The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults and adolescents, 12 years of age and older.

Device Description

The EsoCheck Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophaqus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.

AI/ML Overview

The provided text describes the EsoCheck Cell Collection Device, but it does not contain specific acceptance criteria or performance metrics in a table format, nor does it detail a study that defines such criteria and measures the device's performance against them.

The "Performance Data" section in the document refers to a GLP animal study that supported the expansion of the device's indications for use to include adolescents. However, this study focused on safety (successful esophageal deployment and no significant injuries) rather than specific performance metrics like sensitivity, specificity, or cell collection efficiency which would typically be associated with acceptance criteria for such a device.

Here's an analysis based on the information provided, and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing. The document does not provide a table with acceptance criteria or quantitative performance metrics for cell collection, diagnostic accuracy, or similar. The "performance data" discussed is related to safety for expanded use in adolescents.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The only study mentioned is a GLP animal study in a porcine model.
Sample size: Not specified.
Data provenance: Prospective (animal study).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The animal study was for safety (lack of injury), not for establishing diagnostic ground truth requiring expert interpretation of collected samples.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The animal study focused on physical outcomes (esophageal deployment, injury assessment), not diagnostic interpretation requiring adjudication methods.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a cell collection device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device does not have an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the animal study related to the expanded indication, the "ground truth" was the absence of significant injuries and successful deployment observed during evaluations after the procedure. This would be based on direct veterinary assessment or pathological examination of the animal tissues.

8. The sample size for the training set

Not applicable. The device is a physical cell collection device; there is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. (No training set for an algorithm).

Summary of what is available regarding performance for the expanded indication:

The document states: "The animal study found that the EsoCheck Cell Collection Devices demonstrated successful esophageal deployment, and evaluations after the EsoCheck procedure found no significant injuries in the test population." This is the reported performance for the specifically mentioned study designed to support the expanded indication for adolescents. It focuses on the safety and mechanical functionality in an adolescent-representative model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 26, 2022

Lucid Diagnostics, Inc. % Kelliann Payne Partner Hogan Lovells US LPP 1735 Market Street Floor 23 Philladelphia, PA 19103

Re: K222366

Trade/Device Name: EsoCheck 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: August 4, 2022 Received: August 4, 2022

Dear Kelliann Payne:

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. Although this letter refers to your product as a device, please be aware 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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

{1}------------------------------------------------

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal,Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known) K222366

Device Name

EsoCheck™ Cell Collection Device

Indications for Use (Describe)

The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of the esophaqus in the general population of adults and adolescents, 12 years of age and older.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

{3}------------------------------------------------

510(k) SUMMARY

Lucid Diagnostics Inc.'s EsoCheck™ Cell Collection Device

Submitter's Information and Date Prepared

Lucid Diagnostics One Grand Central Place, Suite 4600 New York, NY 10165 Phone: (212) 949-4319 Fax: (212) 634-7403 Contact Person: Lishan Aklog, MD

Date Prepared: August 4, 2022

Device Information

Trade Name: EsoCheck™ Cell Collection Device

Common or Usual Name: Balloon Cell Collection Device

Classification Name: Esophagoscope (flexible or rigid) and accessories 21 CFR 874.4710, Class II, Product Code EOX

Predicate Device

EsoCheck Cell Collection Device (K210137)

Indications for Use

Technological Characteristics

The subject device is technologically identical to the previously cleared version (K210137). The only change is the indication, which has expanded to include adolescents aged 12 years and older.

{4}------------------------------------------------

Performance Data

To support the expansion of the indications for use to include adolescents, the company performed a GLP animal study in a porcine model representative of the human adolescent esophagus. The animal study found that the EsoCheck Cell Collection Devices demonstrated successful esophageal deployment, and evaluations after the EsoCheck procedure found no significant injuries in the test population. Therefore, the study supports the expansion of the indication to include adolescents.

Substantial Equivalence

The subject EsoCheck Cell Collection Device is as safe and effective as the predicate EsoCheck device. The EsoCheck Cell Collection Device has the same intended uses, technology, and principles of operation as the predicate device, and it has similar indications foruse. The difference in the indications for use between the subject Eso Check Cell Collection Device and its predicate device raises no new issues of safety or effectiveness, as supported by a GLP animal study which showed that the specifications and size of the EsoCheck Cell Collection Device do not result in excess resistance nor result in unacceptable tissue injurv (i.e., perforation and trauma) when used in the proposed adolescent patient population. The EsoCheck Cell Collection Device is as safe and effective as the predicate EsoCheck device. Thus, the subject EsoCheck Cell Collection Device is substantially equivalent.

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.