The Endoscopic Applicator is a sterile, single-use, disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm (or larger) trocar. The Endoscopic Applicator is designed with a luer connector, which is used for connection to a syringe containing the hemostatic agent. The Endoscopic Applicator system consists of a cannula and stylet. The non-reflective cannula is a composite sheath constructed of PolyMed" (a high strength fiber with ester vinyl resin) with an Acrylonitrile Butadiene Styrene (ABS) over-molded luer lock. The stylet (obturator) consists of a PolyMed® composite rod, an ABS over-molded tip, and an ABS over-molded handle. The Endoscopic Applicator cannula and stylet are packaged in a double sterile barrier tray configuration and sterilized using ethylene oxide. Six individually sterile packaged applicators are contained in a shelf carton along with instructions for use.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called an "Endoscopic Applicator." The document focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical trial data or performance metrics. As such, much of the requested information about acceptance criteria for AI performance is not present.

However, I can extract the available information regarding non-clinical performance and a general understanding of the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical testing "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." However, the specific quantitative acceptance criteria for each test are not provided in this summary. Instead, it lists the types of tests performed.

Test	Acceptance Criteria (Not Explicitly Stated in Document)	Reported Device Performance
Volume test	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Flex test (stylet and cannula)	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Luer Lock tests (ISO 594-2)	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Hemostatic usage test	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Device leak test	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Pull / Torque tests (cannula)	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Pull / Bend tests (stylet)	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Cannula tissue compliance	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Shipping validation	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Shelf life evaluations	(Specific values not provided)	Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use.
Biocompatibility	Adherence to ISO 10993-1 (2009) criteria	Considered safe for its intended biocontact.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size used for each non-clinical test. It generally refers to "test articles."
Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by Micromedics, Inc. or a contracted testing facility (Intertek Testing Services is mentioned as a contact for Micromedics for this submission). There is no mention of country of origin for data in the sense of patient data, as this is a non-clinical submission. The testing would be considered "prospective" in the sense that it was performed specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The tests performed are engineering and material science tests, not clinical evaluations requiring expert medical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical engineering tests. The results of these tests (e.g., force required to bend, leak rate) would be objectively measured against pre-defined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an Endoscopic Applicator, and the submission is focused on physical and mechanical properties, not the performance of an AI algorithm that would typically be evaluated with MRMC studies.

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

This information is not applicable. The device is a physical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established engineering specifications, international standards (e.g., ISO 594-2 for Luer Lock, ISO 10993-1 for biocompatibility), and internal product design requirements.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI system that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated above.

Summary

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42060.f

Micromedics, Inc ·

Traditional 510{k) Premarket Notification Endoscopic Applicator

510(k) Summary 5

MAR 1,5 2012

Date Prepared: December 22, 2011

510(k) Submitter
Micromedics, Inc.
1270 Eagan Industrial Road, Suite 120
St. Paul, MN 55121-1385

Contact for Official Correspondence Lise W. Duran - General Manager Tel: 651-452-1977; Fax: 651-452-1787 Email: Lise.Duran@nordsommicromedics.com

General Information
Trade Name	Endoscopic Applicator	Common Name	Endoscopic Applicator
Classification Information	Endoscope and accessoriesper 21 CFR 876.1500 (Class II)	Product Code	GCJ
		Panel	General & Plastic Surgery
Predicate Devices	Endoscopic Applicator; Ethicon, Inc. (K051732)Endoscopic Applicator; Baxter Healthcare Corporation (K031882)

Device Description

Intended Use / Indications

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

Substantial Equivalence Comparison

The Endoscopic Applicator has substantially equivalent intended use/indications, principles of use and functional characteristics as the predicate Ethicon and Baxter endoscopic applicators. All three devices are intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar. The subject and predicate device systems consist of a cannula and stylet. The cannula allows a common syringe containing hemostatic agent to be attached and permits delivery of the hemostatic agent to the intended bleeding site with the aid of the stylet. While all three devices allow access through a 5 mm trocar, they differ in length and biomaterials.

Summary of Non-Clinical Performance Data

Summaly of Non-Chilitin's crossments through design verification and biocompatibility t its Endosoph reportation of the many of the secordance with ISO 10993 - Biological evaluation of medical devices, Part 1 – Evaluation and tests (2009) show the device is considered safe for of montanian intended biocontact. Non-clinical testing included the below tests and showed the test

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Micromedics, Inc

KI2.obof

Traditional 510(k) Premarket Notification Endoscopic Applicator

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.

Volume test .
. Flex test (stylet and cannula)
Luer Lock tests (ISO 594-2) .
Hemostatic usage test .
Device leak test .
Pull / Torque tests (cannula) o
Pull / Bend tests (stylet) o
Cannula tissue compliance .
Shipping validation
Shelf life evaluations

Substantial Equivalence Conclusion The 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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 1 5 2012

Micromedics, Inc. % Intertek Testing Services Ms. Paula Wilkerson 2307 E. aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K120608

Trade/Device Name: Endoscopic Applicator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 28, 2012 Received: February 29, 2012

Dear Ms. Wilkerson:

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. Paula Wilkerson

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 (OS) 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/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K12060f

Indications for Use

510(k) Number (if known): _

Device Name:

Endoscopic Applicator

Indications for Use:

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Dyke for mxn

Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120608

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.