(43 days)
Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated for the repair or replacement of chordae tendinae.
The device is a non-absorbable monofilament ePTFE suture using 4 Chord-X ePTFE sutures in a looped configuration provided in the following sizes and meeting the USP standards: 2-0 Suture with 22mm Taper Point Needle (3/8 Circle and 1/2 Circle) and 18mm Taper Point Needle (3/8 Circle and 1/2 Circle) with adjustable loop lengths of 0, 12mm, 16mm, 20mm, and 24mm. Also, 3-0 Suture with 22mm Taper Point Needle (3/8 Circle and 1/2 Circle) and 18mm Taper Point Needle (3/8 Circle and 1/2 Circle) with adjustable loop lengths of 0, 12mm, 16mm, 20mm, and 24mm. All configurations are supplied with two (2) 0.118 X 0.276 X 0.059 inches (3 X 7 X 1.5 mm) pledgets. All suture strands used in the construction of the prosthesis are 32 inches in length. The loops are made simply as a convenience for the surgeon who currently must tie these at the operating table as described in the medical literature (Gillinov AM, Banbury MK. Pre-Measured Artificial Chordae for Mitral Valve Repair. Ann Thorae Surg 2007;84:2127-2129.) It eliminates a step in the operation. They are provided as sterile, single use products and contain no dyes or additives.
The provided text is a 510(k) summary for the "Chord-X Pre-Measured Loops for Mitral Chordal Replacement" device. It is a submission to the FDA for market clearance, demonstrating substantial equivalence to a predicate device. This document focuses on the technical characteristics, biocompatibility, and sterilization of the device, rather than clinical study results establishing performance against acceptance criteria in the way an AI/ML device would be evaluated for clinical performance.
Therefore, many of the requested points regarding acceptance criteria and clinical performance studies for an AI/ML device (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical outcomes) are not applicable or available in this type of regulatory document.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and functionality.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document focuses on demonstrating substantial equivalence to existing predicate devices (Chord-X ePTFE Suture and Covidien Tetraflouroethylene (TFE) Polymer Pledget) based on material, intended use, and various physical and biological tests. There isn't a direct "acceptance criteria" table with performance metrics in the way one would define for an AI/ML diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated by meeting USP standards, passing biological tests, and exhibiting comparable physical properties to the predicate devices.
| Characteristic / Test | Acceptance Criteria / Standard | Reported Device Performance (Chord-X Loops) |
|---|---|---|
| Material(s) | ePTFE monofilament | ePTFE monofilament (Same as predicate Chord-X ePTFE Suture, different from Covidien Pledget which is PTFE felt but implied to be equivalent in function) |
| Intended Use | Chordal repair | Chordal repair (Same as predicate Chord-X ePTFE Suture, Covidien Pledget is for Cardiovascular suture buttress but deemed equivalent) |
| Meets USP | Yes | Yes |
| Configuration | USP 2-0 and 3-0 with pledgets | USP 2-0 and 3-0 with pledgets |
| Needle Choices | 3/8 and ½ circular taper point | 3/8 and ½ circular taper point |
| Knot Pull Tensile Strength (2-0) | Comparable to predicate (4.85 lbf for Chord-X ePTFE Suture) | 4.85 lbf |
| Stiffness | Comparable to predicate (62779 kgf for Chord-X ePTFE Suture) | 62779 kgf |
| % Elongation | Comparable to predicate (2.23% for Chord-X ePTFE Suture) | 2.23% |
| Usage | Single use | Single use |
| Sterilization | Validated to ISO 11135-1 | Meets requirements of standard |
| Shelf Life | Robust packaging, maintains integrity for 3 years (accelerated aging) | Confirmed for at least 3-years |
| Biological Endpoint: Cytotoxicity | Non-Cytotoxic | Grade 0, Non-Cytotoxic |
| Biological Endpoint: Sensitization | Non-Sensitizer | Non-Sensitizer |
| Biological Endpoint: Intracutaneous Irritation | Nonirritant | Nonirritant |
| Biological Endpoint: Acute Systemic Toxicity | No signs of acute, systemic toxicity | No signs of acute, systemic toxicity |
| Biological Endpoint: Material Mediated Pyrogenicity | Nonpyrogenic | Nonpyrogenic |
| Biological Endpoint: Hemocompatibility | Nonhemolytic & Not an activator (for Complement) | Nonhemolytic (ASTM Hemolysis - Direct Contact & Extraction), Not an activator (C3a & SC5b-9 Complement Activation) |
| Physicochemical: Residue Mass (PW extraction) | Low residue (e.g., < 0.2mg/cm² or similar internal standard) | 0.2 mg total / 0.002 mg/cm length |
| Physicochemical: Residue Mass (Ethanol extraction) | Low residue | 0.4 mg total / 0.004 mg/cm length |
| Physicochemical: Residue Mass (Hexane extraction) | Low residue | 0.5 mg total / 0.006 mg/cm length |
| Physicochemical: IR Match (extracted residues) | No major bands detected (indicating minimal leachable material) | No major bands detected |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not explicitly stated for specific test sets in a clinical performance context. The testing described involves bench testing (physical properties, physicochemical extraction) and biocompatibility testing using animal models or in-vitro methods. The "sample size" would refer to the number of devices or material samples tested for each specific bench or biological test. For instance, for physicochemical extraction, it mentions specific sample amounts (e.g., 123.7 cm² of material). No clinical data or human subject data is mentioned.
- Data Provenance: Not specified, but generally, regulatory submissions like this derive data from laboratory testing conducted by the manufacturer or contracted labs.
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):
- Not applicable. This document does not describe a clinical study requiring expert ground truth for interpretation (like image analysis by radiologists). The "ground truth" for the tests performed is established by adherence to recognized standards (e.g., USP, ISO, ASTM) and validated laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical study design for subjective evaluations, not the objective physical and biological tests performed for this device.
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:
- Not applicable. MRMC studies are specific to evaluating diagnostic image interpretation, particularly with AI assistance. This device is a surgical implant, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For physical/chemical tests: Ground truth is based on engineering specifications, validated test methods (e.g., ASTM standards), and material properties.
- For biological tests: Ground truth is established by standardized biological assays (e.g., cytotoxicity, sensitization, pyrogenicity tests) and their predefined pass/fail criteria, often referencing ISO standards (e.g., ISO 10993 for biocompatibility).
8. The sample size for the training set:
- Not applicable. This refers to AI/ML model training data.
9. How the ground truth for the training set was established:
- Not applicable. This refers to AI/ML model training data.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 23, 2023
On-X Life Technologies, Inc. John Ely Executive Vice President 1300 East anderson Lane Building B Austin, Texas 78752
Re: K141060
Trade/Device Name: Chord-X Pre-measured Loops For Mitral Chordal Replacement Regulation Number: 21 CFR 878.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene Regulatory Class: Class II Product Code: PAW
Dear John Ely:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 6, 2014. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under 21 CFR 878.3470.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jaime Raben, OHT2: Office of Cardiovascular Devices, (301)796-1137, jaime.raben(0)fda.hhs.gov.
Sincerely,
Jaime Raben -S
Jaime Raben Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2014
On-X Life Technologies, Inc. John Ely Executive Vice President 1300 East Anderson Lane Building B Austin, Texas 78752
Re: K141060
Trade/Device Name: Chord-x pre-measured loops for mitral chordal replacement Regulation Number: 21 CFR 878.5035 Regulation Name: Non-Absorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: PAW Dated: Mav 6. 2014 Received: May 7, 2014
Dear Mr. Ely,
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 device
{2}------------------------------------------------
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/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,
M. A. Hilleman
for
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: K141060
Device Name: Chord-X Pre-Measured Loops for Mitral Chordal Replacement
Indications for use:
Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated for the repair or replacement of chordae tendinae.
Prescription Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillebrenner
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510(k) Summary (K141060)
Date: June 4, 2014
Company Name, Address and Contacts
On-X Life Technologies, Inc. 1300 East Anderson Lane, Bldg B Austin, TX 78752 Telephone: 512-339-8000 X226 Contact Person: John Ely
Establishment Registration Number: 1649833
Device Information
Proprietary Name: Chord-X Pre-Measured Loops for Mitral Chordal Replacement Common Name: ePTFE suture Classification Name: Non-absorbable expanded polytetrafluoroethylene surgical suture Review Panel: Cardiovascular Classification: 21CFR878.5035 Product code: PAW Class: Il Substantial Equivalence: Chord-X ePTFE Suture - KI21173 - On-X Life Technologies, Inc. Tetraflouroethylene (TFE) Polymer Pledget - K953289 - Davis and Geck - Now Covidien
Device Description
The device is a non-absorbable monofilament ePTFE suture using 4 Chord-X ePTFE sutures in a looped configuration provided in the following sizes and meeting the USP standards:
| 2-0 Suture | ||||
|---|---|---|---|---|
| 22mm Taper Point Needle | 18mm Taper Point Needle | |||
| Loop | ||||
| Length | 3/8 Circle | 1/2 Circle | 3/8 Circle | 1/2 Circle |
| Adjustable | CXL-20-2238-0 | CXL-20-2212-0 | CXL-20-1838-0 | CXL-20-1812-0 |
| 12mm | CXL-20-2238-12 | CXL-20-2212-12 | CXL-20-1838-12 | CXL-20-1812-12 |
| 16mm | CXL-20-2238-16 | CXL-20-2212-16 | CXL-20-1838-16 | CXL-20-1812-16 |
| 20mm | CXL-20-2238-20 | CXL-20-2212-20 | CXL-20-1838-20 | CXL-20-1812-20 |
| 24mm | CXL-20-2238-24 | CXL-20-2212-24 | CXL-20-1838-24 | CXL-20-1812-24 |
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| 3-0 Suture | ||||
|---|---|---|---|---|
| 22mm Taper Point Needle | 18mm Taper Point Needle | |||
| Loop Length | 3/8 Circle | 1/2 Circle | 3/8 Circle | 1/2 Circle |
| Adjustable | CXL-30-2238-0 | CXL-30-2212-0 | CXL-30-1838-0 | CXL-30-1812-0 |
| 12mm | CXL-30-2238-12 | CXL-30-2212-12 | CXL-30-1838-12 | CXL-30-1812-12 |
| 16mm | CXL-30-2238-16 | CXL-30-2212-16 | CXL-30-1838-16 | CXL-30-1812-16 |
| 20mm | CXL-30-2238-20 | CXL-30-2212-20 | CXL-30-1838-20 | CXL-30-1812-20 |
| 24mm | CXL-30-2238-24 | CXL-30-2212-24 | CXL-30-1838-24 | CXL-30-1812-24 |
All configurations are supplied with two (2) 0.118 X 0.276 X 0.059 inches (3 X 7 X 1.5 mm) pledgets. All suture strands used in the construction of the prosthesis are 32 inches in length.
The loops are made simply as a convenience for the surgeon who currently must tie these at the operating table as described in the medical literature (Gillinov AM, Banbury MK. Pre-Measured Artificial Chordae for Mitral Valve Repair. Ann Thorae Surg 2007;84:2127-2129.) It eliminates a step in the operation. They are provided as sterile, single use products and contain no dyes or additives.
Intended Use
Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated to be used in repair or replacement of chordae tendinae.
Summary of Technological Characteristics
| Characteristic | Chord-X Loops | Chord-X ePTFESuture | Covidien Pledget |
|---|---|---|---|
| Material(s) | ePTFEmonofilament | ePTFEmonofilament | PTFE felt |
| Intended Use | Chordal repair | Chordal repair | Cardiovascularsuture buttress |
| Meets USP | Yes | Yes | NA |
| Configuration | USP 2-0 and 3-0with pledgets | USP 2-0 and 3-0 | 3 X 7 X 1.5 mmwith 2 holes |
| NeedleChoices | 3/8 and ½circular taperpoint | 3/8 and ½ circulartaper point | NA |
| Packaging | Case within apeel-pouch | Double peel-pouchtype | -- |
| Knot PullTensileStrength (2-0) | 4.85 lbf | 4.85 lbf | -- |
| Stiffness | 62779 kgf | 62779 kgf | -- |
| % Elongation | 2.23% | 2.23% | -- |
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| AND AND ANDJsage | Single use | Single use | Single use |
|---|---|---|---|
| terilized | I | I | |
| ﺔ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤLife | -vear | -vear | ----------- |
Biological Test Data of Chord-X Pre-Measured Loops
| Biological Endpoint | Results |
|---|---|
| Cytotoxicity | Grade 0, Non-Cytotoxic |
| Sensitization | Non-Sensitizer |
| Sensitization | Non-Sensitizer |
| Intracutaneous Irritation | Nonirritant |
| Intracutaneous Irritation | Nonirritant |
| Acute Systemic Toxicity | No signs of acute, systemic toxicity |
| Acute Systemic Toxicity | No signs of acute, systemic toxicity |
| Material Mediated Pyrogenicity | Nonpyrogenic |
| Hemocompatibility | ASTM Hemolysis - Direct Contact |
| ASTM Hemolysis - Extraction | |
| C3a Complement Activation | |
| SC5b-9 Complement Activation | |
| Nonhemolytic | |
| Nonhemolytic | |
| Not an activator | |
| Not an activator |
Physicochemical Results following Exhaustive Extraction of the Chord-X Loops
| ExtractionVehicle | SampleAmount | Number ofExtractions | ResidueMass | ResidueMass/cm Length |
|---|---|---|---|---|
| PW | 123.7 cm²89.5 cm length | 2 | 0.2 mg | 0.002 mg |
| Ethanol | 127.2 cm²90.0 cm length | 2 | 0.4 mg | 0.004 mg |
| Hexane | 127.2 cm²89.5 cm length | 2 | 0.5 mg | 0.006 mg |
3
・
.
. . . .
:
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| Extraction Vehicle | IR Match | NAMSA Lab Number |
|---|---|---|
| PW | No major bands detected | 12T_20903_15 |
| Ethanol | No major bands detected | 12T_20903_16 |
| Hexane | No major bands detected | 12T_20903_17 |
Infrared Scans of the Residues Obtained from the Chord-X Loops
Shelf Life
Testing to validate shelf life for Chord-X Pre-Measured Loops final packaging was conducted as per the requirements listed in ISO 11607-1. An accelerated aging method per the appropriate reference standard has been employed to simulate actual shelf life duration to 3-years. Sterile barrier and product integrity tests confirm that the package is robust enough to withstand shipping and storage for at least 3-years.
Sterilization
Ethylene oxide (EO) is used to sterilize the Chord-X Pre-Measured Loops and the process is validated to ISO 11135-1. The sterilization established that the process and product meet the requirements of the standard.
4
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).