The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit are indicated for real-time imaging of selected blood vessels and nearby anatomic structures before and during percutaneous procedures, ultrasonic guidance for needle placement and vessel catheterization in a sterile environment, and Doppler confirmation of directional blood flow.

Device Description

The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System with associated transducer and accessories is designed and manufactured to provide hands-free ultrasound vascular imaging (simultaneous transverse and longitudinal views) for percutaneous vascular punctures (needle placement and vessel catheterization). The PunctSURE® System consists of three major subsystems: (1) the Transducer and Cable, (2) the Dual Image Monitor, and (3) the Sterile Vascular Imaging Procedure Kit. The sterile, single use, and disposable PunctSURE® Vascular Imaging Procedure Kit contains products used for the diagnostic procedure (magnetic laminate, acoustic coupling gel, sheath, snap ring, transducer cover, gauze sponges, and cotton swabs).

AI/ML Overview

The provided text describes the 510(k) summary for the Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness with human readers.

Here's the breakdown of what is available in the provided text:

Acceptance Criteria and Reported Device Performance

The document describes the device's technological and operational characteristics in comparison to a predicate device (Site~Rite 3). The "performance testing" section primarily references compliance with FDA guidance and various safety and electromagnetic compatibility standards, rather than clinical performance metrics.

Characteristic	Acceptance Criteria (Implied by Predicate Device Equivalence)	Reported Device Performance (PunctSURE®)
Intended Use	Vascular imaging for needle guidance	Yes
Fundamental Technology	Pulsed echo ultrasound	Pulsed echo ultrasound
Real time	Yes	Yes
B-Mode	Yes	Yes
Digital	Yes	Yes
Software-controlled	Yes	Yes
Hands-free visualization	No (for predicate)	Yes
Doppler confirmation of directional blood flow	No (for predicate)	Yes
Probes (Imaging element)	9.0 MHz, 7.5 MHz, 5.9 MHz, 3.5 MHz (for predicate)	7.5 MHz
Probes (Doppler element)	N/A (for predicate)	5.0 MHz
Sterilizable probe	No	No
Probe disinfection instructions	Yes	Yes
Focal Depth (Imaging element)	Min: 0.5 cm (9.0 MHz probe), Max: 18 cm depth (3.5 MHz probe) for predicate	20 mm ± 5 mm
Focal Depth (Doppler element)	N/A (for predicate)	35 mm ± 5 mm
Sector angle	26 degrees (9.0 and 7.5 MHz probes), 75 degrees (3.5 MHz) for predicate	N/A
Views	Transverse or Longitudinal	Transverse and Longitudinal
Dual image monitor	No	Yes
Screen size	4 ½" diagonal CRT	12.1" diagonal LCD
Freeze frame	Yes	No
Video output	Yes	No
Battery powered	Yes	No
AC powered	Yes	Yes
Portable System	Yes	Yes
Sterile kit	Yes (from other source)	Yes (part of system package)

Note on Acceptance Criteria: The document primarily uses the predicate device (Site~Rite 3) for establishing substantial equivalence. Thus, the "acceptance criteria" are largely implied by meeting or demonstrating similar functionality/safety as the predicate, along with compliance to recognized standards. There are no explicit quantitative performance metrics (e.g., sensitivity, specificity) stated as acceptance criteria in this summary.

Study Details

The provided text does not include information about a clinical study with a test set, ground truth, or expert review that would typically prove device performance in terms of diagnostic accuracy or effectiveness. The "Performance Testing" section states:

"The PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit were tested according to and demonstrated in compliance with requirements set forth in FDA Guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (1997) including the following, FDA-recognized, voluntary standards... In addition, verification and validation testing demonstrates that the System fulfills performance specifications."

This indicates that internal verification and validation were performed to ensure the system meets its own specifications and complies with regulatory standards, which are largely related to safety, electrical, and electromagnetic compatibility. It does not describe a clinical performance study as typically understood in the context of diagnostic accuracy.

Therefore, the following information is not available in the provided text:

Sample size used for the test set and the data provenance: Not mentioned. The testing described is compliance-focused, not clinical performance-focused with a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned as there's no described clinical performance study with a ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: Not mentioned. This device is an ultrasound imaging system from 2002, and the concept of "AI assistance" in this context is likely not applicable.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not mentioned. The device is described as an imaging system intended for real-time human-in-the-loop use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary

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JUL = 2 2002 1021984

Attachment A-2

510(k) Summary

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510(k) Summary for the Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System

1. SPONSOR

Inceptio Medical Technologies, L.C. 1401 N. Hwy 89, Suite 220 Farmington, Utah 84025

Contact Person: Bradley J. Stringer

Telephone: 801-447-7000 Fax: 801-447-7400

Date Prepared: May 30, 2002

2. Device Name

Proprietary Name:	PunctSURE® Ultrasound Vascular Imaging System
Common/Usual Name:	Diagnostic pulsed Doppler imaging systemPulse echo imaging system
Classification Name:	Diagnostic ultrasound system

3. PREDICATE DEVICES

Site~Rite 3 (K993624)

4. DEVICE DESCRIPTION

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5. INTENDED USE

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Inceptio Medical Technologies, L.C. claims equivalence of the PunctSURE® Ultrasound Vascular Imaging System to the Site~~Rite 3 based on intended use, technological, and operational characteristics. A side-by-side comparison of the PunctSURE® System and the Site~~Rite 3 is provided in the table below.

Side-by-Side Comparison of the Inceptio PunctSURE® Ultrasound Vascular Imaging System with the Dymax Site~Rite 3

Characteristic	InceptioPunctSURE®	Site~Rite 3DymaxK993624
Indications for Use:Vascular imaging for needle guidance	Yes	Yes
Contraindication	Implanted pacemaker	None specified
Fundamental Technological Characteristics
Fundamental Technology	Pulsed echo ultrasound	Pulsed echo ultrasound
Real time	Yes	Yes
B-Mode	Yes	Yes
Digital	Yes	Yes
Software-controlled	Yes	Yes
Design and Operational Characteristics
Hands free visualization	Yes	No
Doppler confirmation of directional blood flow	Yes	No
Probes	Image element: 7.5 MHzDoppler element: 5.0 MHz	9.0 MHz7.5 MHz5.9 MHz3.5 MHz
Sterilizable probe (transducer)	No	No
Probe disinfection instructions provided	Yes	Yes

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Side-by-Side Comparison of the Inceptio PunctSURE® Ultrasound Vascular Imaging System with the Dymax Site~Rite 3 (Continued)

Characteristic	InceptioPunctSURE®	Site-Rite 3DymaxK993624
Focal Depth	Imaging element: 20 mm ± 5 mmDoppler element: 35 mm ± 5 mm	Min: 0.5 cm (9.0 MHz probe)Max: 18 cm depth (3.5 MHz probe)
Sector angle	N/A	9.0 and 7.5 MHz probes: 26 degrees3.5 MHz: 75 degrees
Views	Transverse and Longitudinal	Transverse or Longitudinal
Dual image monitor	Yes	No
Screen size	12.1" diagonal LCD	4 ½" diagonal CRT
Freeze frame	No	Yes
Video output	No	Yes
Battery powered	No	Yes
Battery time	Not applicable	2 hour run5 hour recharge
Battery type	Not applicable	Nickel metal hydride
AC powered	Yes	Yes
Portable System	Yes	Yes
Sterile kit	AccessoriesYes	Yes (from other source)
Kit contents	4 x 4 gauzeAdhesive laminateAcoustic gelProbe cover (sheath)Magnetic coverSnap ringPrep trayCSR wrap	Needle guideAcoustic gelProbe cover

7. PERFORMANCE TESTING

The PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit were tested according to and demonstrated in compliance with requirements set forth in FDA Guidance

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"Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers"(1997) including the following, FDArecognized, voluntary standards:

Safety of Medical Electrical Equipment Part 2: "Particular Requirements . for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment"
EN60601-1 Medical Electrical Equipment Part 1, General Requirements . for Safety (1988), Amendment 1 (1991), Amendment 2 (1995)
UL2601-1. Second Edition .
CAN/CSA-C22.2 No. 601-1-M90 ●
IEC 60601-1-1 Medical Electrical Equipment Part 1-1: General . Requirements for Safety, Collateral Standard: Safety requirements for medical electrical systems (2000)
IEC 60601-1-4 Medical Electrical Equipment Part 1-1: General . Requirements for Safety, Collateral Standard: Programmable electrical medical systems (2000)
IEC 60601-2-37 Medical Electrical Equipment Part 2-37: Particular . Requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (2001)
Electromagnetic Immunity (IEC 60601-1-2, §36.202) Medical electrical ● equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Electromagnetic Emissions [IEC 60601-1-2: 2001, §36.201/CISPR 11: . 1997, Class A; IEC 61000-3-2: Electromagnetic compatibility (EMC) -Part 3-2: Limits - Limits for harmonic current emissions (equipment input current <= 16A per phase)(1995); IEC 61000-3-3: Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection (1995)].

In addition, verification and validation testing demonstrates that the System fulfills performance specifications.

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Image /page/5/Picture/2 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 emblem featuring a stylized image of three human profiles facing to the right, with three abstract shapes above them.

JUL = 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inceptio Medical Technologies, L.C. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K021984

Trade Name: PunctSURER Ultrasound Vascular Imaging System, PunctSURE® Vascular Imaging Procedure Kit Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: June 17, 2002 Received: June 18, 2002

Dear Mr. Mosenkis:

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 PunctSURE Ultrasound Vascular Imaging System, PunctSURES Vascular Imaging Procedure Kit, as described in your premarket notification:

Transducer Model Number

Ultrasonic Piezoelectric Transducer (Part #: IN00001)

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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); 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 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, please 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.

Nancyc brogdon

Nancy C. Brdedon 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

510(k) Number (if known): KOJ/984

Device Name: Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and Vascular Imaging Procedure Kit

Diagnostic ultrasound imaging and blood flow directional analysis as follows: Intended Use:

ClinicalApplication	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Specify)
Intraoperative
Neurological
Pediatric
Small organ(Specify)
Neonatal cephalic
Cardiac
Transesophageal
Transrectal
Intravascular
Peripheral vascular		N		N		N
Laparoscopic
MusculoskeletalConventional
MusculoskeletalSuperficial
Other (Specify)

N=New Indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

Indications for Use: The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit are indicated for real-time imaging of selected blood vessels and nearby anatomic structures before and during percutaneous procedures, ultrasonic guidance for needle placement and vessel catheterization in a sterile environment, and Doppler confirmation of directional blood flow.

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

Nancy Slogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021984

Prescription Use (Per 21 CFR 801.109)

Response to Abbreviated 510(k) June 12, 2002 Inceptio Medical PunctSURE® Ultrasound Vascular Imaging System Revised Page 2-1

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): K021984

Device Name: Inceptio Medical Technologies, L.C. PunctSÜRE® Ultrasound Transducer

Diagnostic ultrasound imaging and blood flow directional analysis as follows: Intended Use:

Clinical	Mode of Operation
Application	A	B	M	PWD	CWD	Color	Amplitude	Color	Combined	Other
						Doppler	Doppler	Velocity	(Specify)	(Specify)
								Imaging
Ophthalmic
Fetal
Abdominal
Intraoperative(Specify)
Intraoperative
Neurological
Pediatric
Small organ(Specify)
Neonatal cephalic
Cardiac
Transesophageal
Transrectal
Intravascular
Peripheral vascular		N		N		N
Laparoscopic
MusculoskeletalConventional
MusculoskeletalSuperficial
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 NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

Radiological Devices
10(k) Number K021984

Prescription Use (Per 21 CFR 801.109)

Response to Abbreviated 510(k) June 12, 2002 Inceptio Medical PunctSURE® Ultrasound Vascular Imaging System Revised Page 2-2

Regulation Number and Section

N/A