1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Smiths Industries Medical Systems. The logo consists of the word "sims" in a stylized font, with a solid black circle above the "i". To the right of "sims" are the words "SMITHS INDUSTRIES" in a bold, sans-serif font, with the words "Medical Systems" below in a smaller, serif font. The words "SMITHS INDUSTRIES" and "Medical Systems" are underlined. K991861 # JAN 18 2000 #### SIMS Portex Inc. 10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703 # H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ## 510(K) SUMMARY: ## COMPANY INFORMATION: SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager, Regulatory Affairs #### PREPARATION DATE OF SUMMARY: May 28, 1999 #### TRADE NAME: 1st Response Infant Manual Resuscitator 1st Response Pediatric Manual Resuscitator ## COMMON NAME: Manual Resuscitator ## PRODUCT CLASS/CLASSIFICATION: Class II, 73 BTM, 21 CFR 868.5915 ## PREDICATE DEVICE(S): Hudson Respiratory Care Inc., Temecula California, Neonate Manual Resuscitator, Cat. No. 5360 and Pediatric Manual Resuscitator, Cat. No. 5365. SIMS Portex Inc., Ft. Myers Florida, 1st Response Infant Manual Resuscitator, Cat. No. 008027MP and 1st Response Pediatric Manual Resuscitator Cat. No. 008120 {1}------------------------------------------------ #### DESCRIPTION: The 1st Response infant and pediatric manual resuscitators are disposable, single use emergency manual ventilators. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservoir or tube reservoir. These reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used. The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15mm ID x 22 mm OD patient connector, exhalation port, manometer port, and a pressure limiting valve (PLV). The device is provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter. #### INDICATIONS FOR USE: ## Infant Manual Resuscitator The 18 Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of < 10 kg (22 lbs). #### Pediatric Manual Resuscitator The 1* Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to pediatric patients suffering from respiratory distress. It is intended for use on patients with a body mass of > 10 kg (22 lbs) and <25 kg (55 lbs). ## TECHNICAL CHARACTERISTICS: The device has the same technical characteristics as the predicate device marketed by Hudson Respiratory Care Inc. and our manual resuscitators. ## NON-CLINICAL DATA: Performance and specifications of the modified device are consistent with all requirements for this device type specified by ISO 8382:1988 (E) Resuscitators intended for use with humans and ISO 5356-1: 1987 - Anaesthetic and respiratory equipment -Conical connectors - Part 1: Cones and sockets. {2}------------------------------------------------ ## CONCLUSION: The comparison to the predicate devices demonstrate that the proposed devices are safe and effective and are substantially equivalent to the predicate devices. Very truly yours, SIMS PORTEX INC. Timothy J. Talbot Timothy J. Takott Manager, Regulatory Affairs {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 18 2000 Mr. Timothy J. Talcott SIMS Portex Inc. 10 Bowman Drive P.O. Box 0724 Keene, NH 03431 Re : K991861 186 Response Infant and Pediatric Manual Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: October 28, 1999 Received: October 29, 1999 Dear Mr. Talcott: 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 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. {4}------------------------------------------------ #### Page 2 - Mr. Timothy J. Talcott 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 Also, please note the regulation entitled, (301) 594-4639. "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/dsma/dsmamain.html". Sincerely yours, Jeans A Westerlun for, Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # B: INTENDED USE OF DEVICE ## PROPOSED INDICATIONS FOR USE: Page 1 of 1 510(k) Number (if known): Unknown Device Name: 1* Response Infant and Pediatric Manual Resuscitator Indications For Use: #### Infant Manual Resuscitator The 1st Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of < 10 kg (22 lbs). #### Pediatric Manual Resuscitator The 1* Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to pediatric patients suffering from respiratory distress. It is intended for use on patients with a body mass of > 10 kg (22 lbs) and <25 kg (55 lbs). (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (QDE) (Division Sign-Off) Division of Cardiovascular, Respiratory, Neurological Devices | Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> | |-------------------------|----------------------------------------------------------------| | OR Over-The-Counter Use | <span style="text-decoration: overline;"></span> | | 510(k) Number | <span style="text-decoration: overline;">K991861</span> |