The Cstat is a ring-handled instrument with integrated Doppler sensor, which allows for blood flow sensing of blood vessels by connecting to a commercially available portable transceiver box. The Cstat is manufactured from nylon and polycarbonate.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Cstat," a vascular clamp with an integrated Doppler sensor. However, it does not explicitly detail acceptance criteria or a study that proves the device meets specific performance metrics in the way a typical clinical study report would.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria for a new clinical indication.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study for the Cstat

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, detection rates, occlusion success rates) and their corresponding reported device performance values are NOT explicitly stated.

The document's "acceptance criteria" are primarily related to safety, electrical/thermal compliance, and acoustic output, rather than clinical efficacy. The "reported device performance" is a general statement of compliance.

Acceptance Criteria (Implied)	Reported Device Performance
Electrical and Thermal Safety (IEC 60601-1)	"Designed and tested to comply with the requirements of IEC 60601-1"
Acoustic Output Power (FDA Guidance Document)	"Measurements were performed in accordance with the FDA Guidance document... Test results indicate reliable performance when the device is used in accordance with the Instructions for Use."
Does not raise new issues of safety, effectiveness, or performance compared to predicates	"The Cstat does not raise new issues of safety, effectiveness, or performance."

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document does not describe a clinical test set with a patient sample size for evaluating the device's diagnostic or therapeutic performance. The "tests" mentioned are nonclinical (electrical, thermal, acoustic).
Data Provenance: Not applicable, as no clinical test data with patient provenance is described. The tests were nonclinical, likely performed in a lab setting by the manufacturer.

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

Number of Experts: Not applicable. No human experts were involved in establishing ground truth for a clinical test set in the provided document, as it describes nonclinical tests.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set or human interpretation requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done or described in the provided text.
Effect Size of Human Readers with/without AI: Not applicable, as this device is not an AI-assisted diagnostic tool, and no human reader study (with or without assistance) is mentioned.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No, a standalone (algorithm only) performance study was not done or described. This device is a physical instrument with an integrated sensor, not a software algorithm. Its "performance" in the context of the document refers to its physical and functional integrity.

7. Type of Ground Truth Used

Type of Ground Truth: For the nonclinical tests, the "ground truth" would be established by technical specifications, engineering standards, and regulatory guidance documents (e.g., IEC 60601-1 compliance, FDA acoustic output guidance). There is no "clinical ground truth" (like pathology or outcomes data) mentioned, as no clinical study is described.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

Ground Truth for Training Set Establishment: Not applicable. As there is no training set, this question is not relevant to the provided information.

In summary: The provided 510(k) summary focuses on demonstrating that the Cstat device is substantially equivalent to existing predicate devices based on its intended use, technological characteristics, and compliance with nonclinical safety and performance standards. It does not contain information about a clinical study with specific acceptance criteria, test set characteristics, expert ground truth, or an MRMC/AI performance evaluation that would typically be found in submissions for novel diagnostic algorithms or devices requiring clinical performance data.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in This JTO(K) summary of sales) at the SMDA and 21 CFR 807.92.

Submitter's name, address, telephone number, contact person, and date 1. summary prepared:

a.	Submitter:	Vascular Control Systems, Inc.32236-E Paseo AdelantoSan Juan Capistrano, CA 92675(949) 488-8700
b.	Contact Person:	Kathleen RobertsSr. Regulatory Affairs SpecialistTelephone: (949) 488-8700 ext. 11.Fax: (949) 488-8708
c.	Date Summary Prepared: August 19, 2003

Name of device, including trade name and classification name: 2.

Trade/Proprietary Name: ~ Cstat a.
Classification name: Vascular Clamp b.
Identification of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:

Company:	Vascular Control Systems, Inc.
Device:	VCS-A Clamp
510(k):	K023154
Date Cleared:	December 20, 2002
Company:	Vascular Control Systems, Inc.
Device:	Transvaginal Doppler Probe
510(k):	K023024
Date Cleared:	September 26, 2002
Company:	Medical Designs LLC
Device:	Hand Drill
510(k):	K022712
Date Cleared:	November 12, 2002

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A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

ഗ് Statement of intended use:

The Cstat is intended for detection and temporary occlusion of blood vessels.

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

The Cstat and the predicate VCS-A Clamp and Transvaginal Doppler Probe detect blood flow of blood vessels using an 8 MHz pulsed-wave Doppler sensor. The Doppler crystals in all three devices are located at the distal end to allow for forward detection of blood flow.

The Cstat and the predicate VCS-A Clamp are intended to temporarily occlude blood vessels. The Transvaginal Doppler Probe is not intended to occlude blood vessels.

The Cstat and the predicate Medical Designs Hand Drill are each constructed of glass-filled nylon.

7. Brief summary of nonclinical tests and results:

The Cstat has been designed and tested to comply with the requirements of IEC 60601-1 for electrical and thermal safety. Acoustic output power measurements were performed in accordance with the FDA Guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. Test results indicate reliable performance when the device is used in accordance with the Instructions for Use.

The Cstat does not raise new issues of safety, effectiveness, or performance.

্

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three birds in flight, stacked vertically on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 2004

Vascular Control Systems, Inc. c/o Ms. Kathleen Roberts Senior Regulatory Affairs Specialist 32236 Paseo Adelanto, Suite E San Juan Capistrano, CA 92675

Re: K032125

CSTAT Vascular Clamp Regulation Number: 21 CFR 870.4450, 892.1570 Regulation Name: Vascular Clamp and Transducer, Ultrasound, Diagnostic for Regulatory Class: Class II (two) Product Code: DXC, ITX Dated: November 10, 2003 Received: November 12 2003

Dear Ms. Roberts:

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 Vascular Technology, Inc. Doppler Transceiver, 8 MHz Selectable Channel, and Part number 108900, as described in your premarket notification:

Transducer Model Numbers

09-0014-01 09-0014-02

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Page 2 -- Ms. Kathleen Roberts

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 (OS) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a post-clearance 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, 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".

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Page 3 – Ms. Kathleen Roberts

If you have any questions regarding the content of this letter, please contact CDR O.D. Hottenstein, Ph.D. at (301) 443-8262, extension 163.

Sincerely yours,

Donna R. Lochner

(J) Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K032125

Device Name: Čstat

Indications for Use: The Cstat is intended for detection and temporary occlusion of blood vessels during vascular surgical procedures.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vuna R. Viunes

Page 1 of 1

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 03 2 | 25

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Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify) Vascular				N
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
LaparoscopicMusculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments: Model # 09-0014-01, 09-0014-02

The transducer is specified for use with the Vascular Technology, Inc. Doppler Transceiver,

8 MHz Selectable Channel, VII I'/N 108900 ____________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Marria L

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_K0 32

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).