(382 days)
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Not Found
No
The device description focuses solely on the mechanical aspects of sample collection and does not mention any computational analysis or algorithms.
No
The device is intended for the collection of cytologic samples for diagnostic purposes and does not directly provide therapy or treatment.
Yes
The device's intended use is "to determine the presence of abnormalities like Barrett's Esophagus" through cytologic analysis, which is a diagnostic purpose.
No
The device description clearly outlines a physical catheter with a balloon and brush for sample collection, indicating it is a hardware device, not software-only.
Based on the provided information, the Barrett's Cytology Device is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- IVD devices are used in vitro (outside the body) to examine specimens derived from the human body. The Barrett's Cytology Device is a tool used in vivo (inside the body) to collect the specimen (cytologic samples from the esophageal mucosa).
- The device's intended use is to collect samples for cytologic analysis. The analysis itself, which determines the presence of abnormalities, is the diagnostic part and would be performed using laboratory techniques and potentially other IVD devices (like microscopes, stains, etc.) on the collected sample.
Think of it this way: a blood collection tube is not an IVD, but the tests performed on the blood in the tube are IVDs. Similarly, this device collects the sample, and the subsequent analysis of that sample is where the diagnostic process occurs.
Therefore, the Barrett's Cytology Device is a sample collection device used in a procedure that leads to an in vitro diagnostic analysis.
N/A
Intended Use / Indications for Use
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 abrorralities bil abnormalities like Barrett's Esophagus.
Product codes (comma separated list FDA assigned to the subject device)
78 FCF
Device Description
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 catheter lumen. The entire catheter is withdrawn from the patient and the cytology brush is again deployed to prepare microscopic slides for analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophageal mucosa, esophagus, stomach, lower esophageal sphincter (LES)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
Not Found
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
§ 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.
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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
201
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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
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