SOFTPAP CERVICAL CELL COLLECTOR

{0}------------------------------------------------ K072381 October 11, 2007 CONTACT: Richard Domanik, Ph.D. CytoCore, Inc. 414 North Orleans Chicago, IL 60610 NAME OF DEVICES: JAN 30 2008 Trade Name: Common Names/Descriptions: Classification Name: Classification Product Code: SoftPAP™ Collector Cervical Cytology Specimen Collector Spatula, cervical, cytological HHT PREDICATE DEVICE: CytoCore e2™ Collector, K013285 DEVICE DESCRIPTION: Intended Use: For the collection of cervical cytology specimens for Pap test analysis. The SoftPAP™ Cervical Sample Collector should not be used after the first 10 weeks of gestation in pregnant patients. Product Description: The CytoCore, Inc. SoftPAP™ Collector is a multicomponent assembly for the collection of exfoliated cervical epithelial cells. Its major components are a disposable Balloon assembly (Balloon and rod), and a reusable Handle. The Balloon provides the conformal surface upon which the cells are collected. The Handle provides a means of manipulating and expanding the Balloon during the sampling process. The Balloon inflates against the cervix and conformally contacts the entire areas to be sampled, namely the ectocervical, the transformation zone, and the endocervical surfaces. ## SUBSTANTIAL EQUIVALENCE: This Special 510(k) was submitted to describe modifications to the device for physician ease-of-use and manufacturability issues. The modifications did not affect the Intended Use, Indications for Use, balloon material, balloon inflation profile, or any components that come in contact with the patient or patient cells. Therefore, the modified device is substantially equivalent to the original e2 Collector™ which was FDA-cleared on May 31, 2002 (K013258). The substantive differences between the e-TM and SoftPAP™ Collectors are summarized in the following table. {1}------------------------------------------------ | Differences between the e2 and SoftPAP Collectors | | |----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | e² Collector | SoftPAP Collector | | Single integrated unit | Separate reusable handle and single use collection device | | Vacuum used to collapse the collector balloon | A mechanism in the handle mechanically collapses the collector balloon | | A syringe is used to directly inflate the collector balloon | A syringe is used to inject air into a reservoir in the handle. The reservoir is discharged into the collector balloon by pressing a button on the handle | | The collector balloon is deflated via a combination of a controlled leak and a separate push valve | The collector balloon is automatically deflated upon releasing the button on the handle | | No sanitary cover over the handle | A disposable sanitary cover that minimizes the potential for handle contamination is part of each collector. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. JAN 30 2008 Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Richard A. Domanik, Ph.D. President CytoCore, Inc. 414 North Orleans, Suite 502 CHICAGO IL 60610 Re: K072381 Trade/Device Name: CytoCore SoftPAPTM Collector Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HHT Dated: January 10, 2008 Received: January 11, 2008 Dear Dr. Domanik: 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. 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. In the center of the logo is the acronym "FDA" in a bold, stylized font. The logo is surrounded by a dotted border and three stars are located at the bottom. Protecting and Promoting Public Health {3}------------------------------------------------ Page 2 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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) 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 premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ 510(k) Number (if known): K072381 Device Name: CytoCore SoftPAP™ Collector Indication For Use: For the collection of cervical cytology specimens for Pap test analysis. The SoftPAP™ Cervical Sample Collector should not be used after the first 10 weeks of gestation in pregnant patients. Prescription Use _ × (21 CFR Part 801 Subpart D) Subpart C) And/Or Over the Counter Use (21 CFR Part 801 (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Vance Burgdon Division Sign-C Office of Device Evaluation 510(k) K₀7238|