(104 days)
No
The description focuses on electromagnetic navigation and displaying the instrument's location on pre-existing images. There is no mention of AI/ML for image processing, analysis, or decision support.
No
The device is described as an instrument for locating and removing substances during ENT procedures, specifically as an aid for surgical guidance, not for directly treating a disease or condition.
No
Explanation: The Malleable Suction™ Instrument is a surgical instrument used in ENT procedures for removing fluids, substances, and tissue, and for surgical guidance when used with Medtronic computer-assisted surgery systems. It aids in precisely locating anatomical structures during surgery but does not diagnose medical conditions.
No
The device description explicitly states that the Malleable Suction instruments are "sterile, single use instruments" and "electromagnetically navigated devices that are designed to be bendable by hand". It also mentions that "Each Malleable Suction instrument incorporates a tracking system within the instrument tip." These are all descriptions of physical hardware components, not software.
Based on the provided information, the Malleable Suction™ Instrument is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for use in surgical procedures (ENT procedures) to locate and remove substances, tissue, and bone dust. It is an instrument used during surgery, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description details a surgical instrument that attaches to a vacuum suction system and incorporates a tracking system for surgical navigation. This aligns with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
The device is a surgical instrument that utilizes navigation technology as an aid during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
PGW
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MR-based model, fluoroscopy images
Anatomical Site
Skull, long bone, vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical care setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
**Bench-top and simulated environment
**Accuracy: Tested navigated instrument in 2D and 3D space.
**Accelerated Life Functionality: Tested navigated instruments functionality after accelerated life exposures and user conditions.
**Simulated Use: Tested instruments according to user's needs and intended use.
**Sterilization: Verified the ability to effectively EO sterilize the instruments (SAL 106) and that EO residuals are within the defined limits.
**Shipping: Tested instruments and packaging after simulated shipping conditions.
**General Requirements and Performance: Tested instruments to assure conformance with identified design and performance specifications.
**Tool Cards: Verified the Malleable Suction Tools package has met the required interface needs of the application software.
**Electrical Safety: Verified conformance to IEC 60601-1 and IEC 60601-1-2, electrical safety and EMC standards.
**Chemical Resistance: Tested exposure of Malleable Suction instruments to substances common to ENT procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Accuracy Requirement: 95% confidence / 99.5% reliability, as dictated by risk analysis, of
§ 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).
0
MAR 1 3 2014 K133665
510(k) Summary
November 27, 2013
| I. | Company: Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, Colorado 80027 USA
Telephone Number: 720-890-3200
Fax Number: 720-890-3500 |
| ---- | -------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- 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:
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
1
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 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 .
2
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 System | |||
| Option | K001284 | 06/12/2000 | Electromagnetic Navigation |
| technology | |||
| Medtronic Quadcut | K130608 | 08/07/2013 | Suction and Navigation |
| Medtronic ENT Suction | |||
| Devices | Medtronic Letter to | ||
| File (MOD-058 | |||
| which references | |||
| K001284 | |||
| K050438) | 7/26/2010 | PNs 9734307, 9734308 – | |
| suction comparison and , | |||
| 9734309 and 9734310 – | |||
| navigation accuracy | |||
| comparison | |||
| StealthStation System | |||
| Update | K050438 | 06/02/2005 | Inclusion of ENT procedures |
| in indications for use |
3
| 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. K001284 |
| The 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 K050438 | |
| The 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 K130608 | |
| 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. | ||
| Item | Subject Devices | |
| (Malleable Suction Instruments) | Predicate Devices | |
| Establishment of | ||
| Stereotactic | ||
| Coordinates | ||
| (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 Accuracy | ||
| Requirement | 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 | ||
| Shaft | ||
| Flex/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 shaft | |
| Pebax Liner | ||
| LCP Tip | ||
| Polyester 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
4
Malleable Suction Instruments
5
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 Life | |
| Functionality | Tested navigated instruments functionality after |
| accelerated life exposures and user conditions | |
| Simulated Use | Tested instruments according to user's needs and |
| intended use. | |
| Sterilization | Verified the ability to effectively EO sterilize the |
| instruments (SAL 106) and that EO residuals are | |
| within the defined limits. | |
| Shipping | Tested instruments and packaging after simulated |
| shipping conditions | |
| General Requirements and | |
| Performance | Tested instruments to assure conformance with |
| identified design and performance specifications | |
| Tool Cards | Verified the Malleable Suction Tools package has |
| met the required interface needs of the application | |
| software | |
| Electrical Safety | Verified conformance to IEC 60601-1 and IEC |
| 60601-1-2, electrical safety and EMC standards | |
| Chemical Resistance | Tested exposure of Malleable Suction instruments |
| to 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.
6
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.
7
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
8
Indications for Use
510(k) Number (if known):
Device Name: Malleable Suction Instruments
Indications for Use:
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 .
- 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'
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