(172 days)
No
The description focuses on mechanical irrigation and suction controlled by a peristaltic pump, with no mention of AI or ML technologies for decision-making, image analysis, or control.
No
The device facilitates intraprocedural cleaning of the colon during a colonoscopy by irrigating and evacuating fluid and feces. This is a procedural aid, not a device that treats or diagnoses a disease/condition.
No
The device is designed for intraprocedural cleaning of the colon by irrigating and evacuating fluids and feces, which is a therapeutic/interventional function, not a diagnostic one. Its purpose is to facilitate a procedure (colonoscopy) by improving visibility and decreasing cancellation rates due to poor bowel preparation, rather than to identify or determine a disease or condition.
No
The device description explicitly states it is composed of two major units: a disposable Irrigator and a reusable Control cabinet, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- ClearPath's Function: The ClearPath is used during a colonoscopy procedure to physically clean the colon by irrigating and evacuating fluid and feces. It is a device that interacts directly with the patient's internal anatomy to facilitate a medical procedure.
- No Sample Analysis: The ClearPath does not analyze any samples taken from the patient. Its purpose is mechanical cleaning, not diagnostic testing of biological material.
Therefore, the ClearPath falls under the category of a medical device used for a procedural purpose, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClearPath is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water) and feces.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
Product codes
FDF
Device Description
The ClearPath's main purpose is to improve procedure reliability and decrease colonoscopy procedures cancellation rate by enabling intra-procedural cleaning of a poorly prepared colon.
The ClearPath utilizes a suction / irrigation head for the purpose of irrigating or cleaning the colon and enabling the rapid evacuation of large amounts of water and feces.
The ClearPath is composed of two major units:
- . The disposable Irrigator and
- . the reusable Control cabinet.
The disposable Irrigator is attached to a standard colonoscope by means of silicon bands and does not hinder colonoscope functionality nor affects the procedure sequence in any way.
The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon
Indicated Patient Age Range
Individuals undergoing procedures where a colonoscope is used.
Intended User / Care Setting
trained medical personnel located in hospitals, clinics, and doctors' offices.
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)
We have performed testing to demonstrate that the operating performance specifications of the ClearPath is equivalent to the predicates for flow rate, irrigation and vacuum pressures.
| Proposed ClearPath (ACE- 1000) | Olympus (KeyMed) OFP-1 endoscopic flushing pump | |
|---|---|---|
| 510(k) number | K000948 | |
| Air / Water pressure specifications | Up to 30 Psi | 52 Psi |
| Flow rate | Up to 300 ml/min | Up to 300 ml/min |
| Suction specifications | Standard wall suction Approximately 0.5 Bar | Standard wall suction Approximately 0.5 Bar |
In addition we have preformed testing under the following standards:
- IEC 60601 .
- IEC 60601-1 .
- . IEC 60601-2-18
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
K09/305
ClearPath
510(k) Summary Page 1 of 2 30-Apr-09
| EasyGlide Ltd.
30 Ha'Ella St.
Kfar Truman, 73150
| Israel | OCT 23 2009 |
|---|---|
| Tel - 011-972-528565644 | |
| Fax - 011-972-776201003 | |
| Official Contact: | Izhak Fabian - CEO |
| Proprietary or Trade Name: | ClearPath |
| Common/Usual Name: | External uterine monitor |
| Classification Name/Code: | FDF - colonoscope and accessories, flexible/rigid |
| CFR 876.1500 | |
| Device: | ClearPath |
| Predicate Devices: | K032688 - Sightline - Colonsight 510B |
| K031773 - Bryne Medical - EndoGator | |
| K000948 Olympus (KeyMed) - OFP-1 endoscopic flushing pump |
Device Description:
The ClearPath's main purpose is to improve procedure reliability and decrease colonoscopy procedures cancellation rate by enabling intra-procedural cleaning of a poorly prepared colon.
The ClearPath utilizes a suction / irrigation head for the purpose of irrigating or cleaning the colon and enabling the rapid evacuation of large amounts of water and feces.
The ClearPath is composed of two major units:
- . The disposable Irrigator and
- . the reusable Control cabinet.
The disposable Irrigator is attached to a standard colonoscope by means of silicon bands and does not hinder colonoscope functionality nor affects the procedure sequence in any way.
The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.
Indications for Use:
The ClearPath is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water) and feces.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
1
K091305
ClearPath
510(k) Summary Page 2 of 2 30-Apr-09
Patient Population:
Individuals undergoing procedures where a colonoscope is used.
Environment of Use:
Hospitals, clinics, and doctors' offices.
Summary of substantial equivalence:
We have performed testing to demonstrate that the operating performance specifications of the ClearPath is equivalent to the predicates for flow rate, irrigation and vacuum pressures.
| | Proposed
ClearPath (ACE-
1000) | Olympus (KeyMed)
OFP-1 endoscopic
flushing pump |
|----------------------------------------|------------------------------------------------|-------------------------------------------------------|
| 510(k) number | | K000948 |
| Air / Water pressure
specifications | Up to 30 Psi | 52 Psi |
| Flow rate | Up to 300 ml/min | Up to 300 ml/min |
| Suction
specifications | Standard wall suction
Approximately 0.5 Bar | Standard wall suction
Approximately 0.5
Bar |
In addition we have preformed testing under the following standards:
- IEC 60601 .
- IEC 60601-1 .
- . IEC 60601-2-18
The ClearPath is viewed as substantially equivalent to the predicate devices because:
Indications -
- Identical to predicate K032688 Sightline Colonsight 510B .
Technology -
Environment of Use -
- . Identical to predicate - K032688 - Sightline Colonsight 510B
Performance specifications -
- Irrigation pressures, flow rate and suction pressures are equal or less than the predicates . - K000948 Olympus (KeyMed) OFP-1 endoscopic flushing pump
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 8 2009
EasyGlide Ltd. c/o Mr. Paul E. Dryden President Regulatory Consultant ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134-2958
Re: K091305
Trade/Device Name: ClearPath Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: October 12, 2009 Received: October 14, 2009
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 of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K09/305
181/
Indications for Use Statement
Page 1 of 1
510(k) Number:
K09/305(To be assigned)
Device Name:
ClearPath
Indications for Use:
The ClearPath is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water) and feces.
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)
Hulutleum
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _