(382 days)
The Barrett's Cytology Device is intended to collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus.
The Barrett's Cytology Device is a catheter that is advanced into the esophagus much like a gastric lavage catheter. The catheter with the aid of common intubation techniques is further advanced into the stomach. The placement into the stomach is confirmed by the use of a distal inflatable balloon which is used to identify the lower esophageal sphincter (LES). Identification of the LES is required because the target sample location is typically the distal esophagus. Once the LES is identified an external slide disc on the catheter is used to mark the length of the patient's esophagus from the dental arches. At this time the balloon will be deflated and the catheter withdrawn away from the LES into the esophagus using the slide disc and catheter markings for distance reference as to how far back the catheter is to be withdrawn. When the catheter is withdrawn to the desired location to sample a cytology brush contained within the catheter is deployed out the distal end of catheter and the cytologic brushing commences. Once the brushing of the esophagus is completed the brush is withdrawn back inside the catheter to contain the cell harvest within the catheter lumen. The entire catheter is withdrawn from the patient and the cytology brush is again deployed to prepare microscopic slides for analysis.
The provided document is a 510(k) summary for the "Barrett's Esophageal Cytology Device" and primarily focuses on its intended use and general regulatory information. It does not include detailed studies or data regarding specific acceptance criteria and device performance as requested.
Therefore, I cannot provide the complete answer based solely on the provided text. The document states that the "Summary of Safety and Effectiveness...reflects data available and presented at the time the submission was prepared," but the actual data and study details are not present in this excerpt.
However, I can extract the available information and highlight what is missing:
Acceptance Criteria and Device Performance Study
As per the provided 510(k) summary, specific acceptance criteria for device performance (e.g., sensitivity, specificity for detecting Barrett's Esophagus or dysplasia) and a detailed study proving the device meets these criteria are not included. The document describes the device's function and intended use but does not present a formal study with statistical data to validate its diagnostic accuracy.
Available Information and Missing Details:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the given text. The document describes the device's purpose to "collect cytologic samples...for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus," but does not quantify performance metrics like sensitivity, specificity, or accuracy against specific criteria.
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Sample Size used for the test set and the data provenance: This information is not provided in the given text.
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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 given text.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the given text.
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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: This information is not provided. The device described is a cytology collection device, not an AI-assisted diagnostic tool for interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not provided. Again, this device is for sample collection, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided in the given text. The device aims to collect samples for "cytologic analysis," implying the ground truth would be based on pathology/cytology reports, but the method for establishing it in a study is not detailed.
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The sample size for the training set: This information is not provided in the given text.
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How the ground truth for the training set was established: This information is not provided in the given text.
Summary of Device and Context from the Text:
- Device Name: Barrett's Esophageal Cytology Device
- Intended Use: To collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus.
- Regulatory Clearance: K984168 (cleared on Dec 7, 1999)
- Classification: Class II, 21 CFR 876.1075 / Procode: 78 FCF
- Predicate Device: The submission implies comparison to legally marketed predicate devices, but specific details of the predicate device performance used for substantial equivalence are not provided in this excerpt.
- Methodology: Combines non-endoscopic intubation catheter methods and cytology brush technology. Involves advancing a catheter with an inflatable balloon to identify the LES, marking the esophagus length, withdrawing the catheter to the desired sampling location, deploying a cytology brush, and collecting cells.
Conclusion based on provided text:
The provided 510(k) summary describes the device and its intended use for collecting cytology samples. However, it does not contain the detailed study results, acceptance criteria, sample sizes, ground truth establishment methods, or expert qualifications that would typically be found in a study report proving the device meets specific performance criteria. The document refers to "data available and presented at the time the submission was prepared," but these specific data points are absent from the provided excerpt.
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12/7/99
SECTION II 510k SUMMARY OF SAFETY AND EFFECTIVENESS
The Summary of Safety and Effectiveness on the Barrett's Esophageal Cytology Device reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Procedure/Product Overview
The Barrett's Cytology Device is intended to collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus. In the past the methods of obtaining cytologic samples from the gastrointestinal tract were limited to brush cytology completed under direct visualization methods via endoscopy. This method although proven has a high procedure cost associated with it. The Barrett's Cytology Device combines non endoscopic intubation catheter methods and cytology brush technology to provide a device that will lower the cost of surveillance for this patient population. The Barrett's Cytology Device is a catheter that is advanced into the esophagus much like a gastric lavage catheter. The catheter with the aid of common intubation techniques is further advanced into the stomach. The placement into the stomach is confirmed by the use of a distal inflatable balloon which is used to identify the lower esophageal sphincter (LES). Identification of the LES is required because the target sample location is typically the distal esophagus. Once the LES is identified an external slide disc on the catheter is used to mark the length of the patient's esophagus from the dental arches. At this time the balloon will be deflated and the catheter withdrawn away from the LES into the esophagus using the slide disc and catheter markings for distance reference as to how far back the catheter is to be withdrawn. When the catheter is withdrawn to the desired location to sample a cytology brush contained within the catheter is deployed out the distal end of catheter and the cytologic brushing commences. the Once the brushing of the esophagus is completed the brush is withdrawn back inside the catheter to contain the cell harvest within the
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catheter lumen. The entire catheter is withdrawn from the patient and the cytology brush is again deployed to prepare microscopic slides for analysis.
Contraindications
The use of the Barrett's Cytology Device is contraindicated and is not appropriate in cases where the patients have or present with:
- Consideration of bleeding complications in patients with liver । cirrhosis, esophageal varices, active gastroduodenal bleeding
- Consideration of the potential complications of esophageal or . gastric bleeding and or perforation and aspiration digestive fluids into the lung.
- i Consideration of stress associated with intubation procedures (gagging, discomfort) in patients with severe heart disease, hypertension, or pulmonary deficiencies.
- ー Reaction to topical anesthetics.
- -Insertion may be complicated in patients with esophageal obstruction, acute laryngitis, or general debilitation of the patient due to other causes.
- । Other contraindications as determined by physician.
Manufacturing Overview
U.S.E. will manufacture and test the product to performance specifications based on predicate and/or substantially equivalent devices.
U.S.E. quality system is based on the requirements of The FDA Quality System Regulations and it is also certified to ISO 9001 and EN46001 and markets devices under following the requirements of The European Medical Device Directive. The U.S.E. quality system methods and procedures are utilized to assure the product conformance to design specifications. The device design, development and validation will be implemented following relevant design control procedures.
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Sterilization
This device will be offered in a sterile packaging configuration. The ethylene oxide gas process, packaging materials and methods will be subject to the validation requirements of the U.S.E. quality system.
Bibliography
- Falk G, Chittajallu R, et al. Alimentary Tract Surveillance of Patients with Barrett's Esophagus for Dysplasia and Cancer with Balloon Cytology. Gastroenterology. 1997;112:1787-1797
- Falk G, Richter J, Reflux Disease and Barrett's Esophagus. Endoscopy. 1998; 30: 61-72
- Roth M, Liu S, et al. Cytologic Detection of Baophageal Squamous Cell Carcinoma and Precursor Lesions Using Balloon and Sponge Samplers in Asymtomatic Adults in Linxian, China. Cancer. 1997; vol.80: 2047-2059
- Rayhorn N, Intubation and Drainage. Gastroenterology Nursing A Core Curriculum.1998; Chapter 29:307-321
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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH &" is visible above the eagle, and "HUMAN SERVICES" is visible below the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 7 1999
Mr. Dean Secrest U.S. Endoscopy Group 5976 Heisley Road Mentor, OH 44060
Re: K984168 Barrett's Esophageal Cytology Device Dated: October 7, 1999 Received: October 12, 1999 Requiatory Class: Il 21 CFR 876.1075/Procode: 78 FCF
Dear Mr. Secrest:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 reclasslified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements conceming your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number if Known_
Device Name: Barrett's Cytology Device
Indications for Use:
The Barrett's Cytology Device is intended to collect cytologic samples from the esophageal mucosa without the aid of endoscopy abrorralities bil abnormalities like Barrett's Esophagus.
(please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE) Prescription Use OR Over-the-Counter Use (Per 21 CFR 801.109)
David C. Severson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984168/5
2
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.