(99 days)
No
The device description and performance studies focus on mechanical function and sealing capabilities, with no mention of AI/ML terms or image processing.
No.
The device facilitates endoscopic therapy by helping to maintain an appropriate field of view for the physician, but it does not directly perform the therapy itself. Its function is to control insufflation for visualization, not to treat a condition or disease.
No
Explanation: The device's intended use is to maintain insufflation for better visualization during endoscopy, which is a therapeutic aid rather than a diagnostic function. It facilitates the physician's view, but does not provide diagnostic information itself.
No
The device description clearly states it is a "single-use device" comprising a "cylindrical body with a conical-shaped tip and an open channel for endoscope insertion," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Air Assist device is a physical accessory used externally to assist with an endoscopic procedure. It helps maintain insufflation during a colonoscopy by creating a seal against the anus. It does not analyze any biological samples or provide diagnostic information based on those samples.
- Intended Use: The intended use is to "facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation... so the physician can better maintain an appropriate field of view." This is a procedural aid, not a diagnostic test.
- Device Description: The description clearly states it's a "single-use device that is used to aid in maintaining air/CO2 and insufflation during a colonoscopy." It's a physical tool for a medical procedure.
The device's function and intended use are entirely focused on assisting with a medical procedure (colonoscopy) by managing insufflation, not on performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Air Assist is intended to slide over the outer surface of an endoscope to facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation (air/CO2) so the physician can better maintain an appropriate field of view.
Product codes (comma separated list FDA assigned to the subject device)
FER, FED
Device Description
The Gastro Concepts Air Assist Device is a single-use device that is used to aid in maintaining air/CO2 and insufflation during a colonoscopy. The Air Assist, a single-use device, comprises a cylindrical body with a conical-shaped tip and an open channel for endoscope insertion. Positioned against the anus (not inserted into the rectum), it forms a temporary seal, maintaining air/CO2 insufflation leading to adequate colonic distension for enhanced visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anus, Rectum, Lower sigmoid colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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 following bench tests were performed on the Gastro Concepts Air Assist Device:
- Dimensional Testing
- Simulated Use
- Mechanical Properties: Structural integrity, compression and tension strength
- Leak Rate and Sealing Capability
Testing was conducted to establish that the Gastro Concepts Air Assist device can withstand clinically relevant mechanical forces. Leak testing was also completed to demonstrate a reduction in air loss during insufflation. The bench testing proved that the Air Assist device was able to withstand forces greater than expected during clinical use and that the device was successful in reducing the leak rate during simulated colonic insufflation.
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 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
December 13, 2024
Gastro Concepts, LLC % Sarah Moss Regulatory Consultant Prime Path Medtech 1321 Upland Dr. #6792 Houston, Texas 77043
Re: K242668
Trade/Device Name: Gastro Concepts Air Assist Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FER, FED Dated: November 13, 2024 Received: November 13, 2024
Dear Sarah Moss:
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 (the 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 available 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.
1
Page
2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
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).
Sincerely,
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
3
Indications for Use
Submission Number (if known)
Device Name
Gastro Concepts Air Assist
Indications for Use (Describe)
Air Assist is intended to slide over the outer surface of an endoscope to facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation (air/CO2) so the physician can better maintain an appropriate field of view.
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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4
510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Gastro Concepts |
|---|---|
| Company Contact Person: | |
| Phone: | |
| Email: | Rick Brown, President |
| (787) 642-2532 | |
| rick.brown@gastroconcepts.com | |
| Submission | |
| Correspondent: | Sarah Moss, Regulatory Affairs Consultant |
| Address: | |
| Phone: | |
| Email: | 1321 Upland Dr. Suite 6792, Houston, TX 77043 |
| (281) 795-1812 | |
| smoss@primepathmedtech.com | |
| Date Prepared: | Sept 2024 |
| Proprietary Name: | Gastro Concepts Air Assist |
| Common Name: | Anoscope and accessories |
| Product Code/CFR: | FER, FED; 876.1500 Endoscope and accessories |
| Device Classification: | Class II |
| Predicate Device: | GelPOINT Path Transanal Access Platform (K110792) |
Device Description:
The Gastro Concepts Air Assist Device is a single-use device that is used to aid in maintaining air/CO2 and insufflation during a colonoscopy. The Air Assist, a single-use device, comprises a cylindrical body with a conical-shaped tip and an open channel for endoscope insertion. Positioned against the anus (not inserted into the rectum), it forms a temporary seal, maintaining air/CO2 insufflation leading to adequate colonic distension for enhanced visualization.
Indications for Use:
Air Assist is intended to slide over the outer surface of an endoscope to facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation (air/CO2) so the physician can better maintain an appropriate field of view.
5
| | Gastro Concepts
Air Assist | GelPOINT Path Transanal
Access Platform
(Predicate Device) | Embrella™ Endoscopic
Distal Attachment | Comparison Result |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Specification | | | | |
| 510(k) Number | | K110792 | K190030 | Similar |
| Device
Description | The Gastro Concepts Air
Assist Device is a single-use
device that is used to aid in
maintaining air/CO2 and
insufflation during a
colonoscopy. The Air
Assist, a single-use device,
comprises a cylindrical
body with a conical-shaped
tip and an open channel
for endoscope insertion.
Positioned against the anus
(not inserted into the
rectum), it forms a
temporary seal,
maintaining air/CO2
insufflation leading to
adequate colonic
distension for enhanced
visualization. | The GeIPOINT Path is a
sterile, single use,
disposable surgical
instrument designed to
provide multiple
instrument or camera
access into the rectal
cavity and lower
sigmoid colon. The
device is used in concert
with standard
laparoscopic
instruments. | The proposed device
Embrella™ Endoscopic
Distal Attachment is an
additional
device, made of medical
grade silicone rubber
designed to attach to the
distal end of the
endoscope. Its shape is
umbrella shaped, with six
flexible wings that
easily to fold backwards
and forwards. It can be
used to facilitate
endoscopic
therapy and maintain an
appropriate endoscopic
field of view. Embrella™
Endoscopic Distal
Attachment has two
models, one is EM-S-01,
which is compatible with
endoscopy distal diameter
12.8-14.5mm; the other is
EM-S-02, which is
compatible with endoscopy
distal diameter 11.5-
13.0mm. | |
| Indication for
Use | Air Assist is intended
to slide over the outer
surface of an
endoscope to facilitate
endoscopic therapy by
providing a manual,
reversible method to
control the insufflation
(air/CO2) so the
physician can better
maintain an
appropriate field of
view. | The GeIPOINT Path is a
sterile, single use,
disposable surgical
instrument designed to
provide multiple
instrument or camera
access into the rectal
cavity and lower
sigmoid colon. | Embrella™ Endoscopic
Distal Attachment is
intended to be attached
to the distal end of the
endoscope to facilitate
endoscopic therapy and
maintain an appropriate
endoscopic field of view. | Similar/In-Scope for
Product Code |
| Product
Code | FER | FER | FED | Same as predicate |
| | | | | K242668
Page 3 of 4 |
| Specification | Gastro Concepts
Air Assist | GelPOINT Path Transanal
Access Platform
(Predicate Device) | Embrella™ Endoscopic
Distal Attachment | Comparison Result |
| Regulations | 21CFR 876.1500 | 21CFR 876.1500 | 21CFR 876.1500 | Equivalent |
| Class | 2 | 2 | 2 | Equivalent |
| Single Use | Yes | Yes | Yes | Equivalent |
| Scope
Compatibility
(diameter) | 11.5-13mm | Not published | 11.5-14.5mm | Similar |
| Device
Functionality | Provides improved
field of view by
maintaining proper
insufflation | Provides improved
field of view by
maintaining proper
insufflation. | Provides improved field of
view by prohibiting the
surrounding tissues from
block the distal end of the
scope | Equivalent |
| Mechanism
of Action | The device uses a
physical barrier to
impede pressure loss.
This allows the colon
to be insufflated, thus
enlarging the
operative space. | The device uses a
physical barrier to
impede pressure loss.
This allows the colon
to be insufflated, thus
enlarging the
operative space. | Flexible wings that
easily fold backwards and
forwards. It can be used to
facilitate endoscopic therapy
and maintain an appropriate
endoscopic field of view. | Equivalent |
| Device
Placement | Device is placed
immediately adjacent
to the anus | Device is inserted into
the anus | Device is attached to the
distal end of the scope and
inserted into the body cavity. | Not equivalent
(Air assist is less invasive) |
| Supplied
Sterile/Non-
Sterile | Non-sterile | Sterile | Sterile | Not equivalent
(Air assist is not inserted
into the body) |
| Materials | Silicone Rubber | Gel material | Silicone Rubber | Similar to predicate
Equivalent to reference |
| Biocompatibil
ity: ISO
10993-1 | Yes | Yes | Yes | Equivalent |
| Shelf Life | 6 months | One Year | One Year | Similar |
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Performance Testing (Bench)
The following bench tests were performed on the Gastro Concepts Air Assist Device:
- Dimensional Testing
- Simulated Use
- Mechanical Properties: Structural integrity, compression and tension strength
- Leak Rate and Sealing Capability
Testing was conducted to establish that the Gastro Concepts Air Assist device can withstand clinically relevant mechanical forces. Leak testing was also completed to demonstrate a reduction in air loss during insufflation. The bench testing proved that the Air Assist device was able to withstand forces greater than expected during clinical use and that the device was successful in reducing the leak rate during simulated colonic insufflation.
The Air Assist device meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process."
Therefore, the performance of the Air Assist device was shown to be at least equivalent to the predicate device and did not raise any new safety or effectiveness questions.
Clinical Testing
No Clinical Testing was required for this product.
Statement of Equivalence
Based on comparison of indications for user population, performance testing, mechanical and technological features, the Air Assist device has been shown to be substantially equivalent to the legally marketed predicate device does not raise any new safety or effectiveness questions as compared to the predicate device.