(153 days)
No
The device description and performance studies focus on mechanical function (flow rate, backflow prevention) and compatibility with existing equipment. There is no mention of data processing, algorithms, or learning capabilities.
No.
The device is intended to supply air/CO2 and sterile water to an endoscope during procedures, and no portion of the device comes into direct contact with patients. It facilitates endoscopic procedures but does not inherently treat a medical condition or disease.
No
The device's intended use is to supply air/CO2 and sterile water to an endoscope during endoscopic procedures, and its description focuses on the mechanics of fluid delivery. There is no mention of the device collecting or analyzing data for diagnostic purposes.
No
The device description clearly outlines physical components made of metals, plastics, and elastomers, and describes a sterile, disposable device with tubes, a bottle cap, a tube weight, a pinch clip, and a connector. This is a hardware device.
Based on the provided information, the Endo SmartCap™ is not an In Vitro Diagnostic (IVD) 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 device used during a medical procedure on a patient, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details how the device physically connects to a sterile water source and an air/CO2 source and delivers these to the endoscope. It describes a mechanical system for fluid and gas delivery.
- No mention of testing biological samples: There is no indication that the device is used to analyze blood, urine, tissue, or any other biological sample.
- No mention of diagnostic information: The device's function is to facilitate the endoscopic procedure, not to provide diagnostic information based on the analysis of samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Endo SmartCap™ does not fit this definition.
N/A
Intended Use / Indications for Use
The Endo SmartCap™ 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
FAJ
Device Description
The Endo SmartCap™ supplies sterile water and either air or CO2 to an endoscope during endoscopic procedures when connected to a sterile water source and an air or CO2 source. Two tubes are arranged coaxially; air or CO2 supplied through the outer tube pressurizes the sterile water container, forcing water up through the inner tube and to the endoscope. The proximal end of the tube set includes a bottle cap for attachment to a user-provided sterile water container; the Endo SmartCap™ is compatible with all major brands of sterile water containers. The proximal end of the tube set terminates in a tube weight which keeps the tip of the tubing submerged. A pinch clip prevents water from dripping from the tube's distal end when the device is detached from the endoscope. The distal end of the tube set terminates in a connector which mates with the corresponding brand of endoscope; Endo SmartCap™ models are available for all major brands of endoscopes. The device is provided sterile (EtO). The device is fabricated from metals, plastics, and elastomers. The Endo SmartCap™ is intended for 24 hour multi-patient use and should be discarded daily. No portion of the device comes 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)
The subject Endo SmartCap is equivalent to the predicate Endo SmartCap, aside from the modifications subject of this submission. The flowrate testing and backflow prevention testing were conducted using the same methodology as that indicated in the predicate 510(k), K093665, to confirm the safety and effectiveness of the subject device has not been compromised with the device modification.
The following testing has been conducted to demonstrate that the use of a Endo SmartCap is safe and effective for its intended use:
Test: Confirmation of flow rate; Acceptance Criteria: The average mean flow of the 100551-production sample must be no lower than 10% of the flow of the same tubeset without a filter; Result: PASS
Test: Prevention of backflow; Acceptance Criteria: The 100551 shall not allow water to backflow into the CO2EFFICIENT insufflator; Result: PASS
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.
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.
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March 1, 2023
Medivators, Inc. Disha Kabrawala Senior Regulatory Affairs Specialist 14605 28th Ave North Minneapolis, MN 55447
Re: K223040
Trade/Device Name: Endo SmartCapTM Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: January 26, 2023 Received: January 30, 2023
Dear Disha Kabrawala:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223040
Device Name Endo SmartCap™
Indications for Use (Describe)
The Endo SmartCap™ 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) — K2203040 Summary For Endo SmartCap™
Medivators Inc 14605 28th Ave N, Minneapolis, MN 55447 Fax No: 844-348-5637
| Contact Person: | Disha Kabrawala
Senior Regulatory Affairs Specialist
Phone: 732-319-7766
Email: Disha.Kabrawala@cantel.com |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Summary Date: | October 19, 2022 |
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1. Device Name
| Trade Name: | Endo SmartCap™ |
|---|---|
| 510(K) | K2203040 |
| Device Class: | II |
| Common/usual Name: | Sterile Water Bottle Adapter |
| Classification Name: | Endoscopes and Accessories |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | FAJ |
2. Predicate Devices
K093665: ENDO SMARTCAP
3. Description of Devices
The Endo SmartCap™ supplies sterile water and either air or CO2 to an endoscope during endoscopic procedures when connected to a sterile water source and an air or CO2 source. Two tubes are arranged coaxially; air or CO2 supplied through the outer tube pressurizes the sterile water container, forcing water up through the inner tube and to the endoscope. The proximal end of the tube set includes a bottle cap for attachment to a user-provided sterile water container; the Endo SmartCap™ is compatible with all major brands of sterile water containers. The proximal end of the tube set terminates in a tube weight which keeps the tip of the tubing submerged. A pinch clip prevents water from dripping from the tube's distal end when the device is detached from the endoscope. The distal end of the tube set terminates in a connector which mates with the corresponding brand of endoscope; Endo SmartCap™ models are available for all major brands of endoscopes. The device is provided sterile (EtO). The device is fabricated from metals, plastics, and elastomers. The Endo SmartCap™ is intended for 24 hour multi-patient use and should be discarded daily. No portion of the device comes in direct contact with patients.
5
4. Intended Use / Indications for Use
The Endo SmartCap™ 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.
5. Comparison of Technological Characteristics with the Predicate Device
The Endo SmartCap™ is the same as the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices is included in Table 1. Since there are no technological differences between the proposed and predicate devices, there are no new concerns of safety and effectiveness.
Table 1.: Physical Description and Technological Properties vs the Predicate Device
| Feature | Proposed
Endo SmartCap | Predicate (K093665)
Endo SmartCap | Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications
for Use | The Endo SmartCap™ 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. | The Endo SmartCap™ 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. | Identical |
| Feature | Proposed Endo SmartCap | Predicate (K093665) Endo SmartCap | Comparison |
| Device Use/Principle of operation | The Endo SmartCap tubesets' mode of operation is the same as the device provided by the endoscope manufacturer when installed to commonly used sterile water bottles used in endoscopic procedures. The threaded cap is installed onto commonly used, readily available sterile water bottles and uses a coaxial tube to partition water and air/CO2 which is connected to the endoscope-interfacing connector. Pressurized air or CO2 provided by the endoscope's processor/light source or a CO2 insufflator is fed into the endoscope (either directly or first through the Endo SmartCap & bottle system via luer connection). | The Endo SmartCap tubesets' mode of operation is the same as the device provided by the endoscope manufacturer when installed to commonly used sterile water bottles used in endoscopic procedures. The threaded cap is installed onto commonly used, readily available sterile water bottles and uses a coaxial tube to partition water and air/CO2 which is connected to the endoscope-interfacing connector. Pressurized air or CO2 provided by the endoscope's processor/light source or a CO2 insufflator is fed into the endoscope (either directly or first through the Endo SmartCap & bottle system via luer connection). | Identical |
| Intended Use | Daily (24hr) multi-patient use | Daily (24hr) multi-patient use | Identical |
| Reprocessing | None; Daily disposal | None; Daily disposal | Identical |
| Patient Contact | No direct contact | No direct contact | Identical |
| Water Bottles | Supplied by user; Disposed of daily | Supplied by user; Disposed of daily | Identical |
| Materials | Metals, plastics, and elastomers | Metals, plastics, and elastomers | Identical |
| Water Flow Rate Performance | Meet or exceed the endoscope manufacturer's requirements in the average of total volume of water flowed through the endoscopes | Meet or exceed the endoscope manufacturer's requirements in the average of total volume of water flowed through the endoscopes | Identical |
| Gas Flow Rate performance | Meet or exceed the endoscope manufacturer's requirements in the average of total volume of gas flowed through the endoscopes | Meet or exceed the endoscope manufacturer's requirements in the average of total volume of gas flowed through the endoscopes | Identical |
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Cantel Medical Special 510(k) PREMARKET NOTIFICATION Modification to Endo SmartCapTM
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6. Summary of Changes
The changes that are the subject of this submission are as follows:
- The use of Endo SmartCap source tubing, PN 100551 with the ● CO2Compact (K111648) and Co2Co-efficient (K053008) insufflators. There is no impact on device design. The change has been initiated to accommodate with customer need.
- The use of the Endo SmartCap CO2 source tubing, PN 100551 with Endo SmartCap- CO2 extension tubing as tubing kits. The change has been initiated to accommodate with customer preferences. There is no impact to the device design, safety and efficacy.
7. Summary of the Performance Data
The subject Endo SmartCap is equivalent to the predicate Endo SmartCap, aside from the modifications subject of this submission.
The flowrate testing and backflow prevention testing were conducted using the same methodology as that indicated in the predicate 510(k), K093665, to confirm the safety and effectiveness of the subject device has not been compromised with the device modification.
The following testing has been conducted to demonstrate that the use of a Endo SmartCap is safe and effective for its intended use:
| Test | Acceptance Criteria | Result |
|---|---|---|
| Confirmation of flow rate | The average mean flow of the 100551- | |
| production sample must be no lower than | ||
| 10% of the flow of the same tubeset | ||
| without a filter | PASS | |
| Prevention of backflow | The 100551 shall not allow water to | |
| backflow into the CO2EFFICIENT | ||
| insufflator | PASS |
7. Conclusion
Based on the intended use, technological characteristics and for the non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K093665), Class II (21 CFR 876.1500), product code FAJ.