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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically expected for medical device performance evaluation (e.g., sensitivity, specificity, accuracy metrics). Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't provide a quantitative table of acceptance criteria with corresponding performance metrics. The "Summary of Effectiveness" section vaguely states: "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."

The core of the submission is a comparison of technological characteristics to a predicate device. This comparison implicitly defines the "acceptance criteria" as being substantially equivalent in function and safety to the predicate.

Technological Specification	Acceptance Goal (Implicit - Equivalent to Predicate)	Welch Allyn Image Management System Performance (Reported)
Intended Use	Capture, display, export, and print images obtained from a video colposcope.	Capture, display, export, and print images obtained from the Welch Allyn video colposcope.
Grab images from modalities w/o digital export	Yes	Yes - from Welch Allyn colposcope
Grab single images	Yes	Yes
Grab sequences of images	Yes	Yes
Operated by computer keyboard	Yes	Yes
Operated by an external device	Yes (implied, as predicate does this for some functions)	Yes - Welch Allyn video colposcope
Single channel color acquisition	Not explicitly required by predicate comparison	N/A (not applicable or not specified as a feature)
Multi-channel monochrome images	Not explicitly required by predicate comparison	N/A (not applicable or not specified as a feature)
Various frame grabber boards available	Yes (predicate has this)	No (difference noted, but deemed acceptable)
Grabbed image can be manipulated	No	No
Images can be added to a study	Yes (predicate has this)	N/A (not applicable or not specified as a feature)
User enter patient demographic data	Yes (predicate has this)	No (difference noted, but deemed acceptable)
Images can be stored with demographic data	Yes (predicate has this)	No (difference noted, but deemed acceptable)
Can be used with any device with video data stream output	Yes	Yes - but labeling indicates it is for use with Welch Allyn video colposcope
User selectable video sources	Yes	Yes - but labeling indicates it is for use with Welch Allyn video colposcope

2. Sample sized used for the test set and the data provenance:

The document does not specify a quantitative "test set" and a sample size in the context of clinical performance evaluation (e.g., number of patients or images). The evaluation seems to be based on engineering and functional testing to ensure the system performs its intended technical functions (capture, display, save, export, print) correctly. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The device's images are explicitly stated as "not intended for diagnostic purposes," which means no diagnostic "ground truth" (e.g., clinical diagnosis) was likely established for performance evaluation with respect to diagnostic accuracy. The ground truth, if any, would be related to the accurate capture and representation of the video feed.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring expert adjudication for ground truth is described.

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:

No, an MRMC comparative effectiveness study was not done. The device is an "Image Management System" and is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone system for image capture and management. Its performance is evaluated on its ability to correctly perform these functions, not on an algorithm's diagnostic output.

7. The type of ground truth used:

The concept of "ground truth" as it pertains to diagnostic accuracy is not relevant here, as the device is not for diagnostic purposes. The ground truth for its functional performance would be that the captured, displayed, saved, exported, and printed images accurately represent the video signal from the colposcope. This would be established through technical validation and user testing.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning system that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI/machine learning algorithm.

Summary

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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.

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Technological Characteristics:

Table 1
Predicate device feature and specification comparison:
TechnologicalSpecification	Welch Allyn Image ManagementSystem	Chili Video, Chili VideoPro
Intended Use:	Capture, display, export, and printimages obtained from the Welch Allynvideo colposcope.	Provide the user with a means tocapture and digitize image data from avideo data stream.
Used to grab images frommodalities that do not havedigital export functions?	Yes - from Welch Allyn colposcope	Yes
Can grab single images	Yes	Yes
Can grab sequences ofimages	Yes	Yes
Operated by computerkeyboard	Yes	Yes
Operated by an externaldevice	Yes - Welch Allyn video colposcope	No
Single channel coloracquisition	N/A	Yes
Multi-channel monochromeimages	N/A	Yes
Various frame grabber boardsavailable	No	Yes
Grabbed image can bemanipulated	No	No
Images can be added to astudy	N/A	Yes
User enter patientdemographic data	No	Yes
Images can be stored withdemographic data	No	Yes
Can be used with any devicethat has video data streamoutput	Yes - but labeling indicates it is for usewith Welch Allyn video colposcope	Yes
User selectable video sources	Yes - but labeling indicates it is for use	Yes

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.

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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,

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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

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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

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

Regulation Number and Section

§ 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.