(93 days)
The Edwards E360 surgical ablation device is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, and colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).
The Edwards E360 surgical ablation device is indicated for use in medicine and surgery with 980 to 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Cardiac/Thoracic Surgery, Plastic Surgery, and Dermatology.
The Edwards E360 surgical ablation device is a sterile, single-use, disposable device for delivery of 980 nm laser energy in the contact mode.
This document does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria in the typical sense of a clinical or analytical performance study with statistical endpoints.
Instead, this is a 510(k) summary for the Edwards E360 surgical ablation device. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing numerical performance metrics against predefined acceptance criteria for a novel device.
Here's an analysis based on the provided text, while acknowledging the information gap:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document is a 510(k) summary demonstrating substantial equivalence, not a detailed performance study with quantitative acceptance criteria. The "Functional/Safety Testing" mentioned generally confirms "successfully completed design verification testing," but specific acceptance criteria and performance metrics are not reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available. No specific test set, its sample size, or data provenance is detailed for a clinical or analytical performance study. The testing mentioned ("design verification testing") would typically involve engineering tests, not patient data in the context of a "test set" for performance evaluation against ground truth.
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 information is not available. As there is no described test set for performance evaluation against a specific ground truth, there is no mention of experts involved in establishing such ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No adjudication method is mentioned as there is no specific test set or performance evaluation described.
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 information is not available. An MRMC study is not mentioned. This device is a surgical ablation device, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available. No specific ground truth is mentioned. The testing described is design verification, which likely involves engineering specifications and safety standards rather than clinical ground truth establishment.
8. The sample size for the training set
This information is not available. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not available. There is no mention of a training set or its associated ground truth.
Summary of what the document does provide regarding "proof" of meeting criteria:
The primary "proof" in this 510(k) submission is the demonstration of substantial equivalence to predicate devices.
- Acceptance Criteria (Implicit): The implicit acceptance criteria for a 510(k) is demonstrating that the new device is "as safe and effective as a legally marketed device." This is achieved by showing comparable design, intended use, materials, and principle of operation to predicate devices, and successful completion of design verification testing.
- Study Proving Device Meets Criteria: The "study" is the Comparative Analysis and Functional/Safety Testing described:
- Comparative Analysis: "It is demonstrated that the Edwards E360 surgical ablation device is comparable to the predicate device in design, intended use, materials, and principal of operation." This is the core of the substantial equivalence argument.
- Functional/Safety Testing: "The Edwards E360 surgical ablation device has successfully completed design verification testing." This confirms the device meets its own engineering and safety specifications, which support the claim of being as safe and effective as the predicates.
In essence, for this type of medical device submission, the "study" is the entire submission package which argues for substantial equivalence based on comparisons to predicate devices and internal design/safety verification, rather than a clinical performance study with statistical endpoints against a "ground truth" as might be required for a novel diagnostic or AI device.
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Image /page/0/Picture/1 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads 'K041739'. The characters are written in a casual, cursive style, with some variations in stroke thickness. The image is in black and white.
September 13, 2004
Attachment 3 - 510(k) Summary K041739
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Elizabeth Moran, Regulatory Affairs Specialist |
| Date Prepared: | September 13, 2004 |
| Trade Name: | Edwards E360 surgical ablation device |
| Classification Name: | Class II, Laser Surgical Instrument |
| Predicate Device(s): | Malleable Surgical Lightstic 180 (Marketed under the tradename of Edwards surgical ablation handpiece) (K013901) |
| AFx FLEX 10 Accessory for the AFx Microwave AblationSystem (K013946) | |
| Edwards Retrograde Cardioplegia Cannula (K880103) | |
| Edwards Swan-Ganz™ Synthetic ControlCathThermodilution Catheter (K001063) | |
| Device Description: | The Edwards E360 surgical ablation device is a sterile,single-use, disposable device for delivery of 980 nm laserenergy in the contact mode. |
| Indications for Use: | The Edwards E360 surgical ablation device is intended tobe used as a surgical instrument for coagulation of softtissue (including cardiac tissue) in conjunction with orwithout endoscopic equipment (including laparoscopes,hysteroscopes, bronchoscopes, cystoscopes, gastroscopes,and colonoscopes), and coagulation of soft tissue in thecontact mode in both open or closed surgical procedures(with or without handpiece). |
| The Edwards E360 surgical ablation device is indicated foruse in medicine and surgery with 980 to 1064 nmwavelength laser energy in the following surgicalspecialties: General Surgery, Cardiac/Thoracic Surgery,Plastic Surgery, and Dermatology. |
PROPRIETARY INFORMATION: This document and information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC.
K041739 Amendment 2
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| Comparative Analysis: | It is demonstrated that the Edwards E360 surgical ablation device is comparable to the predicate device in design, intended use, materials, and principal of operation. |
|---|---|
| Functional/Safety Testing: | The Edwards E360 surgical ablation device has successfully completed design verification testing. |
| Conclusion: | The Edwards E360 surgical ablation device is substantially equivalent to the predicate device. |
PROPRIETARY INFORMATION. This document and information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC.
K041739 Amendment 2
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB 2 1 2008
Edwards Lifesciences, LLC c/o Ms. Elizabeth Moran Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614
Re: K041739
Trade Name: Edwards E360 Surgical Ablation Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: September 13, 2004 Received: September 14, 2004
Dear Ms. Moran:
This letter corrects our substantially equivalent letter of September 29, 2004.
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 (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 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.
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Page 2 - Ms. Elizabeth Moran
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 continue 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
eemall
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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Attachment 2 - Indications for Use Statement
510(k) Number (if known): K041739
Device Name:
Edwards E360 surgical ablation device
Indications for Use:
The Edwards E360 surgical ablation device is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without equipment (including laparoscopes, hysteroscopes, bronchoscopes, endoscopic cystoscopes, gastroscopes, and colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).
The Edwards E360 surgical ablation device is indicated for use in medicine and surgery with 980 to 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Cardiac/Thoracic Surgery, Plastic Surgery, and Dermatology.
041239 Blümmerstern
ivision Sign-Off)
vision of Cardiovascular Devices
: 0(k) Number
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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PROPRIETARY INFORMATION: This document and information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC.
K041739 Amendment 2
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.