(50 days)
The Attain LDS 6216 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 catheters for passing venogram balloon catheters or appropriate leads an adjustable hemostasis valve to reduce blood loss during the implant procedure, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters and a percutaneous introducer kit to facilitate venous access. The Attain LDS 6216 is intended for single use only and will be distributed independently for use with current and future leads. The Attain LDS 6216 combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.
The provided text describes a 510(k) premarket notification for the Attain LDS 6216 Left-heart delivery system. This document is a regulatory submission demonstrating substantial equivalence to previously marketed devices and does not contain acceptance criteria or study results in the format requested for a device with performance metrics like sensitivity, specificity, or accuracy.
The information provided focuses on the safety and functional performance of a medical device (catheter delivery system) through a comparison to predicate devices and general testing, rather than a diagnostic algorithm or AI system. Therefore, many of the specific questions regarding acceptance criteria, performance metrics, ground truth, and expert involvement are not applicable to the content of this document.
However, based on the provided text, I can extract the following relevant information regarding the device's validation:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a delivery system, explicit "acceptance criteria" presented as quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not detailed in the same way they would be for a diagnostic device or AI algorithm. Instead, the "acceptance criteria" are implied by the successful completion of various engineering and clinical performance tests, ensuring the device functions as intended and is safe. The "reported device performance" refers to the successful outcomes of these tests and its performance in clinical trials where it was used.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device components (guide catheters, dilator, introducer kit, slitters) must perform their intended functions (e.g., enable passage of balloon catheters/leads, reduce blood loss, facilitate venous access, remove catheters). | "Attain LDS 6216 passed all of the in vitro specified requirements, and ensures that the Attain LDS 6216 meets all of its design and performance requirements.""The Attain LDS 6216 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus." |
| Compatibility | Device must be compatible with existing leads and venogram balloon catheters. | "Compatibility Testing...was performed to support substantial equivalence to the predicate devices." (Implied successful compatibility) |
| Biocompatibility | All blood-contacting materials must be biocompatible according to recognized standards. | "Biocompatibility testing was performed on the materials which are blood contacting. Testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible." |
| Sterilization | Device must be effectively sterilized with a validated process. | "The Attain LDS 6216 Left-heart delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated." |
| Package Integrity | The packaging must maintain device sterility and integrity. | "incoming inspection of final packaged device and package qualification testing was performed to support substantial equivalence to the predicate devices." (Implied successful package integrity) |
2. Sample size used for the test set and the data provenance
- Test Set (Clinical Data): The device was included in two clinical investigations:
- Medtronic Model 8040 InSync System (MIRACLE) clinical investigation (G980219)
- Model 7272 InSync ICD System (MIRACLE ICD) clinical investigation (G990176)
- Sample Size: The document does not specify the exact number of patients or cases where the Attain LDS 6216 was used within these larger clinical trials. It only states its inclusion.
- Data Provenance: The studies were prospective clinical investigations (implied by "clinical investigation" and "approved" by the FDA with corresponding G-numbers). The country of origin for these specific clinical investigations is not explicitly stated in the provided text, but Medtronic is a US-based company, suggesting these were likely US-based or international trials following FDA guidance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For a delivery system, "ground truth" as typically defined for diagnostic AI (e.g., presence/absence of disease confirmed by an expert) is not directly applicable. The "ground truth" in this context would be the successful use and performance of the delivery system in facilitating a procedure, which would be assessed by the physicians performing the procedure in the clinical trials.
4. Adjudication method for the test set
This information is not provided nor directly applicable in the same way it would be for a diagnostic tool where multiple readers might disagree on findings. Success and failure in a surgical delivery system are often objective (e.g., successful lead placement, absence of complications).
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 MRMC study was conducted or is applicable here. The device is a physical delivery system, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Attain LDS 6216 is a physical medical device, not an algorithm. Its performance is always "human-in-the-loop" as it requires a physician to operate it.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical performance aspects, the "ground truth" would be the clinical outcomes data from the MIRACLE and MIRACLE ICD investigations, specifically focusing on the successful placement of leads and balloon catheters, and the absence of device-related adverse events during these procedures. For the in-vitro testing, the "ground truth" was established by engineering specifications and test standards.
8. The sample size for the training set
This question is not applicable. The device is a physical product, not a machine learning model that requires a training set. Its design and development would involve engineering prototypes and bench testing.
9. How the ground truth for the training set was established
This question is not applicable. As explained in point 8, there is no "training set" in the context of an algorithm. The "ground truth" for the device's design and in-vitro testing would be established through industry standards, performance specifications, and engineering validation processes.
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Attachments
Attain LDS 6216 Left-heart Delivery System
510(k) Premarket Notification
AUG 2 8 2001
510(k) Summary of Substantial Equivalence
| Date prepared | July 6, 2001 | |
|---|---|---|
| Submitter: | Medtronic, Inc.7000 Central Avenue N.E.Minneapolis, MN 55432 | |
| Contact: | Karen ReidtSr. Product Regulation Manager | |
| Telephone: | (763) 514-3914 | |
| Fax: | (763) 514-6424 | |
| E-Mail: | karen.reidt@medtronic.com | |
| Proprietary Name: | Attain™ LDS 6216 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 catheters for passing venogram balloon catheters or appropriate leads an adjustable hemostasis valve to reduce blood loss during the implant procedure, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters and a percutaneous introducer kit to facilitate venous access.
The Attain LDS 6216 is intended for single use only and will be distributed independently for use with current and future leads.
The Attain LDS 6216 combines devices 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 LDS 6216 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
onfidential
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| Attain LDS 6216Left-heartDelivery SystemDevice | Predicate Device | Predicate Device Manufacturer | Predicate 510(k) |
|---|---|---|---|
| 40 cm and 45 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 | |
| PercutaneousIntroducer Kit | Percutaneous Introducer Kit(Component) | MedAmicusMinneapolis, MN 55447 | K965167 |
| 4 Fr and 6 FrGuide CatheterSlitters | Percutaneous Introducer Kit(Component) | MedAmicusMinneapolis, MN 55447 | K965167 |
Substantially Equivalent Devices
Attain LDS 6216 Left-heart Delivery System Predicate Devices
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 LDS 6216 passed all of the in vitro specified requirements, and ensures that the Attain LDS 6216 meets all of its design and performance requirements.
The Attain LDS 6216 was included in the Medtronic Model 8040 InSync System (MIRACLE) clinical investigation (G980219, approved, September 30, 1998) and Model 7272 InSync ICD System (MIRACLE ICD) clinical investigation (G990176, approved per 5-day notification, October 6, 2000). The Attain LDS 6216 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.
Biocompatibility Information
Biocompatibility testing was performed on the materials which are blood contacting. Testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible.
Image /page/1/Picture/10 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. To the left of the word is a circular graphic with a stylized image of a person. To the right of the word "Medtronic" is the word "Confidential" in a smaller, non-bold font.
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Sterilization Validation
The Attain LDS 6216 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 LDS 6216 Left-heart delivery system to be substantially equivalent to the previously discussed legally marketed predicate devices.
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
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: K012130
Trade Name: Attain LDS 6216 Left-Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulatory Class: Class II (two) Product Code: 74 DQY Dated: July 6, 2001 Received: July 9, 2001
Dear Ms. Reidt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in 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 comply with the GMP regulation 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 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 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,
Deale Telle
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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510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
NA RO12130
Attain™ LDS 6216 Left-heart delivery system
The Attain LDS 6216 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 V (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Dell Tule
Division of Cardiovascular & Respiratory Devices
510(k) Number K012150
Image /page/5/Picture/16 description: The image shows the Medtronic logo and the word "Confidential" in black font. The Medtronic logo is on the left side of the image. The word "Medtronic" is in bold font and is larger than the word "Confidential". The word "Confidential" is on the right side of the image.
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§ 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).