(95 days)
Not Found
No
The description focuses on a mechanical flushing device and does not mention any AI/ML components or functionalities.
No.
The device is described as a flushing and washing device for mucosal tissue in the gastrointestinal tract, which is a supportive function during endoscopic procedures, not a therapeutic treatment itself.
No
The device is described as an accessory for applying solutions to wash mucosal tissue in the gastrointestinal tract, not for diagnosing any condition.
No
The device description clearly states it is a sterile, disposable, single-use device composed of a catheter with a spray tip, indicating it is a physical hardware device.
Based on the provided information, the JetPrep Flushing Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to apply solutions for washing mucosal tissue in the gastrointestinal tract. This is a procedure performed in vivo (within a living organism).
- Device Description: The device is described as a flexible endoscopic accessory used to apply fluids within the endoscope working channel for irrigation. This is a direct interaction with the patient's internal tissues.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to diagnose diseases or conditions.
The JetPrep Flushing Device is clearly designed for a therapeutic or procedural purpose within the body, not for analyzing samples in a lab setting.
N/A
Intended Use / 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.
Product codes
OCX
Device Description
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 a funnel shaped 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. This 510(k) notice adds an additional model of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal tract
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)
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.
The modified JetPrep Flushing Device has the same intended use, principles of operation, and technological characteristics as the cleared JetPrep Flushing Device. The minor differences in the modified JetPrep Flushing Device do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified JetPrep Flushing Device is as safe and effective as the cleared JetPrep Flushing Device. Thus, the modified JetPrep Flushing Device is substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) SUMMARY
JetPrep, Ltd. JetPrep Flushing Device
Sponsor / Manufacturer:
Date Summary Prepared:
Submitter / Representative:
JetPrep, Ltd. 71 Ha'Nadiv St. Herzliya 46485 lsrael Phone: +972-9-950-6712 Fax: +972-9-950-6710 Contact: David Nitsan, CEO
September 6, 2012
John Smith, MD, JD Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 Phone: +1-202-637-5600 Fax: +1-202-637-5910
Trade Name / Common Name: JetPrep Flushing Device Classification Name: Endoscopic irrigation/suction system Product Code: OCX Classification Regulation: 21 C.F.R. § 876.1500
Predicate Device:
Device:
Purpose of the special 510(k) notice:
Intended Use:
Device Description:
JetPrep Flushing Device JetPrep, Ltd. K111274
The JetPrep Flushing Device is a modification to cleared JetPrep Flushing Device (K111274).
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.
DEC 1 0 2012
1
Technological Characteristics:
Performance Data:
Substantial Equivalence:
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 a funnel shaped 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. This 510(k) notice adds an additional model of the device.
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.
The modified JetPrep Flushing Device has the same intended use, principles of operation, and technological characteristics as the cleared JetPrep Flushing Device. The minor differences in the modified JetPrep Flushing Device do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified JetPrep Flushing Device is as safe and effective as the cleared JetPrep Flushing Device. Thus, the modified JetPrep Flushing Device is substantially equivalent to its predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2012
JetPrep. Ltd. % John Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K122740
Trade/Device Name: JetPrep Flushing Device Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: December 5, 2012 Received: December 5, 2012
Dear Dr. 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.
3
Page 2 - John Smith, M.D., J.D.
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. or any I each states and 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 n you attp://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.
Sincerely yours,
Benjamin R. Fisher -S
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
4
Indications for Use Statement
510(k) Number (if known):
K 122740
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
AND/OR
Over-The-Counter Use
(Per 21 C.F.R. 801 Subpart D)
(Per 21 C.F.R. 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2012.12.10 16:00:34 -05'00'
Division Sign-Off) of Reproductive, Gastro-Renal, and 510(k) Numb