(18 days)
The Voyager is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide oxientation and reference information during intra-operative procedures.
The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a tigid anatomical structure may be made, such as:
- . Intra-crania surgical procedures involving space occupying lessons or malformations (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neutal decompression, or ● resection of spinal neoplasms
- ENT Procedures .
- Orthopedic surgical procedures ●
The Voyager System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Voyager uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal and external patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.
The document provided is a 510(k) summary for the Z-KAT, Inc. Voyager Linux stereotaxic instrument. This type of regulatory document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results or acceptance criteria for a new device's performance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies cannot be fully extracted from the provided text. The document primarily describes the device, its intended use, and its substantial equivalence to an existing device (Voyager 6.0 Software Option; Marconi Medical Systems, K000310).
Here's what can be stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document does not define specific performance acceptance criteria for the Voyager Linux device, nor does it report performance metrics against such criteria. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence in design, materials, and intended use as opposed to new clinical efficacy/performance trials against predefined criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. The document does not mention any specific test sets, sample sizes, or data provenance related to a performance study for the Voyager Linux device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted. No information is provided about experts used for ground truth establishment, as no test set or performance study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No information about adjudication methods is provided, as no test set or performance study is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be extracted. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance. The Voyager Linux is described as an image-guided surgical device, not an AI-driven diagnostic tool that would typically involve "human readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. The document does not describe any standalone performance studies. Given it's a "stereotaxic instrument" and "image guided surgical device," it inherently involves human interaction and is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. As no performance study is described, no information on the type of ground truth used is available.
8. The sample size for the training set
- Cannot be extracted. The document does not mention any training sets, as it is not describing a machine learning or AI algorithm in the context of a new development or training process.
9. How the ground truth for the training set was established
- Cannot be extracted. As no training set is mentioned, there is no information on how its ground truth was established.
Summary of available information:
- Device Name: Voyager Linux
- Predicate Device: Voyager 6.0 Software Option; Marconi Medical Systems, K000310
- Device Description: An image-guided surgical device including an optical detector, computer, dedicated instrumentation, and operating software. Uses diagnostic images for pre-surgical planning and intra-operative navigation.
- Intended Use/Indications: To assist physicians with presurgical planning and to provide orientation and reference information during intra-operative procedures for stereotactic surgery involving rigid anatomical structures. Specifically mentioned for:
- Intra-cranial surgical procedures (space occupying lesions, malformations including soft tissue, vascular, osseous)
- Spinal surgical procedures (stabilization, neural decompression, resection of spinal neoplasms)
- ENT procedures
- Orthopedic surgical procedures
In conclusion, the document serves its purpose as a 510(k) summary for substantial equivalence but does not provide the detailed performance study information requested.
{0}------------------------------------------------
DEC 2 0 2002
K0239rs
2901 simms street tel 954 927 2044
510(K) SUMMARY
SUBMITTER: Z-KAT, Inc.
z-kat, inc.
ADDRESS: 2901 Simms Street
Hollywood, FL 33020
PHONE NUMBER: 954-927-2044
FAX NUMBER: 954-927-0446
CONTACT PERSON: Christina Vance
DATE PREPARED: November 27, 2002
TRADE NAME: Voyager Linux
COMMON NAME: Stereotaxic Instrument
CLASSIFICATION NAME: Class II
SUBSTANTIAL EQUIVALENCE CLAIMED TO:
- Voyager 6.0 Software Option; Marconi Medical Systems, K000310 1.
DEVICE DESCRIPTION:
The Voyager System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Voyager uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal and external patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
Voyager will consist of following basic components:
-
- High Resolution color liquid crystal display (LCD) Touch Screen Monitor
-
- Breakout Box
- Tool Interface Unit (TIU) 3)
- Uninterruptable Power Supply (UPS) 4)
- Central Processing Unit (CPU) 5)
{1}------------------------------------------------
- Isolation Transformer 6)
- 12023975
-
- Keyboard and Mouse
-
- Optical Detector (on wheeled-base pedestal)
- Operating Room Cart 9)
-
- Tools and accessories surgical tools and accessories instrumented with LEDs or reflective markers
INTENDED USE:
The Voyager is intended for use as a device, which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
- Intra-cranial surgical procedures involving space occupying lesions or malformations ● (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or . resection of spinal neoplasms
- ENT procedures
- Orthopedic surgical procedures .
2 of 2
_灯
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.
Ms. Christina Vance Regulatory Affairs Representative Z-Kat. Inc. 2901 Simms Street Hollywood, Florida 33020
Re: K023975
Trade/Device Name: Voyager Linux Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 27, 2002 Received: December 2, 2002
Dear Ms. Vance:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 801); 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. This letter will allow you to begin marketing your device as described in your Section 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.
{3}------------------------------------------------
Page 2 - Ms. Christina Vance
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Miriam C. Provost
{61 Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
z-kat, inc.
2901 simms street hollywood, florida 33020 tol 954.927.2044 fax 954.927.0446 zkat@z-kat.com www.z-kat.com
INDICATIONS FOR USE
| 510(k) Number (if known): | K023975 |
|---|---|
| --------------------------- | --------- |
Device Name: Voyages
Indications for Use:
The Voyager is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide oxientation and reference information during intra-operative procedures.
The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a tigid anatomical structure may be made, such as:
- . Intra-crania surgical procedures involving space occupying lessons or malformations (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neutal decompression, or ● resection of spinal neoplasms
- ENT Procedures .
- Orthopedic surgical procedures ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use | OR | Over-the-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
| Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
|---|---|
| 510(k) Number | K023975 |
§ 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).