← Product Code [EOX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX) · K142695 # Cytosponge Cell Collection Device (K142695) _Covidien, LLC · EOX · Nov 26, 2014 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX/K142695 ## Device Facts - **Applicant:** Covidien, LLC - **Product Code:** [EOX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX.md) - **Decision Date:** Nov 26, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4710 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat ## Intended Use The Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. ## Device Story Cytosponge™ is a sterile, single-use device for esophageal cell collection. It consists of a size 00 vegetable-derived capsule containing a 30mm spherical sponge, attached to a silicone-coated braided polyester suture secured to a retainer card. The patient swallows the capsule; it dissolves in the stomach, releasing the self-expanding sponge. A clinician retrieves the sponge via the attached cord; during withdrawal, the sponge collects surface cells from the esophageal lining. The device provides a minimally invasive method for obtaining esophageal tissue samples for diagnostic evaluation. It is intended for use in a clinical setting. ## Clinical Evidence No clinical data provided. Evidence consists of bench performance testing (suture length, dissolution, sponge diameter, tensile strength, laceration testing), animal testing, biocompatibility, sterilization, packaging validation, shelf-life testing, and user validation. ## Technological Characteristics Sterile, single-use device. Components: vegetable-material-derived capsule, 30mm spherical sponge, silicone-coated braided polyester suture, ABS plug. Principle: passive dissolution of capsule in stomach, mechanical retrieval of expanded sponge. Dimensions: size 00 capsule, 30mm sponge. Sterilization: not specified. Connectivity: none. ## Regulatory Identification An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier. ## Predicate Devices - Cell-Mate Mass Cytology Cellular Retrieval System ([K934193](/device/K934193.md)) - US Endoscopy Cytology Brush ([K103437](/device/K103437.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/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 an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 26, 2014 Covidien LLC Richelle Hover Regulatory Affairs Specialist 15 Hampshire St Mansfield. MA 02048 > K142695 Trade/Device Name: Cytosponge™ Cell Collection Device Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOX Dated: September 19, 2014 Received: September 22, 2014 Dear Richelle Hover, Re: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Herbert P. Lerner -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K142695 #### Device Name Cytosponge™ Cell Collection Device #### Indications for Use (Describe) The Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### 510(k) Summary ### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Covidien IIc 15 Hampshire Street Mansfield, MA 02048 Contact: Richelle Hover 540 Oakmead Pkwy Sunnyvale, CA 94085 Phone: (408) 328-7342 Facsimile: (408) 328-7342 (same as phone#) Date Prepared: November 19, 2014 #### Name of Subject Device Cytosponge™ Cell Collection Device #### Establishment Registration Number/Owner Operator Number Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497 Legal Manufacturer: Covidien, Ilc 15 Hampshire Street Mansfield, MA 02048 Manufacturing Facility: Covidien, Formerly BÄRRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085 ### Common or Usual Name Esophagoscope (flexible or rigid) #### Regulation Description Description: Esophagoscope (flexible or rigid) and accessories Classification: Class II, 21 CFR 874.4710 Product Code: EOX Classification Panel: Ear Nose & Throat Panel {5}------------------------------------------------ ### Predicate Devices Primary Predicate: - . Cell-Mate Mass Cytology Cellular Retrieval System (K934193) Reference Predicate: - US Endoscopy Cytology Brush (K103437) # Device Description The subject device the Cytosponge™ Cell Collection Device is a sterile single-use device. The Cytosponge™ Cell Collection Device consists of a clear, size 00 vegetable-material-derived capsule, which holds a 30mm spherical sponge inside of the capsule containing the sponge is attached to silicone-coated braided polyester suture. The suture is attached and secured to a retainer card via an ABS plug. The Cytosponge™ Cell Collection Device consists of a swallowable capsule, which dissolves in the stomach, releasing a self-expandable sponge is then retrieved from the esophagus using an attached cord; during the retrieval process, the sponge collects cells from the outer layer of esophageal tissue # Indication for Use The Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. ### Technological Characteristics of Device Compared to Predicate Devices The Cytosponge™ Cell Collection Device is substantially equivalent to the legally marketed Cell-Mate Mass Cytology Cellular Retrieval System in terms of intended use, principle of operation, technological characteristics, ergonomics of patient -user interface, anatomical location, operating instructions and single-use disposition. The Cytosponge™ Cell Collection Device is also substantially equivalent to the legally marketed US Endoscopy Cytology Brush Endoscopy brush in terms of indications for use, anatomical location of use and single-use disposition. ### Summary of Testing Performed Verification and Validation activity for the Cytosponge™ Cell Collection Device consisted of animal testing to support the indication for use, biocompatibility testing, sterilization, packaging validation, shelf life testing, user validation, and bench performance testing which consisted of the following tests: (1) suture length testing (2) dissolution testing (3) sponge diameter testing (4) suture tensile testing (5) and laceration testing. ### Conclusion Covidien, Ilc considers the Cytosponge™ Cell Collection Device to be substantially equivalent to legally marketed predicates: Cell-Mate Mass Cytology Cellular Retrieval System (K934193) and US Endoscopy Cytology Brush (K103437). {6}------------------------------------------------ The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX/K142695](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX/K142695) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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