(67 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a steerable introducer, with no mention of AI or ML capabilities.
No
The device is used for introducing catheters into the heart, which is a procedural step, not a direct therapeutic intervention.
No
Explanation: The device is an introducer kit designed to facilitate the insertion of other cardiovascular catheters into the heart. Its purpose is to physically introduce, not to diagnose. While it mentions pressure monitoring and blood sampling, these are functionalities enabling other diagnostic tools, not diagnostic capabilities of the introducer itself.
No
The device description clearly outlines physical components such as a dilator, guide wire, steerable sheath, hemostasis valve, sideport, handle with rotating knob, distal holes, radiopaque tip marker, and materials of construction including polymers and stainless steel. This indicates it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "introducing various cardiovascular catheters into the heart." This is a procedural device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical device (introducer, dilator, guide wire) designed for insertion into the body. It mentions features like a hemostasis valve, sideport, steerable tip, and radiopaque marker, all related to its function during a medical procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
Therefore, the HeartSpan™ Steerable Introducer Kit is a medical device used for a therapeutic or diagnostic procedure performed directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HeartSpan™ Steerable Introducer Kit is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The HeartSpan™ Steerable Introducer set consists of a dilator, guide wire, and steerable sheath, which are designed for catheter introduction into the cardiac anatomy. The device is provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities.
The steerable introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer handle includes a rotating knob to enable clockwise and counterclockwise tip deflection >180° with a radius of 10 - 56 mm (measured at 180° deflection) . The steerable introducer also includes distal holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an atraumatic soft tip, and a lubricious coating on the inner and outer surfaces. The dilator is designed to conform to the inner diameter of the sheath, and has a tapered tip.
The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement and deflection wires in the introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, interatrial septum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals or healthcare facilities
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)
The HeartSpan™ Steerable Introducer Kit has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the HeartSpan™ Steerable Introducer Kit:
- Risk Analysis .
.
.
- Requirements/Specification Reviews
- . Design Reviews
- Performance Testing (Verification) including but not limited to: .
Safety & Performance Tests
- Tip articulation o
- Leak resistance o
- Kink resistance O
- Length 0
- Inner/Outer diameter O
- Curve radius 0
- Marker band location 0
- Tip/tube detachment force O
- Side hole diameter and location o
- Sterilization validation (ethylene oxide)
- Biocompatibility Testing (Verification) .
The results of the testing demonstrated that the modified HeartSpan™ Steerable Introducer Kit meets the predetermined acceptance criteria applicable to safety and efficacy of the device.
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.
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
Merit Medical Systems, Inc. HeartSpan™ Steerable Introducer Kit Special 510(k)
Attachment A 510(k) Summary
510(k) Summary Correspondent Name: Merit Medical Systems, Inc. Address: 65 Great Valley Parkway Malvern, PA 19355 General Telephone Number: 610-651-5000 SEP 1 7 2013 Provisions Fax Number: 610-651-5003 Contact Person: Alina Stubbs Date of Preparation: July 08, 2013 Registration Number: 2529252 Trade Name: HeartSpan™ Steerable Introducer Kit Subject Common/Usual Name: Steerable Introducer Kit Device Classification Name: Catheter Introducer (21 CFR §870.1340) Trade Name: HeartSpan™ Steerable Introducer Kit Classification Name: Catheter Introducer (21 CFR §870.1340) Premarket Notification: K122431 Predicate Manufacturer: Merit Medical Systems, Inc. Device 65 Great Vallev Parkway Malvern, PA 19355 (formerly operating as Thomas Medical Products, Inc.) Class II 21 CFR §870.1340 Classification FDA Product Code: DYB Review Panel: Cardiovascular The HeartSpan™ Steerable Introducer Kit is indicated for introducing Intended Use various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
1
Merit Medical Systems, Inc. HeartSpan™ Steerable Introducer Kit Special 510(k)
Device
Description
Attachment A 510(k) Summary
The HeartSpan™ Steerable Introducer set consists of a dilator, guide wire, and steerable sheath, which are designed for catheter introduction into the cardiac anatomy. The device is provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities.
The steerable introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer handle includes a rotating knob to enable clockwise and counterclockwise tip deflection >180° with a radius of 10 - 56 mm (measured at 180° deflection) . The steerable introducer also includes distal holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an atraumatic soft tip, and a lubricious coating on the inner and outer surfaces. The dilator is designed to conform to the inner diameter of the sheath, and has a tapered tip.
The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement and deflection wires in the introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.
2
・
| Comparison to
Predicate | Technical
Characteristics | Predicate Device
(K122431) | Modified Device
(K132164) |
|--------------------------------------------------|------------------------------------------------------|------------------------------------------|--------------------------------------------|
| | Hemostasis valve provided | Yes | Yes |
| | Dilator to Guide wire
Compatibility | up to 0.038" | up to 0.038" |
| | Guide wire Design /
Dimensions | Standard
Non-Coated
0.038" x 135cm | Super-Stiff
with PTFE
0.032" x 180cm |
| | Compatibility with
Standard Transseptal
Needle | Yes | Yes |
| | Length | 74 cm | 74 cm |
| | French size | 8.6F | 8.6F |
| | Bi-Directional Curving | Yes
≥180° in both
directions | Yes
≥180° in both
directions |
| | One-Handed Operation of
Curving Mechanism | Yes | Yes |
| | Wire braid reinforcement
completely encapsulated | Yes | Yes |
| | Radiopaque tip or marker | Yes | Yes |
| | Soft Atraumatic Tip | Yes | Yes |
| Side port for infusion and
contrast injection | Yes | Yes | |
.
Summary of the technological characteristics of the device compared to the predicate devices:
3
The HeartSpan™ Steerable Introducer Kit has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the HeartSpan™ Steerable Introducer Kit:
- Risk Analysis .
.
.
- Requirements/Specification Reviews
- . Design Reviews
- Performance Testing (Verification) including but not limited to: .
Safety & Performance Tests
- Tip articulation o
- Leak resistance o
- Kink resistance O
- Length 0
- Inner/Outer diameter O
- Curve radius 0
- Marker band location 0
- Tip/tube detachment force O
- Side hole diameter and location o
- Sterilization validation (ethylene oxide)
- Biocompatibility Testing (Verification) .
The results of the testing demonstrated that the modified HeartSpan™ Steerable Introducer Kit meets the predetermined acceptance criteria applicable to safety and efficacy of the device.
4
Merit Medical Systems, Inc.
HeartSpan™ Steerable Introducer Kit
Special 510(k)
| International
Standards | No performance standards have been established under section 514
of the Food, Drug and Cosmetic Act for this device. Performance
testing of the modified HeartSpan™ Steerable Introducer Kit was
conducted based on the risk analysis and based on the requirements
of the following international standards:
• ANSI/AAMI/ISO 10993-3:2003 Biological Evaluation of Medical
Devices - Part 3: Tests of Genotoxicity, Carcinogenicity, and
Reproductive Toxicity
• ANSI/AAMI/ISO 10993-4:2002 Biological Evaluation of Medical
Devices - Part 4: Selection of Tests for Interactions with Blood
• ANSI/AAMI/ISO 10993-5:1999 Biological Evaluation of Medical
Devices - Part 5: Tests for In Vitro Cytotoxicity
• ANSI/AAMI/ISO 10993-7: 2008, Biological Evaluation of Medical
Devices - Part 7: Ethylene Oxide Sterilization Residuals
• ANSI/AAMI/ISO 10993-10: 2010, Biological Evaluation of Medical
Devices - Part 10: Tests for Irritation and Skin Sensitization
• ANSI/AAMI/ISO 10993-11: 2006, Biological Evaluation of Medical
Devices - Part 11: Tests for Systemic Toxicity
• ISO 11070:1998 Sterile Single-Use Intravascular Catheter
Introducers - Annex B
• ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health Care
Products - Ethylene oxide - Part 1: Requirements for
Development, Validation and Routine Control of Sterilization
Process for Medical Devices
• ISTA P2A (2011) - Packaged-Products 150 lb (68kg) or Less |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Merit Medical Systems, Inc. considers the HeartSpan™ Steerable
Introducer Kits to be substantially equivalent to the currently
marketed predicate device (HeartSpan™ Steerable Introducer Kit
K122431). This assessment is based upon analysis of similar
technological characteristics, bench testing, and indications for use. |
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2013
Ms. Alina Stubbs Regulatory Affairs Specialist II Merit Medical Systems, Inc. 65 Great Valley Parkway Malvern, PA 19355
Re: K132164
Trade Name: HeartSpan™ Steerable Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: August 16, 2013 Received: August 19, 2013
Dear Ms. Stubbs:
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 application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
6
Page 2 - Ms. Alina Stubbs
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
7
Section 4 Indications for Use Statement
510(k) Number (if known): K132164
HeartSpan™ Steerable Introducer Kit Device Name:
Indications for Use:
The HeartSpan™ Steerable Introducer Kit is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/7/Picture/12 description: The image shows the text "Bram D. Zuckerman -S 2013.09.17 16:01:06 -04'00'". The text appears to be a timestamp or some other kind of identifier. The text is black and the background is white. The text is arranged in two lines.