The Malleable Suction™ Instrument is indicated for use in ENT procedures where surgical navigation or image-guided surgery may be necessary to locate and remove fluids, semi-fluid substances, tissue, and bone dust. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and Medtronic ENT software.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The Malleable Suction™ Instrument is indicated for use in the following procedures:

. Pituitary tumor removal only ENT procedures
CSF leak repair only related or from an ENT procedure . ●
- Skull base procedures for ENT access .
- Transsphenoidal procedures .
· Intranasal procedures
- Optic nerve decompression procedures .
- . Orbital decompression procedures
- . Polyposis procedures
- Endoscopic dacryocystorhinostomy .
- Encephalocele procedures .
- Sinus procedures, such as maxillary antrostomies .
- Ethmoidectomies .
- Sphenoidotomies/sphenoid explorations .
- Turbinate resections and frontal sinusotomies .

Device Description

The Malleable Suction instruments are sterile, single use instruments intended for use with the ENT software applications on a Medtronic computer assisted surgery systems, StealthStation® systems (S7, i7 and Fusion®). The Malleable Suction instruments are electromagnetically navigated devices that are designed to be bendable by hand into a shape by the user in order to customize the instrument to the needs of the surgeon for each individual patient's anatomy and disease.

Each Malleable Suction instrument incorporates a tracking system within the instrument tip. The mobile emitter of the navigation system generates a low-energy magnetic field to locating the tracker mounted within the tip of the instrument. The navigation system software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.

The instrument attaches to, and functions with, standard surgical vacuum suction systems and comes with a cleaning stylet to assist in dislodging blockages.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Medtronic Malleable Suction™ Instruments based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
System Accuracy Requirement	Bench-top and simulated environment: 95% confidence / 99.5% reliability, as dictated by risk analysis, of ≤ 3.00 mm.
Suction Capabilities	Capable of removing fluids, semi-fluid substances, tissue, and bone dust.
Shaft Flex/Configurations	Bendable, configuration surgeon defined
Tip Configurations	Standard (straight), Angle, Ball
Materials	Aluminum shaft, Pebax Liner, LCP Tip, Polyester Shrink tubing
Sterile/Reusable	Sterile, Single Use

Note on "Reported Device Performance": The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the types of tests performed. For some criteria, such as "Shaft Flex/Configurations," "Tip Configurations," "Materials," and "Sterile/Reusable," the "reported device performance" is essentially a description of the device's characteristics that meet the intended design and comparison with predicate devices. The accuracy criterion is the most quantitative.

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

The document does not explicitly state the sample size for a "test set" in the context of an algorithm or AI performance evaluation. The "Accuracy" testing was conducted in "2D and 3D space" and "Accelerated Life Functionality" tests involved "accelerated life exposures and user conditions" in a "bench-top and simulated environment." The data provenance is described as "bench-top and simulated environment," implying laboratory testing rather than human patient data, and therefore, no specific country of origin or retrospective/prospective designation applies.

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

This information is not applicable and is not provided in the document. The device is a physical surgical instrument and not an AI or diagnostic algorithm that requires expert ground truth for its performance evaluation for this 510(k) submission.

4. Adjudication Method

This information is not applicable. The device is a surgical instrument, and its performance testing as described does not involve expert adjudication of results in the way an AI diagnostic tool would.

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

No. This document describes a 510(k) submission for a surgical instrument, not an AI or software device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No. This document describes a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth for the device's performance, specifically its accuracy, would be established by metrology standards and measurements in a controlled laboratory environment. For functionality tests like suction capabilities and malleability, the ground truth is simply whether the device performs its intended mechanical function as designed and specified.

8. Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning algorithm, and therefore there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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MAR 1 3 2014 K133665

510(k) Summary

November 27, 2013

I.	Company: Medtronic Navigation, Inc.826 Coal Creek CircleLouisville, Colorado 80027 USATelephone Number: 720-890-3200Fax Number: 720-890-3500
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Contact: Charles Copperberg Principal Regulatory Affairs Specialist Telephone number: 720-890-2291 Email: Charles.copperberg@medtronic.com
Proprietary Trade Name: Malleable Suction™ Instruments

Description	Part Number
Malleable Suction Small, Standard Tip	9735015
Malleable Suction Medium, Standard Tip	9735016
Malleable Suction Medium, Angle Tip	9735017
Malleable Suction Medium, Ball Tip	9735018
Malleable Suction Large, Standard Tip	9735019

II. Common Name: Stereotaxic Instrument
III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
IV. Classification: Class II (21 CFR 882.4560) Ear, Nose and Throat Devices
V. Product Code: PGW

元 ***

VI. Product Description:

Each Malleable Suction instrument incorporates a tracking system within the instrument tip. The mobile emitter of the navigation system generates a low-energy magnetic field

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to locating the tracker mounted within the tip of the instrument. The navigation system software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.

The instrument attaches to, and functions with, standard surgical vacuum suction systems and comes with a cleaning stylet to assist in dislodging blockages.

VII. Indications for Use:

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The Malleable Suction™ Instrument is indicated for use in the following procedures:

. Pituitary tumor removal only ENT procedures
CSF leak repair only related or from an ENT procedure . ●
- Skull base procedures for ENT access .
- Transsphenoidal procedures .
· Intranasal procedures
- Optic nerve decompression procedures .
- . Orbital decompression procedures
- . Polyposis procedures
- Endoscopic dacryocystorhinostomy .
- Encephalocele procedures .
- Sinus procedures, such as maxillary antrostomies .
- Ethmoidectomies .
- Sphenoidotomies/sphenoid explorations .
- Turbinate resections and frontal sinusotomies .

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VIII. Identification of Legally Marketed Devices (Predicate Devices)

The Malleable Suction Instruments have the same intended use and technological characteristics as the predicate devices shown in the following tables.

Predicate Devices

Predicate Description	510(k) Number	Clearance Date	Predicate Substantial Equivalence Characteristic
StealthStation®GoldenEye™ Micro-Magnetic Tracking SystemOption	K001284	06/12/2000	Electromagnetic Navigationtechnology
Medtronic Quadcut	K130608	08/07/2013	Suction and Navigation
Medtronic ENT SuctionDevices	Medtronic Letter toFile (MOD-058which referencesK001284 K050438)	7/26/2010	PNs 9734307, 9734308 –suction comparison and ,9734309 and 9734310 –navigation accuracycomparison
StealthStation SystemUpdate	K050438	06/02/2005	Inclusion of ENT proceduresin indications for use

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IX.	Comparison of the Technological Characteristics
Item	Subject Devices(Malleable Suction Instruments)	Predicate Devices
Indications for Use	The Malleable SuctionTM Instrument is indicated for use in ENT procedures where surgical navigation or image-guided surgery may be necessary to locate and remove fluids, semi-fluid substances, tissue, and bone dust. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and Medtronic ENT software.	StealthStation Golden Eye Micro-magnetic System. K001284The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.Example procedures include but are not limited to:ENT Procedures:Transphenoidal procedures, Intranasal procedures, Sinus procedures such as Maxillary antrostromies, Ethmoidectomies, Sphenoidotomies/sphenoid explorations, Turbinate resections, and frontal sinusotomies.
	The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.	Medtronic Reusable, Navigated Suction Devices K050438The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. For the optical based and EM based system, example procedures include, but are not limited to:ENT Procedures:Transphenoidal procedures, Intranasal procedures, optical nerve decompression procedures, optic nerve decompression procedures, polyposis procedures, endoscopic dacryocystorhinostomy, encephalocele procedures, Sinus procedures such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/sphenoid explorations, Turbinate resections, and frontal sinusotomies.
	The Malleable SuctionTM Instrument is indicated for use in the following procedures: Pituitary tumor removal only ENT procedures, CSF leak repair only related or from an ENT procedure, Skull base procedures for ENT access, Transphenoidal procedures, Intranasal procedures, Optic nerve decompression procedures, Orbital decompression procedures Polyposis procedures, Endoscopic dacryocystorhinostomy, Encephalocele procedures, Sinus procedures, such as maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/sphenoid explorations, Turbinate resections and frontal sinusotomies	Medtronic Quadcut K130608The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.
Item	Subject Devices(Malleable Suction Instruments)	Predicate Devices
Establishment ofStereotacticCoordinates(Tracking Method)	Electromagnetic, tip tracking	StealthStation® GoldenEye™ Micro-Magnetic Tracking System (K001284) -Electromagnetic (Tip Tracked)Medtronic ENT Suction Devices (MOD-058 (K001284 and K050438))Electromagnetic, proximal tracking
System AccuracyRequirement	Bench-top and simulated environment:95% confidence / 99.5% reliability, as dictated by risk analysis, of $\le$ 3.00 mm.	Medtronic ENT Suction Devices (MOD-058 (K001284 and K050438))95% confidence / 99.5% reliability, as dictated by risk analysis, of $\le$ 3.00 mm.Equivalent
Suction Capabilities	Capable of removing fluids, semi-fluid substances, tissue, and bone dust.	StealthStation® GoldenEye™ (K001284)95% confidence / 99.5% reliability, as dictated by risk analysis, of $\le$ 3.00 mm.Equivalent
ShaftFlex/Configurations	Bendable, configuration surgeon defined	Medtronic ENT Suction Devices (MOD-058 (K001284 and K050438))Equivalent
Tip Configurations	Standard (straight), Angle, Ball	Medtronic ENT Suction Devices (MOD-058 (K001284 and K050438))Fixed, Straight, 45° curve, 90° curve
Materials	Aluminum shaftPebax LinerLCP TipPolyester Shrink tubing	Medtronic ENT Suction Devices (MOD-058 (K001284 and K050438))Standard (straight), Angle, Ball
Sterile/ Reusable	Sterile, Single Use	Medtronic ENT Suction Devices (MOD-058 (K001284 and K050438))Stainless Steel, Titanium
		Medtronic ENT Suction Devices (MOD-058 (K001284 and K050438))Reusable, clean and sterilize prior to use

Malleable Suction Instruments

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Malleable Suction Instruments

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X. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic navigation systems. The following table summarizes the performance testing completed:

Test	Description
Accuracy	Tested navigated instrument in 2D and 3D space
Accelerated LifeFunctionality	Tested navigated instruments functionality afteraccelerated life exposures and user conditions
Simulated Use	Tested instruments according to user's needs andintended use.
Sterilization	Verified the ability to effectively EO sterilize theinstruments (SAL 106) and that EO residuals arewithin the defined limits.
Shipping	Tested instruments and packaging after simulatedshipping conditions
General Requirements andPerformance	Tested instruments to assure conformance withidentified design and performance specifications
Tool Cards	Verified the Malleable Suction Tools package hasmet the required interface needs of the applicationsoftware
Electrical Safety	Verified conformance to IEC 60601-1 and IEC60601-1-2, electrical safety and EMC standards
Chemical Resistance	Tested exposure of Malleable Suction instrumentsto substances common to ENT procedures

XI. Conclusions

The Malleable Suction Instruments have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 13, 2014

Medtronic Navigation, Inc. % Mr. Charles M. Copperberg Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, CO 80027

Re: K133665

Trade/Device Name: Malleable Suction™ Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Ear, Nose, and Throat Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: February 6, 2014 Received: February 7, 2014

Dear Mr. Copperberg:

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 10 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.

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Page 2 - Mr. Charles M. Copperberg

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 vours.

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Malleable Suction Instruments

Indications for Use:

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The Malleable Suction™ Instrument is indicated for use in the following procedures:

. Pituitary tumor removal only ENT procedures
CSF leak repair only related or from an ENT procedure .
t Skull base procedures for ENT access
Transsphenoidal procedures .
Intranasal procedures .
Optic nerve decompression procedures ●
Orbital decompression procedures .
Polyposis procedures
Endoscopic dacryocystorhinostomy .
. Encephalocele procedures
Sinus procedures, such as maxillary antrostomies .
Ethmoidectomies ◆
Sphenoidotomies/sphenoid explorations .
Turbinate resections and frontal sinusotomies .

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sageev George -S 2014.03.10 15:06:17 -04'00'

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).