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

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance criteria in terms of diagnostic accuracy or clinical efficacy. The document is a 510(k) premarket notification for the Cytosponge Cell Collection Device, focusing on demonstrating substantial equivalence to predicate devices rather than clinical performance for diagnostic purposes.

Here's a breakdown of the information that is available and what is missing based on your request:

Missing Information (Crucial for answering most of your questions):

Acceptance Criteria for Device Performance: The document does not define specific performance metrics like sensitivity, specificity, or accuracy that the device needs to meet for cell collection for diagnostic purposes. It only states the device's function: "collection and retrieval of surface cells in the esophagus."
Study Proving Device Meets Acceptance Criteria: There is no detailed clinical study presented with a test set, ground truth, expert adjudication, or effectiveness measures for cell collection in a clinical diagnostic context.
Sample Size for Test Set: Not applicable as no such diagnostic performance study is described.
Data Provenance (Country, Retrospective/Prospective): Not applicable.
Number of Experts & Qualifications: Not applicable.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not mentioned.
Standalone Performance (Algorithm only): Not applicable, as this is a physical cell collection device, not an AI algorithm.
Type of Ground Truth: Not applicable, as no diagnostic performance study is detailed.
Sample Size for Training Set: Not applicable, as there's no machine learning algorithm being trained.
How Ground Truth for Training Set was Established: Not applicable.

Information Available from the Text:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The document implies "conformance to the requirements for its indications for use" and "substantial equivalence" to predicate devices. However, explicit quantitative acceptance criteria for diagnostic performance (e.g., cell yield percentage, detection rate of abnormalities) are not provided.
Reported Device Performance: The document only mentions "Verification and Validation activity" which included:
- Animal testing to support the indication for use
- Biocompatibility testing
- Sterilization
- Packaging validation
- Shelf life testing
- User validation
- Bench performance testing:
  - Suture length testing
  - Dissolution testing (of the capsule)
  - Sponge diameter testing
  - Suture tensile testing
  - Laceration testing

Table (Based on the limited information):

Acceptance Criterion (Implied/Tested Aspect)	Reported Device Performance (Summary of Testing)
Support for Indication for Use	Animal testing conducted.
Biocompatibility	Biocompatibility testing conducted.
Sterility	Sterilization testing conducted.
Packaging Integrity	Packaging validation conducted.
Shelf Life	Shelf life testing conducted.
User Acceptability	User validation conducted.
Suture Length Conformance	Bench testing performed.
Capsule Dissolution	Dissolution testing performed.
Sponge Diameter Conformance	Sponge diameter testing performed.
Suture Tensile Strength	Suture tensile testing performed.
Device Material Integrity (Laceration)	Laceration testing performed.
Clinical Diagnostic Performance	Not specified in this document.

In summary, this 510(k) submission focuses on the safety and foundational functional aspects of the device and its substantial equivalence to previously approved devices, rather than a detailed clinical performance study for diagnostic accuracy, which would typically involve the criteria you've asked about (test set, ground truth, expert adjudication, etc.). The "animal testing to support the indication for use" is the closest mention to clinical data, but no specifics are provided regarding its design, results, or how it directly ties to acceptance criteria for diagnostic performance.

Summary

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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

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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

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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)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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

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Predicate Devices

Primary Predicate:

. Cell-Mate Mass Cytology Cellular Retrieval System (K934193) Reference Predicate:
US Endoscopy Cytology Brush (K103437)

Device Description

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).

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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.

Regulation Number and Section

§ 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.