(28 days)
No
The document describes accessories for a previously cleared stereotactic surgery system and does not mention AI or ML in its description, intended use, or performance studies.
No
This device is described as an aid to the surgeon for precisely locating anatomical structures during procedures, not for treating a disease or condition itself.
No
This device, an accessory to the InstaTrak 3000 System, is intended as an aid to surgeons for precisely locating anatomical structures during procedures, using pre-existing medical images (CT or MR). It does not generate diagnostic information itself but is used for surgical navigation.
No
The device description explicitly states that the aspirators and pointers are physical aspiration and/or localization devices supplied as accessories. It also mentions testing related to cleaning, sterilization, and functionality after reuse cycles, which are characteristic of hardware devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an aid to the surgeon for precisely locating anatomical structures during open or percutaneous procedures. This describes a device used in vivo (within the living body) for surgical guidance, not a device used in vitro (outside the living body) to examine specimens like blood or tissue for diagnostic purposes.
- Device Description: The description refers to "aspiration and/or localization devices" used as accessories to a surgical navigation system. This further supports its role in surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, providing diagnostic information based on laboratory tests, or any other activities typically associated with IVD devices.
The device is a surgical navigation accessory used for real-time guidance during surgery, which falls under the category of surgical instruments or systems, not IVDs.
N/A
Intended Use / Indications for Use
The aspirators and pointers are accessories of the previously cleared InstaTrak 3000 System, (K983529) and therefore have the same intended use.
The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.
Product codes
90 LLZ
Device Description
The aspirators and pointers described above are aspiration and/or localization devices supplied as accessories with the InstaTrak 3000 System. The aspirators and pointers have the same principle of operation, as those accessories described in the predicates, K960330, K981998, K982994, and K983529. Other than the non-sterile reusable labeling and a color change to a non-patient contact portion of the instrument the devices are the same as the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR
Anatomical Site
anatomical structures anywhere on the human body, rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Testing was performed on the aspirators and pointers to demonstrate their ability to be cleaned and sterilized and to confirm functionality after multiple reuse cycles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K960330, K981998, K982994, K983529
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K990919
APR 15 109
Attachment 4
510(k) SUMMARY
1. Date Prepared March 12, 1999
Submitter (Contact) 2. Peter Ohanian Visualization Technology, Inc. Wilmington, MA 01887 (978) 933-1000
3. Device Name
Proprietary Name:
The following names are proposed and may be subject to change: Straight Aspirator, 90 Degree Aspirator, 45 Degree Aspirator, 7 French Aspirator, Extended Straight Aspirator, 13.9 cm Straight Pointer, 4.7 cm Aspirator
(Note: the above are all accessories of the InstaTrak 3000 K983529.)
Common Name(s): Aspirators and pointers
- The aspirators and pointers are accessories of the InstaTrak 3000, which is Classification Name: classified as a Computer tomography x-ray system.
4. Device Classification
Computer tomography x-ray system (Product Code 90 LLZ, Class II; 21 CFR 892.1750)
5. Device Description
The aspirators and pointers described above are aspiration and/or localization devices supplied as accessories with the InstaTrak 3000 System. The aspirators and pointers have the same principle of operation, as those accessories described in the predicates, K960330, K981998, K982994, and K983529. Other than the non-sterile reusable labeling and a color change to a non-patient contact portion of the instrument the devices are the same as the predicate.
6. Intended Use
The aspirators and pointers have the same intended use as the accessories in the InstaTrak 3000, K983529.
The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.
7. Substantial Equivalence
The predicate devices described in K960330, K981998, K982994, and K983529 have the same intended use, use the same operating principle, incorporate the same design and materials, and allow for sterlization. In summary, the aspirators and pointers in this submission are, in our opinion, substantially equivalent to the predicate devices.
Visualization Technology, Inc.
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1
8. Technological Characteristics
. . .
The technological characteristics of the aspirators and pointers are identical to those of the predicate devices.
9. Performance Data
Testing was performed on the aspirators and pointers to demonstrate their ability to be cleaned and sterilized and to confirm functionality after multiple reuse cycles.
:
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles forming a bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
APR 1 5 1999
Peter Ohanian VP Regulatory Affairs & Quality Assurance Visualization Technology, Inc. 200 Research Drive Wilmington, MA 01887
Re:
Straight Aspirator , 45 Degree Aspirator, 90 Degree Aspirator, 7 French Aspirator, Extended Straight Aspirator, 13.9 cm Straight Pointer and 4.7 cm Straight Pointer Dated: March 17, 1999 Received: March 18, 1999 Regulatory class: II 21 CFR 892.1750/Procode: 90 LLZ
Dear Mr. Ohanian:
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 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 requlation (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
Attachment 2
Indications for Use Statement
| 510 (k) Number
| (if known) | K990919 |
|---|---|
| Device Name | Straight Aspirator, 45 Degree Aspirator, 90 Degree Aspirator, 7 French |
| Aspirator, Extended Straight Aspirator, 13.9 cm Straight Pointer, and 4.7 cm | |
| Straight Pointer | |
| Indications for Use | The aspirators and pointers are accessories of the previously cleared |
| InstaTrak 3000 System, (K983529) and therefore have the same intended | |
| use. |
The InstaTrak 3000 System is intended as an aid to the surgeon for precisely
locating anatomical structures anywhere on the human body during either
open or percutaneous procedures. It is indicated for any medical condition
that may benefit from the use of stereotactic surgery and which provides a
reference to rigid anatomical structures such as sinus, skull, cranial, a long
bone or vertebra, visible on medical images such as CT or MR. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Sezem
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ~
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Visualization Technology, Inc.
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