The Captiva Blood Containment Device is intended for blood containment during vascular access procedures. Upon entering the vessel, the Captiva Blood Containment Device provides visualization of flashback and containment of blood within a sealed chamber. It also allows placement of a guidewire through the device for subsequent catheterization.

Device Description

The CaptivaTM Blood Containment Device is designed to contain the flow of a patient's blood during vascular access procedures, thereby helping to reduce the healthcare professionals' exposure to bloodborne pathogens while controlling patient blood loss. It also provides for vascular access by maximum 0.038 inch guidewires.

AI/ML Overview

The provided document describes the Captiva™ Blood Containment Device and its substantial equivalence to a predicate device, the Novoste™ PulsePlus Blood Containment Device. This is a 510(k) summary, which focuses on demonstrating equivalence rather than providing a detailed technical study report with specific acceptance criteria directly quantifiable. Therefore, some information requested may not be explicitly present as a rigorous clinical trial or AI model validation would detail.

Here's an attempt to extract and infer the requested information based on the available text:

Acceptance Criteria and Device Performance

The document states: "The Captiva™ Blood Containment Device has met all pre-determined acceptance criteria." and "The performance data indicate that the applicant and the predicate devices have substantially equivalent values." It also mentions "No new safety and effectiveness issues arise as a result of the proposed device modifications." This implies the acceptance criteria were based on demonstrating equivalence to the predicate device in terms of safety and efficacy for its intended use.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Acceptance Criteria (Inferred from "Substantially Equivalent" and Intended Use)	Reported Device Performance
Ability to contain blood during vascular access procedures	The device is designed to contain the flow of a patient's blood during vascular access procedures, helping to reduce healthcare professionals' exposure to bloodborne pathogens while controlling patient blood loss. Performance data indicate substantial equivalence to the predicate device in achieving this function.
Ability to provide visualization of flashback	Upon entering the vessel, the Captiva Blood Containment Device provides visualization of flashback. Performance data indicate substantial equivalence to the predicate device in achieving this function.
Ability to allow placement of a guidewire (maximum 0.038 inch)	The device allows for vascular access by maximum 0.038 inch guidewires and allows placement of a guidewire through the device for subsequent catheterization. Performance data indicate substantial equivalence to the predicate device in achieving this function.
Use of medical grade, biocompatible materials for blood containment	Both the predicate and applicant devices utilize medical grade, biocompatible materials for blood containment. No new safety and effectiveness issues are identified, suggesting the materials meet required standards.
Non-deleterious effects of modifications	The document states: "There is no indication that the proposed modifications have any deleterious effects on applicant device performance and no new safety and efficacy questions arise when the applicant device is used as intended." This confirms the device modifications do not negatively impact safety or efficacy.
Robustness for intended use	The document states: "the modified design of the applicant device is sufficiently robust for its intended use." This ensures the device can withstand the stresses of its intended application.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "pre-clinical tests" and "performance data" that indicate substantial equivalence. It does not provide specific numbers of units tested.
- Data Provenance: Not explicitly stated. The tests are described as "pre-clinical," suggesting laboratory or bench testing rather than human clinical data. There is no information about the country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This device, being a physical blood containment device, would not typically have "ground truth" established by experts in the way an AI diagnostic algorithm would. The safety and efficacy are likely evaluated against predetermined engineering and performance specifications and comparison to the predicate device.
- Qualifications of Experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging or clinical trials, which is not described here. Device performance is likely measured against objective metrics.
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:
- MRMC Study: No. This is not an AI-assisted diagnostic device or an imaging device. Therefore, a multi-reader multi-case study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The concept of "ground truth" in the context of an AI algorithm is not directly applicable here. For this device, the "ground truth" would be related to material properties, functional performance (e.g., ability to contain fluid, allow guidewire passage), and biocompatibility testing, compared against established standards and the characteristics of the predicate device. The "truth" is whether it performs its stated function safely and effectively, and is substantially equivalent to a legally marketed predicate device.
The sample size for the training set:
- Sample Size: Not applicable. This is a physical device, not a machine learning model. There is no "training set" in the context of AI.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Merit Medical Systems, Inc. c/o Mr. John W. Nicholson Senior Regulatory Affairs Specialist 1600 West Merit Pkwy South Jordan, UT 84095

Re: K031922

CaptivaTM Blood Containment Device Regulation Number: 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: September 11, 2003 Received: September 12, 2003

Dear Mr. Nicholson:

This letter corrects our substantially equivalent letter of October 1, 2003 regarding the address change.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. John W. Nicholson

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 continue marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Elsie Olay for

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

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OCT = 1 2003

510(k) Summary of Safety and Effectiveness

Submitter's Information:	Merit Medical Systems, Inc.1600 W. Merit ParkwaySouth Jordan, UT 84095Phone- 801-253-1600FAX - 801-253-1684Contact: John W. NicholsonAlternate Contact: Jerrie HendricksonPreparation Date: June 19, 2003
Device InformationTrade Name:Common Name:Classification Name:Classification Number:	CaptivaTM Blood Containment DeviceBlood Containment DeviceCatheter Introducer870.1340 - Class II
Predicate Device:	Novoste™ PulsePlus Blood Containment Device
Product Description:	The CaptivaTM Blood Containment Device is designed to contain theflow of a patient's blood during vascular access procedures, therebyhelping to reduce the healthcare professionals' exposure to bloodbornepathogens while controlling patient blood loss. It also provides forvascular access by maximum 0.038 inch guidewires.
Intended Use:	The Captiva Blood Containment Device is intended for bloodcontainment during vascular access procedures. Upon entering thevessel, the Captiva Blood Containment Device providesvisualization of flashback and containment of blood within asealed chamber. It also allows placement of a guidewire throughthe device for subsequent catheterization.
TechnologicalCharacteristics:	Both the predicate and applicant devices achieve equivalent clinicalfunctions by utilizing medical grade, biocompatible materials for bloodcontainment during vascular access procedures. Both devices also help toreduce clinician exposure to patient blood while still allowing forguidewire access through the device. Both devices provide avisualization chamber to identify correct vessel access. The devices' sub-components are similar in shape, size, materials used and function. Thematerials of construction and design, though not identical, aresufficiently similar to provide for equivalent pre-clinical performancedata. No new safety and effectiveness issues arise as a result of theproposed device modifications.

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25-17.2.

Non-Clinical Testing: Merit has performed a series of pre-clinical tests to support a substantially equivalent determination and/or to demonstrate the device's safety and efficacy when used as intended. The performance data indicate that the applicant and the predicate devices have substantially equivalent values. They also indicate that the modified design of the applicant device is sufficiently robust for its intended use. There is no indication that the proposed modifications have any deleterious effects on applicant device performance and no new safety and efficacy questions arise when the applicant device is used as intended. Conclusion: The Captiva™ Blood Containment Device has met all pre-determined acceptance criteria. Based upon FDA's substantial equivalence criteria, the Captiva™ Blood Containment Device has been demonstrated to be substantially equivalent to the predicate Novoste™ PulsePlus Blood Containment Device.

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Indications for Use Statement*

510(k) Number (if known): K031922

Device Name: Captiva™ Blood Containment Device

Indications for Use: The Captiva Blood Containment Device is intended for blood containment during vascular access procedures. Upon entering the vessel, the Captiva Blood Containment Device provides visualization of flashback and containment of blood within a sealed chamber. It also allows placement of a guidewire through the device for subsequent catheterization.

Signature of 510(k) Submitter

Duv W. Michalson

Printed Name of Submitter: John W. Nicholson,

Senior Regulatory Affairs Specialist

Date: Sept. 10, 2003

*Suggested language and format to meet the requirements of 513(i) of FD&C Act, as amended, and sections 807.92 and 801.4 of 21CFR.

Concurrence of Office of Device Evaluation

510(k) Number	1631922
Division Sign-off
Office of Device Evaluation
Prescription Use	X	OR Over-the-Counter Use

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).