(65 days)
No
The device description and performance studies focus on the mechanical function of a cell collection device and do not mention any computational analysis or AI/ML components.
No.
The device is used to collect cells for diagnostic purposes, not to treat a disease or condition.
No.
The device is a cell collection device, not a device that analyzes or interprets the collected cells to provide a diagnosis.
No
The device description clearly outlines physical components (capsule, sponge, suture, plug, retainer card) and the performance studies include bench testing of these physical components, indicating it is a hardware device.
Based on the provided information, the Cytosponge™ Cell Collection Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection and retrieval of cells from the esophagus. It does not mention any diagnostic purpose or analysis of the collected cells in vitro.
- Device Description: The description focuses on the physical mechanism of collecting cells using a sponge. It doesn't describe any components or processes related to analyzing biological samples outside of the body.
- Lack of Diagnostic Information: There is no mention of any diagnostic tests, assays, or analysis being performed by the device itself or in conjunction with the device as part of a diagnostic procedure.
- Performance Studies: The performance studies listed focus on the physical characteristics and functionality of the device (suture strength, dissolution, etc.) and its ability to collect cells (animal testing). They do not include performance metrics typically associated with IVDs, such as sensitivity, specificity, AUC, etc., which relate to the accuracy of a diagnostic test.
- Predicate and Reference Devices: The predicate and reference devices listed are also cell collection devices (Cytology Cellular Retrieval System, Cytology Brush), not diagnostic devices.
The Cytosponge™ is a tool for sample collection, which is a step that can be part of an in vitro diagnostic process, but the device itself is not performing the diagnostic function. The collected cells would likely be sent to a laboratory for in vitro analysis (e.g., cytology, molecular testing) to arrive at a diagnosis.
N/A
Intended Use / Indications for Use
The Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
Product codes (comma separated list FDA assigned to the subject device)
EOX
Device Description
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
1
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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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
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
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).
6
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.