CHORD-X EPTFE SUTURE

K121173 · On-Xlifetechnologies · PAW · Aug 16, 2012 · Cardiovascular

Device Facts

• Record ID: K121173
• Device Name: CHORD-X EPTFE SUTURE
• Applicant: On-Xlifetechnologies
• Product Code: PAW · Cardiovascular
• Decision Date: Aug 16, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Chord-X ePTFE suture is indicated to be used in repair or replacement of chordae tendinae.

Device Story

Chord-X ePTFE Suture is a non-absorbable, monofilament expanded polytetrafluoroethylene (ePTFE) surgical suture. It is designed for use in cardiac surgery for the repair or replacement of chordae tendinae. The device is provided sterile, for single-use, and contains no dyes or additives. It is available in USP 2-0 and 3-0 sizes with 3/8 or 1/2 circle taper point needles. The suture is used by surgeons during cardiac procedures to restore valve function. The device provides mechanical support for the valve leaflets, potentially benefiting patients by correcting mitral valve regurgitation or other chordal pathologies.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility), physicochemical analysis (exhaustive extraction and infrared scans), and shelf-life validation (accelerated aging per ISO 11607-1). Sterilization validation was performed per ISO 11135-1.

Technological Characteristics

Material: ePTFE monofilament. Configurations: USP 2-0 and 3-0. Needles: 3/8 and 1/2 circle taper point. Sterilization: Ethylene oxide (EtO) validated to ISO 11135-1. Shelf life: 3 years validated per ISO 11607-1. Packaging: Double peel-pouch.

Indications for Use

Indicated for the repair or replacement of chordae tendinae.

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

• Gore-Tex ePTFE Suture (P820083)
• Osteogenics Cytoplast ePTFE Suture (K072076)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

June 23, 2023

On-X life Technologies, Inc. John Ely Executive Vice President 1300 East Anderson Lane Bldg B Austin, Texas 78752

Re: K121173

Trade/Device Name: Chord-X ePTFE Suture Regulation Number: 21 CFR 870.3470 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 August 16, 2012. 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 1 6 2012

On-X Life Technologies, Inc. c/o Mr. John Ely Executive Vice President Regulatory Affairs and Quality Assurance 1300 East Anderson Ln. Austin, TX 78752

Re: K121173

Trade/Device Name: Chord-X ePTFE Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetrafluoroethylene surgical suture Regulatory Class: Class II Product Code: PAW Dated: July 8, 2012 Received: August 9, 2012

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

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Page 2 - Mr. John Ely

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

2

Enclosure

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#### Indications for Use

510(k) Number (if known): K121173

Device Name: Chord-X ePTFE Suture

Indications For Use:

Chord-X ePTFE Suture for chordae tendinae repair or replacement is indicated for the repair or replacement of chordae tendinae.

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use . (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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(Division Sign-Off
Division of Cardiovascular Devices
510(k) Number KL21173.

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#### 510(k) Summary (K121173)

### Date: July 8, 2012

#### Company Name, Address and Contacts

AUG 16 2012

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 ePTFE Suture |
|--------------------------|-----------------------------------------------------------------|
| Common Name: | ePTFE suture for chordae tendineae repair or replacement |
| Classification Name: | Non-absorbable expanded polytetrafluoroethylene surgical suture |
| Classification Panel: | Cardiovascular |
| Classification: | 21CFR878.5035 |
| Product code: | PAW |
| Class: | II |
| Substantial Equivalence: | |

Gore-Tex ePTFE Suture - P820083 subsequently reclassified Osteogenics Cytoplast ePTFE Suture - K072076

#### Device Description

The device is a non-absorbable monofilament ePTFE suture provided in the following configurations and meeting the USP standards:

USP 2-0 with 3/8 circle needle (Model - CX2038A)

- USP 2-0 with ½ circle needle (Model CX2012A)
USP 3-0 with 3/8 circle needle (Model - CX3038A)

USP 3-0 with ½ circle needle (Model - CX3012A)

It is provided as a sterile, single use product and contains no dyes or additives.

#### Intended Use

Chord-X ePTFE suture is indicated to be used in repair or replacement of chordae tendinae.

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# Summary of Technological Characteristics

:

:

| Characteristic | Chord-X ePTFE<br>Suture | Gore-Tex Suture<br>for Chordae<br>Tendineae | Osteogenics -<br>Cytoplast Suture |
|----------------------------------------|--------------------------------------|-------------------------------------------------------|-----------------------------------|
| Material(s) | ePTFE<br>monofilament | ePTFE<br>monofilament | ePTFE<br>monofilament |
| Intended Use | Chordal repair | Chordal repair | Cardiovascular<br>soft tissue |
| Meets USP | Yes | No - differs in<br>diameter and knot<br>pull strength | Yes |
| Configuration | USP 2-0 and 3-0 | CV-4<br>CV-5<br>(approx. 2-0 and 3-0) | USP 4-0 |
| Needle<br>Choices | 3/8 and ½<br>circular taper<br>point | ½ circular taper<br>point | ½ circular taper<br>point |
| Packaging | Double peel-<br>pouch type | Same type | Same type |
| Knot Pull<br>Tensile<br>Strength (2-0) | 4.85 lbf | 3.99 lbf | -- |
| Stiffness | 62779 kgf | 35814 kgf | -- |
| % Elongation | 2.23% | 3.30% | -- |
| Usage | Single use | Single use | Single use |
| Sterilized | EtO | EtO | EtO |
| Shelf Life | 3-year | 3-year | Unknown |

## Biological Test Data of Chord-X Suture

| Biological Endpoint | Results |
|---------------------------|--------------------------------------|
| Cytotoxicity | Grade 0, Non-Cytotoxic |
| Sensitization | Non-Sensitizer |
| | Non-Sensitizer |
| Intracutaneous Irritation | Nonirritant |
| | Nonirritant |
| Acute Systemic Toxicity | No signs of acute, systemic toxicity |
| | No signs of acute, systemic toxicity |

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| Biological Endpoint | Results | |
|--------------------------------|------------------------------------|------------------|
| Material Mediated Pyrogenicity | Nonpyrogenic | |
| Hemocompatibility | ASTM Hemolysis -<br>Direct Contact | Nonhemolytic |
| | ASTM Hemolysis -<br>Extraction | Nonhemolytic |
| | C3a Complement<br>Activation | Not an activator |
| | SC5b-9 Complement<br>Activation | Not an activator |

#### Physicochemical Results following Exhaustive Extraction of the Chord-X Suture

| 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 |

#### Infrared Scans of the Residues Obtained from the Chord-X Suture

| 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 |

#### Shelf Life

Testing to validate shelf life for Chord-X final packaging was also conducted by LSO 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 Suture and the process is validated to ISO 11135-1. The sterilization validation established that the process and product meet the requirements of the standard.