← Product Code [LNI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI) · K984167

# SAGE 7 (K984167)

_GE Medical Systems · LNI · Jan 12, 1999 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K984167

## Device Facts

- **Applicant:** GE Medical Systems
- **Product Code:** [LNI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI.md)
- **Decision Date:** Jan 12, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Indications for Use

SAGE 7 is a package of software tools for MR spectroscopic data processing and display. SAGE 7 is indicated for use for a wide variety of MR spectroscopic data management tasks, including file handling, display, processing/modeling, analysis, storage and hard copy output. The resultant spectroscopic presentations, when interpreted by a trained physician, can provide physiological / chemical information that can be useful in determining a diagnosis.

## Device Story

SAGE 7 is a software toolkit for MR spectroscopy data management, operating on GE Signa Horizon Systems and Advantage Windows workstations. It processes raw spectroscopy data to reconstruct, analyze, and display spectra and spectroscopic images. The system enables trained clinical spectroscopists to perform tasks such as file handling, modeling, and numerical analysis (e.g., peak positions, widths, heights, areas). Outputs are viewed by physicians to derive physiological or chemical information for diagnostic support. The device enhances the previously marketed SA/GE Analysis option by improving the user interface and leveraging modern workstation computational power to perform sophisticated curve-fitting algorithms that were previously impractical.

## Clinical Evidence

Bench testing only. The device was evaluated for compliance with international medical equipment safety standard IEC 601-2-33 (Particular requirements for the safety of magnetic resonance equipment for medical diagnosis).

## Technological Characteristics

Software-based MR spectroscopy analysis toolkit. Operates on GE Signa Horizon Systems and Advantage Windows workstations. Implements standard spectroscopic processing algorithms including Fourier transform, phasing, peak-picking, integration, and curve-fitting. Complies with IEC 601-2-33 safety standards.

## Regulatory Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

## Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Predicate Devices

- SA/GE Analysis option

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circular border, which has decorative swirls or flourishes around the perimeter. The logo is presented in black and white.

page 1 of 2

K984167

P.O. Box 414. W-709 Milwaukee. WI 53201 USA

JAN 1 2 1999

## SUMMARY OF SAFETY AND EFFECTIVENESS

- o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, November 19, 1998
- o Identification of the Product SAGE 7 Spectroscopy Analysis Option

| Manufactured by: | GE Medical Systems<br>3200 N. Grandview Blvd.<br>Waukesha, WI 53188 |
|------------------|---------------------------------------------------------------------|
|------------------|---------------------------------------------------------------------|

- 0 Marketed Devices
The SAGE 7 Spectroscopy Analysis option is an enhancement to the currently marketed SA/GE Analysis option in distribution since the reclassification of Magnetic Resoncance Diagnostic devices (ref. 53 FR 5078, Feb. 1, 1989).

- Device Description
0

The GE SAGE 7 Spectroscopy Analysis Software is designed to operate on GE Signa Horizon Systems and GE Advantage Windows workstations. It provides a toolkit of software applications to handle a wide variety of tasks associated with spectroscopy data management. The SAGE (Spectroscopy Analysis GE) package provides the capability for the trained clinical spectroscopist to reconstruct, analyze, and display spectra and spectroscopic images to provide information to support a diagnosis. SAGE 7 provides a tool for the spectroscopist to process raw spectroscopy data into spectra or spectroscopic images, view them, and optionally perform numerical analyses to obtain spectroscopic parameters (ex. peak positions, widths, heights, areas, etc.).

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, creating a strong contrast. The logo is a well-known symbol associated with the General Electric company.

page 2 of 2

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

# SUMMARY OF SAFETY AND EFFECTIVENESS

#### o Indications for Use

SAGE 7 is a package of software tools for MR spectroscopic data processing and display. SAGE 7 is indicated for use for a wide variety of MR spectroscopic data management tasks, including file handling, display, processing/modeling, analysis, storage and hard copy output. The resultant spectroscopic presentations, when interpreted by a trained physician, can provide physiological / chemical information that can be useful in determining a diagnosis.

#### 0 Comparison with Predicate

The SAGE 7 Spectroscopy Analysis option is an enhancement to the SA/GE Analysis option. The basic operations (ex. Fourier transform, phasing, peak-picking, integration, fitting, etc.) have not significantly changed, and are provided in both SAGE 7 and the SA/GE Analysis option. What has changed is the sophistication of the user interface. In addition, the increased computational capability of modern workstations have made possible as routine operations some sophisticated curve-fitting algorithms that were impractical on older computer hardware.

### o Summary of Studies

The SAGE 7 Spectroscopy Analysis option was evaluated to International medical equipment safety standard IEC 601-2-33 titled Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The SAGE 7 Spectroscopy Analysis option is comparable to the SA/GE Spectroscopy option.

- 0 Conclusions
It is the opinion of GE that the SAGE 7 Spectroscopy Analysis option is substantially equivalent to the SA/GE Spectroscopy option. SAGE 7 does not include any new indications for use, nor does use of this device result in any new potential hazards.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is likely part of a document or sign.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard

JAN 1 2 1999

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 . W-709 Milwaukee, WI 53201

Re: K984167

SAGE 7 Spectroscopy Dated: November 19, 1998 Received: November 20, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNI

Dear Dr. Kroger:

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 vour 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: SAGE 7 Spectroscopy

Indications For Use:

SAGE 7 is a package of software tools for MR spectroscopic data processing and display. SAGE 7 is indicated for use for a wide variety of MR spectroscopic data management tasks, including file handling, display, processing/modeling, analysis, storage and hard copy output. The resultant spectroscopic presentations, when interpreted by a trained physician, can provide physiological / chemical information that can be useful in determining a diagnosis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymon

(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological I 510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K984167](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K984167)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com