INPATH E2 COLLECTOR

{0}------------------------------------------------ K013258 Page 1 of 2 # ATTACHMENT 3 Revised 510(K) SUMMARY Submitter: Molecular Diagnostics, Inc. Contact Person: Julie Hoff, Pharm.D. 414 North Orleans, Suite 510 Chicago, IL 60610 Phone: 312-222-9550 Fax: 312-222-9580 Date Prepared: May 28, 2002 Trade Name: Product Code: InPath™ e2 Collector™ Classification Name: and Number: Class II, 21 CFR 884.4530 HHT (K930955). Predicate Device(s): Device Description: The InPath e2 Collector (e2 Collector) is a multi-component assembly for the collection and transport of exfoliated cervical epithelial cells. The major e2 Collector components are a balloon that provides the conformal surface upon which the cells are collected, and a handle that provides a means of manipulating and expanding the balloon during the sampling process. The Molecular Diagnostics, Inc. InPath™ e2 Collector™ equivalent to the Digene Cervical Brush from the Digene Corporation (K971586) and the Rovers Cervex-Brush cervical cytology collection device is substantially The balloon consists of a medical grade silicone and colorant. The tip of the balloon is designed to be expanded during sampling by at least a factor of two over its resting diameter to accommodate the range of endocervical canal diameters commonly encountered in clinical practice. The body of the balloon is sized to collect cells from an area of the ectocervix, centered on the cervical canal, which is approximately 23 mm-diameter. The balloon tip measures about 3 mm in diameter, and 12 mm in length when uninflated, and it can be introduced without difficulty to the endocervix. {1}------------------------------------------------ K013258 Page 2 of 2 Intended Use: Functional and Safety Testing: Conclusion: The InPath™ e2 Collector™ is intended for the collection of cervical cytology specimens for Pap test analysis. The InPath™ e2 Collector™ should not be used after the first 10 weeks of gestation in pregnant patients. Representative samples of InPath™ e2 Collectors underwent design testing to demonstrate substantially equivalent functional characteristics. In addition, manufacturing process testing is done to assure that the devices produced meet design requirements. The InPath™ e2 Collector™ manufactured by Molecular Diagnostics, Inc. is substantially equivalent to the Digene Cervical Brush from the Digene Corporation (K971586) and the Rovers Cervex-Brush (K930955). This conclusion is based upon the fact that these devices have essentially identical indications for use, substantially equivalent principles of operation, and clinical trial results that demonstrate performance equal to, or better than, the predicate devices. Page 2 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, possibly representing care or protection. The logo is in black and white. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAY 31 2002 Molecular Diagnostics, Inc. % Ms. Ann Quinlan-Smith Consultant to Molecular Diagnostics Alquest, Incorporated 4050 Olson Memorial Hway., Suite 350 MINNEAPOLIS MN 55422 #### Re: K013258 Trade/Device Name: InPath™ e2 Collector Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: 85 HHT Dated: March 29, 2002 Received: March 29, 2002 Dear Ms. Quinlan-Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed four becaused in added is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the enactment date of 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 r ou mayy aroney interes 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 (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. 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. {3}------------------------------------------------ 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 noutication. The I Dri miding of bassion 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 IT you desire specific advice for your ac rise on our of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on any pease note the regulation entitled, "Misbranding Offically of Comphilation" (21 CFR Part 807.97). Other general information on by releve to promative nearcharday be obtained from the Division of Small Manufacturers, your responsional and Consumer 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, Nancy Crogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Page 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ K013258 Device Name: The InPath™ e2 Collector™ ## Indications for Use: The InPath™ e² Collector™ is intended for the collection of cervical cytology specimens The InPath™E Collector™ Is michdod for the conceasing hot be used after the first 10 weeks of gestation in pregnant patients. Concurrence of CDRH, Office of Device Evaluation (ODE) **Prescription Use** (Per 21 CFR 801.109) Daniel A. Ingram Division Sign-Off Division of Renn 510(k) Nu