(100 days)
Not Found
Not Found
No
The summary describes a mechanical device for blood containment and does not mention any computational or algorithmic components, let alone AI/ML.
No
The device aids in blood containment and guidewire placement during vascular access, primarily for safety and control, not for treating a disease or condition.
No
The device is a blood containment device used during vascular access procedures to reduce exposure to bloodborne pathogens and control blood loss. It does not provide any diagnostic information.
No
The device description clearly indicates a physical device designed to contain blood and allow guidewire placement, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "blood containment during vascular access procedures" and "visualization of flashback and containment of blood within a sealed chamber." This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description reinforces the intended use, focusing on containing blood flow during a procedure and allowing guidewire placement.
- Lack of Diagnostic Function: There is no mention of analyzing blood components, detecting biomarkers, or providing any diagnostic information about the patient's health status.
- No Mention of Sample Analysis: The device handles blood in vivo (within the body) during a procedure, not in vitro (in a lab setting) for analysis.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Captiva Blood Containment Device's function is purely procedural and containment-based.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The CaptivaTM Blood Containment Device has met all pre-determined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Novoste™ PulsePlus Blood Containment Device
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
OCT = 1 2003
510(k) Summary of Safety and Effectiveness
| Submitter's Information: | Merit Medical Systems, Inc.
1600 W. Merit Parkway
South Jordan, UT 84095
Phone- 801-253-1600
FAX - 801-253-1684
Contact: John W. Nicholson
Alternate Contact: Jerrie Hendrickson
Preparation Date: June 19, 2003 |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Information
Trade Name:
Common Name:
Classification Name:
Classification Number: | CaptivaTM Blood Containment Device
Blood Containment Device
Catheter Introducer
870.1340 - Class II |
| Predicate Device: | Novoste™ PulsePlus Blood Containment Device |
| Product 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. |
| Intended 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. |
| Technological
Characteristics: | Both the predicate and applicant devices achieve equivalent clinical
functions by utilizing medical grade, biocompatible materials for blood
containment during vascular access procedures. Both devices also help to
reduce clinician exposure to patient blood while still allowing for
guidewire access through the device. Both devices provide a
visualization chamber to identify correct vessel access. The devices' sub-
components are similar in shape, size, materials used and function. The
materials of construction and design, though not identical, are
sufficiently similar to provide for equivalent pre-clinical performance
data. No new safety and effectiveness issues arise as a result of the
proposed device modifications. |
3
- 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.
4
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 |