(83 days)
No
The summary describes a mechanical cell collection device and does not mention any computational analysis or processing of the collected cells using AI/ML.
No.
The device is used for collecting cells for diagnostic analysis, not for treating a disease or condition.
No
The device description clearly states its purpose is to "collect and retrieve surface cells of the esophagus." While these collected cells are "sent for diagnostic processing and analysis," the device itself is a collection tool, not a diagnostic one. It does not perform the analysis or make a diagnosis.
No
The device description clearly outlines a physical, single-use disposable balloon capsule catheter designed for cell collection, indicating it is a hardware device.
Based on the provided information, the EsoCheck Cell Collection Device itself is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: IVDs are devices intended for use in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes.
- EsoCheck's Function: The EsoCheck device is a tool used to collect the specimen (esophageal cells). It is used in vivo (inside the body) for this collection process.
- Subsequent Processing: The description explicitly states that the collected specimen is "then sent for diagnostic processing and analysis." This indicates that the diagnostic part happens after the EsoCheck device has completed its function of collection.
The EsoCheck device is a specimen collection device that provides the sample for subsequent IVD testing. The diagnostic analysis itself would be performed using other methods and potentially other IVD devices on the collected cells.
N/A
Intended Use / Indications for Use
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.
Product codes
EOX
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 esophagus. 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 Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process.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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
adults and adolescents, 12 years of age and older
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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
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.
Technological Characteristics
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.
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.