(111 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of supplying water and air/CO2, with no mention of AI or ML.
No.
The device is designed to supply air/CO2 and sterile water to an endoscope for purposes such as rinsing the lens and insufflating the anatomical lumen to improve visualization, not to directly treat a medical condition or disease.
No
The device description indicates its function is to supply water, air/CO2 to an endoscope for rinsing and insufflation, which are procedural support functions, not diagnostic ones.
No
The device description clearly outlines physical components (connector cap, water bottle, threaded cap, small tube, male luer) made of plastics and elastomers, indicating it is a hardware device.
Based on the provided information, the EndoSmart Bottle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to supply air/CO2 and sterile water to an endoscope during endoscopic procedures. This is a direct interaction with the endoscope and the patient's body during a procedure, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces its function in providing water for lens rinsing and air/CO2 for insufflation during the procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.), analyze biomarkers, or provide diagnostic information based on in vitro analysis.
- Predicate Device: The predicate device (Endo SmartCap) is also likely not an IVD, as it serves a similar function in endoscopic procedures.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The EndoSmart Bottle's function is purely procedural support during an endoscopic examination.
N/A
Intended Use / Indications for Use
The EndoSmart Bottle is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
Endo Smart Bottle is designed to be attached to an endoscope, to help supply water, air/CO2. The device consists of a connector cap, a water bottle, a threaded cap, a small tube, and a male luer. The main function of the subject device is -
- . To provide water for rinsing the lens.
- To provide air or CO2 to insufflate the anatomical lumen, to help the end user to see . the inner wall more clearly.
Similar to its predicate device, the subject device is provided sterile to the end user, fabricated from plastics, and elastomers, intended for daily (24 hour) multi-patient use and must be discarded daily. Both the subject device and its predicate device do not come in direct contact with patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Medivators has conducted the following conformance testing to demonstrate that Endo Smart Bottle has performance characteristics equivalent to its predicate Endo Smart Cap –
- . Design Verification including functional testing
- o Lens Rinsing Function
- o Insufflation Function
- o Safety
- Biocompatibility .
- Cytotoxicity Evaluation 0
- Intracutaneous Irritation Test o
- o Sensitization
- Shelf-life validation .
- Functional Testing O
- O Dye Penetration Testing
- Peel Strength Testing 0
- o Visual Seal Inspection
- . Sterilization validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 876.1500 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
Image /page/0/Picture/1 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a stylized graphic to the left of the company name. The graphic is a circle with several horizontal lines running through it. The text "MEDIVATORS" is in all caps and bolded, with the text "A Cantel Medical Company" in a smaller font size below it.
JUL 1 5 2014
Endo Smart Bottle
Section 05. 510(k) Summary
| Manufacturer: | Medivators, A Cantel Medical Company |
|---|---|
| Address: | 3150 Pollok Dr, Conroe, TX - 77303 |
| (963) 539-0391 | |
| Official Contact: | Kinnari Shah, MS |
| Regulatory Affairs Specialist | |
| Trade Name: | Endo Smart Bottle, Rinse and Insufflation System |
| Common Name: | Endoscopic Irrigation/Suction System |
| Classification Name: | Endoscope and accessories |
| Product Code: | OCX |
| Device Class: | II |
| Classification Regulation: | 876.1500 |
Medivators Inc. has supplied the following information to the US Food and Drug Administration to support substantial equivalence of Endo Smart Bottle, Rinse and Insufflation System to its predicate - Endoscope accessories - Endo Smart Cap.
1. Device Description
Endo Smart Bottle is designed to be attached to an endoscope, to help supply water, air/CO2. The device consists of a connector cap, a water bottle, a threaded cap, a small tube, and a male luer. The main function of the subject device is -
- . To provide water for rinsing the lens.
- To provide air or CO2 to insufflate the anatomical lumen, to help the end user to see . the inner wall more clearly.
Similar to its predicate device, the subject device is provided sterile to the end user, fabricated from plastics, and elastomers, intended for daily (24 hour) multi-patient use and must be discarded daily. Both the subject device and its predicate device do not come in direct contact with patients.
1
Image /page/1/Picture/1 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a circular graphic on the left, followed by the word "MEDIVATORS" in bold, sans-serif font. Below the company name is the text "A Cantel Medical Company" in a smaller, less bold font. The graphic on the left appears to be a stylized representation of concentric circles or waves.
5. Conclusion
Medivators has provided appropriate premarket notification in the form of a 510(k) to support the substantial equivalence of Endo Smart Bottle to legally marketed predicate device. The information and performance data provided indicates that the Endo Smart Bottle is safe and effective for its intended use when used in accordance with the device labeling.
2
Image /page/2/Picture/0 description: The image shows the text 'K140753' on the first line. The second line says 'Pg. 3 of 3'. This likely indicates a page number within a document, specifically page 3 of a 3-page document, with an associated identifier 'K140753'.
Image /page/2/Picture/1 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a stylized graphic to the left of the company name. The graphic is a circular design with several curved lines, resembling a fingerprint or a stylized sun. The text "MEDIVATORS" is in a bold, sans-serif font, and below it, in a smaller font, is the text "A Cantel Medical Company."
2. Intended Use
The EndoSmart Bottle is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Comparison to Other Devices in Commercial Distribution Within the United States 3.
Endo SmartBottle is equivalent in function, intended use and technology to Medivators Endo SmartCap cleared under 510k - K093665. Endo SmartBottle is closely related to its predicate device - Endo SmartCap.
Both the predicate device and the subject device have intended use, principle of operation and scientific technology. Only difference between the 2 devices is - Endo Smart Bottle has concise tubing and an integrated water bottle unlike its predicate. Endo SmartCap and Endo Smart Bottle are daily (24 hour) disposable version of reusable analogues predicate of Endo SmartCap, this eliminating the risk of disinfection. A predicate device comparison table which supports substantial equivalence of Endo SmartBottle to its predicate is contained in the Substantial Equivalence section of this submission.
বাঁ Summary of Non-Clinical Performance Data
Medivators has conducted the following conformance testing to demonstrate that Endo Smart Bottle has performance characteristics equivalent to its predicate Endo Smart Cap –
- . Design Verification including functional testing
- o Lens Rinsing Function
- o Insufflation Function
- o Safety
- Biocompatibility .
- Cytotoxicity Evaluation 0
- Intracutaneous Irritation Test o
- o Sensitization
- Shelf-life validation .
- Functional Testing O
- O Dye Penetration Testing
- Peel Strength Testing 0
- o Visual Seal Inspection
- . Sterilization validation
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002
July 15, 2014
Medivators, Inc. Kinnari Shah Regulatory Affairs Specialist 14605 28th Ave N Minneapolis, MN 55447
K140753 Re:
Trade/Device Name: Endo Smart Bottle System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: March 25, 2014 Received: March 26, 2014
Dear Kinnari Shah,
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 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.
4
Page 2 - Kinnari Shah
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140753
Device Name Endo Smart Bottle
Indications for Use (Describe)
The EndoSmart Bottle is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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6
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