(25 days)
The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
The AtriClip Gillinov Cosgrove LAA Clip is a single use, sterile, self-closing, implantable Clip to be deployed with a Reusable Clip Applier. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. This Special 510(k) does not include any changes to the Clip.
This Special 510(k) includes modifications to package the Clip individually to be loaded on a Reusable Clip Applier.
This 510(k) summary document describes a modification to an existing device, the AtriClip Gillinov-Cosgrove LAA Clip. The core of the submission is to demonstrate substantial equivalence to the previously cleared device (K093679 and K122276), asserting that the modifications do not affect performance.
Therefore, the submission does not contain a new study that defines and tests against acceptance criteria for device performance as a standalone product. Instead, it relies on the previous clearances and tests demonstrating that the new packaging does not degrade the previously established performance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable in the format of specific functional performance criteria for the device itself.
The acceptance criteria in this specific 510(k) are focused on the impact of packaging modifications.
- Acceptance Criteria: The new individual packaging must adequately protect the device during shipment.
- Reported Device Performance: "The Clip was tested to confirm new packaging of the Clip adequately protects the device during shipment." (The document states testing was done, implying it met the criteria, but doesn't provide specific test results or metrics here).
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for the packaging test.
- Data Provenance: The testing for the packaging modification would have been internal AtriCure, Inc. testing, likely prospective for the new packaging configuration.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for packaging protection is determined by engineering and performance testing (e.g., integrity, sterility, functional checks after simulated shipping), not expert consensus in a clinical sense.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data, which is not described for this packaging modification.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for occlusion of the left atrial appendage, not an AI or imaging diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implantable medical device.
7. The type of ground truth used
For the packaging modification, the "ground truth" would be the successful completion of specified packaging validation tests (e.g., sterile barrier integrity, product integrity after shipping simulation, etc.).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states: "The Clip was tested to confirm new packaging of the Clip adequately protects the device during shipment. Complete Design Control testing for the Clip was previously included in the original 510(k) K093679."
This indicates that:
- A specific test (or series of tests) was conducted to evaluate the individual packaging's ability to protect the device during transit. The details of this test (e.g., specific parameters, number of units tested, acceptance criteria for "adequately protects") are not provided in this summary but would have been part of the full 510(k) submission.
- For the performance of the Clip itself (e.g., sealing, occlusion effectiveness, biocompatibility), the submission relies on the comprehensive design control testing and evaluations performed for the original 510(k) K093679. The current submission asserts "there is no change to indications for use/intended use, the implant Gillinov-Cosgrove Clip, or the basic design of the Clip and Clip Applier configuration," and "The modifications do not affect the ability of the Clip to be successfully deployment on the LAA." Essentially, the previous studies prove the device meets its core acceptance criteria, and this submission demonstrates the change does not compromise those criteria.
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510(k) Summary
General Information
MAY 1 4 2013
| Classification | Class 2 |
|---|---|
| Trade name | AtriClip™ Gillinov-Cosgrove™ LAA Clip |
| Common name | Implantable Clip |
| Classification Name | Clip, Implantable (21 CFR 878.4300, Product Code FZP) |
| Manufacturer | AtriCure, Inc. |
| 6217 Centre Park Dr. | |
| West Chester, OH 45069 | |
| P: 513-755-4100 | |
| F: 513-755-4108 | |
| Contact | Rebecca Walters, RAC |
| Regulatory Affairs Manager |
Date of Submission April 17, 2013
Intended Use
The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Cleared Device
The device proposed for modification in this submission is the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip cleared via 510(k) K093679 on June 10, 2010 and K122276 on August 29, 2012.
Device Description
The AtriClip Gillinov Cosgrove LAA Clip is a single use, sterile, self-closing, implantable Clip to be deployed with a Reusable Clip Applier. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. This Special 510(k) does not include any changes to the Clip.
This Special 510(k) includes modifications to package the Clip individually to be loaded on a Reusable Clip Applier.
Materials
There are no changes to materials of the Clip. All materials in the Clip are suitable for their Testing was conducted in accordance with ISO 10993-1 to ensure appropriate intended use. biocompatibility of all materials.
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Testing
The Clip was tested to confirm new packaging of the Clip adequately protects the device during shipment. Complete Design Control testing for the Clip was previously included in the original 510(k) K093679.
Summary of Equivalence
The AtriClip Gillinov-Cosgrove LAA Clip is equivalent to the previously cleared AtriClip LAA Exclusion System as there is no change to indications for use/intended use, the implant Gillinov-Cosgrove Clip, or the basic design of the Clip and Clip Applier configuration. The modifications do not affect the ability of the Clip to be successfully deployment on the LAA,
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2013
AtriCure, Inc. Rebecca Walters Regulatory Affairs Manager 6217 Centre Park Drive West Chester, OH 45069
Re: K131107
Trade/Device Name: AtriClip™ Gillinov-Cosgrove™ LAA Clip Regulation Number: 21 CFR 870.4300 Regulation Name: Clip, Implantable Regulatory Class: Class II Product Code: FZP Dated: April 17, 2013 Received: April 19, 2013
Dear Ms. Walters:
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
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Page 2 - Ms. Rebecca Walters
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/Resourcesfor You/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.
Matthew Gallillebrenner
D
for 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
510(k) Number (if known) _K131107
Device Name: AtriClip Gillinov-Cosgrove LAA Clip
Indications for Use:
The AtriClip Gillinov-Cosgrove Clip is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Prescription Use ਮ (Part 21 CRF 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CRF 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew G. Hillebrenner
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.