Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound imaging device and does not mention any AI or ML components in the device description, intended use, or performance studies.

Therapeutic

No
The device is described as diagnostic and displays images, which is not a therapeutic function.

Diagnostic

Yes
The device is described as generating images for "Diagnostic ultrasound imaging" of the eye, indicating its use in diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "PC-based digital instrument that utilizes ultrasonic energy" and includes "pulser circuitry" and a "transducer," indicating it is a hardware device that uses software for control and display, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states the device "utilizes ultrasonic energy to generate various images of the eye." It acquires and displays images of the anterior segment of the eye.
No Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. It directly interacts with the patient's eye using ultrasound.

Therefore, this device falls under the category of imaging devices used for diagnostic purposes, but not as an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To acquire and display high resolution images of the anterior segment of the eye.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (Model P60, B-Scan (10 MHz), B-Scan (20 MHz), 35 MHz Water-Path, 50 MHz Water-Path)

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

IYO, ITX

Device Description

The Model P60 UBM is a PC-based digital instrument that utilizes ultrasonic energy to generate various images of the eye. The pulser circuitry is designed to accept information from the user via a graphical user interface provided by the software. The pulser generates signals specific to the probe installed. The signal acquired from the transducer is translated into an image that is displayed on an LCD monitor.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

anterior segment of the eye, Ophthalmic

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The Model P60 UBM has been tested to and meets the applicable requirements of IEC60601-1.

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.

Paradigm Medical Model P45 Ultrasonic Bio-Microscope

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.

Not Found

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

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

0

K050980

MAY 2 6 2005

MEDICAL INDUSTRIES, INC.

510(k) Premarket Notification a esta resultado a sempera e Model P60 UBM Ultrasonic Bio-Microscope

510(k) SUMMARY

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Paradigm Medical Industries, Inc. 2355 South 1070 West Salt Lake City, Utah 84119 Phone: (801) 977-8970 (801) 977-8973 Fax:

Contact Person: Edward A. Kroll Representative Consultant for Paradigm Medical Industries, Inc. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9810 Fax: (440) 546-9124

древозможности пристемвати се представления представления продавания по полнения подательного полнения подат

April 15, 2005 Date Prepared

Name of Device

Model P60 Ultrasonic Bio-Microscope

Common or Usual Name

Ultrasound System

Classification Name

Ultrasonic Pulsed Echo Imaging System

Predicate Devices

Paradigm Medical Model P45 Ultrasonic Bio-Microscope

Intended Use

To acquire and display high resolution images of the anterior segment of the eye.

1

Device Description

The Model P60 UBM is a PC-based digital instrument that utilizes ultrasonic energy to generate various images of the eye. The pulser circuitry is designed to accept information from the user via a graphical user interface provided by the software. The pulser generates signals specific to the probe installed. The signal acquired from the transducer is translated into an image that is displayed on an LCD monitor.

Performance Data

The Model P60 UBM has been tested to and meets the applicable requirements of IEC60601-1.

2

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a series of wavy lines, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paradigm Medical Industries, Inc. c/o Mr. Edward A. Kroll President Spectre Solutions, Inc. 5905 Fawn Lane CLEVELAND OH 44141

Re: K050980

Trade Name: Paradigm Medical Model P60 Ultrasonic Bio-Microscope Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: April 15, 2005 Received: April 21, 2005

Dear Mr. Kroll:

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 meets as of mirror price s 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 I cachi 1 ood, Drag, and sions of the Act. The general controls provisions of the Act include the general volulens proveels and isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

MAY 2 6 2005

This determination of substantial equivalence applies to the following transducers intended for r ms utth the Paradigm Medical Model P60 Ultrasonic Bio-Microscope as described in your premarket notification:

Transducer Model Numbers

35 MHz Water-Path 50 MHz Water-Path B-Scan (20 MHz) B-Scan (10 MHz)

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

3

Page 2 - Mr. Edward Kroll

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 does not mean r lease be determination that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or any I callated and registments, including, but not limited to: registration and listing (21 Comply with an the Her s requirements, we seen manufacturing practice requirements as set CI IT at 6077, mooning (21 CFR 220), and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I ms device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, including acoustic occasio of the Centember 30, 1997 "Information for Manufacturers In Appendix U, (cheroova) of the Standstic Ultrasound Systems and Transducers." If the special Secking Marketing Creatures or macceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not 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 no special report in a see a mould 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication. The I Drice results in 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 ucan't specific advice is 3 % (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Court to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

4

Page 3 – Mr. Edward Kroll

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

Sincerely yours,

Daniel A. Syson

first

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

Enclosures

5

System: Transducer: Model P60 ____________________________________________________________________________________________________________________________________________________________________

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

| Mode Of Operation | | | | | |-------------------------------| | Clinical Application | A Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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-skeletal Conventional | | Musculo-skelatal Superficial | | Other (Specify) | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | | |
-----------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| B | M | PWD | CWD | Color
| N | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |

tive (Spear)
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 Center for Devices and Radiological Health, Office of Device Evaluation

Daniel R. Lynn

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _____________

6

System:
Transducer:	B-Scan (10 MHz)

Transducer:

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

Clinical Application	B	CWD
Ophthalmic	N
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 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 Center for Devices and Radiological Health, Office of Device Evaluation

David A. Hynn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

・・ .

7

System:	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ (30 MHz)
---------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

B-Scan (20 MHz) 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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other*
(Specify)
Ophthalmic		N
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 Conventional
Musculo-skelatal 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 Center for Devices and Radiological Health, Office of Device Evaluation

David A. Dyson

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _

1

8

System:
Transducer:	35 MHz Water-Path

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

	Mode Of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other*
(Specify)
Ophthalmic		N
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 Conventional
Musculo-skelatal Superficial

Other (Specify)

ther (Speary)
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 Center for Devices and Radiological Health, Office of Device Evaluation

Daniel H. Ingram

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

9

System:
---------	--

50 MHz Water-Path Transducer:

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

Clinical Application	Mode Of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other*
(Specify)
Ophthalmic		N
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 Conventional
Musculo-skelatal 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 Center for Devices and Radiological Health, Office of Device Evaluation

Daniel R. Syzmanski

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _