. Cataracts
Retinal Detachments (a separation of the retina from the middle coat of the eyeball) .
Orbital Lesions .
Tumors 에
Foreign bodies .
. Inflammation
Vascular Irregularities r
The I SYSTEM-ABD™ is a diagnostic ophthalmic ultrasound instrument designed to be used by ophthalmologists for diagnosis of the eye. It is expected that the user is trained in operation of ophinamogiles for the medical interpretation of ultrasonic images. The intended use is the same for the entire I 'SYSTEM-ABD™ product family.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (A and B mode)

Device Description

The difference between the Version 2 system and the existing 13 SYSTEM-ABD™ Diagnostic Ultrasound system is the operating system on which it runs. The new version has a 32-bit operating system, the current version has a DOS based operating system. No changes have been made to any external accessories or probes.

AI/ML Overview

The information provided in the document K041947 is a 510(k) summary for a modified diagnostic ultrasound system (I3 SYSTEM-ABD™ Diagnostic Ultrasound, Version 2). The purpose of this 510(k) is to indicate substantial equivalence to a predicate device (I3 SYSTEM-ABD™ Diagnostic Ultrasound, Version 1) because the operating system is being updated from DOS-based to a 32-bit Windows-based system. The hardware and external accessories/probes remain the same.

The document discusses Verification and Validation but does not provide specific acceptance criteria or study results demonstrating performance for clinical indications. Instead, it states that "All verification and validation tests have been performed as specified in the Design Controls Procedures (QAP 4.4) in conformance with 21 CFR 820.30. The tests have demonstrated that the unit complies with the intended functional requirements and system specifications." This implies that the focus of the submission is to confirm that the change in operating system does not negatively impact the existing, already-cleared performance of the device.

Therefore, many of the requested details, such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods, are not present in this specific 510(k) summary because the submission is for a software update to an already cleared device, not for the initial clearance of a new device with new performance claims.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document implicitly indicates that the acceptance criteria are that the modified device (Version 2) continues to meet the "intended functional requirements and system specifications" (page 1) as established for the predicate device (Version 1). This is a qualitative statement of equivalence for functional compliance after a software update, rather than quantitative performance metrics.

Reported Device Performance:
The document does not provide specific quantitative performance data for clinical indications or diagnostic accuracy for either the predicate or the modified device. The submission’s purpose is to affirm that the change in the operating system does not alter the intended use or performance of the device, which was presumably assessed during the original 510(k) clearance (K902007) for the predicate device.

Table:
Given the information, a table of specific acceptance criteria and reported device performance directly from this document cannot be created as these details are not provided. The critical "performance" stated is that "the unit complies with the intended functional requirements and system specifications" after the software update.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The verification and validation tests mentioned refer to internal Design Controls Procedures (QAP 4.4) (page 1). There is no mention of clinical data or patient studies for this specific 510(k).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable/Not specified. This 510(k) does not describe a study involving expert-established ground truth for performance evaluation of clinical indications.

4. Adjudication Method for the Test Set

Not applicable/Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done as described in this document. This submission focuses on a software update, not a comparative clinical performance study.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/Not specified. The device is a diagnostic ultrasound system intended for use by ophthalmologists for diagnosis, so it is inherently human-in-the-loop. The submission is not for a standalone algorithm.

7. The Type of Ground Truth Used

Not applicable/Not specified. No external ground truth data from clinical cases is mentioned as being used for this submission. The validation focuses on functional and system specifications.

8. The Sample Size for the Training Set

Not applicable/Not specified. This submission is for a software update to an existing device, not for a new algorithm that would typically require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not specified.

Summary

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

K041947

AUG 1 6 2004

Section 3: 510K Summary Innovative Imaging, Inc. Submitting Company Name: 9940 Business Park Drive* Suite 155 Sacramento, CA 95827 *Manufacturing and packaging also. Cynthia Kendall, President & CEO Contact: Tel (800) 765-7226 Fax (916) 363-3815 July 18, 2004 Application Date: 13 SYSTEM-ABD™ Diagnostic Ultrasound Name of Predicate Device: Version 1 (V1) Model of Predicate Device: 13 SYSTEM-ABD™ Diagnostic Ultrasound Name of Mccified Device: (For which trus Special 510(k) is being submitted) Model of Madified Device: Version 2 (V2) (For which this Special 510(k) is being submitted) 2950189 Establishment Regi:stration No.: Class II Classification of Device: Ultrasound, Diagnostic K902007 Original 510(k) Submission No .:

Reason for 510(k):

System software is being ported/rewritten utilizing a new Windows operating system. Existing iSYSTEM-ABD™ Diagnostic Ut rasound system hardware will remain the same.

Indications for Use:

. Cataracts
Retinal Detachments (a separation of the retina from the middle coat of the eyeball) .
Orbital Lesions .
Tumors 에
Foreign bodies .
. Inflammation
Vascular Irregularities r

Intended Use:

The I SYSTEM-ABD™ is a diagnostic ophthalmic ultrasound instrument designed to be used by ophthalmologists for diagnosis of the eye. It is expected that the user is trained in operation of ophinamogiles for the medical interpretation of ultrasonic images. The intended use is the
same for the entire I 'SYSTEM-ABD™ product family.

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

Description and Comparison of Device:

Verification and Validation:

All verification and validation tests have been performed as specified in the Design Controls Procedures (QAP 4.4) in conformance with 21 CFR 820.30. The tests have demonstrated that the unit complies with the intended functional requirements and system specifications.

Sterilization Information:

The 13 SYSTEM-ABD Diagnostic Ultrasound unit is not a sterile device.

Proposed Labeling and Marketing:

There will be no changes to either the labeling or marketing of the 13 SYSTEM-ABD Diagnostic Ultrasound.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

Ms. Cynthia Kendall President & CEO Innovative Imaging, Inc. 9940 Business Park Drive Suite 155 SACRAMENTO CA 95827

Re: K041947

Trade Name: 13 SYSTEM-ABD™ Diagnostic Ultrasound Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: July 1, 2004 Received: July 20, 2004

Dear Ms. Kendall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave forlowed your bowe 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 mendments, or to devices that have been reclassified in accordance with the provisions of the Amendinents, of to devices and its t (Act). You may, therefore, market the device, subject to I cacial I ood, Drug, and Goomene root et. The general controls provisions of the Act include the general bonnels pro registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for I mis determination of substantial Diagnostic Ultrasound, as described in your premarket notification:

Transducer Model Number

10 MHz Biometry A-Probe 8 MHz Diagnostic A-Probe 10MHz Diagnostic B-Scan 20MHz Diagnostic B-Scan

{3}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 v) into . Existing major regulations affecting your device . FDA it may be subject to such additional controls. Entering any arts 800 to 898 In addition, FDA can oc found in the Ood of over of concerning your device in the Federal Register. may publish further announcements concerning your acceptivalence determination does not mean r lease oc advised that i Dris assuates over device complies with other requirements of the Act that FDA has made a decommancir an a Joinistered by other Federal agencies. You must of any I cuttar statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, mendage anufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800), good if applicable, the electronic a form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping This detelmination of Substance squares special report. This report should contain complete the first device, you submit a postored are special is production line devices, requested information, including acousine output messes and 1997 "Information for Manufacturers
in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Mariaturer III Appendix OJ (cherosou) of the Senter College of Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved report is incomplete or comains anavept apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and I he special report should rolers. FILE' and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket I mis letter will anow you to ocgin manuting your device to a legally marketed noutheation. THE I Driven a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please If you dostro specific at (301) 594-4591. Additionally, for questions on the contact the Office of Compilance at (301), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket 40.5% Also, picase now the regaration on ther general information on your responsibilities under the houricallon (21 OFF Cricing of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

{4}------------------------------------------------

Page 3 - Ms. Kendall

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

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

Enclosures

{5}------------------------------------------------

I³SYSTEM-ABD Diagnostic System

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each uttrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityimaging	Combined(specify)	Other(specify)
Ophthalmic	✓	✓
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF A EEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Broydon

(Division Sign-Off)

Division of Reproductive F-3 and Radiological Devices 510(k) Number

{6}------------------------------------------------

10 MHz Biometry A-probe

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each rransducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the h Jman body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic	✓
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:__________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Harvey C. Broglon

(Division Sign Off) Division of Reproductive and Radiological Devices 510(k) Number

F-3

{7}------------------------------------------------

8$\mu$H$_2$ Diagnostic A-probe

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic	✓
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

Other (speat)
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancye brogdon

(Division Sign-Off), Division of Reproductive, and Radiological Device : " .. mber ''

F-3

{8}------------------------------------------------

10 MHz Diagnostic B-scan

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each Iransducer.

intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic		✓
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PASSE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C Brogdon

(Division Sign-Off) sion of Reproductive, Abdomin a Padiological Devices : ()(k) Number .

E-3

{9}------------------------------------------------

30 MHz Diagnostic B-scan

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each "transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the h Jman body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic		✓
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS UNE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hogdon

(Division Sign-Off) asion of Reproductive, Abdomi ം Radiological Devices ()(k) Number __

F-3

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.