I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

K041947 · Innovative Imaging, Inc. · IYO · Aug 16, 2004 · Radiology

Device Facts

• Record ID: K041947
• Device Name: I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
• Applicant: Innovative Imaging, Inc.
• Product Code: IYO · Radiology
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

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.

Device Story

I SYSTEM-ABD™ is a diagnostic ophthalmic ultrasound system. Input: ultrasonic signals from transducers (10 MHz Biometry A-Probe, 8 MHz Diagnostic A-Probe, 10MHz Diagnostic B-Scan, 20MHz Diagnostic B-Scan). Operation: system processes ultrasonic echoes to generate diagnostic images of eye structures. Output: visual ultrasound images for clinical interpretation. Used in clinical settings by ophthalmologists. Version 2 (V2) updates the system by porting software to a 32-bit Windows operating system from a previous DOS-based system; hardware and accessories remain unchanged. Output assists ophthalmologists in diagnosing ocular conditions, potentially improving patient management and treatment planning.

Clinical Evidence

Bench testing only. Verification and validation tests were performed in accordance with Design Controls Procedures (QAP 4.4) and 21 CFR 820.30 to confirm compliance with functional requirements and system specifications following the operating system update.

Technological Characteristics

Diagnostic ultrasound system; 32-bit Windows operating system; transducers include 10 MHz Biometry A-Probe, 8 MHz Diagnostic A-Probe, 10MHz Diagnostic B-Scan, and 20MHz Diagnostic B-Scan. Non-sterile. No changes to hardware or accessories.

Indications for Use

Indicated for ophthalmic diagnostic ultrasound imaging of cataracts, retinal detachments, orbital lesions, tumors, foreign bodies, inflammation, and vascular irregularities.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• I3 SYSTEM-ABD™ Diagnostic Ultrasound Version 1 (V1) (K902007)

Submission Summary (Full Text)

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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 [phone] Fax [phone] 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.

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### Description and Comparison of Device:

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.

#### 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.

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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

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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 [phone]. Additionally, for questions on the contact the Office of Compilance at (301), please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 - Ms. Kendall

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

:

:

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

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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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| 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

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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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| 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

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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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| 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

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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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| 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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| 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