(44 days)
No
The description focuses on mechanical and image-guided tracking technology, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
No
The device is described as a surgical tool for excision of tissues, which is an interventional procedure rather than a therapeutic one designed to treat a condition. While surgery can be part of a treatment plan, the device itself performs a mechanical function of tissue removal, not a therapeutic action like drug delivery or electric stimulation.
No
The device is described as a surgical tool (Hummer Trak System) used for excision of tissues in sinus cavities and head/neck surgery. Its function is to perform physical tissue removal, not to diagnose conditions. The mention of its use with an image-guided system is for surgical assistance (positioning) rather than diagnosis.
No
The device description clearly details physical hardware components including a handpiece, power unit, flexible drive shaft, and various attachments (shaver blade, bur). It also describes mechanical interactions and physical interlocks. While it interfaces with an image guided system (which likely involves software), the core device itself is a physical surgical instrument system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for excising tissue during procedures (Functional Endoscopic Sinus Surgery, plastic/reconstructive/aesthetic surgery). IVDs are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mechanical surgical tool (handpiece, power unit, shaver blade/bur attachment) designed for physical interaction with tissue within the body. This is characteristic of a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or providing diagnostic information based on laboratory tests.
The device is a surgical instrument that can be used in conjunction with an image-guided system for navigation during surgery. This further reinforces its classification as a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended to be utilized during Functional Endoscopic Sinus Surgery (FESS) for the excision of soft and osseous tissues in the sinus cavities. The device may be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the head and neck. May be used in conjunction with Visualization Technologies, Inc. (VTI) InstaTrak (K960330) image guided system.
Product codes
77 ERL
Device Description
The Hummer Trak System can be sub-divided into two systems, the handpiece and the power unit. The power unit is placed in a secure position, permitting the handpiece to access the surgical site. The power unit contains a motor that drives the handpiece via a flexible drive shaft. Slots are cut in the body of the power unit, permitting lashing straps to secure the unit. The power unit is connected to the TPS Console (K942956 and K943563/S2). The handpiece is mechanically driven from the power unit via the flexible drive shaft. The handpiece effectively transmits the motor energy of the power unit to the shaver blade or bur attachment. A slot is cut longitudinally along the circumference of the handpiece body, securing irrigation tubing. A ball-type valve is provided to regulate suction from the shaver blade or bur attachment. Suction tubing is connected to the handpiece utilizing a suction fitting. A quick release trinkle-type mechanism is used to secure shaver blade and bur attachments. A receiver mount is located on the upper portion of the handpiece body, allowing an image guided sensor to be secured. The InstaTrak image guided sensor is secured to the handpiece by means of a receiver mount. The mount holds the sensor in place by engaging a notch within the sensor and a Delrin latch. The sensor provides three dimensional visualization of the shaver blade or bur attachment's precise location. Small magnets embedded within the receiver mount identify the handpiece as a probe type to the image guided surgery system. Two physical interlocks ensure that calibration is performed when required. Removal of the image guided sensor triggers recalibration when the magnets are no longer detected. Additionally, a mechanical arm connected to the locking mechanism shifts the magnets, creating an intermittent signal loss, forcing recalibration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sinus cavities, head and neck
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
0
| Image: Stryker logo and 2/19/99 | |||
|---|---|---|---|
| 2590 Walsh Avenue | |||
| Santa Clara, CA 95051 | 510(k) Summary | (408) 567-9100 | |
| (408) 567-2505 Fax | |||
| 1. | Name: | Stryker Endoscopy | |
| 2. | Address: | 2590 Walsh Ave | |
| Santa Clara, CA 95051 | |||
| 3. | Phone number: | (408) 567-2176 | |
| 4. | Fax number: | (408) 567-2507 | |
| 5. | Contact person: | David Himes | |
| 6. | Summary prepared: | 12/30/98 | |
| 7. | Proprietary name: | Hummer Trak | |
| 8. | Common name: | Electrical surgical shaver with irrigation. | |
| 9. | Classification name: | Ear, nose, and throat electric or pneumatic surgical | |
| drill |
-
- Description: The Hummer Trak System can be sub-divided into two systems, the handpiece and the power unit. The power unit is placed in a secure position, permitting the handpiece to access the surgical site. The power unit contains a motor that drives the handpiece via a flexible drive shaft. Slots are cut in the body of the power unit, permitting lashing straps to secure the unit. The power unit is connected to the TPS Console (K942956 and K943563/S2). The handpiece is mechanically driven from the power unit via the flexible drive shaft. The handpiece effectively transmits the motor energy of the power unit to the shaver blade or bur attachment. A slot is cut longitudinally along the circumference of the handpiece body, securing irrigation tubing. A ball-type valve is provided to regulate suction from the shaver blade or bur attachment. Suction tubing is connected to the handpiece utilizing a suction fitting. A quick release trinkle-type mechanism is used to secure shaver blade and bur attachments. A receiver mount is located on the upper portion of the handpiece body, allowing an image guided sensor to be secured. The InstaTrak image guided sensor is secured to the handpiece by means of a receiver mount. The mount holds the sensor in place by engaging a notch within the sensor and a Delrin latch. The sensor provides three dimensional visualization of the shaver blade or bur attachment's precise location. Small magnets embedded within the receiver mount identify the handpiece as a probe type to the image guided surgery system. Two physical interlocks ensure that calibration is performed when required. Removal of the image guided sensor triggers recalibration when the magnets are no longer
1
detected. Additionally, a mechanical arm connected to the locking mechanism shifts the magnets, creating an intermittent signal loss, forcing recalibration.
-
- Intended use: The device is intended to be utilized during Functional Endoscopic Sinus Surgery (FESS) for the excision of soft and osseous tissues in the sinus cavities. The device may also be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the head and neck. Additionally, the device may be used in conjunction with Visualization Technologies, Inc. (VTI) InstaTrak (K960330) image guided system.
-
- Technological characteristic comparison: The Hummer II Microdebrider System (K952681 and K972584) and Hummer Trak System have identical indications for use, excluding the capability of the Hummer Trak System to accept an image guidance sensor. Both devices are driven by the same DC brushless motor and controller. Due to interference with image guided surgery sensors, all electromagnetic materials, including stainless steel and magnets, within the Hummer Trak handpiece had to be minimized or reduced. In order to eliminate interference from the motor rotor magnets, a flexible drive shaft is used to isolate the motor assembly from the handpiece housing. Suction controls are employed in both devices and operate by constricting flow within a channel. Due to space constraints, the Hummer Trak suction operates in a side-to-side fashion. This has no affect on safety and efficacy. The Hummer Trak has a receiver mount, which facilitates attachment of an image guided sensor. The mount features an interlock, which triggers the image guided sensor to force recalibration upon insertion of a new attachment. Both devices accommodate identical attachments. Both devices will be tested to the following standards: IEC 601-1, CSA 601.1, UL 2601, IEC 601-1-2, and MDD 93/42/EEC to ensure electrical, thermal, and radiation compliance and safety.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1999
David Himes Stryker Endoscopy Research and Development Group 2590 Walsh Avenue Santa Clara, CA 96051
Re:
K990038 Hummer Trak System Dated: December 30, 1998 Received: January 6, 1999 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL
Dear Mr. Himes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
**3**
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
:
- The device is intended to be utilized during Functional Endoscopic Sinus ● Surgery (FESS) for the excision of soft and osseous tissues in the sinus cavities.
- The device may be utilized for endoscopic or open plastic, reconstructive, . and aesthetic surgery of the head and neck.
- May be used in conjunction with Visualization Technologies, Inc. (VTI) . InstaTrak ([K960330](https://510k.innolitics.com/search/K960330)) image guided system.
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Severson
---
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devic
. Radiological Devices
510(k) Number [K990038](https://510k.innolitics.com/search/K990038)
OR
Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter Use_