Cytosponge Cell Collection Device

K181020 · Covidien, LLC · EOX · Aug 16, 2018 · Ear, Nose, Throat

Device Facts

• Record ID: K181020
• Device Name: Cytosponge Cell Collection Device
• Applicant: Covidien, LLC
• Product Code: EOX · Ear, Nose, Throat
• Decision Date: Aug 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4710
• Device Class: Class 2

Intended 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.

Device Story

Cytosponge Cell Collection Device is a non-sterile, single-use device for esophageal cell sampling. Device consists of a size 00 vegetable-derived capsule containing a 30mm compressed spherical sponge, attached to a silicone-coated braided polyester suture secured to a retainer card via an ABS plug. Operation: patient swallows capsule; capsule dissolves in stomach; sponge self-expands; clinician retrieves sponge via suture; sponge collects surface cells from esophageal tissue during withdrawal. Output: collected esophageal cells for subsequent cytological and histological analysis. Used in clinical settings by healthcare providers to facilitate diagnostic sampling. Benefits: provides minimally invasive method for obtaining esophageal tissue samples for analysis.

Clinical Evidence

Bench testing only. Performance testing included functional testing (compression, diameter, laceration, dissolution, tensile), shelf life testing, biocompatibility testing, and user validation. Results demonstrate performance equivalence to predicate devices.

Technological Characteristics

Non-sterile, single-use device. Materials: vegetable-derived capsule, compressed spherical sponge, silicone-coated braided polyester suture, ABS plug. Principle: passive dissolution of capsule in stomach followed by mechanical retrieval of self-expanding sponge. Dimensions: 30mm sponge, size 00 capsule. No software or electronic components.

Indications for Use

Indicated for the collection and retrieval of surface cells in the esophagus for cytological and histological analyses in patients requiring esophageal cell sampling.

Regulatory Classification

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

• Cytosponge™ Cell Collection Device (K152794)
• Cytosponge™ Cell Collection Device (K142695)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/7 description: The image shows the FDA logo on the left side. On the right side, the text "Jeffrey W. Cooper -S" is displayed, followed by the date and time "2018.08.16 15:43:58". The last line of text is "-04'00'".

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: [phone] Fax: [phone]

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.

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## 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.