(8 days)
The Attain™ Prevail® Left Heart Delivery System is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The Medtronic Attain™ Prevail® Left Heart Delivery System features a steerable catheter and accessories to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart. The components of the Attain Prevail Left Heart Delivery System include: Prevail steerable catheter, 45 cm straight guide catheter, 50 cm straight guide catheter, 0.016" stainless steel guide wire, 0.035" stainless steel guide wire, 3- way stopcock, Universal slitter, Introducer valve, Guide catheter dilator, Y-connector with adjustable hemostasis valve assembled with an extension tube, Guide wire torque tools, Guide wire clips. The Prevail steerable catheter features a single lumen for passage of devices up to 0.035' (0.89 mm) diameter or injection of contrast solutions. Transvenous devices with an inner diameter of 7 French (2.3 mm) or larger can be loaded on and delivered over the Prevail catheter. The catheter features a steerable distal section and is radiopaque for visibility under fluoroscopy. The Attain Prevail Left Heart Delivery System is provided STERILE and is intended for single use only.
Here's an analysis of the provided 510(k) summary, specifically addressing your questions about acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not detail specific, quantitative acceptance criteria for the device's performance. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All specified design and performance requirements met. | "The Attain Prevail Left Heart Delivery System met all specified design and performance requirements." |
| Biocompatibility consistent with ISO-10993 requirements. | "All specified biocompatibility requirements were met." |
| Sterilization validation through an Ethylene Oxide (EtO) process. | "The Attain Prevail Left Heart Delivery System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process." |
2. Sample Size Used for the Test Set and Data Provenance
The summary states, "Verification testing included system compatibility and packaging integrity testing." However, it does not specify the sample size used for these tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. The type of testing described (system compatibility, packaging integrity, biocompatibility) typically does not involve human expert adjudication in the same way, for example, an imaging diagnostic AI would.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the "verification testing" described, it's unlikely a formal human adjudication method (like 2+1 or 3+1) was employed. These tests would usually involve objective measurements and established protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting medical images or data. The Attain™ Prevail® Left Heart Delivery System is a physical medical device (a catheter and delivery system) used in procedures, not a diagnostic algorithm.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. As explained above, this device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device would be established by objective physical and chemical testing. For example:
- System Compatibility: Successful deployment of transvenous devices through the Prevail catheter, without entanglement, breakage, or failure to deliver within specified tolerances.
- Packaging Integrity: Maintenance of sterility and physical integrity of the product after simulated transport and storage.
- Biocompatibility: Laboratory tests (e.g., cytotoxicity, sensitization, irritation) according to ISO-10993 standards, demonstrating the materials do not elicit an adverse biological response.
- Sterilization Validation: Confirmation that the Ethylene Oxide (EtO) process achieves a specified sterility assurance level (SAL).
8. Sample Size for the Training Set
This is not applicable and not provided. The Attain™ Prevail® Left Heart Delivery System is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As explained in point 8, there is no "training set" for this device.
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SEP - 3 2003
510(k) Summary of Substantial Equivalence
| Date Prepared: | August 25, 2003 | ||
|---|---|---|---|
| Submitter: | Medtronic, Inc.7000 Central Avenue N.E.Minneapolis, MN 55432 | ||
| Contact: | Lynn JensenSr. Regulatory Affairs Specialist | ||
| Telephone: | (763) 514-4459 | ||
| Fax: | (763) 514-6424 | ||
| E-Mail: | lynn.a.jensen@medtronic.com | ||
| Proprietary Name: | Attain™ Prevail® Left Heart Delivery System | ||
| Common Name: | Catheter, Percutaneous | ||
| Device Classification: | Class II, 21 CFR § 870.1250 |
74DQY Product Code:
Device Description
The Medtronic Attain™ Prevail® Left Heart Delivery System features a steerable catheter and accessories to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The components of the Attain Prevail Left Heart Delivery System include:
- Prevail steerable catheter ●
- 45 cm straight guide catheter ●
- 50 cm straight guide catheter .
- 0.016" stainless steel guide wire .
- 0.035" stainless steel guide wire ●
- 3- way stopcock ●
- Universal slitter ●
- Introducer valve ●
- Guide catheter dilator
- Y-connector with adjustable hemostasis valve assembled with an extension tube .
- Guide wire torque tools .
- Guide wire clips ●
Image /page/0/Picture/20 description: The image shows the Medtronic logo and the word "Confidential" in black text. The Medtronic logo is on the left side of the image and consists of a circle with a stylized figure inside. The word "Medtronic" is in bold, sans-serif font, and the word "Confidential" is in a smaller, regular font.
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The Prevail steerable catheter features a single lumen for passage of devices up to 0.035' (0.89 mm) diameter or injection of contrast solutions. Transvenous devices with an inner diameter of 7 French (2.3 mm) or larger can be loaded on and delivered over the Prevail catheter. The catheter features a steerable distal section and is radiopaque for visibility under fluoroscopy.
The Attain Prevail Left Heart Delivery System is provided STERILE and is intended for single use only.
Indications for Use
The Attain Prevail Left Heart Delivery System is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
| Predicate Device | Predicate DeviceManufacturer | Predicate 510(k) | |
|---|---|---|---|
| Catheter | Medtronic AttainPrevail SteerableCatheter SetModel 6228CTH | Medtronic | K031211 |
| Catheter | Medtronic AttainAccess Left-HeartDelivery SystemModel 6218A | Medtronic | K021589 |
| Introducer Valve | Introducer ValveModel 6228VAL | Cook VascularIncorporated | K010128 |
| Universal Slitter | Class I device, exempt from premarket notification. |
Substantially Equivalent Devices
The Attain Prevail Left Heart Delivery System uses similar technology and has similar intended uses, materials and dimensional characteristics to the predicate devices.
Summary of Studies
Verification testing included system compatibility and packaging integrity testing. The Attain Prevail Left Heart Delivery System met all specified design and performance requirements.
Image /page/1/Picture/9 description: The image shows the Medtronic logo followed by the word "Confidential". The Medtronic logo is a stylized image of a globe with lines running across it. The word "Medtronic" is written in a bold, sans-serif font. The word "Confidential" is written in a smaller, serif font.
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Biocompatibility Information
All device components were assessed for biocompatibility consistent with ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing. All specified biocompatibility requirements were met.
Sterilization Validation
The Attain Prevail Left Heart Delivery System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.
Conclusion
Through the data and information presented, Medtronic, Inc. considers the Attain Prevail Left Heart Delivery System to be substantially equivalent to legally marketed predicate devices.
Image /page/2/Picture/6 description: The image shows the Medtronic logo followed by the word "Confidential". The Medtronic logo is a stylized image of a globe with lines running across it. The word "Medtronic" is written in a bold, sans-serif font. The word "Confidential" is written in a smaller, sans-serif font.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2003
Medtronic, Inc. c/o Ms. Lynn Jensen Senior Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432-3576
Re: K032622
Trade Name: Attain™ Prevail® Left Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 25, 2003 Received: August 26, 2003
Dear Ms. Jensen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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
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Page 2 – Ms. Lynn Jensen
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
J. Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Page 1 of 1
510(k) Number (if known): K032622
Device Name: Attain™ Prevail® Left Heart Delivery System
Model 6228SYS
Indications for Use: The Attain™ Prevail® Left Heart Delivery System is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
(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)
Over-the Counter Use
(Optional Format 1-2-96)
Division Sign-Off
Division of Cardiovascular Devices
OR
510(k) Number K032622
(Optional Format 1-2-96)
§ 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).