(37 days)
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 (B-Mode)
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.
The provided text describes a 510(k) Premarket Notification for the Paradigm Medical Model P60 UBM Ultrasonic Bio-Microscope. The information primarily focuses on the device's technical specifications, intended use, and substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria.
Therefore, it's not possible to populate all the requested fields as a clinical study with detailed performance metrics, ground truth establishment, or expert adjudication as typically seen for AI/ML devices is not present in this document.
However, based on the available information, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets applicable safety requirements | "meets the applicable requirements of IEC60601-1." |
| Display high-resolution images of the anterior segment of the eye (Implied by Intended Use) | Device is designed to "acquire and display high resolution images of the anterior segment of the eye." |
| Functioning as an Ultrasound System | Substantially equivalent to predicate device, implied to function similarly. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The document describes a technical safety compliance and substantial equivalence claim, not a clinical performance study with a test set of patient data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of establishing ground truth with experts for a test set in a clinical performance study.
4. Adjudication method for the test set
- Not applicable. No adjudication method is mentioned as there's no clinical test set being evaluated for performance against a ground truth.
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. This device is an ultrasonic bio-microscope, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device; no algorithm-only performance study would be relevant.
7. The type of ground truth used
- Not applicable in the context of clinical performance data. The "ground truth" for this submission appears to be regulatory standards (IEC60601-1) and the performance characteristics of a legally marketed predicate device (Paradigm Medical Model P45 Ultrasonic Bio-Microscope) for establishing substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
{0}------------------------------------------------
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:
| 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 | 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) |
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:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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-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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 _
§ 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.