(28 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the K990919 device submission:
Based on the provided K990919 submission for "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" (accessories for the InstaTrak 3000 System), the information regarding performance criteria and studies is very limited and primarily focuses on equivalence to predicate devices, rather than detailed performance metrics. This is typical for 510(k) submissions for accessories that are substantially equivalent, where rigorous clinical trials with quantifiable performance metrics are often not required if the new device doesn't introduce new risks or fundamental changes in technology.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (accessories with asserted substantial equivalence), the "acceptance criteria" are not reported as numerical performance targets (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly tied to maintaining the same functional and safety characteristics as the predicate devices. The "performance data" provided confirms these characteristics.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Same principle of operation as predicate devices | The aspirators and pointers have the same principle of operation as those accessories described in the predicates. |
| Design & Materials | Incorporate the same design and materials as predicate devices | The aspirators and pointers incorporate the same design and materials as the predicate devices. |
| Sterilization Compatibility | Allow for sterilization (multiple reuse cycles) | 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. |
| Intended Use | Same intended use as predicate accessories | The aspirators and pointers have the same intended use as the accessories in the InstaTrak 3000, K983529. |
| Technological Characteristics | Identical technological characteristics to predicate devices | The technological characteristics of the aspirators and pointers are identical to those of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any clinical test set in the conventional sense (e.g., number of patients, cases, or image data). The testing mentioned is solely "testing... to demonstrate their ability to be cleaned and sterilized and to confirm functionality after multiple reuse cycles." This suggests bench testing rather than a study involving human subjects or medical data.
Therefore:
- Sample size for test set: Not applicable/not specified for clinical performance. The testing was likely on a sample of the manufactured devices for cleaning/sterilization validation.
- Data provenance: Not applicable. The "testing" refers to internal validation activities by the manufacturer (Visualization Technology, Inc.), likely in a lab setting, to confirm physical and functional integrity.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided and is not applicable to the type of testing described. The "ground truth" for chemical (cleaning/sterilization) and mechanical (functionality after reuse) testing is typically established by established laboratory protocols and standards, not by expert medical review.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable. Since no clinical test set or expert review for diagnostic/treatment performance is described, there's no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done.
The submission focuses on establishing substantial equivalence of accessories based on design, materials, and functional testing (cleaning/sterilization/reuse), not on the comparative clinical performance with or without AI assistance. The InstaTrak 3000 system itself is a surgical navigation system, and the accessories are tools used with it; their primary "performance" is mechanical integrity and compatibility, not diagnostic accuracy or interpretation improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device (aspirators and pointers) is not an algorithm or an AI-powered device. It is a set of physical surgical accessories. The InstaTrak 3000 itself is a computer-aided system, but the submission is for its accessories.
7. The Type of Ground Truth Used
The "ground truth" for the described testing would be:
- Sterility Validation: Confirmation that sterilization processes render the devices sterile according to established microbiological standards (e.g., AAMI, ISO standards).
- Cleanliness Validation: Confirmation that cleaning protocols effectively remove biological and other contaminants to acceptable levels.
- Functional Integrity: Confirmation that the devices maintain their physical properties and intended function after multiple cleaning and sterilization cycles (e.g., no material degradation, no loss of structural integrity).
This is established through laboratory testing and adherence to recognized standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not an AI/algorithm-based system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
{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.
-CONFIDENTIAL-
{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.
:
-CONFIDENTIAL-
{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 FrenchAspirator, Extended Straight Aspirator, 13.9 cm Straight Pointer, and 4.7 cmStraight Pointer |
| Indications for Use | The aspirators and pointers are accessories of the previously clearedInstaTrak 3000 System, (K983529) and therefore have the same intendeduse.The InstaTrak 3000 System is intended as an aid to the surgeon for preciselylocating anatomical structures anywhere on the human body during eitheropen or percutaneous procedures. It is indicated for any medical conditionthat may benefit from the use of stereotactic surgery and which provides areference to rigid anatomical structures such as sinus, skull, cranial, a longbone 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.
-CONFIDENTIAL-
Page 13 of 17
§ 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).