(58 days)
Not Found
No
The document describes a mechanical accessory (headrest and mounting arm) for a navigation system. There is no mention of AI/ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
A therapeutic device is one that treats a disease or condition. This device is an accessory to a surgical navigation system, providing support and positioning for the patient's head and the navigation system's field generator during surgical procedures, but it does not directly treat a medical condition.
No
The device is an accessory (TGS Universal Headrest with Mounting Arm) for a navigation system (Stryker ENT Navigation System) used during stereotactic surgery to provide support to the patient's head and fix the field generator. It does not perform any diagnostic function itself.
No
The device description explicitly states it consists of hardware components: a headrest, mounting arm, and chair adapters. It is an accessory to a navigation system, but the device itself is hardware.
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 Stryker ENT Navigation System and its accessory, the TGS Universal Headrest with Mounting Arm, are used during surgical procedures to provide guidance based on pre-operative imaging (CT or MR). They are physical devices used on the patient during surgery, not for analyzing samples from the patient.
- Intended Use: The intended use clearly describes its application in stereotactic surgery for ENT procedures, referencing anatomical structures and imaging models. This is a surgical navigation tool, not a diagnostic test.
Therefore, this device falls under the category of a surgical navigation system accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker ENT Navigation System, of which the TGS Universal Headrest with Mounting Arm is an accessory, 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 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 the following ENT procedures:
- Transsphenoidal access procedures;
- Intranasal procedures;
- Sinus procedures, such as maxillary antrostomies; sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;
- ENT related anterior skull base procedures.
Product codes
PGW
Device Description
The TGS Universal Headrest with Mounting Arm is a reusable device intended to be used with the Stryker ENT Navigation System. It consists of three main components: a headrest, mounting arm and chair adapters. The mounting arm provides fixation for the field generator of the navigation system allowing it to be positioned in proximity to the patient creating an optimal electromagnetic field. The headrest provides support for the patient's head while undergoing navigation guided procedures. The chair adapters are fixed to the headrest to allow the headrest to various ENT procedure chairs
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR
Anatomical Site
paranasal sinuses, mastoid anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals only (physicians)
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 testing was performed to demonstrate that the TGS Universal Headrest with Mounting Arm performs as intended and meets the design specifications. The testing included dimensional, functional, simulated use, compatibility and distribution testing. Design validation involved ENT physicians familiar with image guided sinus surgery and was conducted to demonstrate that the intended users could perform the critical tasks related to use of the TGS Universal Headrest with Mounting Arm in its expected use environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 14, 2020
Stryker ENT Denise Thompson Principal Regulatory Affairs Specialist 3600 Holly Lane North. Suite 40 Plymouth, Minnesota 55447
Re: K193502
Trade/Device Name: TGS Universal Headrest with Mounting Arm Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: December 17, 2019 Received: December 18, 2019
Dear Denise Thompson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
TGS Universal Headrest with Mounting Arm
| Indications for Use (Describe) | BIRDER BE CONSULTION OF COLLECTION OF CLASS OF CONSULTER OF CLASS OF CONSULTER OF CLASS OF CONSULTER OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CONSULTER OF CONSULTER OF | |
|---|---|---|
The Stryker ENT Navigation System, of which the TGS Universal Headrest with Mounting Arm is an accessory, 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 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 the following ENT procedures:
- · Transsphenoidal access procedures:
- Intranasal procedures:
- · Sinus procedures, such as maxillary antrostomies; sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies:
- · ENT related anterior skull base procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
stryker®
Date Prepared: Submitter Information:
Establishment Registration:
Contact Information:
Device Information: Trade Name: Common Name: Classification Name: Product Code: Classification: Regulation Number: Predicate Devices:
December 17th, 2019 Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
3006345872
Denise Thompson Principal Regulatory Affairs Specialist (269) 888-0219 denise.thompson(@stryker.com
TGS Universal Headrest with Mounting Arm Image Guided Surgery System Ear, Nose, and Throat Stereotaxic Instrument PGW Class II 21 CFR 882.4560 Navigation Headrest Office, K133573 Field Generator Mounting Arm, K161491
Device Description:
The TGS Universal Headrest with Mounting Arm is a reusable device intended to be used with the Stryker ENT Navigation System. It consists of three main components: a headrest, mounting arm and chair adapters. The mounting arm provides fixation for the field generator of the navigation system allowing it to be positioned in proximity to the patient creating an optimal electromagnetic field. The headrest provides support for the patient's head while undergoing navigation guided procedures. The chair adapters are fixed to the headrest to allow the headrest to various ENT procedure chairs
Image /page/3/Picture/12 description: The image shows a chair with a headrest and a field generator attached to it. The field generator is mounted on a mounting arm that is attached to the headrest. A chair adapter is used to connect the mounting arm to the chair. The field generator is provided with the navigation system.
TGS Universal Headrest with Mounting Arm
4
Intended Use:
The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and intended for positioning the Field Generator. It also provides a resting surface for the patient to place their head during procedures requiring navigation.
Indication for Use:
The Stryker ENT Navigation System, of which the TGS Universal Headrest with Mounting Arm is an accessory, 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 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 the following ENT procedures:
- Transsphenoidal access procedures; ●
- . Intranasal procedures;
- . Sinus procedures, such as maxillary antrostomies; sphenoidotomies; sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;
- . ENT related anterior skull base procedures.
Contraindications:
None
Technological Characteristics:
The technological characteristics of the TGS Universal Headrest and Mounting Arm are very similar to the predicate devices, the Navigation Headrest Office (an accessory to the Fiagon Navigation System, K133573) and the Field Generator Mounting Arm (an accessory to the Stryker ENT Navigation System, K161491).
The TGS Universal Headrest and Mounting Arm and its predicates all:
- . position the field generator of a navigation system,
- have articulating hinged design features, ●
- . achieve different positions through use of locking mechanisms,
- . are for use by healthcare professionals only (physicians), and
- are provided non-sterile and intended to be cleaned and disinfected between uses.
Substantial Equivalence:
The TGS Universal Headrest with Mounting Arm has been shown to be substantially equivalent to the predicate devices, the Navigation Headrest Office and the Field Generator Mounting Arm based on Intended Use, Indications for Use, Principles of Operation and technological characteristics.
The TGS Universal Headrest with Mounting Arm most closely resembles the primary predicate, the Navigation Headrest Office. The main difference between devices relates to the mounting mechanism (arm versus bracket) for the field generator. The subject device's mounting mechanism more closely resembles the mounting mechanism of the secondary predicate, the Field Generator Mounting Arm.
5
While there are some minor design differences between the subject and predicate devices, these differences do not raise different questions of safety or efficacy.
Performance Data:
Bench testing was performed to demonstrate that the TGS Universal Headrest with Mounting Arm performs as intended and meets the design specifications. The testing included dimensional, functional, simulated use, compatibility and distribution testing. Design validation involved ENT physicians familiar with image guided sinus surgery and was conducted to demonstrate that the intended users could perform the critical tasks related to use of the TGS Universal Headrest with Mounting Arm in its expected use environment.
Conclusion:
The TGS Universal Headrest with Mounting Arm has been shown to be substantially equivalent to the predicate devices based on Intended Use, Indications for Use, Principles of Operation and technological characteristics. The minor design differences between the subject and predicate devices do not raise different questions of safety or efficacy and bench performance testing has been conducted to demonstrate the TGS Universal Headrest with Mounting Arm performs as intended and equivalently to the predicate devices.