OTI-SCAN 3000

• K Number: K092837
• Device Name: OTI-SCAN 3000
• Manufacturer: OPKO INSTRUMENTATION, INC
• Date Cleared: 2009-12-23 ( 99 days)
• Product Code: IYO
• Regulation Number: 892.1560

Intended Use

The OTI-Scan 3000 ultrasound system is a multi-purpose personal-computer based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including measurement of the axial length for determination of IOL power.

Device Description

The OTI-Scan 3000 is an Ultrasonic ophthalmic A-Scan and B-Scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.

Predicate Devices

K960622, K030770, K031391

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related concepts, and the description focuses on standard ultrasound principles and measurements.

Therapeutic

No
The device is described as an ultrasonic diagnosis system used for visualization and measurement within the eye, not for treating any condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" explicitly states that the device is an "ultrasonic diagnosis system for ophthalmic applications," and its purpose includes "visualize the interior of the eye by means of ultrasound and to make measurements inside the eye." This clearly indicates its role in diagnosing conditions or assessing the state of the eye.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "ultrasonic ophthalmic A-Scan and B-Scan system" that uses "pulsed ultrasound," indicating it includes hardware components for generating and receiving ultrasound waves.

IVD (In Vitro Diagnostic)

Based on the provided information, the OTI-Scan 3000 ultrasound system is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• OTI-Scan 3000 Function: The OTI-Scan 3000 is an ultrasound system that uses sound waves to visualize and measure structures within the eye. It does not analyze samples taken from the body.
• Intended Use: The intended use clearly states it's for "ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye". This is a diagnostic imaging and measurement device, not an in vitro test.

Therefore, the OTI-Scan 3000 falls under the category of a medical device used for diagnostic imaging and measurement, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OTI-Scan 3000 ultrasound system is a multi-purpose personal-computer based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including measurement of the axial length for determination of IOL power.

Product codes

IYO, ITX

Device Description

The OTI-Scan 3000 is an Ultrasonic ophthalmic A-Scan and B-Scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Bench-top testing has been performed on the OTI-Scan 3000 including accuracy tests, ultrasonic emissions tests, electrical safety tests and software validation tests.

Key Metrics

Not Found

Predicate Device(s)

K960622, K030770, K031391

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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DEC 2 3 2009

OPKO Instrumentation OTI-Scan 3000 510(k) Summarv

510(k) Summary
Company:	OPKO Instrumentation, LLC.
621 W 20th Street
Hialeah, FL 33010-2432
Phone: [phone] or 305-575-4178
Contact:	Mario Arbesu
Director, Compliance and Regulatory Affairs
OPKO Instrumentation, LLC.
4400 Biscayne Boulevard
Miami, FL 33137
Phone [phone]
Fax [phone]
Trade Name:	OTI-Scan 3000
Device Type:	Ultrasonic Pulsed Echo Imaging System
Classification Regulation:	892.1560
Class:	II
Panel:	Radiology
Product Code:	IYO
Predicate Devices:	OTI I-Scan (K960622)
OTI Scan with Transducers (K030770)
OTI-Scan HF Module System (K031391)
Device Description:	The OTI-Scan 3000 is an Ultrasonic ophthalmic A-Scan
and B-Scan system that uses the principles of sonar
(pulsed ultrasound) to measure the axial length of the
eyes and to visualize the interior of the eye.
Indications for use:	The OTI-Scan 3000 ultrasound system is a multi-purpose
personal-computer based ultrasonic diagnosis system for
ophthalmic applications, intended to both visualize the
interior of the eye by means of ultrasound and to make
measurements inside the eye, including measurement of
the axial length for determination of IOL power.

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Performance Data:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Mario Arbesu Direction, Compliance and Regulatory Affairs OPKO Instrumentation, Inc. 4400 Biscayne Blvd. MIAMI FL 33137

DEC 2 3 2009

Re: K092837

Trade/Device Name: OTI-Scan 3000 Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Codes: IYO and ITX Dated: August 28, 2009 Received: November 30, 2009

Dear Mr. Arbesu

We have reviewed your Section 510(k) premarket 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 (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.

This determination of substantial equivalence applies to the following transducers intended for use with the OTI-Scan 3000, as described in your premarket notification:

Transducer Model Number

OTI - Scan 20 MHz HF B-Probe

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.

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Page 2 - Mr. Mario Arbesu

Please be advised that FDA's issuance of a substantial equivalence determination does 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 (21 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.

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at [phone].

Sincerely yours,

Joshua C Myppi

for

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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System: OTI-Scan 3000

Intended Use: The OTI-Scan 3000 ultrasound system is a multi-purpose personal-computer based Intended Use: The OTF-Scall 3000 unrasound system a misualize the interior of the eye ulfrasonic dignosis system for opilliamite applications, measurement of the axial length for determination of IOL power.

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic	P						P
(A-Mode)
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previous cleared by FDA; E = added under this appendix

• Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, and Color Velocity ాల

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092837

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System: OTI-Scan 20 MHz HF B-Probe

Intended Use: Transducer for B-Scans with the OTI-Scan 3000 Ultrasound Imaging System.

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic	N
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previous cleared by FDA; E = added under this appendix

• Examples of other modes of operation may include. A-mode, Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, and Color Velocity

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

hormi m why

(Division Sign-O Division in Reproductive, Abdominal, and Kadsoingical Devices 510/k) Mumber