(197 days)
Not Found
No
The device description and performance studies focus solely on the mechanical collection of cells and their subsequent analysis, with no mention of AI/ML for image processing, data analysis, or any other function.
No
The device is used for the collection and retrieval of surface cells for analyses, not for treating a condition.
No
The device is a cell collection device used to collect cells for analysis, but it does not perform the diagnostic analysis itself.
No
The device description clearly outlines physical components (capsule, sponge, suture, retainer card, plug) and a mechanical function (swallowing, dissolving, expanding, retrieving). It is a hardware device for cell collection.
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 for cytological and histological analyses. This describes a sample collection tool, not a device that performs the diagnostic test itself.
- Device Description: The description focuses on the physical components and mechanism of collecting the sample. It doesn't mention any components or processes related to analyzing the sample or providing a diagnostic result.
- Performance Studies: The performance study focuses on "sample adequacy," which is a measure of how well the device collects a usable sample. It does not evaluate the device's ability to diagnose a condition or provide a diagnostic result based on the collected sample.
- Lack of Diagnostic Metrics: The key metric provided is "sample adequacy," not diagnostic metrics like sensitivity, specificity, PPV, or NPV, which are typical for IVD devices.
The Cytosponge is a device used to obtain a sample that will then be used in an in vitro diagnostic process (cytological and histological analyses). The analyses themselves are the IVD part, not the collection device.
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 for cytological and histological analyses.
Product codes
EOX
Device Description
The subject device 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. 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. The 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
In a Covidien sponsored post-market study in a population of individuals with confirmed Barrett's esophagus (BE), sample adequacy was measured by the presence of columnar cells. For the purposes of this investigation, an adequate sample was one in which at least one group of columnar cell was present. No minimal size was required for a group; a group of columnar cells can consist of two cells that are clearly columnar. Sample adequacy was presented as a proportion of subjects who fulfilled this definition after up to two total administrations of the Cytosponge device. Sixty-eight subjects met the inclusion criteria for sample adequacy. Four out of sixty-eight samples were inadequate. Two of the four patients repeated the Cytosponge device swallow and met the criteria for sample adequacy. Sixty-four of sixty-eight Cytosponge samples were sample adequate after one administration. Sixty-six of sixty-eight Cytosponge samples or 97% were sample adequate after two administrations.
The subject Cytosponge™ Cell Collection Device is technologically identical to the cleared predicate device cleared by the agency under K142695. Accordingly, no performance testing was conducted.
Key Metrics
97% sample adequate after two administrations.
Predicate Device(s)
Cytosponge™ Cell Collection Device (K142695)
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2016
Covidien LLC Saket Bhatt Regulatory Affairs Manager 15 Hampshire Street Mansfield, MA 02048
Re: K152794
Trade/Device Name: Cytosponge™ Cell Collection Device Regulation Number: 21 CFR§ 874.4710 Regulation Name: Esophagoscope (Flexible or Rigid) and Accessories Regulatory Class: II Product Code: EOX Dated: March 8, 2016 Received: March 9, 2016
Dear Saket Bhatt,
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.
1
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 vours.
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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
2
Indications for Use
510(k) Number (if known) K152794
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 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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3
510(k) Summary
| Submitter Information | |
|---|---|
| Name: | Covidien IIC |
| Address: | 15 Hampshire Street |
| Mansfield, MA 02048 | |
| Name of contact person: | Saket Bhatt |
| Manager, Regulatory Affairs | |
| 540 Oakmead Parkway | |
| Sunnyvale, CA 94085 | |
| Phone: | |
| Fax number: | (408) 328-7357 |
| (408) 328-7357 (same as phone) | |
| Date prepared: | April 8, 2016 |
| Establishment Registration: | |
| Owner/Operator Number: | 3004904811 |
| 1282497 | |
| Legal Manufacturer: | Covidien, Ilc |
| 15 Hampshire Street | |
| Mansfield, MA 02048 | |
| Manufacturing Facility: | Covidien IIc, GI Solutions |
| 540 Oakmead Parkway | |
| Sunnyvale, CA 94085 | |
| Name of Subject Device: | Cytosponge™ Cell Collection Device |
| Trade or proprietary name: | Cytosponge™ Cell Collection Device |
| Classification Name: | Esophagoscope (Flexible or Rigid) |
| Classification: | Class II |
| Classification panel: | Gastroenterology/Urology |
| Ear Nose & Throat Panel | |
| Regulation: | 21 CFR 874.4710 |
| Product Code: | EOX |
4
| Legally marketed devices to which equivalence is claimed: | Cytosponge™ Cell Collection Device (K142695) |
|---|---|
| Reason for 510(k) Submission: | The purpose of this 510(k) is to notify the Agency of an expanded indication and the addition of clinical information to the labeling resulting from a Covidien clinical study using the Cytosponge™ Cell Collection Device. Additionally the warning of platelet inhibiting agents was moved and combined with the contraindications of antithrombotic drugs that cannot be temporarily discontinued. |
| Device description: | The subject device 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. 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. The 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 |
| Intended use: | The Cytosponge™ Cell Collection Device is intended for use in the collection and retrieval of surface cells in the esophagus. |
| Indications for use: | The Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus for cytological and histological analyses. |
| Technological Characteristics of Device Compared to Predicate Device: | As the subject of this submission is an expanded indication and labeling changes, the Cytosponge™ Cell Collection Device has identical technological characteristics is to the legally marketed predicate device cleared by the agency under K142695. There have been no design or material changes to the Cytosponge™ device cleared on November 26, 2014. There have been minor changes to the package insert that did not require a submission and were documented via Letter to File. The difference between the proposed Cytosponge™ Cell Collection Device and the predicate device (K142695) is an expanded indication and the addition of clinical information to the labeling resulting from a Covidien clinical study. |
5
| Summary of Clinical Tests Performed: | In a Covidien sponsored post-market study in a population of individuals with confirmed Barrett's esophagus (BE), sample adequacy was measured by the presence of columnar cells. |
|---|---|
| For the purposes of this investigation, an adequate sample was one in which at least one group of columnar cell was present. No minimal size was required for a group; a group of columnar cells can consist of two cells that are clearly columnar. Sample adequacy was presented as a proportion of subjects who fulfilled this definition after up to two total administrations of the Cytosponge device. | |
| Sixty-eight subjects met the inclusion criteria for sample adequacy. Four out of sixty-eight samples were inadequate. Two of the four patients repeated the Cytosponge device swallow and met the criteria for sample adequacy. Sixty-four of sixty-eight Cytosponge samples were sample adequate after one administration. Sixty-six of sixty-eight Cytosponge samples or 97% were sample adequate after two administrations. | |
| Performance data: | The subject Cytosponge™ Cell Collection Device is technologically identical to the cleared predicate device cleared by the agency under K142695. Accordingly, no performance testing was conducted. |
| Conclusion: | The clinical study demonstrates the Cytosponge™ Cell Collection Device may be used for cytological and histological analyses and is substantially equivalent to the predicate device. |