(97 days)
Not Found
No
The description focuses on mechanical valves for controlling air, water, and suction during endoscopy, with no mention of AI or ML capabilities.
No
The device primarily controls the functions of an endoscope (air/water and suction) to assist with imaging and visibility during GI procedures, rather than directly treating a disease or condition.
No
The SmartStart™ air/water and suction valves are intended to control the air/water and suction functions on an endoscope during a GI endoscopic procedure. Their purpose is to facilitate the procedure itself by controlling fluid and air, not to diagnose a condition.
No
The device description clearly states it is a physical valve intended to be attached to an endoscope, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control air, water, and suction functions on an endoscope during a GI endoscopic procedure. This is a direct intervention/control during a medical procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the mechanical function of the valves in controlling air, water, and suction flow. It doesn't mention any analysis of biological samples or substances.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a patient's health status
- Using reagents or calibrators
The device is a medical device used during a procedure to facilitate visualization and manipulation within the body, not to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Product codes (comma separated list FDA assigned to the subject device)
ODC
Device Description
The device is intended for single-use, and is supplied sterile, single-use air/water and suction valves help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single patient use item. The air/water valve is designed to be attached to the air/water port of the endoscope and the suction valve to the suction port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
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)
Results from various performance testing indicate that the SmartStart™ Air/Water and Suction Valves function as intended. Performance test results indicate that Air/Water and Suction Valves will perform in accordance with the acceptance criteria for air flow, water flow and leakage.
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 the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Endochoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta, GA 30009
Re: K160403 Trade/Device Name: SmartStart™ Air/Water and Suction Valves Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: ODC Dated: May 4, 2016 Received: Mav 5. 2016
Dear Daniel Hoefer,
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160403
Device Name
SmartStart™ Air/Water and Suction Valves
Indications for Use (Describe)
The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Traditional 510(k) Summary
1. Company Identification
EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Telephone (678) 708 4743 FAX (678) 878 3373 Establishment Registration: 3007591333
2. Contact Person
Daniel Hoefer Regulatory Affairs Manager
3. Device Name
Trade name: SmartStart™ Air/Water and Suction Valves Common/Usual Name: Single Use Air/Water and Suction Valves
4. Device Classification
Regulation Number: 21CFR § 876.1500 Regulation Name: Endoscope and Accessories Classification: 2 Product Code: ODC Committee: Gastroenterology/Urology
5. Indications for Use
The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
6. Device Description
The device is intended for single-use, and is supplied sterile, single-use air/water and suction valves help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single patient use item. The air/water valve is designed to be attached to the air/water port of the endoscope and the suction valve to the suction port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
4
7. Substantial Equivalence
7.1 Predicate devices
The SmartStart™ Air/Water and Suction Valves are equivalent in function, intended use and scientific technology to its predicate devices, the DEFENDO Disposable Air/Water Valve K102409 and DEFENDO Disposable Suction Valve K102581.
7.2 Technical Characteristics
The valves are advanced into the corresponding air/water and suction cylinder until a snap is felt to ensure attachment. Once the air/water and suction valves are installed, air can be introduced through the biopsy channel of the endoscope by covering the air/water button located on the head of the endoscope. Water can be introduced to assist in cleansing the lens by depressing the air/water button located of the endoscope. Suction can be applied to remove debris and fluid by depressing the suction button located on the head of the endoscope.
7.3 Performance Characteristics
The steps for operator use of each of the devices are equivalent to the predicates. The instructions for use describe how to use the device with a standard endoscope.
| Substantial Equivalence Comparison- Suction Valve | |||
|---|---|---|---|
| Device Parameters | EndoChoice Disposable | ||
| Suction Valve | DEFENDO Disposable | ||
| Suction Valve K102581 | Substantial | ||
| Equivalence | |||
| Product Code | ODC | ODC | Identical |
| Regulation No. | 21CFR § 876.1500 | 21CFR § 876.1500 | Identical |
| Classification | 2 | 2 | Identical |
| Manufacturer | EndoChoice, Inc. | Medivators, Inc., a Cantel | |
| Medical Company | NA | ||
| Supplied Sterile | Yes | Yes | Identical |
| Single use | Yes | Yes | Identical |
| Compatibility | Olympus 160/180/190 series | ||
| endoscopes | Olympus and Pentax 90 Series | ||
| GI Endoscopes | Similar | ||
| Indications for use | The SmartStart™ suction | ||
| valve is intended to be used to | |||
| control the suction function on | |||
| an endoscope during a GI | |||
| endoscopic procedure. | The DEFENDO Disposable | ||
| Suction Valve is intended to be | |||
| used to control the suction | |||
| function of an endoscope | |||
| during a GI endoscopic | |||
| procedure. | Identical | ||
| Packaging | Suction and air/water valves | ||
| are housed in a single tray | |||
| and packaged in a sealed | |||
| Tyvek pouch | Suction and air/water valves | ||
| are housed in a single tray and | |||
| packaged in a sealed Tyvek | |||
| pouch | Identical | ||
| Substantial Equivalence Comparison- Air/Water Valve |
7.4 Substantial Equivalence Table
5
| Device Parameters | EndoChoice Disposable
Air/Water Valve | DEFENDO Disposable
Air/Water Valve K102409 | Substantial
Equivalence |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product Code | ODC | ODC | Identical |
| Regulation No. | 21CFR § 876.1500 | 21CFR § 876.1500 | Identical |
| Classification | 2 | 2 | Identical |
| Manufacturer | EndoChoice, Inc. | Medivators, Inc., a Cantel
Medical Company | NA |
| Supplied Sterile | Yes | Yes | Identical |
| Single use | Yes | Yes | Identical |
| Compatibility | Olympus 160/180/190 series
endoscopes | Olympus 140/160/180/240/260
series endoscopes | Similar |
| Indications for use | The SmartStart™ air/water
valve is intended be used to
control the air/water function
on an endoscope during a GI
endoscopic procedure. | The DEFENDO Disposable
Air/Water Valve is intended to
be used to control the air/water
function on an endoscope
during a GI endoscopic
procedure. | Identical |
| Packaging | Suction and air/water valves
are housed in a single tray
and packaged in a sealed
Tyvek pouch | Suction and air/water valves
are housed in a single tray and
packaged in a sealed Tyvek
pouch | Identical |
8. Non-Clinical testing
8.1 Sterilization and Shelf-Life
The SmartStart™ Air/Water and Suction Valves are sterilized by Ethylene Oxide. Validation has been completed in accordance with the following standards:
- . AAMI TIR 16: 2009 Microbiological aspects of ethylene oxide sterilization. 2ed
- ANSI/AAMI/ISO 11135: 2014 Sterilization of Health-Care Products Ethylene Oxide -. Requirements for the Development, Validation and Routine Control of Sterilization Process for Medical Devices, 1ed
- ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health-Care Products Ethylene Oxide Part ● 1: Requirements for development, validation and routine control of a sterilization process for medical devices. 4ed
- ANSI/AAMI/ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene ● oxide sterilization residuals, 3ed
- AAMI TIR 14:2009 Contract sterilization using ethylene oxide, 2ed .
The shelf life of the SmartStart™ Air/Water and Suction Valves is 1 year from the date of manufacture.
8.2 Biocompatibility
Biocompatibility which includes Cytotoxicity, Sensitization testing for this device has been completed and passed all acceptance criteria.
6
8.3 Performance Testing
Results from various performance testing indicate that the SmartStart™ Air/Water and Suction Valves function as intended. Performance test results indicate that Air/Water and Suction Valves will perform in accordance with the acceptance criteria for air flow, water flow and leakage.
9. Conclusion
Based on the above information, the SmartStart™ Air/Water and Suction Valves are substantially equivalent to the predicate devices listed above. The information contained in this submission supports the fact that the SmartStart™ Air/Water and Suction Valves are as safe and effective as the predicate devices.