K Number
K033870
Device Name
IMAGE MANAGEMENT SYSTEM
Manufacturer
Date Cleared
2004-03-12

(91 days)

Product Code
Regulation Number
884.1630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Welch Allyn Basic Image Management system is intended to capture, display, save, export, and print images obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Management system are not intended for diagnostic purposes. The provider shall use the image on the colposcope monitor for clinical diagnosis.
Device Description
The Welch Allyn Image Management System is intended for use with the Welch Allyn Integorient by 510(k) number K955635. This system enables a customer to save an image to the customer's electronic file system for future reference and visit date. The file image may be imported into or based on patient lacklifer and tiertronic medical record/electronic health record if desired. The third-party DV Converter attaches to the Welch Allyn Colposcope through an Svideo connection. The Octposed on prected digitizes the image and sends it to through the Ovideo Intended "The IEEE 1394B connection supplies the TO over an iEE_ sampling frequency of 48kHz/16bit/2ch. Minimum 50 framestoos with a requirements to run the software will be specified. The images captured, displayed, saved, exported, and printed from the Basic Image Management byetem and the colposcope monitor for clinical diagnosis.
More Information

No
The description focuses on basic image capture, display, saving, and export functionalities. There is no mention of AI, ML, or any advanced image analysis beyond simple digitization and storage. The diagnostic responsibility is explicitly placed on the provider using the colposcope monitor, not the image management system.

No
The device is used to capture, display, save, export, and print images from a video colposcope. It is explicitly stated that the images are not for diagnostic purposes and that the provider uses the colposcope monitor for clinical diagnosis. Therefore, it is not a therapeutic device.

No

The "Intended Use / Indications for Use" section explicitly states, "The images captured, displayed, saved, exported, and printed from the Basic Image Management system are not intended for diagnostic purposes." It further clarifies, "The provider shall use the image on the colposcope monitor for clinical diagnosis," implying the diagnostic function resides with the colposcope itself and the user, not this image management system.

No

The device description explicitly mentions a "third-party DV Converter" that attaches to the colposcope and digitizes the image, indicating a hardware component is part of the system.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The images captured, displayed, saved, exported, and printed from the Basic Image Management system are not intended for diagnostic purposes."
  • Diagnostic Responsibility: The text explicitly states that "The provider shall use the image on the colposcope monitor for clinical diagnosis." This indicates that the diagnostic decision is made by the healthcare provider based on the real-time image on the colposcope monitor, not on the images processed or stored by the Basic Image Management system.
  • Functionality: The system's primary functions are image capture, display, saving, export, and printing for future reference and record-keeping. These are data management functions, not diagnostic tests performed on biological samples.

IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not perform such tests.

N/A

Intended Use / Indications for Use

The Welch Allyn Basic Image Management system is intended to capture, display, The Welch Allyn Dasto mages obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Imagement system are not intended for diagnostic purposes. The provider shall use the image on the colposcope monitor for clinical diagnosis.

Product codes (comma separated list FDA assigned to the subject device)

85 HEX and 90 LMA

Device Description

The Welch Allyn Image Management System is intended for use with the Welch Allyn Integorient by 510(k) number K955635.

This system enables a customer to save an image to the customer's electronic This system enables a odotomer to ours allows the customer to review images file system for future rolerence and visit date. The file image may be imported into or based on patient lacklifer and tiertronic medical record/electronic health record if desired.

The third-party DV Converter attaches to the Welch Allyn Colposcope through an The third-party DV Oonvertor attaches video that the Converter accepts Svideo connection. The Octposed on prected digitizes the image and sends it to through the Ovideo Intended "The IEEE 1394B connection supplies the TO over an iEE_ sampling frequency of 48kHz/16bit/2ch. Minimum 50 framestoos with a requirements to run the software will be specified.

The images captured, displayed, saved, exported, and printed from the Basic The Images capturity, displayer not intended for diagnostic purposes. The image Management byetem and the colposcope monitor for clinical diagnosis.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

video colposcope

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Provider

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)

Testing and evaluation indicate that the system meets the needs of the users of the device.

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.

K000411

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.

K955635

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

§ 884.1630 Colposcope.

(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

0

Page 192
K033870

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

MAR 1 2 2004

Submitter's Name & Address: Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, New York 13153

David Klementowski Contact Person & Telephone: (315) 685-4133

September 22, 2003 Date Summary Prepared:

Device Name: Classification Name -| Medical Image Digitizer Common/Usual Name - Image Management System Proprietary Name - Image Management System

Predicate Device: Chili Video, Chili VideoPro (510(k) number K000411)

Device Description:

e Description.
The Welch Allyn Image Management System is intended for use with the Welch The Welch Allyn Integorient by 510(k) number K955635.

This system enables a customer to save an image to the customer's electronic This system enables a odotomer to ours allows the customer to review images file system for future rolerence and visit date. The file image may be imported into or based on patient lacklifer and tiertronic medical record/electronic health record if desired.

The third-party DV Converter attaches to the Welch Allyn Colposcope through an The third-party DV Oonvertor attaches video that the Converter accepts Svideo connection. The Octposed on prected digitizes the image and sends it to through the Ovideo Intended "The IEEE 1394B connection supplies the TO over an iEE_ sampling frequency of 48kHz/16bit/2ch. Minimum 50 framestoos with a requirements to run the software will be specified.

The images captured, displayed, saved, exported, and printed from the Basic The Images capturity, displayer not intended for diagnostic purposes. The image Management byetem and the colposcope monitor for clinical diagnosis.

1

Technological Characteristics:

Table 1
Predicate device feature and specification comparison:
Technological
SpecificationWelch Allyn Image Management
SystemChili Video, Chili VideoPro
Intended Use:Capture, display, export, and print
images obtained from the Welch Allyn
video colposcope.Provide the user with a means to
capture and digitize image data from a
video data stream.
Used to grab images from
modalities that do not have
digital export functions?Yes - from Welch Allyn colposcopeYes
Can grab single imagesYesYes
Can grab sequences of
imagesYesYes
Operated by computer
keyboardYesYes
Operated by an external
deviceYes - Welch Allyn video colposcopeNo
Single channel color
acquisitionN/AYes
Multi-channel monochrome
imagesN/AYes
Various frame grabber boards
availableNoYes
Grabbed image can be
manipulatedNoNo
Images can be added to a
studyN/AYes
User enter patient
demographic dataNoYes
Images can be stored with
demographic dataNoYes
Can be used with any device
that has video data stream
outputYes - but labeling indicates it is for use
with Welch Allyn video colposcopeYes
User selectable video sourcesYes - but labeling indicates it is for useYes

Summary of Safety:

This system is safe for both the patient and user. The system is intended to capture, display, save, export, and print images obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Management system are not intended for diagnostic purposes. The provider shall use the image on the colposcope monitor for clinical diagnosis.

with Weich Allyn video colposcope

Summary of Effectiveness:

The Welch Allyn Image Management System is effective for its intended use. Testing and evaluation indicate that the system meets the needs of the users of the device.

2

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN... USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right. The profiles are stacked vertically, with the top profile being the largest and the bottom profile being the smallest. The seal appears to be an official emblem, possibly representing a government agency related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2004

Mr. David Klementowski Sr. Manager, Regulatory Affairs Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 SKANEATELES FALLS NY 13153-0220

Re: K033870 Trade/Device Name: Basic Image Management System Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 85 HEX and 90 LMA Dated: December 8, 2003 Received: December 16, 2003

Dear Mr. Klementowski:

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. Ilisting 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 docs 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 (2) 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,

3

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4654
Other(301) 594-4692

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) you may obtain. 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

4

510(k) Number (if known): K033870
Device Name: Basic Image Management System

Indications For Use:

The Welch Allyn Basic Image Management system is intended to capture, display, The Welch Allyn Dasto mages obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Imagement system are not intended for diagnostic purposes. The provider shall use the image on the colposcope monitor for clinical diagnosis.

(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

(Optional Format 1-2-96)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number