(75 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML or data-driven algorithms.
No
Explanation: The device is used for suture fastening during surgical procedures, which is a supportive role in surgery rather than directly treating a disease or condition. While it aids in a therapeutic procedure, it does not itself provide therapy.
No
This device is used for suture fastening, not for diagnosing medical conditions. It performs a physical action (deploying fasteners) rather than providing information about a patient's health status.
No
The device description explicitly details physical components: a fastening instrument with a shaft, handle, and trigger, and a fastener loader. These are hardware components, not software.
Based on the provided information, the Edwards Suture Fastening System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "suture fastening in the approximation of soft tissue and prosthetic materials," which is a surgical procedure performed in vivo (within the body).
- Device Description: The device is a surgical instrument designed to deploy a fastener onto a suture during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis.
Therefore, the Edwards Suture Fastening System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Edwards Suture Fastening System is indicated for suture fastening in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings.
Product codes (comma separated list FDA assigned to the subject device)
HCF
Device Description
The Edwards Suture Fastening System is comprised of the fastening instrument and the fastener loader. These components interface together to deploy a nitinol fastener onto a suture and then cut the suture 5 mm proximal to the nitinol fastening instrument has a 3 mm (0.1 inches) diameter shaft which is available in three lengths: 15 cm (5.9 inches), 22 cm (8.7 inches) and 30 cm (11.8 inches). A handle and a trigger are located at the proximal end of the instrument. By activating the trigger, the fastening instrument deploys the nitinol fastener at the intended position and cuts the suture. Each fastener loader holds one nitinol fastener which is pre-loaded in the locking tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Data:
- Function testing:
- Knot loader suture snare tensile strength
- Knotting system suture loading force
- Knotting instrument shaft stiffness
- Knotting instrument weight
- Dimensional interference
- Pinch point area
- Knotting instrument effective length
- Shaft outer diameter
- Overall nitinol knot height
- Knot loader outer diameter
- Knotting system deployment force
- Suture tension
- Knot loader disposable tip push-off force
- Nitinol knot push-off force
- Nitinol knot suture retention strength
- Knotting instrument handle strength
- Knotting instrument corrosion
- Nitinol knot corrosion
- Knotting instrument durability (maximum of 25 deployment cycles)
- Ink adherence
- Nitinol knot magnetic resonance conditional testing
- Nitinol knot durability (600 million cycles)
- Animal studies: To demonstrate use of the device in a cardiovascular application under worse case physiological conditions (i.e., mitral bioprosthesis) using polyester and propylene suture.
- Biocompatibility testing was performed per ISO 10993-1:2009
- Sterility and sterile barrier testing
- Shelf life testing
- Packaging testing
- Design validation
Key results: All results met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2015
Edwards Lifesciences LLC Ms. Nina Brooke Regulatory Affairs Associate III One Edwards Way Irvine, CA 92614
Re: K150882
Trade/Device Name: Edwards Suture Fastening System Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class I Product Code: HCF Dated: April 1, 2015 Received: April 2, 2015
Dear Ms. Brooke:
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 CFR
1
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 (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.
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
2
Indications for Use
510(k) Number (if known) K150882
Device Name
Edwards Suture Fastening System
Indications for Use (Describe)
The Edwards Suture Fastening System is indicated for suture fasteming in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (K150882)
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Nina Brooke, Regulatory Affairs Associate III |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Phone: (949) 244-6444 |
|
| Fax: | (949)756-4573 |
| Date Prepared: | April 1, 2015 |
| Trade Name: | Edwards Suture Fastening System |
| Classification Name: | Instrument Ligature Passing and Knot Tying, General &
Plastic Surgery Panel (21 CFR §878.4800, Product Code
HCF, Class I) |
| Predicate Device: | K141206, Edwards ThruPort OptiClip Knotting System,
Edwards Lifesciences, LLC. |
Device Description
The Edwards Suture Fastening System is comprised of the fastening instrument and the fastener loader. These components interface together to deploy a nitinol fastener onto a suture and then cut the suture 5 mm proximal to the nitinol fastening instrument has a 3 mm (0.1 inches) diameter shaft which is available in three lengths: 15 cm (5.9 inches), 22 cm (8.7 inches) and 30 cm (11.8 inches). A handle and a trigger are located at the proximal end of the instrument. By activating the trigger, the fastening instrument deploys the nitinol fastener at the intended position and cuts the suture. Each fastener loader holds one nitinol fastener which is pre-loaded in the locking tip.
Indications for Use
The Edwards Suture Fastening System is indicated for suture fastening in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings.
Technological Characteristics
The subject device has similar technological characteristics as the predicate device, with minor design optimizations in the disposable tip, the suture snare target, the cutter assembly, and the right handle to improve manufacturability and usability.
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Non-clinical Performance Data
The following nonclinical tests were completed and all results met acceptance criteria:
- . Function testing
- Knot loader suture snare tensile strength: To demonstrate that the Knot Loader suture snare can withstand forces encountered during suture loading within the Knotting Instrument.
- । Knotting system suture loading force: To establish the forces encountered during suture loading within the Knotting Instrument
- Knotting instrument shaft stiffness: To demonstrate that the shaft of the Knotting — Instrument has adequate stiffness to perform effectively within the intended use.
- -Knotting instrument weight: To demonstrate that the weight of the assembled Knotting System allows for adequate tactile feedback.
- -Dimensional interference: To demonstrate that the components of the Knotting System (including the un-deployed nitinol knot) do not exhibit dimensional interference relative to the suture prior to deployment.
- -Pinch point area: To demonstrate that the area of the exposed Knotting System pinch point is less than that of the predicate device.
- Knotting instrument effective length: To demonstrate that the effective length of the -15cm, 22cm, and 30cm Knotting Instrument are as labeled
- -Shaft outer diameter: To demonstrate that the outer diameter of the Knotting Instrument is less than or equal to the predicate device.
- | Overall nitinol knot height: To demonstrate that the deployed nitinol knot height is less than or equal to the predicate device
- -Knot loader outer diameter: To demonstrate that the outer diameter of the Knot Loader is less than or equal to the predicate device outer diameter.
- -Knotting system deployment force: To demonstrate that the force required to fully depress the trigger and deploy a nitinol knot exceeds the weight of the Knotting System and is low enough to ensure ease of use
- -Suture tension: To demonstrate that the tension required to cut suture is less than or equal to the predicate device.
- -Knot loader disposable tip push-off force: To demonstrate that the Knot Loader locking tip will not be pushed off during the deployment of the nitinol knot.
- -Nitinol knot push-off force: To demonstrate that the Knot Loader locking tip will not be pushed off during the deployment of the nitinol knot.
- Nitinol knot suture retention strength: To demonstrate that the nitinol knot can effectively secure the suture upon deployment when used for the intended use.
- -Knotting instrument handle strength: To demonstrate that the handle of the Knotting Instrument can withstand the force of applying suture tension and pressure onto tissue or prosthetic material.
- -Knotting instrument corrosion: To demonstrate that the Knotting Instrument can function after exposure to a simulated use environment.
- | Nitinol knot corrosion: To demonstrate that the nitinol knot does not corrode.
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- -Knotting instrument durability: To demonstrate that the Knotting Instrument can function for a maximum of 25 deployment cycles.
- Ink adherence: To demonstrate that the ink adheres to the device. |
- Nitinol knot magnetic resonance conditional testing: To substantiate the claim of magnetic resonance (MR) conditional.
- -Nitinol knot durability (600 million cycles): Demonstrate that the applicable engineering requirements for nitinol knot fatigue/durability are satisfied when used with Ethibond Excel polyester (braided) suture and 2-0 Ethicon Prolene polypropylene suture.
- Animal studies: To demonstrate use of the device in a cardiovascular application under worse case physiological conditions (i.e., mitral bioprosthesis) using polyester and propylene suture.
- Biocompatibility testing was performed per ISO 10993-1:2009
- Sterility and sterile barrier testing
- . Shelf life testing
- Packaging testing ●
- Design validation
Conclusion
The Edwards Suture Fastening System has similar technological characteristics as the predicate device with minor design modifications. It also has the same general indications for use as the predicate device, with additional specific indications for use in cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings, which does not raise new issues of safety or effectiveness. Nonclinical performance data have demonstrated that the subject device is substantially equivalent to the predicate device.