(63 days)
The AtriClip™ LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes performed by sternotomy (full or partial as well as thoracotomy (single or multiple).
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use 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.
The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) contains manufacturing modifications to the proposed AtriClip LAA Exclusion System intended to provide AtriCure with an alternate raw material source for the Polyethylene terephthalate (PET) of the knit braid polyester used in the AtriClip implant.
This document describes a 510(k) premarket notification for the AtriClip LAA Exclusion System, specifically addressing a manufacturing modification related to an alternate raw material source for a component of the implant. This is not a study proving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm validation. Instead, it demonstrates substantial equivalence to a predicate device through engineering and biocompatibility testing for a material change.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth for device performance in a diagnostic or clinical efficacy context are not applicable to this submission.
Here's an attempt to answer the questions based on the provided document:
1. A table of acceptance criteria and the reported device performance
Based on the nature of this 510(k) submission (a manufacturing modification for an alternate raw material source), the "acceptance criteria" are related to maintaining the performance and safety characteristics of the original device. The document does not provide a table with specific numerical acceptance criteria for a new clinical performance study. Instead, it states that:
| Acceptance Criteria (Implied by submission type) | Reported Device Performance (Summary) |
|---|---|
| Material Equivalence: The new raw material (PET for knit braid polyester) for the AtriClip implant must demonstrate equivalent chemical and biocompatibility characteristics to the previously used material. | "Chemical characterization and in vitro biocompatibility screening testing was conducted to demonstrate equivalence of the knit braided polyester sourced from the various suppliers of PET raw material." This indicates successful testing confirming the new material behaves similarly from a chemical and biological perspective. |
| Functional Equivalence: The device with the new material must maintain the same operating principle, specifications of performance, and overall safety as the predicate device. | "No changes were made in operating principle, or specifications of performance." "The results of the verification and validation testing: Demonstrated equivalency in performance... Did not raise any new issues of safety." This implies a range of engineering and functional tests (though not detailed) confirmed the device with the new material still performs as expected without degradation. "Device biocompatibility remains unchanged." Confirms the material change has not altered the biocompatibility profile. |
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 a "test set" in the context of clinical performance or algorithm validation. The testing described is chemical characterization and in vitro biocompatibility screening of the raw material. Details on sample sizes for these specific lab tests are not provided, nor is the country of origin or whether they were retrospective/prospective.
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 is not applicable. This submission concerns a manufacturing material change for a surgical implant, not a diagnostic device or AI algorithm requiring expert-established ground truth from clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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
This is not applicable. The device is a physical surgical implant, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the material equivalence and functional equivalence, the "ground truth" would be established using validated chemical analysis techniques (e.g., spectroscopy, chromatography) and standard in vitro biological assays (e.g., cytotoxicity, sensitization tests) to compare the new material to the established material. For functional performance, it would involve engineering test standards and specifications. Clinical outcomes data or expert consensus on clinical findings are not the primary "ground truth" for this type of submission.
8. The sample size for the training set
This is not applicable. The device is a physical surgical implant, not an AI algorithm.
9. How the ground truth for the training set was established
This is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Atricure, Inc. Brittany Lowe Regulatory Affairs 6217 Centre Park Drive West Chester, Ohio 45069
Re: K150996
Trade/Device Name: Atriclip LAA Exclusion System with Preloaded Gillinov-cosgrove Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: June 1, 2015 Received: June 2, 2015
Dear Ms. Lowe:
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
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Page 2 - Brittany Lowe
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 of medical devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
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) K150996
Device Name
Atriclip Laa Exclusion System With Preloaded Gillinov-cosgrove Clip
Indications for Use (Describe)
The AtriClip™ LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes performed by sternotomy (full or partial as well as thoracotomy (single or multiple).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the AtriCure logo. The logo is in blue and orange. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C".
510(k) Summary
l. Submitter
| Manufacturer: | AtriCure, Inc.6217 Centre Park Dr.West Chester, OH 45069P: 513-755-4100F: 513-755-4108 |
|---|---|
| Contact Person: | Brittany LoweRegulatory Affairs |
| Alternate Contact: | Jonathan McElwee, RACSenior Regulatory Specialist |
| Date Prepared: | 04/14/2015 |
| II.Device | |
| Name of Device: | AtriClip™ LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
| Common Name: | Implantable Clip and Clip Applier |
| Classification Name: | Implantable Clip and Clip Applier (21 CFR 878.4300 and 4800) |
| Regulatory Class: | Class II |
| Product Code: | FZP |
lll. Predicate 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, K122276 on August 29, 2012, K131107 on May 14, 2013, and K142120 on August 28, 2014.
The predicate devices have not been subject to a design-related recall.
No reference devices were used in this submission.
IV. Device Description
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use 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.
The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) contains manufacturing modifications to the proposed
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AtriClip LAA Exclusion System intended to provide AtriCure with an alternate raw material source for the Polyethylene terephthalate (PET) of the knit braid polyester used in the AtriClip implant.
V. Indications For Use
The AtriClip LAA Exclusion System is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
VI. Comparison Of Technological Characteristics With The Predicate Device
- The devices have the same intended use and; .
- No changes were made in operating principle, or specifications of performance.
- The results of the verification and validation testing:
- Demonstrated equivalency in performance ■
- . Device biocompatibility remains unchanged
- . Did not raise any new issues of safety
- No changes were made to the labeling. ●
- No changes were required in packaging sterilization or expiration dating. ●
VII. Performance Data
Chemical characterization and in vitro biocompatibility screening testing was conducted to demonstrate equivalence of the knit braided polyester sourced from the various suppliers of PET raw material.
VIII. Conclusions
The modified AtriClip LAA Exclusion System is equivalent to the previously cleared AtriClip LAA Exclusion System as there is no change to intended use or the basic design of the Clip.
§ 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.