WELCH ALLYN FRONT-LINE DOC

K984215 · Welch Allyn, Inc. · LLZ · Feb 11, 1999 · Radiology

Device Facts

• Record ID: K984215
• Device Name: WELCH ALLYN FRONT-LINE DOC
• Applicant: Welch Allyn, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Welch Allyn model #77000 Front-Line Doc™ system is intended for dictation and r he volumentation. It also enhaoces medical records by allowing physicians to add images to their dictated patient notes. The device is intended to be used by trained personnel within a medical or school environment.

Device Story

Front-Line Doc is a medical imaging and documentation system comprising a handheld portable instrument and PC-based software. It enables physicians to dictate patient notes and append images to these records. Used in medical or school environments by trained personnel, the system facilitates transcription, review, management tracking, and reporting. The device is non-contact and utilizes low-voltage components. By integrating imaging with dictation, it streamlines documentation workflows, potentially improving record completeness and clinical efficiency.

Clinical Evidence

No clinical data. Effectiveness was determined via on-site evaluations with practicing physicians who compared the device to existing dictation and imaging systems. Evaluators confirmed the device met documentation needs effectively.

Technological Characteristics

Handheld portable instrument with PC-based software. Materials are skin-compatible. Electrical safety per UL 544. Low-voltage halogen lamp (max 5 watts). Non-contact design. Rounded contact surfaces. Software verification and validation performed.

Indications for Use

Indicated for dictation and medical record enhancement by trained personnel in medical or school environments to allow physicians to add images to dictated patient notes.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Image Vault (K974102)

Submission Summary (Full Text)

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

2/11/99

K984215

### "510 (k) SUMMARY" Summary of Safety and Effectiveness

Submitter's Name & Address: Welch Allyn Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, N.Y. 13153-0220

Contact Person & Telephone: Colin Wolff [phone]

November 19, 1998 Date Summary Prepared:

- Classification Name Picture Archiving and Communication System Device Name: Common/Usual Name - Dictation System with PACS Proprietary Name - Welch Allyn Front-Line Doc
model Image Vault (ref. 510(k) #K974102) Predicate Device:

Device Description, Intended Use & Effectiveness:

Front-line Doc is a medical imaging and documentation system. It consists of a handheld portable instrument and software applications bundled to inhance office transcription and documentation. Software applications can be utilized on a PC to perform the transcription, review, and management tracking and reporting processes.

The Welch Allyn model #77000 Front-Line Doc™ system is intended for dictation and also enhances medical records by allowing physicians to add images to their dictated patient notes. The device is intended to be used by trained personnel within a medical or school environment.

The effectiveness of the Front-Line Doc system is the same as current dictation systems and PACS already on the market.

#### Technological Characteristics:

See attachment "A" for a comparison of the Front-Line Doc to the predicate device.

#### Safety:

Numerous safety areas were investigated and reviewed to ensure that the Welch Allyn Front-Line Doc System is as safe, or safer than existing similar devices already in commercial distribution. The device under review is considered very safe for both practitioner and patient. It is non-contact for the patient. The procedure and technique are low risk. The specific safety areas considered are as follows:

- The device is not intended to contact any patient. It is made of Toxicity materials that are skin compatible.
- has agency approval based on standards from UL 544. Electrical
- Light output levels are consistent with output from safe use journal Light

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

| Explosion | Highly unlikely; manufactured of non-explosive materials. The batteries are protected from an electrical short condition. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Surface<br>Temperature | All surfaces have been evaluated for practitioner contact. |
| Fire Hazard | Probability extremely low; this system uses a low voltage halogen<br>lamp, which draws a maximum of 5 watts power. The video and audio<br>portions are also low voltage. |
| Mechanical -<br>(Sharp Edges) | All contact surfaces have been blended and<br>rounded. No injury will result from sharp edges. |
| Software | Risk Analysis, FMEA, and Verf.& Valid. performed for software. |

#### Summary of Effectiveness:

The determination of device effectiveness was coordinated in the following manner:

The Welch Allyn Front-Line Doc development team conducted on-site evaluations of the device with practicing physicians in an effort to determine if the device met all of the practitioner's needs. The evaluating practitioners were also users of either an existing dictaton, or other model dictation and imaging devices (all have the same intended use). The results of the evaluations indicated that the Welch Allyn Front-Line Doc System serves the needs of the documentation procedure in an equivalent or better manner of effectiveness.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Colin Wolff Certified Quality Engineer Welch Allyn, Inc. 4341 State Street Rd. Skaneateles Falls, NY 13153-0220 Re:

K984215 Welch Allyn Front-Line Doc Dated: November 20, 1998 Received: November 24, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Wolff:

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). 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 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.

lf 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

J.J.

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): K984215

Device Name: Welch Allyn Front-Line Doc

## Indications For Use:

The Welch Allyn model #77000 Front-Line Doc™ system is intended for dictation and r he volumentation. It also enhaoces medical records by allowing physicians to add images to their dictated patient notes. The device is intended to be used by trained personnel within a medical or school environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Vimil le. Segpan
(Division Sign-Off)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984215