(67 days)
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.
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.
The provided text describes a Special 510(k) submission for the HeartSpan™ Steerable Introducer Kit. This type of submission generally refers to modifications to a device that has already received 510(k) clearance, and often relies heavily on comparison to the predicate device and established performance standards rather than extensive de novo clinical studies.
Therefore, the study supporting the device's acceptance primarily focuses on bench testing (performance testing) and adherence to international standards to demonstrate substantial equivalence to the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner for most items. Instead, it describes general assurance measures and categories of testing. However, it does list specific technical characteristics of the modified device which are implicitly accepted if they are equivalent or superior to the predicate.
For the purpose of this response, I will interpret "acceptance criteria" as the required performance areas and "reported device performance" as the confirmation that the device "meets the predetermined acceptance criteria." Quantitative values are only available for a few specific technical characteristics.
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance / Assessment |
|---|---|---|
| Safety & Performance Tests | Tip articulation | Meets predetermined acceptance criteria |
| Leak resistance | Meets predetermined acceptance criteria | |
| Kink resistance | Meets predetermined acceptance criteria | |
| Length | Meets predetermined acceptance criteria | |
| Inner/Outer diameter | Meets predetermined acceptance criteria | |
| Curve radius | Meets predetermined acceptance criteria | |
| Marker band location | Meets predetermined acceptance criteria | |
| Tip/tube detachment force | Meets predetermined acceptance criteria | |
| Side hole diameter and location | Meets predetermined acceptance criteria | |
| Biocompatibility | Biological Evaluation | Meets predetermined acceptance criteria (per ISO 10993 standards) |
| Sterilization | Ethylene oxide sterilization validation | Meets predetermined acceptance criteria (per ISO 11135-1) |
| Packaging | Packaged-Products Testing | Meets predetermined acceptance criteria (per ISTA P2A) |
| Technical Characteristics Comparison | Hemostasis valve provided | Yes (Equivalent to Predicate) |
| Dilator to Guide wire Compatibility | up to 0.038" (Equivalent to Predicate) | |
| Guide wire Design / Dimensions | Super-Stiff with PTFE, 0.032" x 180cm (Modified - assumed acceptable) | |
| Compatibility with Standard Transseptal Needle | Yes (Equivalent to Predicate) | |
| Length | 74 cm (Equivalent to Predicate) | |
| French size | 8.6F (Equivalent to Predicate) | |
| Bi-Directional Curving | Yes ≥180° in both directions (Equivalent to Predicate) | |
| One-Handed Operation of Curving Mechanism | Yes (Equivalent to Predicate) | |
| Wire braid reinforcement completely encapsulated | Yes (Equivalent to Predicate) | |
| Radiopaque tip or marker | Yes (Equivalent to Predicate) | |
| Soft Atraumatic Tip | Yes (Equivalent to Predicate) | |
| Side port for infusion and contrast injection | Yes (Equivalent to Predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test sets used for performance testing (bench testing).
The data provenance is from bench testing conducted by Merit Medical Systems, Inc. (location: Malvern, PA, USA) and involves verification of product specifications and user requirements. This would be considered prospective testing in a controlled laboratory environment. No clinical data or patient data is mentioned; therefore, there is no country of origin for patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the study described is purely bench testing and does not involve human expert interpretation or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study described is purely bench testing and does not involve human adjudication. The results are from physical measurements and tests against pre-defined engineering and performance specifications.
5. 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a steerable introducer kit, a physical medical device, not an AI or imaging diagnostic tool. Therefore, the concept of human readers or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing was based on pre-determined product specifications, user requirements, and compliance with international standards (e.g., ISO 10993, ISO 11070, ISO 11135-1, ISTA P2A). These standards and specifications define the acceptable performance limits and characteristics for the device.
8. The sample size for the training set
The document describes a Special 510(k) for a modified physical device. There is no mention of a training set as this is not an AI or machine learning product. The design and manufacturing processes are likely informed by prior engineering knowledge and the predicate device's design, but this is not formally described as a "training set" in the context of this submission.
9. How the ground truth for the training set was established
Since there is no training set mentioned or applicable for this physical medical device, the establishment of "ground truth for the training set" is not applicable.
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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.
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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.
<< This space is intentionally left blank>>
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・
| Comparison toPredicate | TechnicalCharacteristics | Predicate Device(K122431) | Modified Device(K132164) |
|---|---|---|---|
| Hemostasis valve provided | Yes | Yes | |
| Dilator to Guide wireCompatibility | up to 0.038" | up to 0.038" | |
| Guide wire Design /Dimensions | StandardNon-Coated0.038" x 135cm | Super-Stiffwith PTFE0.032" x 180cm | |
| Compatibility withStandard TransseptalNeedle | Yes | Yes | |
| Length | 74 cm | 74 cm | |
| French size | 8.6F | 8.6F | |
| Bi-Directional Curving | Yes≥180° in bothdirections | Yes≥180° in bothdirections | |
| One-Handed Operation ofCurving Mechanism | Yes | Yes | |
| 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 |
.
Summary of the technological characteristics of the device compared to the predicate devices:
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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.
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Merit Medical Systems, Inc.
HeartSpan™ Steerable Introducer Kit
Special 510(k)
| InternationalStandards | No performance standards have been established under section 514of the Food, Drug and Cosmetic Act for this device. Performancetesting of the modified HeartSpan™ Steerable Introducer Kit wasconducted based on the risk analysis and based on the requirementsof the following international standards:• ANSI/AAMI/ISO 10993-3:2003 Biological Evaluation of MedicalDevices - Part 3: Tests of Genotoxicity, Carcinogenicity, andReproductive Toxicity• ANSI/AAMI/ISO 10993-4:2002 Biological Evaluation of MedicalDevices - Part 4: Selection of Tests for Interactions with Blood• ANSI/AAMI/ISO 10993-5:1999 Biological Evaluation of MedicalDevices - Part 5: Tests for In Vitro Cytotoxicity• ANSI/AAMI/ISO 10993-7: 2008, Biological Evaluation of MedicalDevices - Part 7: Ethylene Oxide Sterilization Residuals• ANSI/AAMI/ISO 10993-10: 2010, Biological Evaluation of MedicalDevices - Part 10: Tests for Irritation and Skin Sensitization• ANSI/AAMI/ISO 10993-11: 2006, Biological Evaluation of MedicalDevices - Part 11: Tests for Systemic Toxicity• ISO 11070:1998 Sterile Single-Use Intravascular CatheterIntroducers - Annex B• ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health CareProducts - Ethylene oxide - Part 1: Requirements forDevelopment, Validation and Routine Control of SterilizationProcess for Medical Devices• ISTA P2A (2011) - Packaged-Products 150 lb (68kg) or Less |
|---|---|
| Summary ofSubstantialEquivalence | Merit Medical Systems, Inc. considers the HeartSpan™ SteerableIntroducer Kits to be substantially equivalent to the currentlymarketed predicate device (HeartSpan™ Steerable Introducer KitK122431). This assessment is based upon analysis of similartechnological characteristics, bench testing, and indications for use. |
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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
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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
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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)
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§ 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).