(30 days)
No
The summary describes a navigation system that tracks the position of instruments using electromagnetic fields and displays them on pre-operative scans. There is no mention of AI or ML being used for image processing, analysis, or any other function. The performance testing focuses on accuracy and precision, not on AI/ML-specific metrics.
No
The device is described as an aid for precisely locating anatomical structures during surgery, not as a device that delivers therapy or treats a condition.
No
This device is an aid for precisely locating anatomical structures during surgical procedures, not for diagnosing medical conditions. It is used with a navigation system to track instruments in relation to pre-operative scans.
No
The device description explicitly states that the PointerShell Universal and PointerShell LS are "reusable instruments" and "electromagnetically navigated devices" that incorporate a "sensor device." This indicates the presence of physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PointerShell Universal and PointerShell LS are surgical navigation instruments. They are used during surgical procedures to help the surgeon precisely locate anatomical structures based on pre-operative imaging. They do not analyze biological samples.
- Intended Use: The intended use clearly states it's an "aid for precisely locating anatomical structures in either open or percutaneous procedures" and is used with a navigation system. This is a surgical guidance tool, not a diagnostic test.
- Device Description: The description details it as a reusable instrument with a sensor for tracking within a magnetic field, used to display the instrument's position on pre-operative scans. This aligns with surgical navigation, not in vitro testing.
Therefore, the PointerShell Universal and PointerShell LS fall under the category of surgical instruments or navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The PointerShell Universal and PointerShell LS are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.
Both the instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.
Product codes
PGW
Device Description
The Fiagon Navigation - PointerShell Universal and PointerShell LS are reusable instruments intended to be used with the Fiagon Navigation system. The instruments are electromagnetically navigated devices that are
- Instrument adapters (designed for mechanical connection to shavers or surgical instruments a. with different diameters without motor).
Each device incorporates a sensor device, which is tracked by the navigation system with in the lowenergy magnetic field of a field generator (part of the navigation system)
The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)
Mentions image processing
The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model of the anatomy, CT, MRI, fluoroscopy
Anatomical Site
anatomical structures; ENT surgery, paranasal sinuses, mastoid anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Testing was performed in order to determine device precision and accuracy. The following nonclinical tests were performed to determine substantial equivalence:
A mean bench accuracy as target registration error of 1.1 mm for Pointershell Universal and 1.1 mm for PointerShell LS was measured for the new devices, which compares to the values mean
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized depiction of what appears to be an abstract human form or a symbol representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2016
Fiagon Gmbh Dr. Dirk Mucha CTO Neuendorfstrasse 23b 16761 Hennigsdorf Germany
Re: K160479
Trade/Device Name: Pointershell Universal, Pointershell LS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: February 16, 2016 Received: February 22, 2016
Dear Dr. Mucha:
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.
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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 devicerelated 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 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" (21 CFR 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.
Eric A. Mann -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): K160479
Device Name: Fiagon Navigation - PointerShell Universal , PointerShell LS
Indications for Use:
The PointerShell Universal and PointerShell LS are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.
Both the instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
February 16, 2016
1. Submitter Information/ 510(k) Holder
| Submitter: | Fiagon GmbH |
|---|---|
| Address: | Neuendorfstrasse 23b |
| 16761 Hennigsdorf, Germany | |
| Telephone: | +49 3302 201 21 10 |
| Telefax: | +49 3302 201 21 15 |
Mr. Dirk Mucha, CTO Contact:
2. Device Information
Trade Name: Fiagon Navigation - PointerShell Universal, PointerShell LS Common Name: Image guided surgery system Classification: Class II per 21 CFR 882.4560 Device: Ear, Nose, and Throat Stereotaxic Instrument Product Code: PGW
3. Purpose of Submission
The purpose of this submission is to gain clearance for a geometrically modified instrument for the Image Guided Surgery. The instruments involved in this submission are a modified version of instruments that have been approved within Fiagon Navigation extended instrument Set ENT (K141456).
4. Predicate Device Information
The device described in this submission is substantially equivalent to the following comparable unmodified devices:
| Predicate Device / legally marketed
| device | Manufacturer | 510(k) No. | |
|---|---|---|---|
| 1 | Fiagon Navigation Extended Instrument | ||
| Set ENT | |||
| Component | |||
| PointerShell 3mm, 4mm and 5mm | Fiagon GmbH | K141456 |
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5. Device Description
The Fiagon Navigation - PointerShell Universal and PointerShell LS are reusable instruments intended to be used with the Fiagon Navigation system. The instruments are electromagnetically navigated devices that are
- Instrument adapters (designed for mechanical connection to shavers or surgical instruments a. with different diameters without motor).
Each device incorporates a sensor device, which is tracked by the navigation system with in the lowenergy magnetic field of a field generator (part of the navigation system)
The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)
6. List of components
| Components | Grouping | Sterility State |
|---|---|---|
| PointerShell Universal | Instrument Adapter | user sterilized, reusable, delivered in non-sterile state |
| PointerShell LS | Instrument Adapter | user sterilized, reusable, delivered in non-sterile state |
7. Intended Use
The PointerShell Universal and PointerShell LS are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.
It is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
- -ENT Procedures:
- Transphenoidal access procedures. -
- -Intranasal procedures.
- -Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies,
Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
- -ENT related anterior skull base procedures.
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8. Comparison of Technological Characteristics
The substantial equivalence of the PointerShell Universal and PointerShell LS to the PointerShell 3mm, 4mm and 5mm are shown by similarities in their intended use, indications for use, materials, and performance.
All devices utilize:
- · Electromagnetic tracking technology for navigation included in surgical instruments
- · Are adapters for instruments for enabling image guidance
The primary difference between the unmodified devices and the new devices is change in the shaft diameter of the devices. While the PointerShell 3mm, 4mm and 5mm incorporate devices of their respective diameters, the PointerShell Universal is a combination of all these 3 devices in one. It incorporates instruments of shaft diameters ranging from 2.5mm.The PointerShell LS is used for navigation of octagonal shavers or octagonal surgical instruments with a maximum shaft diameter of 6mm. These changes do not raise new issues of safety and effectiveness.
9. Performance Data
Testing was performed in order to determine device precision and accuracy. The following nonclinical tests were performed to determine substantial equivalence:
A mean bench accuracy as target registration error of 1.1 mm for Pointershell Universal and 1.1 mm for PointerShell LS was measured for the new devices, which compares to the values mean