CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT

K141060 · On-X Life Technologies, Inc. · PAW · Jun 6, 2014 · Cardiovascular

Device Facts

• Record ID: K141060
• Device Name: CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
• Applicant: On-X Life Technologies, Inc.
• Product Code: PAW · Cardiovascular
• Decision Date: Jun 6, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated to be used in repair or replacement of chordae tendinae.

Device Story

Chord-X Pre-Measured Loops are sterile, single-use surgical implants designed to simplify mitral valve repair. The device consists of non-absorbable monofilament ePTFE suture configured into pre-measured loops, supplied with PTFE felt pledgets. Used by surgeons in the operating room, the device replaces the manual intraoperative task of tying chordae tendinae, as described in established medical literature. By providing pre-measured loops, the device eliminates a procedural step, potentially reducing operative time. The device is implanted during cardiac surgery to restore proper mitral valve function, benefiting patients by facilitating precise chordal replacement.

Clinical Evidence

Bench testing only. Evidence includes mechanical performance testing (knot pull tensile strength, stiffness, elongation), biocompatibility testing (ISO 10993 standards for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility), and physicochemical analysis (exhaustive extraction). Shelf life validated to 3 years per ISO 11607-1; sterilization validated per ISO 11135-1.

Technological Characteristics

Materials: ePTFE monofilament suture, PTFE felt pledgets. Configuration: USP 2-0 and 3-0 suture in looped form with 3/8 or 1/2 circle taper point needles. Sterilization: Ethylene oxide (EO) per ISO 11135-1. Packaging: Sterile, single-use, peel-pouch. Mechanical specs: Knot pull tensile strength 4.85 lbf, stiffness 62779 kgf, elongation 2.23%.

Indications for Use

Indicated for the repair or replacement of chordae tendinae in patients requiring mitral valve repair.

Regulatory Classification

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.

Predicate Devices

• Chord-X ePTFE Suture (K121173)
• Tetraflouroethylene (TFE) Polymer Pledget (K953289)

Submission Summary (Full Text)

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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, [phone], 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

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] 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 ePTFE<br>Suture | Covidien Pledget |
|----------------------------------------|--------------------------------------|-----------------------------------|-----------------------------------|
| Material(s) | ePTFE<br>monofilament | ePTFE<br>monofilament | PTFE felt |
| Intended Use | Chordal repair | Chordal repair | Cardiovascular<br>suture buttress |
| Meets USP | Yes | Yes | NA |
| Configuration | USP 2-0 and 3-0<br>with pledgets | USP 2-0 and 3-0 | 3 X 7 X 1.5 mm<br>with 2 holes |
| Needle<br>Choices | 3/8 and ½<br>circular taper<br>point | 3/8 and ½ circular<br>taper point | NA |
| Packaging | Case within a<br>peel-pouch | Double peel-pouch<br>type | -- |
| Knot Pull<br>Tensile<br>Strength (2-0) | 4.85 lbf | 4.85 lbf | -- |
| Stiffness | 62779 kgf | 62779 kgf | -- |
| % Elongation | 2.23% | 2.23% | -- |

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| AND AND AND<br>Jsage | Single use | Single use | Single use |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------|-------------|
| <br>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 ﺍﻟﻤ<br>Life | -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

| Extraction<br>Vehicle | Sample<br>Amount | Number of<br>Extractions | Residue<br>Mass | Residue<br>Mass/cm Length |
|-----------------------|-----------------------------|--------------------------|-----------------|---------------------------|
| PW | 123.7 cm²<br>89.5 cm length | 2 | 0.2 mg | 0.002 mg |
| Ethanol | 127.2 cm²<br>90.0 cm length | 2 | 0.4 mg | 0.004 mg |
| Hexane | 127.2 cm²<br>89.5 cm length | 2 | 0.5 mg | 0.006 mg |

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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.

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