(252 days)
Not Found
No
The summary describes a mechanical surgical instrument for knot tying and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is used for the "approximation of soft tissue and prosthetic materials," which is a surgical function and not explicitly stated as having a direct therapeutic effect or treating a disease/condition.
No
The device description and intended use indicate it is for approximating soft tissue, a surgical function, not for diagnosing medical conditions. The performance studies focus on mechanical and material properties, not diagnostic accuracy.
No
The device description explicitly states it is a surgical instrument made of metal and polymeric materials, indicating it is a physical hardware device. The performance studies also focus on physical properties and functional bench testing of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the approximation of soft tissue and prosthetic materials." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "surgical instrument." IVDs are typically reagents, kits, or instruments used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for surgical use in approximating tissues and materials within the body.
N/A
Intended Use / Indications for Use
The knotting instrument used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot is indicated for use in the approximation of soft tissue and prosthetic materials.
Product codes (comma separated list FDA assigned to the subject device)
GAW, HCF
Device Description
Edwards Lifesciences' ThruPort OptiClip Knotting System is a sterile, nonpyrogenic, single-use surgical instrument made of metal and polymeric materials. lt consists of the ThruPort OptiClip Knotting Instrument and the ThruPort OptiClip Knot Loader.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
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)
Functional bench testing (design verification) was performed, and all results met acceptance criteria.
Tests included:
- 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
- Knotting System Packaging Integrity
- Nitinol Knot Magnetic Resonance Conditional Testing
Biocompatibility testing was performed per ISO 10993-1:2009.
Sterility and sterile barrier testing were performed.
Shelf life testing was performed.
Packaging testing was performed.
Design validation was performed.
MR evaluation testing was conducted. Non-clinical testing demonstrated that the nitinol knot is MR Conditional under specific conditions:
- Static magnetic field of 1.5 Tesla and 3.0 Tesla only
- Maximum spatial gradient magnetic field of 3,000 Gauss/cm (30 T/m) or less
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
Under these conditions, the nitinol knot is expected to produce a maximum temperature rise of less than 1.5 ℃ after 15 minutes of continuous scanning.
Image artifact caused by the nitinol knot extends approximately 1 mm from the nitinol knot when imaged with a spin echo pulse sequence in a 3.0 T MRI system and 5 mm from the nitinol knot when imaged with a gradient echo pulse sequence in a 3.0 T MRI system.
The knotting instrument and knot loader are MR Unsafe.
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
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Edwards Lifesciences LLC Ms. Nina Brooke Regulatory Affairs Associate III One Edwards Way Irvine, California 92614
Re: K141206
Trade/Device Name: ThruPort Knotting Instrument Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW, HCF Dated: January 12, 2015 Received: January 14, 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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 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/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 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K141206
Device Name ThruPort Knotting Instrument
Indications for Use (Describe)
The knotting instrument used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot is indicated for use in the approximation of soft tissue and prosthetic materials.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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| 510(k) Summary | |
|---|---|
| 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: | January 15, 2015 |
| Trade Name: | Edwards ThruPort OptiClip Knotting System |
| Classification Name: | Suture, Nonabsorbable, Synthetic, Polypropylene (21 CFR |
| §878.5010, Product Code GAW, Class II) | |
| Instrument Ligature Passing and Knot Tying, General & | |
| Plastic Surgery Panel (21 CFR §878.4800, Product Code | |
| HCF, Class I) | |
| Predicate Device: | K100593, Suture Placement Devices and Accessories, LSI |
| Solutions, Inc. |
Device Description:
Edwards Lifesciences' ThruPort OptiClip Knotting System is a sterile, nonpyrogenic, single-use surgical instrument made of metal and polymeric materials. lt consists of the ThruPort OptiClip Knotting Instrument and the ThruPort OptiClip Knot Loader.
Intended Use:
Intended for use in the approximation of soft tissue and prosthetic materials.
Indications for Use:
The ThruPort Knotting Instrument is used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot and is indicated for use in the approximation of soft tissue and prosthetic materials.
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Comparative Analysis:
The subject device has the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate device. It has been demonstrated that the subject device is comparable to the predicate device in fundamental scientific technology, material types, principles of operation, and functional performance evaluations.
Functional and Safety Testing:
The functional data indicate that the device performs in a substantially equivalent manner when compared to the predicate device. The following functional tests were completed and all results met acceptance criteria:
- . Functional bench testing (design verification)
- Knot Loader Suture Snare Tensile Strength: 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: Demonstrate that the shaft of the Knotting Instrument has adequate stiffness to perform effectively within the intended use.
- . Knotting Instrument Weight: Demonstrate that the weight of the assembled Knotting System allows for adequate tactile feedback.
- Dimensional Interference: 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: Demonstrate that the area of the exposed Knotting System pinch point is less than that of the predicate device.
- . Knotting Instrument Effective Length: Demonstrate that the effective length of the 15cm, 22cm, and 30cm Knotting Instrument are as labeled
- . Shaft Outer Diameter: Demonstrate that the outer diameter of the Knotting Instrument is less than or equal to the predicate device.
- . Overall Nitinol Knot Height: Demonstrate that the deployed nitinol knot height is less than or equal to the predicate device
- Knot Loader Outer Diameter: Demonstrate that the outer diameter of the . Knot Loader is less than or equal to the predicate device outer diameter.
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- Knotting System Deployment Force: 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: Demonstrate that the tension required to cut suture is less than or equal to the predicate device.
- Knot Loader Disposable Tip Push Off Force: Demonstrate that the Knot Loader locking tip will not be pushed off during the deployment of the nitinol knot.
- . Nitinol Knot Push Off Force: Demonstrate that the Knot Loader locking tip will not be pushed off during the deployment of the nitinol knot.
- Nitinol Knot Suture Retention Strength: Demonstrate that the nitinol knot . can effectively secure the suture upon deployment when used for the intended use.
- Knotting Instrument Handle Strength: 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: Demonstrate that the Knotting Instrument . can function after exposure to a simulated use environment.
- Nitinol Knot Corrosion: Demonstrate that the nitinol knot does not corrode. ●
- Knotting Instrument Durability: Demonstrate that the Knotting Instrument . can function for a maximum of 25 deployment cycles.
- . Knotting System Packaging Integrity: Demonstrate that the packaging configuration of the Knotting System is able to maintain a sterile barrier after worst case conditioning.
- Nitinol Knot Magnetic Resonance Conditional Testing: To substantiate . the claim of magnetic resonance (MR) conditional.
- · Biocompatibility testing was performed per ISO 10993-1:2009
- · Sterility and sterile barrier testing
- · Shelf life testing
- · Packaging testing
- · Design validation
MR evaluation testing:
Per testing conducted the following MR safety statement will be added to our labeling
MRI SAFETY INFORMATION
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Image /page/6/Picture/2 description: The image shows a black triangle with the letters "MR" in bold black font in the center. The triangle is equilateral, and the letters are horizontally centered within it. The background is plain white.
Non-clinical testing has demonstrated that the nitinol knot is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5 Tesla and 3.0 Tesla only .
- Maximum spatial gradient magnetic field of 3,000 Gauss/cm (30 T/m) or less .
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
Under the scan conditions defined above, the nitinol knot is expected to produce a maximum temperature rise of less than 1.5 ℃ after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the nitinol knot extends approximately 1 mm from the nitinol knot when imaged with a spin echo pulse sequence in a 3.0 T MRI system and 5 mm from the nitinol knot when imaged with a gradient echo pulse sequence in a 3.0 T MRI system.
The knotting instrument and knot loader are MR Unsafe.
A patient identification card is included with the knot loader, which contains the MRI safety information for the nitinol knot. Fill out the patient specific information including patient name, date of implant, doctor name, and doctor phone number and then distribute to the patient at discharge.
Conclusion:
The Edwards Thruport OptiClip Knotting System is substantially equivalent to the cited predicate device. Additionally, the device testing confirms the safety and effectiveness of the device when compared to the predicate device.