Pie Medical's 50L Tringa ultrasound system is to be used by or under the direction of a physician to perform general non-invasive and invasive diagnostic ultrasound imaging studies, to include: abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular and musculoskeletal (conventional and superficial). The system provides ultrasound guidance for freehand or biopsy guided placement of needles and catheters in vascular or other anatomical structures.

Device Description

The 50L Tringa ultrasound system is a lightweight, low-output, portable, real-time, ultrasound scanner used to acquire and display images in 2D, M or a combination of these modes. The 50L Tringa system has one linear probe and can be operated via rechargeable battery and/or mains connection.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Ko33604 device:

Based on the provided 510(k) summary for the 50L Tringa Ultrasound Imaging System (K033604), there is no specific information detailing acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or studies designed to prove the device meets such criteria in terms of diagnostic capability.

This document primarily focuses on establishing substantial equivalence to predicate devices. Substantial equivalence is determined by demonstrating that the new device has the same intended use as a legally marketed predicate device and has either the same technological characteristics or, if it has different technological characteristics, that the new device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. This often involves comparing technical specifications and safety standards rather than new clinical outcome studies.

Therefore, many of the requested elements for a detailed study description are not present in this type of 510(k) submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable or available in this document. The submission establishes equivalence based on intended use and technological characteristics compared to predicate devices. Performance is implied to be equivalent to the predicate devices and compliant with safety standards.

Acceptance Criteria (Explicitly Stated)	Reported Device Performance (as implied by equivalence)
Intended Use Equivalence:	The 50L Tringa matches the intended uses of the predicate devices for the specified clinical applications (see comparison table below).
Technological Characteristics Equivalence:	The 50L Tringa's features (e.g., imaging modes, transducer type, display, digital archival) are comparable to the predicate devices.
Safety Standard Compliance:	EN60601-1 (Electrical Safety), Track 1 (Ultrasound Safety)
Clinical Applications:	The system is indicated for: Abdominal, Neonatal cephalic, Pediatric, Peripheral vascular, Small organs, Intraoperative abdominal, Intraoperative vascular, and Musculoskeletal (conventional and superficial). As per the "Indications for Use" forms.

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

Not applicable. This submission does not describe a clinical performance study with a test set of patient data to measure diagnostic accuracy. Instead, it relies on demonstrating equivalence to predicate devices, which generally means no new clinical data is presented for diagnostic performance.

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

Not applicable. No test set requiring ground truth establishment by experts is described in this regulatory submission.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert ground truth establishment is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or reported in this document. The submission is for substantial equivalence, not a comparative effectiveness study that measures the improvement of human readers with AI assistance. Ultrasound systems like this are tools, not AI assistants.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an ultrasound imaging system, a hardware and software system that provides images for a human operator (physician) to interpret. It's not an AI algorithm that produces a standalone diagnostic output.

7. The Type of Ground Truth Used

Not applicable. No diagnostic performance study is described that would require a ground truth. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. The device is an ultrasound imaging system, not an AI model trained on a dataset.

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

Not applicable. As above, this device is an ultrasound imaging system.

Summary of How the Device Meets Acceptance Criteria (and Substantial Equivalence)

The primary method for "proving" the device meets implied acceptance criteria is through demonstrating substantial equivalence to legally marketed predicate devices, as allowed under the 510(k) pathway.

The core of the submission involves a comparison:

Reference: Section 807.92(a)(3) and the "Additional Substantial Equivalence Information" table.

Feature / Indication	50L Tringa (This Submission)	Pie Medical 50S Tringa (K020112 - Predicate 1)	SonoSite iLook 25 (K021628 - Predicate 2)
Intended Use:	General diagnostic ultrasound imaging studies (as listed) + guidance for needle/catheter placement.	Similar, but fewer specific clinical applications listed.	Similar, encompassing the listed clinical applications + guidance.
Clinical Applications:	Pediatric, Small Organs, Intraoperative (abdominal & vascular), Peripheral Vascular, Musculoskeletal (Conventional & Superficial), Abdominal, Neonatal Cephalic.	Less comprehensive than 50L Tringa (e.g., no Pediatric, Neonatal Cephalic, Intraoperative).	Very similar to 50L Tringa.
Transducer Type:	Linear	No (implied different type or not specified)	Yes (Linear)
2D Freq MHz:	10 - 5	3.5/5.0/7.5	10 - 5
Biopsy Guidance:	Yes	No	Yes
Free-Hand Vascular Access:	Yes	No	Yes
Display Type:	LCD	LCD	LCD
Imaging Modes:	2D / M-mode	2D / M-mode	2D - Color Doppler
Monitor Size:	5 inch	5 inch	5 inch
Digital Archival capabilities:	Yes	Yes	Yes
VCR:	Yes	Yes	Yes
Electrical Safety:	EN60601-1	EN60601-1	EN60601-1
Ultrasound Safety:	Track 1	Track 1	Track 3

Conclusion from Equivalence:
The 50L Tringa demonstrates substantial equivalence by offering similar or expanded clinical applications and technological characteristics compared to the predicate devices. Where there are differences (e.g., expanded intended uses like "Pediatric," "Neonatal Cephalic," "Intraoperative" relative to Predicate 1, or differences in imaging modes compared to Predicate 2's Color Doppler), the submission implies these do not raise new questions of safety or effectiveness, or that the device is at least as safe and effective. The compliance with recognized safety standards (EN60601-1, Track 1) is a key part of demonstrating safety.

The FDA's letter (K033604) confirms this by stating: "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..."

The "study" used to "prove" acceptability is the substantial equivalence comparison against predicate devices, and adherence to recognized electrical and ultrasound safety standards, rather than a clinical performance study for diagnostic accuracy.

Summary

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Ko33604

DEC 1 5 2003

510(k) Sommarv

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

Submitter Information

Colleen Densmore, Official Correspondent 8000 Castleway Drive Indianapolis, IN 46250 (317) 849-1916 Phone: (317) 5779070 Facsimile:

Colleen Densmore Contact Person:

November 11, 2003 Date:

807.92(a)(2)

Trade Name:	50L Tringa Ultrasound Imaging System
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic pulsed echo imaging system	892.1560
Classification Number:	90IYO
807.92(a)(3)
Pie Medical	50S Tringa	K020112
SonoSite	i Look 25	K021628

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table

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Device Description

807.92(a)(5)

Intended Use(s)

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	Pie Medical50L TringaThis Submission	Pie Medical50S TringaK020112	SonositeiLook 25K021628
General characteristics
Intended Use
Pediatric	Yes	No	Yes
Small Organs	Yes	Yes	Yes
Intraoperative(abdominal and vascular)	Yes	No	Yes
Peripheral Vascular	Yes	Yes	Yes
Musculoskeletal(Conventional & Superficial)	Yes	No	Yes
Abdominal	Yes	Yes	Yes
Neonatal Cephalic	Yes	No	Yes
Transducer Type
Linear	Yes	No	Yes
2D Freq MHz	10 - 5	3.5/5.0/7.5	10 - 5
Biopsy Guidance	Yes	No	Yes
Free-Hand Vascular Access	Yes	No	Yes
Display Type	LCD	LCD	LCD
Imaging Modes	2D / M-mode	2D / M-mode	2D - ColorDoppler
Monitor Size	5 inch	5 inch	5 inch
Digital Archival capabilities	Yes	Yes	Yes
VCR	Yes	Yes	Yes
Safety
Electrical Safety	EN60601-1	EN60601-1	EN60601-1
Ultrasound Safety	Track 1	Track 1	Track 3

Comparison Chart for Substantial Equivalence i

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.

Public Health Service

DEC 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pie Medical % Ms. Colleen Densmore Official Correspondent The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K033604

Trade Name: 50L Tringa Ultrasound Imaging System 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: November 11, 2003 Received: November 17, 2003

Dear Ms. Densmore:

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 50L Tringa Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

LA/7.5 MHz/L20/64el

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.

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);

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labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality fabeling (21 OF R Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable 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 prominently marked "ADD-TO-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 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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, alease note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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".

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

Sincerely vours.

David A. Syzman

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

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

					Mode of Operation
Clinical application	A	B	M	PWD	ColorDoppler	Ampl.Doppler	ColorVelocityImaging	Combined	Other
Ophthalmic
Fetal							(2)	(1)
Abdominal		N	N					(2)	(1)
Pediatric		N	N					(2)	(1)
Small organs		N	N					(2)	(1)
Neonatal cephalic		N	N
Cardiac
Cardiac Pediatric
Transesophageal
Transrectal
Transvaginal
Transurethral
Intra-operative(abdominal)		N	N					(2)	(1)
Intra-operative		N	N					(2)	(1)
(vascular)
Peripheral vascular		N	N					(2)	(1)
Laparoscopic								(2)	(1)
Musculoskeletalconventional		N	N					(2)	(1)
Musculoskeletalsuperficial		N	N					(2)	(1)
Other

aning System ound Im ﺔ ﺍﻟ

N = new indication

Additional comments:

Additional comments:
(1) Small organs include Thyroid, Breast and Testicles, Included within this 510(k) is (1) Small organs include Thyrold, Breast and resticals, models with the many of ther anatomical structures

arratornical sa society of mode and B+M mode

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
------------------	--

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	1033604

લુકાઓ પૈકીના એક એવા દિવસાય તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્

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Diagnostic Ultrasound Indications for Use Form

LA /7.5MHz / L20 /64el
Mode of Operation
Clinical application	A	B	M	PWD	ColorDoppler	Ampl.Doppler	ColorVelocityImaging	Combined	Other
Ophthalmic
Fetal							(2)	(1)
Abdominal		N	N					(2)	(1)
Pediatric		N	N					(2)	(1)
Small organs		N	N					(2)	(1)
Neonatal cephalic		N	N					(2)	(1)
Cardiac
Cardiac Pediatric
Transesophageal
Transrectal
Transvaginal
Transurethral
Intra-operative(abdominal)		N	N					(2)	(1)
Intra-operative(vascular)		N	N					(2)	(1)
Peripheral vascular		N	N					(2)	(1)
Laparoscopic
Musculoskeletalconventional		N	N					(2)	(1)
Musculoskeletalsuperficial		N	N					(2)	(1)
Other

1 4 / 7 5MHz / 1 20 / 64el

N = new indication

Additional comments:

Additional comments.
(1) Small organs include Thyroid, Breast and Testicles, Included within this 510(k) is (1) Small organs include Thylod, Dreast and Toboase, Misl. 2007
imaging to assist in the placement of needles and catheters in vascular or other anatomical structures

(2) Combined is: B+B mode and B+M mode

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

Prescription Use

Daniela Salzman

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices NUSBJ 0(k) Number __ 2/18/2009 ALCH

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.