RONDEX CPR ISO-SHIELD

{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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 25, 2022 Rondex Products, Inc. Gene Baldwin President P.O. Box No. 1829 Rockford, Illinois 61110 Re: K981169 Trade/Device Name: Rondex CPR Iso-Shield Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing valve Regulatory Class: Class II Product Code: CBP Dear Gene Baldwin: 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 May 19, 1998. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code CBP. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact James J. Lee, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-8463, James.J.Lee@fda.hhs.gov. Sincerely, Image /page/0/Picture/9 description: The image shows the text "James J. Lee -S" in a large, bold font. The text is arranged horizontally, with the name "James J. Lee" appearing first, followed by a hyphen and the letter "S". The font is sans-serif and the color is black. The background is white. James J. Lee, Ph.D. Division Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized representation of a bird or eagle with three heads, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 9 1998 Mr. Gene R. Baldwin Rondex Products, Inc. P.O. Box No. 1829 Rockford, IL 61110 Re: K981169 CPR Shield Regulatory Class: II (two) Product Code: 73 LYM Dated: March 25, 1998 March 30, 1998 Received: Dear Mr. Baldwin: 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 aqainst 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 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 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 - Mr. Gene R. Baldwin 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 devices), please contact the Office of Compliance 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 requlation 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. Callahon Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health 2 Enclosure {3}------------------------------------------------ K981169/A ' Page of K981169 510 (k) NUMBER (IF KNOWN) : DEVICE NAME : Rondex CPR Iso-Shield INDICATIONS FOR USE: To provide a means for a person to administer artificial ventilation using the mouth-to-mouth technique while reducing the risk of the operator's mouth coming in contact with body fluids from the non-breathing victim. FDA/CDRH/ODE/DMC 15 Apr 98 12 45 RECEIVED (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) . Puzic (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K981169 SK-15 {4}------------------------------------------------ ## MAY | 9 1998 RONDEX PRODUCTS, INC. P.O. Box 1829 Rockford, Illinois May 4, 1994 phone: 815-226-0452 contact: Gene R. Baldwin Device Name: CPR ISO-SHIELD Common Name: CPR Shield Predicate Devices: Microshield a • Res-Cue Key b . ## 510K SUMMARY OF SAFETY AND EFFECTIVENESS The CPR ISO-SHIELD is a device designed as an adjunct for mouth-to-mouth ventilation on a non-breathing adult or child mouth-co-mouth vehiclate the operator's mouth from the victim's body fluids. The CPR ISO-SHIELD has a shield barrier, a plastic bite block/air tube with walve which is placed between the The operator blows into the tube and uses victim's teeth. victim's ceeth. The victim's exhalation is acceptable of their breath escaping around the valve and between the shield and their face. Design characteristics: The large surface area of the besign onataoquare inches reduces the risk of vomitus barrier, 40 Square inides of the shield and coming in contact with the operator's face side of the shield. Two plastic grips are added to the ISO-SHIELD, attached to the valve housing below the barrier on the victim's side. This allows the operator to handle the device under the protective the operator of ize the transfer of contamination to the top These grips also have memory which should help lift " surface. surface. "Incoc getim's face after the operator releases his mouth. The technological characteristics of the device differ somewhat from Microshield. ISO-SHIELD has a polyethylene somewhat from from Microshield uses vinyl (PVC ?). Res-Cue Key appears to use polyethylene material. ISO-SHIELD uses a silicone rubber flapper design for the This results in less This is similar to Res-Cue Key. valve. valve. This is claires by the operator blowing into the valve as compared to Microshield. The ISO-SHIELD has two plastic grips attached to the valve Microshield and Res-Cue Key do not have this housing. The grips allows the operator to position and feature. remove the shield without touching the top surface. Touching the top surface increases the risk of contamination being the cop bad to the blowing surface where the operator puts his lips. The grips also help release the shield from the victim's face after the operator releases his mouth. {5}------------------------------------------------ page 2 RONDEX PRODUCTS, INC. ## SAFETY & EFFECTIVENESS TO OTHER MARKETED PRODUCTS: The victim can breathe spontaneously, if they have the The victim can breathe spontaneously, II oney and the device is in ability, without operator assistance when the victim's face. ability, without operator assistance whon the victimes face. place and the shield is released from the victim's face. The shield Same as Microshield. The CPR ISO-SHIELD has a means to help lift the shield The CPR ISO-SHIELD has a means to facilitate exhalation barrier away from victim's face to laciried. Canada on top of especially if the operator pinches the nose closed on top of especially if the operator pinches the nose offer this. the shield. Microshield and Res-Cue Key do not offer this. Device can be handled beneath the protective shield barrier, Device can be handled beneath the protective one areas against the victim's side, to increase safety to the operator's face side the victim's side, to increase salety to the operator's face side, contamination being transferred to the operater of the this. Effective resuscitation was achieved using the technique Effective resuscitation was achieved using on an adult Laerdal similar to mouth resuscitation on an adult Laerdal similar to mouth-to-mouth resulscroabson Sealing and Anne and Armstrong child manikin Timmy - Southly ventilation effectiveness were equivalent to Microshield. Ambu's ISO SHIELD has a 4 mil polyethylene shield barrier. I material man al mil (polyethylene?) material for ISO SHIELD has a 4 mil polyethylene?) material for the a I mil (polyechylche. , is very thin and shield barrier. shield barrier. This thickness, I mis, victim's or one is high risk of it tearing on the Vioram of the 11 mil vinyl material.