(335 days)
The JetPrep Flushing Device is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract.
The JetPrep Flushing Device is a sterile, disposable, single use device, intended for use as flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract. The device is composed of a catheter with a spray tip on its distal tip. During operation, the catheter should be inserted into the endoscope working channel. The spray tip location can be manually controlled by the user to be positioned on the distal end of the endoscope working channel, and thus apply 360 degree irrigation spray pattern. The device does not impede aspiration of debris and fluids through the endoscope working channel while it remains within the endoscope. For providing irrigation fluids, the device should be connected to legally marketed irrigation pumps or manual syringe for endoscopy.
The provided text is a 510(k) summary for the JetPrep Flushing Device. It describes the device, its intended use, and states that it has been subjected to "extensive safety and performance validations prior to release." However, it does not contain specific acceptance criteria or detailed results of a study demonstrating the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (Hobbs Mistifier Spray Catheter) based on indications for use, design, and operation principles, rather than presenting a formal performance study with predefined acceptance criteria. This is common for 510(k) submissions where substantial equivalence is demonstrated through comparison to an already cleared device, potentially relying on non-clinical performance data (e.g., biocompatibility) and design similarities rather than extensive clinical efficacy trials.
Therefore, most of the requested information cannot be extracted from this document, as it is not present.
Here's what can be addressed based on the provided text:
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1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document states "The JetPrep Flushing Device has been subjected to extensive safety and performance validations prior to release" and "The device parts that come in contact with the irrigation fluids and/or the patient's tissue are composed of materials that were tested for biocompatibility." However, it does not specify what those performance validations were, what their acceptance criteria were, or the quantitative results.
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided in the document. No specific test set or study details are mentioned.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not provided in the document. No ground truth establishment is described.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the document.
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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: This information is not provided in the document. This device is a flushing device, not an AI-assisted diagnostic tool, so such a study would not be applicable.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not provided in the document. This device is a physical medical device, not an algorithm.
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7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): This information is not provided in the document.
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8. The sample size for the training set: This information is not provided in the document, as no training set is mentioned.
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9. How the ground truth for the training set was established: This information is not provided in the document, as no training set or ground truth establishment is mentioned.
In summary, the provided 510(k) summary focuses on substantial equivalence and general safety/biocompatibility, rather than detailed performance study data with explicit acceptance criteria.
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510(k) SUMMARY
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JetPrep, Ltd. JetPrep Flushing Device K111274
| Manufacturer: | JetPrep, Ltd.71 Ha'Nadiv St.Herzliya 46485lsraelPhone: +972-9-950-6712Fax: +972-9-950-6710Contact: David Nitsan, CEO |
|---|---|
| Date Summary Prepared: | June 6, 2011 |
| Representative/Consultant: | John Smith, MD, JDHogan Lovells US LLPColumbia Square555 Thirteenth Street, NWWashington, DC 20004Phone: +1-202-637-5600Fax: +1-202-637-5910 |
| Device: | Trade Name: JetPrep Flushing DeviceCommon/Classification Name: Endoscope and accessoriesProduct Code: KOGClassification Regulation: 21 C.F.R. § 876.1500 |
| Predicate Devices: | Hobbs Mistifier Spray CatheterHobbs Medical, Inc.K030765 |
| Device Description: | The JetPrep Flushing Device is a sterile, disposable, singleuse device, intended for use as flexible endoscopicaccessory to apply legally marketed solutions for washingmucosal tissue in the gastrointestinal tract. |
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Intended Use: The JetPrep Flushing Device is intended for use as a flexible endoscopic accessory to apply leqally marketed solutions for washing mucosal tissue in the gastrointestinal tract. Technological Characteristics: The device is composed of a catheter with a spray tip on its distal tip. During operation, the catheter should be inserted into the endoscope working channel. The spray tip location can be manually controlled by the user to be positioned on the distal end of the endoscope working channel, and thus apply 360 degree irrigation spray pattern. The device does not impede aspiration of debris and fluids through the endoscope working channel while it remains within the endoscope. For providing irrigation fluids, the device should be connected to legally marketed irrigation pumps or manual syringe for endoscopy. Performance Data: The JetPrep Flushing Device has been subjected to extensive safety and performance validations prior to release. The device parts that come in contact with the irrigation fluids and/or the patient's tissue are composed of materials that were tested for biocompatibility. JetPrep, Ltd., demonstrated that, for the purposes of FDA's Substantial Equivalence: requlation of medical devices, JetPrep Flushing Device is substantially equivalent in indications for use, design and operation principles to a legally marketed predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JetPrep, Ltd. % Mr. John J. Smith, MD, JD Partner Hogan Lovells US LLP Columbia Square 555 13th Street, NW WASHINGTON DC 20004
Re: K111274
Trade/Device Name: JetPrep Flushing Device Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: March 26, 2012 Received: March 26, 2012
Dear Mr. Smith:
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 r four of a how a determination that your device complies with other requirements of the Act that I Drinan statutes and regulations administered by other Federal agencies. You must or urf I cather the Act's requirements, including, but not limited to: registration and listing Configity with an the 110 b ong (21 CFR Part 801); medical device reporting (reporting of medical
APR - 4 2012
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerély vours,
Sincerely yours,
Benjamin R. Twichell
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): K111274
Device Name:
JetPrep Flushing Device
Indications for Use:
The JetPrep Flushing Device is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract.
Prescription Use _ X
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Virological Devices
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.