(56 days)
The Attain Access 6218 Left-heart delivery system is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
The left-heart delivery system features two guide wires to facilitate venous access, an adjustable hemostasis valve to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field. A steerable 7 French or smaller intracardiac catheter is recommended for use to assist in placing guiding catheters to access cardiac veins via the coronary sinus. The Attain Access 6218 is intended for single use only and will be distributed independently for use with current and future leads. The Attain Access Model 6218 combines components that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.
This document describes the Medtronic Attain Access 6218 Left-heart delivery system, a Class II medical device intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Here's an analysis of the provided information regarding acceptance criteria and studies:
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | All in vitro specified requirements for the Attain Access 6218 (implied to include various mechanical and functional aspects of the system components such as guide catheters, dilator, valve, guide wires, and slitters). | "Attain Access passed all of the in vitro specified requirements, and ensures that the Attain Access 6218 meets all of its design and performance requirements." |
| Biocompatibility | Found to be biocompatible according to ISO 10993-1 for blood-contacting materials. | "Complete testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible." |
| Sterilization | Sterilization using 100% Ethylene Oxide (ETO) process. Appropriate processes for sterilizing the devices were validated. | "The Attain Access 6218 Left-heart delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated." |
| Clinical Performance | Performed as expected in the clinical environment during venogram imaging and left ventricular lead placement via the coronary sinus. | "The Attain Access 6218 was included in two (2) Medtronic sponsored IDE clinical studies... The Attain Access 6218 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus." |
| Substantial Equivalence | Demonstrate substantial equivalence to legally marketed predicate devices. | The document extensively lists predicate devices and states, "Medtronic Inc, considers the Attain Access 6218 Left-heart delivery system to be substantially equivalent to the previously discussed legally marketed predicate devices." |
Study Details:
The provided document describes the device's performance through various tests and clinical observations, primarily for demonstrating substantial equivalence for 510(k) clearance.
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Sample size used for the test set and the data provenance:
- In vitro testing (Mechanical/Physical Performance): No specific sample size is provided, but it states "all of the in vitro specified requirements" were passed, implying a sufficient number of tests were conducted to cover the specified requirements. The data provenance is from Medtronic's internal testing.
- Biocompatibility Testing: No specific sample size of tested materials is given, but it states "Complete testing according to ISO 10993-1 was conducted." The data provenance is from Medtronic's internal testing or contracted labs.
- Sterilization Validation: No specific sample size is provided for devices undergoing sterilization validation. The data provenance is from Medtronic's internal testing or contracted labs.
- Clinical Studies: The device "was included in two (2) Medtronic sponsored IDE clinical studies." No specific sample size (number of patients or procedures) is provided for these clinical studies. The data provenance is prospective, from clinical studies sponsored by Medtronic.
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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):
- For the in-vitro, biocompatibility, and sterilization testing, the "ground truth" is typically defined by established engineering standards, laboratory protocols, and regulatory guidelines (e.g., ISO 10993-1), rather than expert clinicians. The specific number and qualifications of technical experts or engineers involved in setting up and validating these tests are not provided.
- For the clinical studies, without further details, it's impossible to determine the number and qualifications of experts involved in establishing "ground truth." However, in IDE clinical studies, clinical investigators (physicians) are responsible for patient evaluations and outcomes, effectively establishing the clinical ground truth. Their specific qualifications are not detailed in this summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For in-vitro, biocompatibility, and sterilization testing, a formal adjudication method like "2+1" is typically not applicable. The results are compared directly against predefined criteria.
- For the clinical studies, no details on adjudication methods for clinical outcomes are provided.
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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 MRMC comparative effectiveness study was mentioned. The device described is a medical delivery system (catheter, guidewires, etc.), not an imaging or diagnostic AI-powered device that would typically involve "human readers" or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI/algorithm-based device. Therefore, the concept of "standalone algorithm performance" is not applicable. The device is a physical instrument intended for use by a clinician.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical/Physical Performance, Biocompatibility, Sterilization: The ground truth is based on pre-defined engineering specifications, international standards (e.g., ISO 10993-1), and validated protocols.
- Clinical Studies: The ground truth is based on clinical observations and outcomes data from patients treated in the IDE studies, specifically regarding "venogram imaging, and left ventricular lead placement via the coronary sinus." This would involve physician assessment of the procedure's success and safety.
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The sample size for the training set:
- This is not an AI/machine learning device. Therefore, the concept of a "training set" in the context of algorithm development is not applicable. For physical device development, iterative design and testing would occur, but it's not referred to as a "training set."
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How the ground truth for the training set was established:
- Not applicable as this is not an AI/machine learning device. Design and performance requirements for the device would have been established through a combination of engineering principles, clinical needs, and regulatory requirements.
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Attachment E
510(K) Summary of Substantial Equivalence
| Date prepared | July 2, 2001 |
|---|---|
| Submitter: | Medtronic, Inc.7000 Central Avenue N.E.Minneapolis, MN 55432 |
| Contact: | Karen Reidt, RACSr. Product Regulation Manager |
| Telephone: | (763) 514-3914 |
| Fax: | (763) 514-6424 |
| E-Mail: | karen.reidt@medtronic.com |
| Proprietary Name: | Attain™ Access 6218 Left-heart delivery system |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR § 870.1250 |
| Product Code: | 74 DQY |
Device Description
The left-heart delivery system features two guide wires to facilitate venous access, an adjustable hemostasis valve to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.
A steerable 7 French or smaller intracardiac catheter is recommended for use to assist in placing guiding catheters to access cardiac veins via the coronary sinus. The Attain Access 6218 is intended for single use only and will be distributed independently for use with current and future leads.
The Attain Access Model 6218 combines components that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.
Indications for Use
The intended use of the Medtronic Attain Access 6218 Left-heart delivery system is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus
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| Substantially Equivalent Devices | |
|---|---|
| ---------------------------------- | -- |
Attain Access 6218 Left-heart Delivery System Predicate Devices
| Attain AccessModel 6218 Left-heart DeliverySystem Device | Predicate Device | Predicate Device Manufacturer | Predicate 510(k) |
|---|---|---|---|
| 45 cm and 50 cmGuide Catheters | Medtronic GC IV CoronaryGuiding Catheter | Medtronic InterventionalVascular (MIV)Danvers, MA 01923 | K950490 |
| SafeSheath MSP (Same asSafeSheath CSG) | Thomas MedicalMalvern, PA 19355 | K003731 | |
| GC III (Vector, Vector X)Coronary Guiding Catheter | Medtronic InterventionalVascular (MIV)Danvers, MA 01923 | K950179 | |
| Zuma Guiding Catheter | Medtronic InterventionalVascular (MIV)Danvers, MA 01923 | K990707 | |
| Guide CatheterDilator | Percutaneous Introducer Kit(Component) | MedAmicusMinneapolis, MN 55447 | K965167 |
| SafeSheath MSP (Same asSafeSheath CSG) | Thomas MedicalMalvern, PA 19355 | K003731 | |
| AdjustableHemostasis Valve | Y-Adaptor W/Touhy BorstValve | Angeion CorpPlymouth, MN 55441 | K895580 |
| 120 cm GuideWires | TFX Medical Guide Wire | TFX Medical GroupJaffrey, NH 03452 | K963320 |
| 4 Fr and 6 FrGuide CatheterSlitters | Percutaneous Introducer Kit(Component) | MedAmicusMinneapolis, MN 55447 | K965167 |
| Guide Wire Clip | Class I device, exempt from premarket notification |
Summary of Studies
Compatibility Testing, incoming inspection of final packaged device and package qualification testing was performed to support substantial equivalence to the predicate devices. Attain Access passed all of the in vitro specified requirements, and ensures that the Attain Access 6218 meets all of its design and performance requirements.
The Attain Access 6218 was included in two (2) Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain Access 6218 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.
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Biocompatibility Information
Biocompatibility testing was performed on the materials which are blood contacting. Complete testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible.
Sterilization Validation
The Attain Access 6218 Left-heart delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated.
Conclusion
Through the data and information presented, as well as similarities to legally marketed devices, Medtronic Inc, considers the Attain Access 6218 Left-heart delivery system to be substantially equivalent to the previously discussed legally marketed predicate devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2001
Ms. Karen Reidt Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576
Re: K012083
Trade Name: Attain Access 6218 Left-Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulatory Class: Class II (two) Product Code: 74 DQY Dated: July 2, 2001 Received: July 3, 2001
Dear Ms. Reidt:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your becally is substantially equivalent (for the indications for use above and we nere acterine as a marketed predicate devices marketed in interstate commerce stated in une encrosare) to tegally markets of the Medical Device Amendments, or to devices that prior to may 20, 1978, and in the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act. The Act. The general controls provisions of the Act include requirements for annual provisions of the Frea - Frices, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Frenancer Ippe of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspootions, the Food and may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Ms. Karen Reidt
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Dalla Mela
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Preliminary Information
Indications for Use
| 510(k) Number (if known): | N/A K012083 |
|---|---|
| Device Name: | Attain™ Access 6218 Left-heart delivery system |
| Indications For Use: | The Attain Access 6218 Left-heart delivery system is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K612083
Meditronic confidential
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).