(221 days)
Not Found
No
The 510(k) summary describes a simple mechanical system for delivering water and gas to an endoscope. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No
The device is described as an accessory for an endoscope, facilitating lens wash and insufflation functions, not providing direct therapeutic intervention itself.
No
The device is a non-patient contacting accessory for endoscopes that facilitates sterile water for lens wash and air/CO2 for luminal insufflation functions. It does not provide any diagnostic information.
No
The device description clearly outlines physical components such as a bottle, cap, lines, and connectors, indicating it is a hardware device, not software only.
Based on the provided text, the Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate the delivery of sterile water, air, and CO2 for lens wash and luminal insufflation functions during an endoscopic procedure. This is a direct interaction with the patient's body (via the endoscope) for a procedural purpose, not for testing samples in vitro (outside the body).
- Device Description: The description clearly states that the device is used with endoscopes and has a "non-patient contacting portion" (the bottle assembly) and a "patient contacting portion" (within the endoscope). IVD devices typically interact with biological samples (blood, urine, tissue, etc.) outside the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or assays.
- Measuring biomarkers or other biological indicators.
The Saneso Lens Wash Bottle Assembly is a component of an endoscopic system, which is a medical device used for visualization and procedures within the body. It facilitates the operation of the endoscope itself, rather than performing a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is intended to be used with FDA-cleared Saneso endoscopes.
It facilitates the following:
-
Sterile water for lens wash function
-
Air / CO2 for luminal insufflation function
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The Saneso Lens Wash Bottle Assembly is intended to be used with Saneso endoscopes.
It facilitates the following:
- Sterile water for lens wash function
- Air / CO2 for luminal insufflation function
Saneso lens wash & insufflation system is divided into proximal and distal sections:
Proximal Section: It comprises the Lens Wash Bottle Assembly and terminates at its connection with the air/water port on the endoscope. It consists of the lens wash bottle, lens wash bottle cap, airline, water line, CO2 line, and air/water connector. This section is the non-patient contacting portion of the system and is covered in this submission.
Distal Section: It starts at the air/water port and terminates at the air/water nozzles on the distal end of the endoscope. It consists of the air/water valve, air/water valve, air/water channel, and the lens wash nozzles, which are all located in the endoscope. This section is the patient contacting portion of the system and is part of the Saneso endoscopes, which is FDA 510k approved (K210052).
The Saneso Lens Wash Bottle Assembly consists of a reusable lens wash water bottle (cylindrical bottle), cap, tubing set and air/water connector.
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)
Performance testing was performed as per the relevant standards and test procedures listed in the Declaration of Conformity.
-
Manual Cleaning Validation
Cleaning validation was performed using Saneso's recommended cleaning procedure. Saneso Lens Wash Bottle Assembly met all the acceptance criteria and demonstrated that the cleaning process does not impact the functionality of the device. -
Steam Sterilization Validation
Sterilization was performed and Saneso Lens Wash Bottle Assembly met all the acceptance criteria. The device is found to be safe and effective.
No animal studies have been conducted for the Subject Device.
No clinical studies have been conducted for the Subject Device.
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.
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February 27, 2023
Saneso, Inc. % Parul Chansoria Founder and CEO Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan, WY 82801
K222173 Re:
Trade/Device Name: Saneso Lens Wash Bottle Assembly (SAN-LWB-A) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: January 24, 2023 Received: January 24, 2023
Dear Parul Chansoria:
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
1
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 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-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advicecomprehensive-regulatory-assistance/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).
Sincerelv.
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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) K222173
Device Name
Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
Indications for Use (Describe) The Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is intended to be used with FDA-cleared Saneso endoscopes.
It facilitates the following:
-
Sterile water for lens wash function
-
Air / CO2 for luminal insufflation function
| 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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Image /page/3/Picture/1 description: The image shows the logo for Saneso. The word "Saneso" is written in large, red, bold letters. Below the word "Saneso" is the phrase "Endoscopy Reinvented" in smaller, gray letters.
This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92.
5.1. Submitter
Saneso, Inc. One Oxford Center, 301 Grant Street Suite 4300 Pittsburgh, PA 15219
Contact Person:
Parul Chansoria, MS, RAC, CQA CEO & Founder, Elexes Medical Consulting Telephone: +408-475-8091 Email: parul@elexes.com Summary prepared: 07/15/2022
5.2. Device Information
Common/Usual Name: Endoscope, Water Bottle with cap and tubing Trade Name: Saneso Lens Wash Bottle Assembly (SAN-LWB-A) Regulation Name: Endoscope and accessories Regulatory Class: Class II Classification Panel: Gastroenterology/Urology Product Code: OCX Regulation Number: 21 CFR Part 876.1500
5.3. Predicate Device Information
Saneso Lens Wash Bottle Assembly is substantially equivalent to the following cleared device:
| Company | Predicate Device
Priority | Product | 510(k) Number |
|-------------|------------------------------|-------------------|---------------|
| Saneso Inc. | Primary | Saneso - A series | K210052 |
5.4. Device Description
The Saneso Lens Wash Bottle Assembly is intended to be used with Saneso endoscopes.
It facilitates the following:
- Sterile water for lens wash function 1.
-
- Air / CO2 for luminal insufflation function
Saneso lens wash & insufflation system is divided into proximal and distal sections:
Proximal Section: It comprises the Lens Wash Bottle Assembly and terminates at its
4
Image /page/4/Picture/1 description: The image shows the logo for Saneso. The word "Saneso" is written in red, with a trademark symbol in the upper right corner. Below the word "Saneso" is the phrase "Endoscopy Reinvented" in a smaller, gray font, also with a trademark symbol.
connection with the air/water port on the endoscope. It consists of the lens wash bottle, lens wash bottle cap, airline, water line, CO2 line, and air/water connector. This section is the non-patient contacting portion of the system and is covered in this submission.
Distal Section: It starts at the air/water port and terminates at the air/water nozzles on the distal end of the endoscope. It consists of the air/water valve, air/water valve, air/water channel, and the lens wash nozzles, which are all located in the endoscope. This section is the patient contacting portion of the system and is part of the Saneso endoscopes, which is FDA 510k approved (K210052).
ર.ડ. Intended Use
5.5.1. Subject Device
The Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is intended to be used with FDA-cleared Saneso endoscopes.
It facilitates the following:
- Sterile water for lens wash function ●
- Air / CO2 for luminal insufflation function ●
5.5.2. Primary Predicate Device
Saneso Colonoscope 360-A
The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon, and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access to therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Processor- A, and other ancillary equipment.
Saneso Gastroscope 360-A
The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A, Processor-A and other ancillary equipment.
Saneso Single Camera Colonoscope-A
The Saneso Single Camera Colonoscope is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Single Camera Colonoscope, Processor-A and other ancillary equipment.
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Image /page/5/Picture/0 description: The image shows the logo for Saneso Endoscopy Reinvented. The word "Saneso" is in large, bold, red letters. Below it, in smaller, gray letters, is the phrase "Endoscopy Reinvented."
Saneso Gastroscope 360- A
The Saneso Single Camera Gastroscope is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach, and duodenum). The system also provides access to therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Single Camera Gastroscope, Processor-A, and other ancillary equipment.
Note: The scope of the submission is not the endoscope (Colonoscope and the gastroscope) but the Lens wash bottle alone. Lens wash bottle is intended to be used only as an accessory to the endoscope system (SAN-A series) which was originally cleared by the FDA with K number K210052. There is no modification in the system, but there is a modification in the accessory where it is changing from single-use to multi-use, and it is supported by the reprocessing validation results.
5.6. Technological Characteristics
| Table 1: Substantial Equivalence Table for Saneso Lens Wash Bottle Assembly | |||
|---|---|---|---|
| Parameter | Subject Device | Primary Predicate | |
| Device | Equivalence | ||
| 510(k) Number | - | K210052 | NA |
| Product code | OCX | FDS, FDF | Equivalent |
| Regulation No. | 21 CFR Part 876.1500 | 21 CFR Part 876.1500 | Equivalent |
| Classification: | Class II | Class II | Equivalent |
| Regulation | |||
| Name | Endoscope and | ||
| Accessories | Endoscope and | ||
| Accessories | Equivalent | ||
| Prescription | |||
| Use/OTC | Prescription Use | Prescription Use | Equivalent |
| Intended Use | The Saneso Lens Wash | ||
| Bottle Assembly is | |||
| intended to be used | |||
| with the FDA cleared | |||
| Saneso endoscopes. It | |||
| facilitates the | |||
| following: | |||
| a. Sterile water for | |||
| lens wash function | |||
| b. Air / CO2 for | Saneso | ||
| Colonoscope | |||
| 360-A | |||
| The Saneso | |||
| Colonoscope 360-A is | |||
| intended for diagnostic | |||
| visualization of the | |||
| lower gastrointestinal | |||
| tract (including the | |||
| rectum, colon, and | |||
| cecum) and Saneso | Equivalent | ||
| Note: The scope of | |||
| the submission is not | |||
| the endoscope | |||
| (Colonoscope and the | |||
| gastroscope) but the | |||
| Lens wash bottle | |||
| alone. | |||
| luminal insufflation | |||
| function | Colonoscope 360-A is | ||
| not indicated for | |||
| ileoscopy procedures. | |||
| The system also | |||
| provides access for | |||
| therapeutic interventions | |||
| using standard | |||
| endoscopy tools. The | |||
| Saneso system consists | |||
| of Saneso Colonoscope | |||
| 360-A, Processor- A and | |||
| other ancillary | |||
| equipment. |
Saneso Gastroscope
360-A
The Saneso Gastroscope
360-A is intended for
diagnostic visualization
of the upper
gastrointestinal tract
(including the
esophagus, stomach and
duodenum). The system
also provides access for
therapeutic interventions
using standard
endoscopy tools. The
Saneso system consists
of Saneso Gastroscope
360-A, Processor-A and
other ancillary
equipment. | Lens wash bottle is
intended to be used
only as an accessory
to the endoscope
system (SAN-A
series) which was
originally cleared by
the FDA with K
number K210052.
There is no
modification in the
system, but there is a
modification in the
accessory where it is
changing from
single-use to
multi-use, and it is
supported by the
reprocessing
validation results. |
| | | Saneso Single Camera
Colonoscope-A
The Saneso Single
Camera Colonoscope is
intended for diagnostic
visualization of the
lower gastrointestinal
tract (including the
rectum, colon and
ileocecal valve). The
system also provides | |
| | | access for therapeutic
interventions using
standard endoscopy
tools. The Saneso
system consists of
Saneso Single Camera
Colonoscope,
Processor-A and other
ancillary equipment. | |
| | | Saneso Gastroscope
360-A | |
| | | The Saneso Single
Camera Gastroscope is
intended for diagnostic
visualization of the
upper gastrointestinal
tract (including the
esophagus, stomach and
duodenum). The system
also provides access for
therapeutic interventions
using standard
endoscopy tools. The
Saneso system consists
of Saneso Single
Camera Gastroscope,
Processor-A and other
ancillary equipment. | |
| Construction/Co
mponents | The Saneso Lens Wash
Bottle Assembly
consists of a reusable
lens wash water bottle
(cylindrical bottle), cap,
tubing set and air/water
connector. | The Saneso Lens Wash
Bottle consists of a
single-use lens wash
water bottle (cylindrical
bottle), cap, tubing set
and air/water connector. | Equivalent |
| Sterile/Non
Sterile | Sold Non - Sterile | Sold Non - Sterile | Equivalent |
| Accessories | Cap CO2 outlet Water line Cap water outlet | Cap CO2 outlet Water line Cap water outlet CO2 line | Equivalent |
| | CO2 line Air Line CO2 clamp Cap Air inlet | Air Line CO2 clamp Cap Air inlet | |
| Usage | Reusable | Single Use | Different |
| Method of
Application | Manual | Manual | Equivalent |
| Compatible
Endoscopes/proce
ssors | Saneso - A series
(K210052), Saneso
Processor - A | Saneso - A series
(K210052), Saneso
Processor - A | Equivalent |
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Image /page/6/Picture/1 description: The image contains the logo for Saneso. The word "Saneso" is in red, and the words "Endoscopy Reinvented" are in gray below it. The logo is simple and modern.
7
Image /page/7/Picture/1 description: The image shows the logo for Saneso. The word "Saneso" is in large, red, bold letters. Below that, in smaller gray letters, is the phrase "Endoscopy Reinvented" with a trademark symbol.
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Image /page/8/Picture/1 description: The image shows the logo for Saneso. The word "Saneso" is written in large, red, bold letters. Below the word "Saneso" is the phrase "Endoscopy Reinvented" written in smaller, gray letters. The logo is simple and modern.
5.6.1. Similarities
The Saneso Lens Wash Bottle Assembly SAN-LWB-A is similar to the Lens Wash Bottle which is cleared under K210052 in terms of intended use, construction/components, method of application.
5.6.2. Differences
The difference between the Saneso Lens Wash Bottle Assembly SAN-LWB-A and the Lens Wash Bottle which is cleared under K210052 is its usage, ie; from single use to multi-use. However, this difference does not raise new questions of safety or efficacy. Differences were justified using Non-Clinical performance testing - Manual Cleaning Validation and Steam Sterilization Validation and demonstrates that the Lens wash bottle Assembly is safe and effective.
5.7. Summary of Non-Clinical Tests
Performance testing was performed as per the relevant standards and test procedures listed in the Declaration of Conformity.
-
- Manual Cleaning Validation Cleaning validation was performed using Saneso's recommended cleaning procedure. Saneso Lens Wash Bottle Assembly met all the acceptance criteria and demonstrated that the cleaning process does not impact the functionality of the device.
-
- Steam Sterilization Validation Sterilization was performed and Saneso Lens Wash Bottle Assembly met all the acceptance criteria. The device is found to be safe and effective.
Summary of Clinical Tests 5.8.
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Image /page/9/Picture/0 description: The image contains the logo for Saneso Endoscopy Reinvented. The word "Saneso" is in red, and the words "Endoscopy Reinvented" are in gray. The logo is simple and modern, and it is likely used to promote a medical device or service.
5.8.1. Animal Study
No animal studies have been conducted for the Subject Device.
5.8.2. Clinical Study
No clinical studies have been conducted for the Subject Device.
5.9. Conclusion
Saneso Lens Wash Bottle Assembly SAN-LWB-A is substantially equivalent to the Lens Wash Bottle which is cleared under K210052 in terms of intended use and technological characteristics. Differences were justified using Non-Clinical performance testing. Thus, Saneso Inc. has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent.