(30 days)
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, 22 years of age and older.
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 Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process.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cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient.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.
This version of the device is a modification to the predicate EsoCheck CCD Cell Collection Device that was cleared under K183262. The minor changes made to the device include minor changes to the secondary packaging design change (addition of a tether) to increase tensile stiffness of the catheter during removal. In addition, the previous version of the device utilized 2 syringes, a 20cc syringe and a 5cc syringe, to complete the procedure. The modified device will utilize a single 20cc syringe to streamline the process and the syringe will have markings printed on its surface indicating different volumes.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EsoCheck Cell Collection Device.
Important Note: The provided document is a 510(k) summary for a device (EsoCheck Cell Collection Device), not an AI algorithm. Therefore, many of the typical AI/ML-related questions (e.g., ground truth for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable to this submission. The "study" mentioned here refers to device validation tests, not a clinical performance study involving AI.
Acceptance Criteria and Device Performance (Based on Device Modifications)
The document primarily discusses the validation of modifications to an already cleared device, not the initial clearance of a novel device. The "acceptance criteria" are implied by the nature of the tests performed to ensure the modified device remains safe and effective and is substantially equivalent to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Sterilization Efficacy | Validated in accordance with AAMI TIR 28:2016 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization. |
| Packaging Integrity | Packaging Validation was performed. |
| Shelf-Life Stability | Shelf-Life Testing was performed. |
| Usability/User Experience | Usability Confirmation Testing was performed. |
| Functional Performance | Bench Performance Testing was performed. |
Note: The document only states that these tests were performed and implies successful completion, leading to the conclusion of substantial equivalence. It does not provide specific metrics or thresholds (e.g., "sterility assurance level X achieved," "packaging passed drop test Y," "95% of users found the device easy to use").
2. Sample Size and Data Provenance
Since this is a device modification validation and not a clinical study on patient data for an algorithm, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) as they relate to AI/ML clinical performance are not directly applicable or reported in this document. The "tests" refer to laboratory and engineering validations.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. Ground truth for AI/ML performance is irrelevant here as it's a device. The "experts" would be the engineers and quality control personnel conducting the validation tests, but their number and qualifications are not specified nor relevant in the context of AI ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the sense of clinical data requiring expert adjudication, as this is a device validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic tool; it is a cell collection device. Therefore, no MRMC study, human reader improvement, or effect size is relevant.
6. Standalone Algorithm Performance
Not applicable. There is no algorithm here whose standalone performance would be measured.
7. Type of Ground Truth Used
The "ground truth" for these device validation tests would be:
- Sterilization: Regulatory standards (AAMI TIR 28:2016) and passing criteria for sterility.
- Packaging: Engineering specifications and industry standards for package integrity.
- Shelf-Life: Material degradation limits and functional requirements over time.
- Usability: User feedback and task completion rates against predefined usability goals.
- Bench Performance: Engineering specifications and functional requirements of the device (e.g., aspiration volume, balloon inflation/deflation, tether tensile strength).
The document does not detail the specific metrics for these.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of the Device and its Modifications:
The EsoCheck Cell Collection Device is a sterile, single-use, disposable, non-endoscopic balloon capsule catheter designed to collect surface cells from the esophagus. The procedure involves swallowing the deflated capsule, inflating the balloon once positioned, and then withdrawing it to swab the esophageal surface. Cells are then retracted into the capsule and protected during withdrawal.
The modified device, K210137, has minor changes compared to its predicate (K183262):
- Minor changes to the secondary packaging design (addition of a tether to increase tensile stiffness during removal).
- Changed from using two syringes (20cc and 5cc) to a single 20cc syringe with printed volume markings to streamline the process.
The "Performance Data" section lists the types of tests performed to validate these minor modifications: Sterilization Validation, Packaging Validation, Shelf-Life Testing, Usability Confirmation Testing, and Bench Performance Testing. The conclusion is that these tests demonstrate the modified device is as safe and effective as the predicate and is substantially equivalent.
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February 18, 2021
Lucid Diagnostics, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103
Re: K210137
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: January 19, 2021 Received: January 19, 2021
Dear Janice Hogan:
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. 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
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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, PhD 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
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Indications for Use
510(k) Number (if known) K210137
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 surface cells of the esophagus in the general population of adults, 22 years of age and older.
| 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)
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510(k) SUMMARY
Lucid Diagnostics EsoCheck Cell Collection Device
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Lucid Diagnostics, Inc. One Grand Central Place, Suite 4600 New York, NY 10165 Phone: (212) 949-4319 Facsimile: (212) 634-7403 Contact Person: Lishan Aklog, M.D.
Date Prepared: January 19, 2021
Name of Device
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 Devices
EsoCheck CCD Cell Collection Device (K183262)
Intended 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, 22 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 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.
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This version of the device is a modification to the predicate EsoCheck CCD Cell Collection Device that was cleared under K183262. The minor changes made to the device include minor changes to the secondary packaging design change (addition of a tether) to increase tensile stiffness of the catheter during removal. In addition, the previous version of the device utilized 2 syringes, a 20cc syringe and a 5cc syringe, to complete the procedure. The modified device will utilize a single 20cc syringe to streamline the process and the syringe will have markings printed on its surface indicating different volumes.
Performance Data
The following tests were performed to validate the modifications to the device:
- Sterilization Validation in accordance with AAMI TIR 28:2016 Product Adoption and ● Process Equivalence for Ethylene Oxide Sterilization;
- . Packaging Validation;
- Shelf-Life Testing; ●
- Usability Confirmation Testing; ●
- Bench Performance Testing. .
Substantial Equivalence
The EsoCheck Cell Collection Device has the same intended use, indications for use, and principles of operation, as well as similar technological characteristics as the previously cleared device. The minor differences in the device design and technical characteristics of the updated device do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified device is as safe and effective as the predicate device. Thus, the modified EsoCheck Cell Collection device is substantially equivalent to its predicate device.
§ 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.