(27 days)
The ClearJet is an irrigation / biopsy adapter and irrigation tubing set used to cover the opening to the biopsy / suction / irrigation channel of standard endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
The proposed ClearJet adapter is intended to perform irrigation through the working channel of an endoscope by providing a means to control the fluid irrigation with the cleared ClearPath control unit. The ClearJet's is design to improve procedure reliability by improving visualization during endoscopic procedures. The ClearJet utilizes an irrigation / biopsy valve adapter on doling attachment to an endoscope's working channel port for the purpose of performing a colon or stomach wash. The ClearJet is composed of two major units: - . A disposable Irrigator and - . A Control cabinet It is designed to fit the standard endoscope models of Pentax, Olympus, and Fuijinon.
The ClearJet is an endoscope accessory intended to improve visualization during endoscopic procedures by providing irrigation through the working channel of an endoscope. The 510(k) summary reports that the device's performance was evaluated through comparative flow and pressure testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Operate within predicate specifications | Confirmed to operate within predicate specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data for performance evaluation. The testing described is comparative flow and pressure testing, likely performed on the device itself rather than human or animal subjects. Thus, there's no mention of sample size for a test set derived from patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for this device's performance was established through objective engineering measurements (flow and pressure testing) against predicate specifications, not expert interpretation of clinical data.
4. Adjudication Method
Not applicable. There was no clinical data requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The device is an accessory for irrigation, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The ClearJet is a physical medical device (an endoscope accessory), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply.
7. Type of Ground Truth Used
The ground truth used was the specifications of the predicate devices for flow and pressure. The ClearJet's performance was compared against these objective engineering parameters.
8. Sample Size for the Training Set
Not applicable. The ClearJet is a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K101094
ClearJet
Premarket Notification 510(k) Section 5 - 510(k) Summary
. 510(k) Summary Page 1 of 2 18-Apr-10
MAY 1 7 2010 EasyGlide Ltd. 30 Ha'Ella St. Tel - 011-972-528565644 Kfar Truman, 73150 Israel Fax -- 011-972-776201003 Official Contact: Izhak Fabian - CEO Proprietary or Trade Name: ClearJet Common/Usual Name: Endoscope accessory Classification Name/Code: KOG - endoscope and/or accessories CFR 876.1500 Device: ClearJet K091305 – Easy Glide – ClearPath Predicate Devices: K0070420 - US Endoscope BioShield
Device Description:
The proposed ClearJet adapter is intended to perform irrigation through the working channel of an endoscope by providing a means to control the fluid irrigation with the cleared ClearPath control unit.
The ClearJet's is design to improve procedure reliability by improving visualization during endoscopic procedures. The ClearJet utilizes an irrigation / biopsy valve adapter on doling attachment to an endoscope's working channel port for the purpose of performing a colon or stomach wash.
The ClearJet is composed of two major units:
- . A disposable Irrigator and
- . A Control cabinet
It is designed to fit the standard endoscope models of Pentax, Olympus, and Fuijinon.
Indications for Use:
The ClearJet is an irrigation / biopsy adapter and irrigation tubing set used to cover the opening to the biopsy / suction / irrigation channel of standard endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
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510(k) Summary Page 2 of 2 18-Apr-10
Patient Population:
Individuals undergoing procedures endoscopic procedures.
Environment of Use:
Hospitals, clinics, and doctors' offices.
Performance Testing Summary
We performed comparative flow and pressure testing to confirm that the ClearJet with the ClearPath controller operate within the predicate specifications, which was conformed.
Summary of substantial equivalence:
We have compared the ClearJet to the listed predicates for:
Indications -
- Identical to predicate for use as a multiple port adapter to the working channel of . endoscopes - K070420 - US Endoscopy Bio-Shield
- Identical to the predicate for use as an irrigation accessory ClearPath Irrigator and . Controller - K091305 - EasyGlide ClearPath
Technology -
- . ldentical technology used -in basic materials and use of a peristaltic pump for control and delivery of irrigation fluids - K091305 - EasyGlide ClearPath
- Identical technology of a multiple port adapter for connecting to and accessing the . working channel of an endoscope - K070420 US Endoscopy Bio-Shield
Materials –
- The materials in fluid contact are identical to the predicate device, ClearPath K091305 or . have been tested per ISO 10993.
Environment of Use -
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized graphic on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. A horizontal line is present below the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
EasyGlide Ltd % Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134
MAY 1 7 2010
Re: K101094
Trade/Device Name: ClearJet Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: April 18, 2010 Received: April 20, 2010
Dear Mr. Dryden:
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.
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. 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
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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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number:
KIO IDATO be assigned)
Device Name:
ClearJet .
Indications for Use:
The ClearJet is an irrigation / biopsy adapter set used to cover the opening to the biopsy / suction / irrigation channel of Pentax, Olympus and Fuijinon endoscopes. It mrovides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
Prescription Use XX (Part 21 CFR 801 Subpart D)
. Or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hee Reuer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.