(121 days)
No
The device description and performance studies focus on the mechanical aspects of cell collection and do not mention any computational analysis or algorithms, including AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used for collection and retrieval of cells for analysis, not for treating a disease or condition.
No
The device is a cell collection device, indicated for collecting cells for analysis. It does not perform the analysis itself or provide a diagnosis.
No
The device description clearly outlines physical components (capsule, sponge, suture, retainer card, plug) and performance studies related to these physical components (compression, diameter, laceration, dissolution, tensile testing). There is no mention of software as a component or function of the device.
Based on the provided information, the Cytosponge Cell Collection Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used in vitro (outside the body) to examine specimens derived from the human body. The Cytosponge device is used in vivo (inside the body) to collect the specimen (esophageal cells).
- The device's intended use is for the collection and retrieval of cells. The diagnostic analysis (cytological and histological analyses) is performed after the cells are collected, likely using separate IVD methods and equipment.
- The device description focuses on the physical mechanism of collection. It doesn't describe any components or processes that perform diagnostic testing on the collected cells within the device itself.
The Cytosponge is a specimen collection device, which is a crucial step in the diagnostic process, but it is not the diagnostic test itself. The diagnostic testing happens after the sample is obtained using this device.
N/A
Intended Use / Indications for Use
The Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus for cytological and histological analyses.
Product codes
EOX
Device Description
The Cytosponge™ Cell Collection Device is a non-sterile, single-use device. The Cytosponge™ Cell Collection Device consists of a clear, size 00 vegetable-material-derived capsule which holds a 30mm compressed spherical sponge inside of the capsule. The capsule containing the sponge is attached to a silicone-coated braided polyester suture. The suture is attached and secured to a retainer card via an ABS plug. The capsule is swallowed and dissolves in the stomach thereby releasing the self-expanding sponge. The sponge is then retrieved from the stomach using the attached suture. During the retrieval process, the sponge collects cells from the outer layer of esophageal tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance testing for the Cytosponge™ Cell Collection Device consisted of bench functional testing, shelf life testing, biocompatibility testing and user validation. Functional testing included compression testing, diameter measurement testing, laceration testing, dissolution and tensile testing. Results of performance testing demonstrate performance equivalence for the Cytosponge™ Cell Collection Device when evaluated against the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
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 brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
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August 16, 2018
Covidien, Ilc. Rachel Silva Principal Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K181020
Trade/Device Name: Cytosponge Cell Collection Device Regulation Number: 21 CFR§ 874.4710 Regulation Name: Esophagoscope (Flexible or Rigid) and Accessories Regulatory Class: II Product Code: EOX Dated: July 27, 2018 Received: July 30, 2018
Dear Rachel Silva:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181020
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 for cytological and histological analyses.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) Number: K181020
Submitter's Name and Address:
Covidien Ilc 15 Hampshire Street Mansfield, MA 02048
Contact Person:
Rachel Silva Principal Regulatory Affairs Specialist Phone: (408) 328-7359 Fax: (408) 328-7359
Date Prepared: July 3, 2018
Name of Device:
Proprietary Name: Cytosponge™ Cell Collection Device Regulation Name: Esophagoscope (Flexible or Rigid) and Accessories Classification Panel: Ear, Nose & Throat Devices Device Regulation: 21 CFR 874.4710, Class II Product Code: EOX
Establishment Registration Number. Owner/Operator Number:
Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497
Predicate Device(s):
K152794 Cytosponge™ Cell Collection Device by Covidien Ilc (Primary predicate) K142695 Cytosponge™ Cell Collection Device by Covidien IIc (Reference predicate)
Device Description:
The Cytosponge™ Cell Collection Device is a non-sterile, single-use device. The Cytosponge™ Cell Collection Device consists of a clear, size 00 vegetable-material-derived capsule which holds a 30mm compressed spherical sponge inside of the capsule. The capsule containing the sponge is attached to a silicone-coated braided polyester suture. The suture is attached and secured to a retainer card via an ABS plug. The capsule is swallowed and dissolves in the stomach thereby releasing the self-expanding sponge. The sponge is then retrieved from the stomach using the attached suture. During the retrieval process, the sponge collects cells from the outer layer of esophageal tissue.
Indications for Use:
The Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus for cytological and histological analyses.
4
Technological Characteristics of the Device Compared to Predicate Device
The Cytosponge™ Cell Collection Device has the same indications for use, principle of operation, and single use disposition as the predicate device Cytosponge™ Cell Collection Device cleared under K142695 and K152794. There also have been no material changes for the subject device from the predicate device. The technological differences are that the subject device is non-sterile, has a change in porosity of the sponge, and thicker suture diameter.
Performance Data
Performance testing for the Cytosponge™ Cell Collection Device consisted of bench functional testing, shelf life testing, biocompatibility testing and user validation. Functional testing included compression testing, diameter measurement testing, laceration testing, dissolution and tensile testing. Results of performance testing demonstrate performance equivalence for the Cytosponge™ Cell Collection Device when evaluated against the predicate device.
Conclusion
Covidien IIc considers the Cytosponge™ Cell Collection Device to be substantially equivalent to the legally marketed predicate device Cytosponge™ Cell Collection Device (K142695 and K152794). Test results provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.