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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Gastro Concepts Air Assist" device. However, it does not contain the detailed acceptance criteria and study results typically found in a comprehensive study report for a device relying on artificial intelligence or complex statistical analysis.

The document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than detailed performance metrics against specific acceptance criteria for AI-driven insights. It explicitly states, "No Clinical Testing was required for this product."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not present in the provided text.

The available information about "performance testing" is limited to bench tests.

Here's what I can extract regarding the performance testing:

Performance Testing (Bench)

The following bench tests were performed:

Dimensional Testing
Simulated Use
Mechanical Properties: Structural integrity, compression and tension strength
Leak Rate and Sealing Capability

Summary of Study Results:

The bench testing demonstrated that the Air Assist device was able to withstand forces greater than expected during clinical use.
The device was successful in reducing the leak rate during simulated colonic insufflation.
The device meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process."

Key Missing Information (Based on your request categories):

Table of acceptance criteria and reported device performance: Not provided. The text only states that the device "meets the requirements" and "was successful" without quantifiable acceptance criteria or specific performance values.
Sample size used for the test set and data provenance: Not applicable/Not provided, as no clinical or specific dataset testing is detailed beyond general bench tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Not provided. This is not an AI-driven device described in the document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is not an AI-driven device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as the performance evaluation relies on physical properties and simulated use, not diagnostic "ground truth."
The sample size for the training set: Not applicable/Not provided.
How the ground truth for the training set was established: Not applicable/Not provided.

In essence, the provided document describes a medical device where substantial equivalence is demonstrated through engineering bench tests and compliance with recognized standards, not through studies involving AI, human readers, or clinical data with expert-established ground truth.

Summary

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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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Page

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)

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:Phone:Email:	Rick Brown, President(787) 642-2532rick.brown@gastroconcepts.com
SubmissionCorrespondent:	Sarah Moss, Regulatory Affairs Consultant
Address:Phone:Email:	1321 Upland Dr. Suite 6792, Houston, TX 77043(281) 795-1812smoss@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:

Indications for Use:

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	Gastro ConceptsAir Assist	GelPOINT Path TransanalAccess Platform(Predicate Device)	Embrella™ EndoscopicDistal Attachment	Comparison Result
Specification
510(k) Number		K110792	K190030	Similar
DeviceDescription	The Gastro Concepts AirAssist Device is a single-usedevice that is used to aid inmaintaining air/CO2 andinsufflation during acolonoscopy. The AirAssist, a single-use device,comprises a cylindricalbody with a conical-shapedtip and an open channelfor endoscope insertion.Positioned against the anus(not inserted into therectum), it forms atemporary seal,maintaining air/CO2insufflation leading toadequate colonicdistension for enhancedvisualization.	The GeIPOINT Path is asterile, single use,disposable surgicalinstrument designed toprovide multipleinstrument or cameraaccess into the rectalcavity and lowersigmoid colon. Thedevice is used in concertwith standardlaparoscopicinstruments.	The proposed deviceEmbrella™ EndoscopicDistal Attachment is anadditionaldevice, made of medicalgrade silicone rubberdesigned to attach to thedistal end of theendoscope. Its shape isumbrella shaped, with sixflexible wings thateasily to fold backwardsand forwards. It can beused to facilitateendoscopictherapy and maintain anappropriate endoscopicfield of view. Embrella™Endoscopic DistalAttachment has twomodels, one is EM-S-01,which is compatible withendoscopy distal diameter12.8-14.5mm; the other isEM-S-02, which iscompatible with endoscopydistal diameter 11.5-13.0mm.
Indication forUse	Air Assist is intendedto slide over the outersurface of anendoscope to facilitateendoscopic therapy byproviding a manual,reversible method tocontrol the insufflation(air/CO2) so thephysician can bettermaintain anappropriate field ofview.	The GeIPOINT Path is asterile, single use,disposable surgicalinstrument designed toprovide multipleinstrument or cameraaccess into the rectalcavity and lowersigmoid colon.	Embrella™ EndoscopicDistal Attachment isintended to be attachedto the distal end of theendoscope to facilitateendoscopic therapy andmaintain an appropriateendoscopic field of view.	Similar/In-Scope forProduct Code
ProductCode	FER	FER	FED	Same as predicate
				K242668Page 3 of 4
Specification	Gastro ConceptsAir Assist	GelPOINT Path TransanalAccess Platform(Predicate Device)	Embrella™ EndoscopicDistal 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
ScopeCompatibility(diameter)	11.5-13mm	Not published	11.5-14.5mm	Similar
DeviceFunctionality	Provides improvedfield of view bymaintaining properinsufflation	Provides improvedfield of view bymaintaining properinsufflation.	Provides improved field ofview by prohibiting thesurrounding tissues fromblock the distal end of thescope	Equivalent
Mechanismof Action	The device uses aphysical barrier toimpede pressure loss.This allows the colonto be insufflated, thusenlarging theoperative space.	The device uses aphysical barrier toimpede pressure loss.This allows the colonto be insufflated, thusenlarging theoperative space.	Flexible wings thateasily fold backwards andforwards. It can be used tofacilitate endoscopic therapyand maintain an appropriateendoscopic field of view.	Equivalent
DevicePlacement	Device is placedimmediately adjacentto the anus	Device is inserted intothe anus	Device is attached to thedistal end of the scope andinserted into the body cavity.	Not equivalent(Air assist is less invasive)
SuppliedSterile/Non-Sterile	Non-sterile	Sterile	Sterile	Not equivalent(Air assist is not insertedinto the body)
Materials	Silicone Rubber	Gel material	Silicone Rubber	Similar to predicateEquivalent to reference
Biocompatibility: ISO10993-1	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.

Regulation Number and Section

§ 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.