(111 days)
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.
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.
This document is a 510(k) summary for the Medivators Endo Smart Bottle, an endoscopic irrigation/suction system. It primarily focuses on demonstrating substantial equivalence to a predicate device, the Endo Smart Cap. The document describes the device, its intended use, and non-clinical performance data to support its safety and effectiveness.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, it lists types of performance tests designed to demonstrate equivalence to the predicate device. The "reported device performance" is described qualitatively as having passed these tests, indicating equivalence.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Qualitative) |
|---|---|
| Lens Rinsing Function | Performed equivalently to predicate |
| Insufflation Function | Performed equivalently to predicate |
| Safety (Design Verification) | Performed equivalently to predicate |
| Cytotoxicity Evaluation | Met biocompatibility requirements |
| Intracutaneous Irritation Test | Met biocompatibility requirements |
| Sensitization | Met biocompatibility requirements |
| Functional Testing (Shelf-life) | Maintained function over shelf-life |
| Dye Penetration Testing (Shelf-life) | Maintained integrity over shelf-life |
| Peel Strength Testing (Shelf-life) | Maintained integrity over shelf-life |
| Visual Seal Inspection (Shelf-life) | Maintained integrity over shelf-life |
| Sterilization Validation | Met sterility requirements |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on the specific sample sizes used for each non-clinical performance test (e.g., how many bottles were tested for lens rinsing function). It also does not mention data provenance (country of origin or retrospective/prospective nature) as these are non-clinical engineering and bench tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. The evaluations described are "Design Verification," "Biocompatibility," "Shelf-life validation," and "Sterilization validation," which are engineering and laboratory tests based on established standards and protocols, not expert consensus on medical interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical engineering and laboratory tests, not clinical performance studies requiring adjudication of results.
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
No such study was conducted or is mentioned. This product is a physical medical device (endoscopic irrigation/suction system) and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a manual accessory for an endoscope and does not involve algorithms or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests would be defined by established engineering and biological standards, specifications, and test methodologies relevant to medical device performance (e.g., maintaining specific flow rates, successfully clearing a lens, demonstrating no cytotoxic effects, maintaining sterile barrier integrity). It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this device.
{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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR A BEACH AND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/5/Picture/13 description: The image shows the name "Benjamin R. Fisher" in bold, black font. Below the name, the date "2014.07.15" and time "11:11:52" are printed in a similar font. There is also some illegible text to the right of the name and date.
{6}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB 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.