The 360° Gas Assisted Endoscopic Applicator is a sterile, single-use, disposable device intended for the application of two non-homogeneous liquids. The 360° Gas Assisted Endoscopic Applicator is designed with two luer connectors at the proximal end, which is used for connection to two syringes containing the non-homogeneous liquids. There is also a connector at the proximal end to be attached to a tubing set which is connected to a compressed air/inert gas power source. The 360° Gas Assisted Endoscopic Applicator is packaged with an air line with filter in a PETG tray/Tyvek lid configuration and sterilized using ethylene oxide. Five individually sterile packaged applicators are contained in a shelf carton along with the instructions for use.

AI/ML Overview

The provided text describes a medical device, the "360° Gas Assisted Endoscopic Applicator," and its non-clinical performance data for 510(k) clearance. However, it does not contain details of a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-enabled device.

The document describes a traditional medical device submission (a special 510(k)) for a physical applicator, not a software or AI-driven diagnostic device. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set size, etc.) are not applicable to the information provided.

Despite this, I will extract the relevant information concerning acceptance criteria and the "study" (non-clinical testing) that demonstrates the device meets these criteria, as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (as per non-clinical testing)
Biocompatibility	Met ISO 10993 Part 1 standards; considered safe for intended biocontact.
Mechanical Integrity	Met pre-defined acceptance criteria, demonstrating mechanical integrity and suitability for intended use over labeled shelf life.
Leak Testing	Met pre-defined acceptance criteria.
Pull (Torque) Testing	Met pre-defined acceptance criteria.
Spray Testing	Met pre-defined acceptance criteria.
Mixing Test	Met pre-defined acceptance criteria.
Sterilization Validation	Met pre-defined acceptance criteria (sterilized using ethylene oxide).
Shelf life Evaluation	Met pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document refers to "test articles" but does not quantify the number of devices or components tested for each non-clinical test.
Data Provenance: Not applicable in the context of clinical data. This refers to design verification and biocompatibility testing performed by Micromedics, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is hardware for fluid application, not an interpretative AI or diagnostic tool requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or clinical adjudication.

5. 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

No. This is not an AI-enabled device; therefore, no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device's performance is based on engineering specifications, standardized test methods (like ISO 10993 for biocompatibility), and internal design verification criteria, not clinical outcomes or expert labels.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML product.

9. How the ground truth for the training set was established

Not applicable. This device does not involve a training set.

Summary

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Special 510(k) Premarket Notification 360° Gas Assisted Endoscopic Applicator

Image /page/0/Picture/2 description: The image shows the text "K122526" in a handwritten style. The text is written in black ink on a white background. The numbers are slightly stylized, with the "2" having a curved shape.

510(K) Summary

NOV 1 6 2012

Date Prepared: October 12, 2012

510(k) Submitter	Contact for Official Correspondence
Micromedics, Inc.1270 Eagan Industrial Road, Suite 120St. Paul, MN 55121-1385	Jodi L. Raus, MBA, RACTel: 651-452-1977; Fax: 651-452-1787Email: jodi.raus@nordsonmicromedics.com

General Information
Trade Name	360° Gas Assisted EndoscopicApplicator	Common Name	Endoscopic Applicator
ClassificationInformation	Endoscope and accessoriesper 21 CFR 876.1500 (Class II)	Product Code	GCJ
		Panel	General & Plastic Surgery
PredicateDevices	Air Assisted Endoscopic Applicator, K042834 cleared on February 11, 2005

Device Description

Intended Use / Indications

The 360° Gas Assisted Endoscopic Applicator is intended for the application of two non-homogenous fluids.

Substantial Equivalence Comparison

The endoscopic applicator subject to this special 510(k) incorporates a flexible Pebax tube at the distal end of the applicator which allows for directional positioning of the tip.

Summary of Non-Clinical Performance Data

The 360° Gas Assisted Endoscopic Applicator was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 - Biological evaluation of medical devices, Part 1 – Evaluation and tests (2009) show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use over the labeled shelf life.

Pull (Torque) Testing .
Leak Testing .
. Spray Testing
Mixing Test .
. Sterilization Validation
Shelf life Evaluation .

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Special 510(k) Premarket Notification 360° Gas Assisted Endoscopic Applicator

Substantial Equivalence Conclusion

Substantial Equivalence Collection
The 360° Gas Assisted Endoscopic Applicator does not raise new questions of safety or effectiveness when compared to the predicate devices and is, therefore, substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 16, 2012

Micromedics, Incorporated % Ms. Jodi Raus MBA, RAC Director of Regulatory, Clinical and Quality Affairs 1270 Eagan Industrial Road, Suite 120 Saint Paul, Minnesota 55121

Re: K122526

Trade/Device Name: 360° Gas Assisted Endoscopic Applicator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 17, 2012 Received: October 18, 2012

Dear Ms. Raus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Jodi Raus MBA, RAC

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Micromedics, Inc

Special 510(k) Premarket Notification 360° Gas Assisted Endoscopic Applicator

Attachment 2

Indications for Use Statement

Continued of the commend of the comments of the comments of the production of the comments of

510(k) Number:

K122526

360° Gas Assisted Endoscopic Applicator Device Name

The 360° Gas Assisted Endoscopic Applicator is intended for the Indications application of two non-homogenous fluids. for Use

Prescription Use _ X (Per 21 CFR 801. 109)

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rinut for MXM

(Division Sign-Off) Division of Surgical Devices K122526 510(k) Number_

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.