(197 days)
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.
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
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Cytosponge™ Cell Collection Device
510(k) Number: K152794
This 510(k) submission is for an expanded indication and the addition of clinical information to the labeling, based on a Covidien clinical study. The device itself is technologically identical to the predicate device (K142695). Therefore, the study focuses on the effectiveness of the device in collecting adequate samples for cytological and histological analyses in a specific patient population (individuals with confirmed Barrett's esophagus).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Adequate sample collection for cytological and histological analyses, defined by the presence of at least one group of columnar cells. (Target performance not explicitly stated as a numerical criterion, but the study aims to demonstrate high adequacy.) | - 64 out of 68 (94.1%) Cytosponge samples were sample adequate after one administration. - 66 out of 68 (97%) Cytosponge samples were sample adequate after two administrations. (Two of the four initial inadequate samples achieved adequacy upon repeat administration). |
2. Sample size used for the test set and the data provenance
- Sample Size: 68 subjects met the inclusion criteria for sample adequacy.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from Covidien LLC, located in Mansfield, MA, USA, and FDA correspondence is to the US.
- Retrospective or Prospective: The text states, "In a Covidien sponsored post-market study," and describes it as an "investigation," implying a prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study measures "sample adequacy" based on the presence of columnar cells, but it doesn't specify who made this determination, how many experts were involved, or their qualifications (e.g., pathologists, histotechnologists).
4. Adjudication method for the test set
This information is not provided in the document. Given that the ground truth establishment details are missing, the adjudication method for determining sample adequacy is also not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC comparative effectiveness study was done. This device is a cell collection device, not an AI-assisted diagnostic tool for image interpretation. The study evaluates the device's ability to collect adequate samples for subsequent cytological and histological analyses, which would then be performed by human experts.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone performance study of an algorithm was done. This device is a physical tool for cell collection, not an AI or algorithmic diagnostic system. Its performance is measured by its ability to collect biological samples suitable for human laboratory analysis.
7. The type of ground truth used
The ground truth for the study was based on the presence of columnar cells in the collected samples, as determined through cytological or histological analyses (implied). Specifically, "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." This effectively serves as an expert consensus/pathology-derived ground truth for sample adequacy, though the exact process and experts are not detailed.
8. The sample size for the training set
This information is not applicable/not provided. This is a study evaluating the performance of a medical device for sample collection, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as point 8.
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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.
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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
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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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510(k) Summary
| Submitter Information | |
|---|---|
| Name: | Covidien IIC |
| Address: | 15 Hampshire StreetMansfield, MA 02048 |
| Name of contact person: | Saket BhattManager, Regulatory Affairs540 Oakmead ParkwaySunnyvale, CA 94085 |
| Phone:Fax number: | (408) 328-7357(408) 328-7357 (same as phone) |
| Date prepared: | April 8, 2016 |
| Establishment Registration:Owner/Operator Number: | 30049048111282497 |
| Legal Manufacturer: | Covidien, Ilc15 Hampshire StreetMansfield, MA 02048 |
| Manufacturing Facility: | Covidien IIc, GI Solutions540 Oakmead ParkwaySunnyvale, 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/UrologyEar Nose & Throat Panel |
| Regulation: | 21 CFR 874.4710 |
| Product Code: | EOX |
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| 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. |
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| 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. |
§ 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.