K242668 · Gastro Concepts, LLC · FER · Dec 13, 2024 · Gastroenterology, Urology
Device Facts
Record ID
K242668
Device Name
Gastro Concepts Air Assist
Applicant
Gastro Concepts, LLC
Product Code
FER · Gastroenterology, Urology
Decision Date
Dec 13, 2024
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
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.
Device Story
Single-use device; cylindrical body with conical tip and open channel for endoscope insertion. Positioned against anus (not inserted into rectum) to form temporary seal; maintains air/CO2 insufflation during colonoscopy. Used by physicians in clinical settings to improve visualization by impeding pressure loss. Benefits patient by ensuring adequate colonic distension for therapy. No electronic components or software.
Clinical Evidence
No clinical data. Bench testing only: dimensional testing, simulated use, mechanical properties (compression/tension strength), and leak rate/sealing capability. Testing confirmed device withstands clinically relevant forces and reduces air loss during simulated insufflation. Biocompatibility verified per ISO 10993-1.
Technological Characteristics
Material: Silicone rubber. Form factor: Cylindrical body with conical tip, open channel for endoscope (11.5-13mm compatibility). Principle: Physical barrier to impede pressure loss. Non-sterile. No energy source. No software.
Indications for Use
Indicated for patients undergoing colonoscopy; facilitates endoscopic therapy by maintaining colonic distension and field of view via manual control of insufflation.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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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.
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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
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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
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### Indications for Use
Submission Number (if known)
K242668
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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# 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:<br>Phone:<br>Email: | Rick Brown, President<br>(787) 642-2532<br>rick.brown@gastroconcepts.com |
| Submission<br>Correspondent: | Sarah Moss, Regulatory Affairs Consultant |
| Address:<br>Phone:<br>Email: | 1321 Upland Dr. Suite 6792, Houston, TX 77043<br>(281) 795-1812<br>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.
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| | Gastro Concepts<br>Air Assist | GelPOINT Path Transanal<br>Access Platform<br>(Predicate Device) | Embrella™ Endoscopic<br>Distal Attachment | Comparison Result |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Specification | | | | |
| 510(k) Number | | K110792 | K190030 | Similar |
| Device<br>Description | The Gastro Concepts Air<br>Assist Device is a single-use<br>device that is used to aid in<br>maintaining air/CO2 and<br>insufflation during a<br>colonoscopy. The Air<br>Assist, a single-use device,<br>comprises a cylindrical<br>body with a conical-shaped<br>tip and an open channel<br>for endoscope insertion.<br>Positioned against the anus<br>(not inserted into the<br>rectum), it forms a<br>temporary seal,<br>maintaining air/CO2<br>insufflation leading to<br>adequate colonic<br>distension for enhanced<br>visualization. | The GeIPOINT Path is a<br>sterile, single use,<br>disposable surgical<br>instrument designed to<br>provide multiple<br>instrument or camera<br>access into the rectal<br>cavity and lower<br>sigmoid colon. The<br>device is used in concert<br>with standard<br>laparoscopic<br>instruments. | The proposed device<br>Embrella™ Endoscopic<br>Distal Attachment is an<br>additional<br>device, made of medical<br>grade silicone rubber<br>designed to attach to the<br>distal end of the<br>endoscope. Its shape is<br>umbrella shaped, with six<br>flexible wings that<br>easily to fold backwards<br>and forwards. It can be<br>used to facilitate<br>endoscopic<br>therapy and maintain an<br>appropriate endoscopic<br>field of view. Embrella™<br>Endoscopic Distal<br>Attachment has two<br>models, one is EM-S-01,<br>which is compatible with<br>endoscopy distal diameter<br>12.8-14.5mm; the other is<br>EM-S-02, which is<br>compatible with endoscopy<br>distal diameter 11.5-<br>13.0mm. | |
| Indication for<br>Use | Air Assist is intended<br>to slide over the outer<br>surface of an<br>endoscope to facilitate<br>endoscopic therapy by<br>providing a manual,<br>reversible method to<br>control the insufflation<br>(air/CO2) so the<br>physician can better<br>maintain an<br>appropriate field of<br>view. | The GeIPOINT Path is a<br>sterile, single use,<br>disposable surgical<br>instrument designed to<br>provide multiple<br>instrument or camera<br>access into the rectal<br>cavity and lower<br>sigmoid colon. | Embrella™ Endoscopic<br>Distal Attachment is<br>intended to be attached<br>to the distal end of the<br>endoscope to facilitate<br>endoscopic therapy and<br>maintain an appropriate<br>endoscopic field of view. | Similar/In-Scope for<br>Product Code |
| Product<br>Code | FER | FER | FED | Same as predicate |
| | | | | K242668<br>Page 3 of 4 |
| Specification | Gastro Concepts<br>Air Assist | GelPOINT Path Transanal<br>Access Platform<br>(Predicate Device) | Embrella™ Endoscopic<br>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<br>Compatibility<br>(diameter) | 11.5-13mm | Not published | 11.5-14.5mm | Similar |
| Device<br>Functionality | Provides improved<br>field of view by<br>maintaining proper<br>insufflation | Provides improved<br>field of view by<br>maintaining proper<br>insufflation. | Provides improved field of<br>view by prohibiting the<br>surrounding tissues from<br>block the distal end of the<br>scope | Equivalent |
| Mechanism<br>of Action | The device uses a<br>physical barrier to<br>impede pressure loss.<br>This allows the colon<br>to be insufflated, thus<br>enlarging the<br>operative space. | The device uses a<br>physical barrier to<br>impede pressure loss.<br>This allows the colon<br>to be insufflated, thus<br>enlarging the<br>operative space. | Flexible wings that<br>easily fold backwards and<br>forwards. It can be used to<br>facilitate endoscopic therapy<br>and maintain an appropriate<br>endoscopic field of view. | Equivalent |
| Device<br>Placement | Device is placed<br>immediately adjacent<br>to the anus | Device is inserted into<br>the anus | Device is attached to the<br>distal end of the scope and<br>inserted into the body cavity. | Not equivalent<br>(Air assist is less invasive) |
| Supplied<br>Sterile/Non-<br>Sterile | Non-sterile | Sterile | Sterile | Not equivalent<br>(Air assist is not inserted<br>into the body) |
| Materials | Silicone Rubber | Gel material | Silicone Rubber | Similar to predicate<br>Equivalent to reference |
| Biocompatibil<br>ity: ISO<br>10993-1 | Yes | Yes | Yes | Equivalent |
| Shelf Life | 6 months | One Year | One Year | Similar |
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K242668
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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.
