VACULINK, MODEL VCL 3000

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for MEDEVCO, which is a medical device company. The logo features a stylized "m" followed by the company name in block letters. Above the company name, the date "APR 1 4 2005" is printed. Appendix C Page 1 of 3 # 510(k) Summary ## Submitter Information: Medevco, Inc. 12201 Merit Drive, Suite 330 Dallas, TX 75251 ## Contact: Ginger Bowman, Director of Marketing Phone: 972.788.4372 Fax: 972.851.0077 ## Date Prepared: March 10, 2005 ## Product Name: This is an accessory to a fetal vacuum extractor, which is a Class II device per 884.4340. Panel: Obstetrics/Gynecology Product Code: HDB #### Predicate Device: This device is substantially equivalent to the vacuum indicator features of Kiwi brand fetal vacuum extractor systems marketed by Clinical Innovations, Inc., under 1981260, and Mityvac brand vacuum extractor systems marketed by Prism Enterprises (now CooperSurgical) under K011532. #### Description: The VacuLink is a small, battery powered single-use vacuum measuring device. It is The VacuLink is a chianing to the vacuum chamber of commercial handheld vacuum connected in praste tasmig on Mityvac & Kiwi PalmPump). As a redundant gauge to assisted delivery bytters gauges on those devices, it electronically measures the the Dourlow applied to the fetal head during a vacuum assisted delivery. It connects to the vacuunt uppired to the ci.e. HP, Corometrics and Spacelabs) via electrical cable. The maternal is numerically displayed in centimeters of mercury (cm Hg). The vacuum vatually is nambroum the uterine activity channel of the maternal/fetal monitor and it {1}------------------------------------------------ is permanently stored in the hospital database. The information may also be displayed on a video monitor as well. The VacuLink incorporates a light sequence of red, yellow, and green. When the I he VacuLink incorporates a ingav three lights will flash in sequence as a quick test vacurant is internal components. At the successful completion of the test, the green LED of the meethal components: - is disconnected from the maternal/fetal monitor. A munimates until the Vaculine is assets voltage is low and the VacuLink should be nashing you've LED mithoutes are oused previously and is reconnected, the red LED illuminates indicating the VacuLink is no longer operational. #### Intended Use: The VacuLink is intended for obstetric use in the measurement and recording of data The Vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart. | SUBSTANTIAL EQUIVALENCE COMPARISON | | | | |--------------------------------------|---------------------|--------------------------|---------------------| | | VacuLink | Kiwi | Mityvac | | Digital display | YES | NO | NO | | Permanent record | YES | NO | NO | | Disposable | YES | YES | NO | | Gauge visible to physician | YES | YES | NO | | Ability to display maximum vacuum | YES | YES | YES | | Units of vacuum measurement | cm Hg | cm Hg, mm Hg, kPa, in Hg | cm Hg, in Hg | | Claimed accuracy/tolerance | at 70 cm Hg = 3.26% | Not published | at 70 cm Hg = 3.27% | | Visible display at variable angles | YES | YES | YES | | Calibration required by the hospital | NO | NO | YES | | Multi-use gauge | NO | NO | YES | #### Comparison to Predicate Device: The VacuLink contains additional features including: - Vacuum data recorded on paper strip chart . - I Visible display on CRT - v isibio display on Orimum vacuum, time at maximum vacuum, total time of ■ vacuum, involuntary releases, reduction of vacuum between contractions, and total number of pulls - Light sequencing system to confirm functionality of VacuLink l {2}------------------------------------------------ Appendix C Page 3 of 3 K043614 ## Performance Data & Conclusions: Performance testing of VacuLink has been conducted in three main phases: - 1. Initial bench testing to compare VacuLink technology to certified reference Intial belien testing to comparate in use at community hospitals. - 2. Initial clinical phase (feasibility study) - 2. Intrail Chinedi phase (reastonity could)) 3. Secondary bench testing on the current configuration of the VacuLink device Performance testing of VacuLink as well as the reusable handheld vacuum devices Ferrormance testing of VacuLink as accurate as the claimed accuracy of the comparable reveals that the Vacurimis is as accurate as the lack of calibration of the comparable vacuum gauges. In actual cinnical VacuLink was more accurate by a factor of 10. Electrical safety and EMC testing was also performed to demonstrate conformance Diectived salery and ENTO testing was aftware validation and sterilization process information have also been provided. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle, with its wings spread and its head facing to the left. The eagle is composed of three thick, curved lines that suggest the shape of the bird. APR 1 4 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medevco, Inc. % Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Rd., #200-207 PLANO TX 75025 Re: K043614 Trade/Device Name: Vaculink Regulation Number: 21 CFR 884.4340 Regulation Name: Fetal vacuum extractor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HDB and HGM Dated: March 10, 2005 Received: March 11, 2005 Dear Ms. Oakes: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave icvicwed your becared by equivalent (for the indications for use stated in above and nave determined the devices marketed in interstate commerce prior to the enclosure) to regally mankeled productions of to device Amendments, or to devices that have been lvay 26, 1970, the clacultions and of the Federal Food, Drug, and Cosmetic Act (Act) that Iteliassified in accordanted with the proval application (PMA). You may, therefore, market the do not require approval of a premainer approvins of the Act. The general controls provisions of the Act device, subject to the general conacis prove, 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 II your device is classified (see above) into caller than existing major regulations affecting your Approval), It may be subject to such ademons. Title 21, Parts 800 to 898. In addition, FDA device can be nound in the Gour of concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Flease be advised mar 1 27 's 158anies of aevice complies with other requirements of the Act or any FDA hade a decemination administered by other Federal agencies. You must comply with all the Federal statues and regulations administration and listing (21 CFR Part 807); labeling Act S requirements, moduling, but not mixed in the requirements as set forth in the quality systems (QS) (21 CFR Part 801); good namalacting practice the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This and the first of the of a line of select of your device to a legall This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The FDA iniding of saostantial of 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), pleased If you desire specific advice for your device on our laboring regarms. contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to prematet notification" (21 CFR Also, please note the regulation entitled, "visorudion on your responsibilities under the Act from the 807.97). You may obtain other gelleral information on your respections. Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address 056-2011 or (3.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Hodgdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) #: K043614 Device Name: VacuLink Indications for Use: The VacuLink is intended for obstetric use in the measurement and recording of data related of any and the county of any and sumber and duration of pulls and number of The Vacul.ink is intended for obsective use in the measurement. to vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart. Prescription Use X (21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David G. Ingram (Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number.