The Stoma Measuring Device comprises a tubular shaft 10 Fr with graduated scale, an inflation valve and retaining balloon. The MIC-KEY* SF Over the Wire Stoma Measuring Device is made of polyurethane tubing, EtO sterilized and for single use. Like the predicate device, it is intended to be use in hospital environment. #### 5. TECHNOLOGICAL CHARACTERISTICS The MIC-KEY* SF Over-the-Wire Stoma Measuring Device is substantially equivalent to the predicate device. The following changes from the predicate device were made: - . the printed device labeling (printed marking was added to the polyurethane molded head indicating the balloon inflation volume) - minor changes to the geometry of the molded polyurethane head ● - minor change to the geometry of the molded tethered cap ● - the ink used for device marking was changed o There are no other significant differences in the design, materials, performance, and technological characteristics from the predicate device. {4}------------------------------------------------ ### 6. SUMMARY OF NONCLINICAL TESTS Performance testing on the device under submission was conducted to demonstrate the modified device continued to meet performance specification. Results of design verification and validation activities did not raise any new issues of safety or effectiveness. Non-clinical verification was conducted through the risk management process according to ISO 14971:2012. The following verification tests were conducted: | Test | Acceptance Criterion | Result | |--------------------------------------|-------------------------------------------------------------------------------------|--------| | Tensile Strength, Head/Tube | ≥ 15 N per EN 1615:2000 | Pass | | Balloon Concentricity | < 2:1 per ASTM F 2528-06 | Pass | | Deflated Balloon Outer Diameter | Pass through 4 Fr size larger ring gauge<br>per ASTM F 2528-06 (without lubricant) | Pass | | Deflated Balloon Outer Diameter | Pass through 2 Fr size larger ring gauge<br>per ASTM F 2528-06 (with lubricant) | Pass | | Tube Outer Diameter | Pass through 1 Fr size larger ring gauge<br>per ASTM F 2528-06 | Pass | | Balloon Valve Luer Tip Compatibility | Able to inflate balloon with a Luer tip<br>syringe | Pass | | Printed Ink Durability | Printing remains legible following cleaning | Pass | | Device Removal Force | ≤ 0.48 lbf | Pass | | Balloon System Leak Test | No leakage when the balloon is inflated<br>for five minutes | Pass | | Collar Movement | The collar can slide along the tubing for<br>the entire length of the printed ruler | Pass | | System Leak Test, Cap/Head | No leakage when pressurized to 0.5 psi | Pass | | Guidewire Insertion | Device can slide along a 0.038" diameter<br>guidewire | Pass | | Device Radiopacity | ASTM F640-7 | Pass | | Sterile Barrier | No bubbles per ASTM F 2096-11 | Pass | The following biocompatibility tests were also conducted, and all met acceptance criteria: ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process AAMI ANSI ISO 10993-5, 2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-11:2006/(R2010): Biological evaluation of medical devices - Part 11: Tests for systemic toxicity #### 7. OVERALL PERFORMANCE CONCLUSIONS The above nonclinical studies demonstrate MIC-KEY* SF Over-the-Wire Stoma Measuring Device is substantial equivalence to the predicate MIC-KEY* SF Over-the-Wire Stoma Measuring Device (K122653) in intended use, design, materials, performance, and biocompatibility attributes. There are no new questions of safety and effectiveness as compared to the predicate device.