(162 days)
Not Found
No
The device description and performance studies focus on mechanical cell collection and retrieval, with no mention of AI or ML for analysis or processing.
No
The device is used for the gathering and recovery of cells and cellular material for cytological and histological analyses, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used to gather and recover cells and cellular material for cytological and histological analyses, which are diagnostic procedures to identify diseases or conditions.
No
The device description clearly outlines physical components like a foam sphere, tether, and capsule, indicating it is a hardware device for cell collection.
Based on the provided information, the EsophaCap® Swallowable Cellular Retrieval Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used to collect the specimen (cells and cellular material from the esophagus).
- The device itself does not perform any diagnostic testing or analysis on the collected sample. The collected sample is then sent for cytological and histological analyses, which are the diagnostic procedures.
- The description focuses on the collection mechanism and the physical properties of the device. It doesn't mention any reagents, assays, or analytical processes performed by the device itself.
The EsophaCap® is a specimen collection device, which is a crucial part of the diagnostic process, but it is not the diagnostic device itself. The diagnostic work is performed on the collected sample using other methods (cytology and histology).
N/A
Intended Use / Indications for Use
The gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.
Product codes
EOX
Device Description
The EsophaCap® Swallowable Cellular Retrieval Device is a non-sterile, non-endoscopic, singleuse Esophageal cell sampling device. The EsophaCap® is composed of an open-cell polyether polyurethane foam sphere attached to a polyester tether cap. The open-cell foam sphere ranging in diameter sizes from 20 mm to 35mm is compressed and encapsulated within a vegetable (hypromellose (HPMC)) capsule. When swallowed the EsophaCap® capsule dissolves releasing the foam sphere. The foam sphere expands to form a cytology and cellular retrieval device that allows a circumferential "bottle brush" collection using the expanded "open cell" foam sphere. The radiopaque polyester tether/stylus is used to slowly withdraw the foam sphere through the esophagus and then to subsequently retrieve the foam sphere with the cellular sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
Not Found
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
The EsophaCap® Swallowable Cellular Retrieval Device performance testing consisted of bench testing, biocompatibility testing and user input. The bench testing included: dissolution testing, and tether /stylus tensile testing, and tether/stylus length test.
Key Metrics
Not Found
Predicate Device(s)
K934193, K142695, K152794, K181020
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.
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May 4, 2021
CapNostics, LLC Martin von Dyck President & CEO 9724 Colts Neck Lane Concord, NC 28027
Re: K203450
Trade/Device Name: EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOX Dated: November 13, 2020 Received: November 23, 2020
Dear Martin von Dyck:
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. 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
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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 (OS) 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 mediation-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
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Indications for Use
510(k) Number (if known) K203450
Device Name
EsophaCap® Swallowable Cellular Retrieval Device
Indications for Use (Describe)
The gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.
| 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
| General Information:
| Date of Submission: | November 13, 2020 |
|---|---|
| Submitter / Owner of the 510(K): | CapNostics, LLC. |
| 9724 Colts Neck Lane | |
| Concord, NC 28027 USA | |
| Contact Person: | Martin von Dyck |
| President & CEO | |
| Phone: (610) 442-1363 | |
| E-mail: mvondyck@capnostics.com |
Trade/Proprietary Name of Device:
| Trade Name: | EsophaCap® Swallowable Cellular Retrieval Device |
|---|---|
| Common Name: | Mass cytology cellular retrieval device |
| Classification Name: | Esophagoscope (Flexible or Rigid) |
| Regulation Number: | 21CFR 874.4710 |
| Product Code: | EOX |
| Device Panel: | Ear, Nose and Throat Devices |
| Device Classification: | Class II |
Legally Marketed Predicate Devices for Claimed Equivalency:
- K934193: Cell-Mate™ Mass Cytology -Cellular Retrieval System a)
- b) K142695, K152794 and K181020: Cytosponge™ Cell Collection Device Note: The CytoSponge device in the original 510(k) submission (K142695) used the Cell-Mate (K934193) as the predicate device.
Device Description:
The EsophaCap® Swallowable Cellular Retrieval Device is a non-sterile, non-endoscopic, singleuse Esophageal cell sampling device. The EsophaCap® is composed of an open-cell polyether polyurethane foam sphere attached to a polyester tether cap. The open-cell foam sphere ranging in diameter sizes from 20 mm to 35mm is compressed and encapsulated within a vegetable (hypromellose (HPMC)) capsule. When swallowed the EsophaCap® capsule dissolves releasing the foam sphere. The foam sphere expands to form a cytology and cellular retrieval device that allows a circumferential "bottle brush" collection using the expanded "open cell" foam sphere. The radiopaque polyester tether/stylus is used to slowly withdraw the foam sphere through the esophagus and then to subsequently retrieve the foam sphere with the cellular sample.
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Indications for Use:
The gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.
Technological Characteristics of the Subject Device Compared to the Predicate Devices:
The EsophaCap® Swallowable Cellular Retrieval Device is substantially equivalent to the legally marketed predicate Cell-Mate™ Mass Cytology Cellular Retrieval System cleared under K934193. The substantial equivalence is in terms of intended use/indications of use, target patient population, anatomical locations, method of operation, operating instructions, and single use.
The technological differences are that this subject device is:
- a. non-sterile, while the predicate device is provided sterile;
- b. there is a change in the dissolvable capsule material from animal based gelatin to a vegetable capsule;
- shelf-life (for the 10 pore per inch foam sphere); ﻥ
- d. an additional foam porosity has been added;
- an additional smaller foam sphere diameter; e.
- f. a smaller capsule has been added;
- the tether cap location has been moved g.
- the tether/stylus was shortened; h.
- i. the labeling/IFU have been updated to reflect the preceding changes.
The EsophaCap® Swallowable Cellular Retrieval Device is also substantially equivalent to the legally marketed Cytosponge™ Cell Collection Device cleared under K142695, K152794, and K181020. The substantial equivalence is in terms of intended use/indications of use, anatomical locations, method of operation, operating instructions, single use, non-sterile, foam porosity, and vegetable capsule.
Testing Performance Data:
The EsophaCap® Swallowable Cellular Retrieval Device performance testing consisted of bench testing, biocompatibility testing and user input. The bench testing included: dissolution testing, and tether /stylus tensile testing, and tether/stylus length test.
Conclusion:
CapNostics LLC, considers the EsophaCap® Swallowable Cellular Retrieval Device to be substantially equivalent to the legally marketed predicates: Cell-Mate™ Mass Cytology Cellular Retrieval System (K934193) and Cytosponge™ Cell Collection Device ( K142695, K152794, and K181020). Based upon the results of performance testing the design modifications to the EsophaCap® Swallowable Cellular Retrieval Device raises no new safety and effectiveness questions.