(166 days)
For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture.
The modified HeartSpan™ Fixed Curve Braided Transseptal Sheath consists of a dilator, guidewire, and fixed curve 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 fixed curve introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with threeway stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer is available in lengths ranging from 60 to 101.5 cm and curve configurations from 15° to 150° to address various anatomical features. The fixed curve introducer also includes distal perfusion 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 wires in the introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.
The HeartSpan™ Fixed Curve Braided Transseptal Sheath is being submitted for 510(k) clearance. The following information provides details on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance testing conducted to verify product specifications and user requirements. While specific quantifiable acceptance criteria values are not explicitly stated in a table format with corresponding reported values, the text indicates that the device "meets the predetermined acceptance criteria applicable to safety and efficacy of the device."
Here's a summary of the performance tests performed, which inherently imply acceptance criteria related to these characteristics:
| Acceptance Criteria (Implied by Performance Test) | Reported Device Performance |
|---|---|
| Sheath Tube Inner Diameter Accuracy | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Tube Outer Diameter Accuracy | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Free Length Accuracy | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Tip Inner Diameter Accuracy | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Visual Inspection - Curve Orientation | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Visual Inspection - Sheath Curve Form | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Visual Inspection - Breakaway Flash | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Visual Inspection - Protruding wires or marker band | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Visual Inspection - Tip Defects | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Visual Inspection - Bumps or protrusion on tube | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Tip Transition to Dilator Quality | Meets predetermined acceptance criteria for safety and efficacy. |
| Visual inspection of sheath inner surface Quality | Meets predetermined acceptance criteria for safety and efficacy. |
| Simulated Use Test Performance | Meets predetermined acceptance criteria for safety and efficacy. |
| Valve housing to tube joint integrity | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Tube Delamination | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Tip Integrity | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Tip to Tube Joint Integrity | Meets predetermined acceptance criteria for safety and efficacy. |
| Sheath Tip Bend Back Performance | Meets predetermined acceptance criteria for safety and efficacy. |
| Sterilization Validation (Ethylene Oxide) | Successful (Implied by statement "Sterilization validation (ethylene oxide)" under quality assurance measures). |
| Biocompatibility Testing (Verification) | Successful (Implied by statement "Biocompatibility Testing (Verification)" under quality assurance measures). |
The document states, "The results of the testing demonstrated that the modified HeartSpan™ Fixed Curve Braided Transseptal Sheath meets the predetermined acceptance criteria applicable to safety and efficacy of the device." This general statement implies that for all the listed performance tests, the device performed within acceptable limits defined prior to testing.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the performance tests (e.g., number of devices tested for inner diameter, integrity, etc.).
The data provenance is from bench testing ("Performance Testing (Verification) listed below"). The document does not indicate the country of origin of the data explicitly, but as the submission is to the US FDA by a US-based company, it can be inferred to be domestically conducted. The tests are prospective in nature, as they involve testing the modified device against defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the described tests are primarily device performance characteristic tests (bench testing) and biocompatibility/sterilization validations, not studies involving human interpretation or expert evaluation of clinical data. Therefore, no "ground truth" established by experts in the context of clinical outcomes or diagnostic accuracy is mentioned for these specific tests.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. The tests are direct measurements or standardized procedures against predetermined criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The submission focuses on technical characteristics, performance testing, and biocompatibility of the device itself, rather than evaluating its clinical effectiveness or impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical medical instrument (transseptal sheath), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used:
For the performance tests, the "ground truth" (or reference standard) is implicitly derived from predetermined product specifications, user requirements, and the requirements of the referenced international standards (e.g., ISO 11070:1998 for catheter introducers). For biocompatibility, the ground truth is established by the specified ISO 10993 series standards, and for sterilization, by ANSI/AAMI/ISO 11135-1. These standards define the acceptable limits and methodologies for demonstrating safety and performance.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a "training set" with ground truth.
{0}------------------------------------------------
Merit Medical Systems, Inc. HeartSpan™ Fixed Curve Braided Transseptal Sheath 510(k)
. . .
.
Attachment 1 510(k) Summary
K132720- Page 1 of 4
| 510(k) Summary | ||
|---|---|---|
| GeneralProvisions | Correspondent Name: | Merit Medical Systems, Inc. |
| Address: | 65 Great Valley ParkwayMalvern, PA 19355 | |
| Telephone Number: | (610) 651-5046 | |
| Fax Number: | (801) 545-4285 | |
| Contact Person: | Alina Stubbs | |
| Date of Preparation: | August 23, 2013 | |
| Registration Number: | 2529252 | |
| SubjectDevice | Trade Name: | HeartSpan™ Fixed Curve BraidedTransseptal Sheath |
| Common/Usual Name: | Transseptal Introducer Kit | |
| Classification Name: | Catheter Introducer (21 CFR §870.1340) | |
| Predicate Device | Trade Name: | HeartSpan™ Fixed Curve BraidedTransseptal Sheath |
| Classification Name: | Catheter Introducer (21 CFR §870.1340) | |
| Premarket Notification: | K004026 - Braided Guiding Introducer | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| 65 Great Valley ParkwayMalvern, PA 19355(formerly operating asThomas Medical Products, Inc.) | ||
| Classification | Class II | |
| 21 CFR §870.1340 | ||
| FDA Product Code: DYBReview Panel: Cardiovascular | ||
| Intended Use | The HeartSpan™ Fixed Curve Braided Transseptal Sheath is indicated "Forthe percutaneous introduction of various types of cardiovascular cathetersto all heart chambers, including the left atrium via transseptal puncture." |
<>
{1}------------------------------------------------
| Merit Medical Systems, Inc. |
|---|
| HeartSpan™ Fixed Curve Braided Transseptal Sheath |
| 510(k) |
The modified HeartSpan™ Fixed Curve Braided Transseptal Sheath consists of a dilator, guidewire, and fixed curve sheath, which are designed introduction into the cardiac anatomy. The device is for catheter provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities.
The fixed curve introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with threeway stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer is available in lengths ranging from 60 to 101.5 cm and curve configurations from 15° to 150° to address various anatomical features. The fixed curve introducer also includes distal perfusion 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 wires in the introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.
| Technical Characteristics | Predicate Device(K004026) | Modified Device(K132720) | |
|---|---|---|---|
| Comparison toPredicate | Hemostasis valve provided | Yes | Yes |
| Dilator to Guide wireCompatibility | up to 0.038" | up to 0.038" | |
| Compatibility with StandardTransseptal Needle | Yes | Yes | |
| Length | 30 cm min. | 60 - 101.5 cm | |
| French size | 8.5F & 9.5F | 8.5F | |
| Curve | 0° - 180° | 15° - 150° | |
| Wire braid reinforcementcompletely encapsulated | Yes | Yes | |
| Radiopaque tip or marker | Yes | Yes | |
| Soft Atraumatic Tip | Yes | Yes | |
| Side port for infusion andcontrast injection | Yes | Yes | |
| UV and Thermal Stabilizationin Sheath Tube and Tip | No | Yes | |
| Distal perfusion holes | No | Yes |
Summary of the technological characteristics of the modified device compared to the predicate devices:
Device
Description
{2}------------------------------------------------
Merit Medical Systems, Inc. HeartSpan™ Fixed Curve Braided Transseptal Sheath 510(k)
l
| InternationalStandards | No performance standards have been established under section 514 ofthe Food, Drug and Cosmetic Act for this device. Performance testingof the modified HeartSpan™ Fixed Curve Braided Transseptal Sheathwas conducted based on the risk analysis and based on therequirements of the following international standards:ISO 10993-1:2009 Evaluation of Medical Devices - Part 1:Evaluation and testing within a Risk Management Process ISO 10993-4:2002/Amendment I 2002, Biological Evaluation ofMedical Devices - Part 4: Selection of Tests for Interactions withBlood ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part5: Tests for In Vitro Cytotoxicity ISO 10993-7: 2008, Biological Evaluation of Medical Devices - Part7: Ethylene Oxide Sterilization Residuals ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part10: Tests for Irritation and Skin Sensitization ISO 10993-11:2006, Biological Evaluation of Medical Devices - Part11: Tests for Systemic Toxicity ISO 11070:1998, Sterile Single-Use Intravascular CatheterIntroducers - Annex C 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 MedicalDevices |
|---|---|
| ---------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
<>
.
{3}------------------------------------------------
. •
Attachment 1
510(k) Summary
| Safety &PerformanceTests | The modified HeartSpan™ Fixed Curve Braided Transseptal Sheathhas been thoroughly tested through verification of product specificationsand user requirements. The following quality assurance measures wereapplied during the development of the modified HeartSpan™ FixedCurve Braided Transseptal Sheath:Risk Analysis Requirements/Specification Reviews Design Reviews Sterilization validation (ethylene oxide) Biocompatibility Testing (Verification) Performance Testing (Verification) listed below: Sheath Tube Inner Diameter Sheath Tube Outer Diameter Sheath Free Length Sheath Tip Inner Diameter Sheath Visual Inspection Curve Orientation Sheath Curve Form Breakaway Flash Protruding wires or marker band Tip Defects Bumps or protrusion on tube Sheath tip transition to dilator Visual inspection of sheath inner surface Simulated Use Test Valve housing to tube joint integrity Sheath Tube Delamination Sheath Tip Integrity Sheath Tip to Tube Joint Integrity Sheath Tip Bend Back The results of the testing demonstrated that the modified HeartSpan™ Fixed Curve Braided Transseptal Sheath meets the predetermined acceptance criteria applicable to safety and efficacy of the device. |
|---|---|
| Summary ofSubstantialEquivalence | Merit Medical Systems, Inc. considers the modified HeartSpan™ FixedCurve Braided Transseptal Sheath substantially equivalent to thecurrently marketed predicate device (Braided Guiding Introducer -K004026). This assessment is based upon analysis of similartechnological characteristics, bench testing, and indications for use. |
<<>>
.
:
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with three wavy lines extending from its arm. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 12, 2014
Merit Medical Systems, Inc. Ms. Alina Stubbs Regulatory Affairs Specialist II 65 Great Valley Parkway Malvern, PA 19355
Re: K132720
Trade Name: HeartSpan™ Fixed Curve Braided Transseptal Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 10, 2014 Received: January 13, 2014
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. 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. 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 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
{5}------------------------------------------------
Page 2 - Ms. Stubbs
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
M. L. Helleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Merit Medical Systems, Inc. HeartSpan™ Fixed Curve Braided Transseptal Sheath Special 510(k)
Section 4 Indications for Use Statement
K132720- Page 1 of 1
Section 4 Indications for Use Statement
510(k) Number (if known): _K132720
HeartSpan™ Fixed Curve Braided Transseptal Sheath Device Name:
Indications for Use:
For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture.
Prescription Use × (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)
M. A. Dilemma
§ 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).