(174 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a passive sensor feature for ergonomic improvement, not AI/ML capabilities.
No.
The device is described as an image-guided surgical system designed to improve ergonomics by eliminating cable connections. It guides surgical procedures but does not directly treat or heal a medical condition.
No
The SNN Scout is described as an "image-guided surgical system" that eliminates cable connections for tracked surgical instruments. Its indications for use relate to patients with lesions or malformations requiring surgery, rather than the detection or diagnosis of conditions.
No
The device description explicitly mentions "tracked surgical instruments" and "eliminating the cable connections between the tracked surgical instruments and the computer workstation," indicating the presence of hardware components (the instruments and the tracking system).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical navigation system used for guiding procedures on the head and spine. This involves direct interaction with the patient's anatomy during surgery, not the analysis of biological samples in vitro (outside the body).
- Device Description: The device description focuses on a surgical system with a passive sensor feature for tracking instruments. This is consistent with a surgical navigation system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SNN Scout clearly falls outside of this definition.
N/A
Intended Use / Indications for Use
The SNN Scout, comprised of a medical workstation and an integrated position-sensing instrument, is intended to be used pre-operatively and intra-operatively.
The passive instrument feature does not change the indications for use of the SNN Scout image-guided surgical device compared with the predicate ISG Family of Viewing Wands. The statement of indications for use continues to be as follows:
"The SNN Scout is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN Scout is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured."
Prescription Use (Per 21 CFR 801.109)
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The passive sensor feature is an addition to the SNN Scout image-guided surgical system. This feature is designed to improve the ergonomics of the user/device interaction by eliminating the cable connections between the tracked surgical instruments and the computer workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, spine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
ﻣﺔ .. .. .. . ﻨﻬﺎ،
المستوى المستوى المستوى المستوى المنتشار المنتشب المنتج المنتخب المنتج المنتخب المنتج المنتخب المنتج المنتخب المنتقل المنتقب المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل
::
98,2570
.
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Submitter: | I.S.G. Technologies Inc. |
| Address: | 6509 Airport Road |
| Mississauga, Ontario | |
| Canada L4V 1S7 | |
| Contact: | Carol Nakagawa, Clinical Scientist |
| Telephone: | (905) 672-2100 |
| Date: | July 17, 1998 |
| Trade Name: | SNN Scout. |
| Common Name: | Image-Guided Surgical System. |
| Classification Name: | Accessory to Stereotaxic Device. |
| Predicate Device: | |
| Device Description: | The passive sensor feature is an addition to the SNN Scout image- |
| guided surgical system. This feature is designed to improve the | |
| ergonomics of the user/device interaction by eliminating the cable | |
| connections between the tracked surgical instruments and the | |
| computer workstation. | |
| Intended Use: | The SNN Scout, comprised of a medical workstation and an |
| integrated position-sensing instrument, is intended to be used pre- | |
| operatively and intra-operatively. | |
| Comparison to | |
| Predicate: | The intended use and technological characteristics of the SNN |
| Scout image-guided surgical device including the passive sensor | |
| feature are substantially equivalent, in the opinion of I.S.G. | |
| Technologies, to those of the predicate device and do not pose any | |
| new issues of safety and effectiveness. |
510/k) Summarv of Safety and Effectiveness
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1999
Ms. Carol Nakagawa Clinical Scientist ISG Technologies, Inc. 6509 Airport Road Mississauga, Ontario Canada L4V 1S7
K982570 Re: Trade Name: SNN Scout Regulatory Class: II Product Code: HAW Dated: November 5, 1998 Received: November 9, 1998
Dear Ms. Nakagawa:
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 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 requirement, as set forth in the Quality System Regulation (OS) 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.
2
Page 2 - Ms. Carol Nakagawa
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) 594-4595. 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/dsmamain.html".
Sincerely yours,
f-Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
3
10. Indications for Use
The passive instrument feature does not change the indications for use of the SNN Scout image-guided surgical device compared with the predicate ISG Family of Viewing Wands. The statement of indications for use continues to be as follows:
"The SNN Scout is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN Scout is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured."
Prescription Use (Per 21 CFR 801.109)
P
(Division Sign-Off) Division of General Restorative Devices 510(k) Number