The reusable FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.

Device Description

The FloShield 10mm Endoscopic Conical Blunt Obturator is a re-usable stainless steel endoscopic instrument delivered non-sterile with the FloShield 10mm Endoscopic Cannula to the hospital where it is cleaned, sterilized (steam / moist heat), and assembled prior to surgery. The FloShield 10mm stainless steel Cannula mates with a disposable Applied Medical 8.5 -13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The stainless steel Obturator has a conical blunt style tip which facilitates the insertion of the cannula through an incision site.

AI/ML Overview

This document describes a 510(k) premarket notification for the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator. The acceptance criteria and supporting study details are heavily focused on demonstrating equivalence to a predicate device rather than establishing new performance benchmarks for a standalone AI system.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is for a medical device (endoscopic cannula and obturator), not an AI algorithm. Therefore, the "acceptance criteria" are related to mechanical and functional performance, as well as biological compatibility and sterilization, rather than diagnostic accuracy or AI model metrics.

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance
Functional Performance	Ability to create and maintain a port of entry during simulated laparoscopic surgery	Demonstrated
	Ability to maintain pneumoperitoneum during surgery	Demonstrated
	Leak Resistance	Comparable to predicate device
	Insufflating Flow Rates	Comparable to predicate device
	Insertion and Removal Force	Comparable to predicate device
	Snap Retention	Comparable to predicate device
Sterilization Validation	Compliance with ISO 17665:2006 (Moist Heat)	Successfully performed
	Compliance with ANSI/AAMI ST81:2004 (R2010)	Successfully performed
Biocompatibility	Not explicitly detailed in this summary, but required for medical devices.	Assumed to be compliant based on predicate equivalence and materials.
Material Equivalence	Stainless steel construction, dimensions for cannula, and compatibility with specific cannula seal.	Same design, materials, and intended use as predicate. Obturator is functionally identical with a different tip style.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI algorithm evaluating data. The performance testing described is for a physical medical device.

Sample Size for Test Set: Not applicable in the context of an AI test set. The number of physical devices tested for performance (e.g., leak resistance, insertion force) is not specified.
Data Provenance: Not applicable in the context of an AI algorithm. The performance testing would be conducted in a laboratory or simulated environment, not on patient data from a specific country.
Retrospective or Prospective: Not applicable for device performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable as the device is a physical instrument, not an AI diagnostic tool. Ground truth in this context would be defined by engineering specifications, validated test methods, and regulatory standards, not by expert consensus on patient data.

4. Adjudication Method

Not applicable for a physical device's performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is not an AI system. The comparison is between the new device and its predicate, primarily on functional and material equivalence, not human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is based on:

Engineering specifications and design requirements: For functional metrics like leak resistance, flow rates, insertion/removal force, and snap retention.
Established industry standards: For sterilization (ISO 17665, ANSI/AAMI ST81) and for biocompatibility.
Predicate device characteristics: The new device must demonstrate comparable characteristics to the legally marketed predicate.

8. Sample Size for the Training Set

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

Summary for the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator:

This submission is for a physical medical device, not an AI algorithm. Therefore, many of the requested categories related to AI performance metrics (like test set size, data provenance, expert ground truth, MRMC studies, training sets) are not applicable.

The study presented in the 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (FloShield 10mm Endoscopic Cannula and Blunt Obturator - K141272) through:

Comparison of technological characteristics: Verifying similar design, materials (stainless steel), and intended use. The only noted difference is the tip style of the obturator (conical blunt vs. full blunt).
Performance and functional testing: To ensure the device fulfills its intended mechanical functions during simulated laparoscopic surgery. This included tests for creating/maintaining port of entry, maintaining pneumoperitoneum, leak resistance, insufflating flow rates, insertion/removal force, and snap retention, all of which were found to be "comparable to the predicates."
Sterilization validation: Conforming to relevant ISO and ANSI/AAMI standards for reusable devices.

The "acceptance criteria" are met by demonstrating that the new device performs equivalently to the predicate and complies with relevant safety and performance standards for medical devices.

Summary

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

April 13, 2015

Minimally Invasive Devices Incorporated Dr. Trudie L. Seeger, Ph.D. Vice President of Regulatory, Quality and Clinical Affairs 1275 Kinnear Avenue Columbus, Ohio 43026

Re: K150705

Trade/Device Name: FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 16, 2015 Received: March 18, 2015

Dear Dr. Seeger:

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 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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K150705

Device Name

FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Minimally Invasive Devices Inc 1275 Kinnear Road Columbus, Ohio 43212

510(k) Summary (21 CFR §807.92(c))

510(k) Number:	K150705
Submitter:	Minimally Invasive Devices, Inc.1275 Kinnear RoadColumbus, Ohio 43212
Contact:	Trudie L. Seeger, Ph.D.V.P., Regulatory/Quality/Clinical AffairsTelephone: 614-484-5036Fax: 614-484-5034E-mail: tseeger@midsurgical.com
Date Summary Prepared:	18 Feb, 2015
Type of Submission:	Special 510(k)
Device Trade Name:	FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator
Common Name:	Cannula and Obturator
Classification Name:	Laparoscope, General & Plastic Surgery (21 CFR §876.1500)
Product Code:	GCJ
Predicate Devices:	FloShield 10mm Endoscopic Cannula and Blunt Obturator(K141272)

Device Description:

510(k) Summary Page 1 of 3

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Minimally Invasive Devices Inc 1275 Kinnear Road Columbus, Ohio 43212

Intended Use/Indications for Use:

Comparison to Predicate Devices:

The FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator has the same design, materials and intended use as the FloShield 10mm Endoscopic Cannula and Blunt Obturator (K141272).

Technological Characteristics:

The technological characteristic of the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator are very similar to the predicate device. The FloShield 10mm Endoscopic Cannula is the same cannula used in the predicate device. The FloShield 10mm Endoscopic Cannula is stainless steel and reusable. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter) and uses the disposable 8.5 = 13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel obturators are functionally identical (i.e., facilitates the insertion of the cannula through an incision site) with the only difference being that the FloShield Conical Blunt Obturator is a Hasson Style conical blunt obturator and the FloShield Blunt Obturator is a full blunt Hasson obturators.

Performance Testing:

The performance and functional testing of the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator included tests to verify its ability to create and maintain a port of entry during simulated laparoscopic surgery, its ability to maintain pneumoperitoneum during the course of surgery and comparable functional characteristics to the predicates (Leak Resistance, Insufflating Flow Rates, Insertion and Removal Force, Snap Retention).

510(k) Summary Page 2 of 3

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Minimally Invasive Devices Inc 1275 Kinnear Road Columbus, Ohio 43212

Sterilization validation for reusable devices was successfully performed in accordance with ISO 17665: 2006 Sterilization of Healthcare Products - Moist Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices and ANSI/AAMI ST81:2004 (R2010): Sterilization of Medical Devices - Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.

Conclusion Drawn from Tests and Analyses:

The intended use and performance parameters of the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator are similar or equivalent to the characteristics of the FloShield 10mm Endoscopic Cannula and Blunt Obturator (K141272) as determined in Section 11.0 of this Premarket Notification (510(k)) submission.

510(k) Summary Page 3 of 3

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.