(121 days)
Chord-X ePTFE Suture for chordae tendinae repair or replacement is indicated for the repair or replacement of chordae tendinae.
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.
The Chord-X ePTFE Suture is a non-absorbable monofilament expanded polytetrafluoroethylene (ePTFE) suture intended for the repair or replacement of chordae tendineae. The device's performance was evaluated through various biological, physicochemical, and sterilization tests to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Chord-X ePTFE Suture) |
|---|---|---|
| General | ||
| Material(s) | ePTFE monofilament | ePTFE monofilament |
| Intended Use | Chordal repair / Cardiovascular soft tissue | Chordal repair |
| Meets USP | Yes (for Osteogenics Cytoplast Suture) | Yes |
| Configuration | USP 2-0 and 3-0 equivalents (CV-4, CV-5) or USP 4-0 | USP 2-0 and 3-0 |
| Needle Choices | 3/8 and ½ circular taper point (Gore-Tex) / ½ circular taper point (Osteogenics) | 3/8 and ½ circular taper point |
| Packaging | Double peel-pouch type | Double peel-pouch type |
| Usage | Single use | Single use |
| Sterilized | EtO | EtO |
| Shelf Life | 3-year (Gore-Tex) / Unknown (Osteogenics) | 3-year (Validated via accelerated aging per ISO 11607-1) |
| Physical Properties (2-0 Suture) | ||
| Knot Pull Tensile Strength (2-0) | 3.99 lbf (Gore-Tex) | 4.85 lbf |
| Stiffness | 35814 kgf (Gore-Tex) | 62779 kgf |
| % Elongation | 3.30% (Gore-Tex) | 2.23% |
| Biological Safety (ISO 10993) | Expected to be biocompatible | |
| Cytotoxicity | Non-cytotoxic | Grade 0, Non-Cytotoxic |
| Sensitization | Non-sensitizer | Non-Sensitizer |
| Intracutaneous Irritation | Non-irritant | Nonirritant |
| Acute Systemic Toxicity | No signs of acute, systemic toxicity | No signs of acute, systemic toxicity |
| Material Mediated Pyrogenicity | Nonpyrogenic | Nonpyrogenic |
| Hemocompatibility (Hemolysis) | Nonhemolytic | Nonhemolytic (Direct Contact), Nonhemolytic (Extraction) |
| Hemocompatibility (Complement) | Not an activator | C3a Complement Activation: Not an activator, SC5b-9 Complement Activation: Not an activator |
| Physicochemical | No significant extractable residues | |
| Extraction Residue Mass (PW) | Minimal | 0.2 mg (0.002 mg/cm length) |
| Extraction Residue Mass (Ethanol) | Minimal | 0.4 mg (0.004 mg/cm length) |
| Extraction Residue Mass (Hexane) | Minimal | 0.5 mg (0.006 mg/cm length) |
| IR Scans of Residues | No major bands detected | No major bands detected |
2. Sample Size and Data Provenance
The document does not specify details about "test sets" in the context of clinical studies with patients. The performance data presented are from in vitro laboratory tests. Therefore, information about sample size for a "test set" in the common sense of clinical data, as well as data provenance (country of origin, retrospective/prospective), is not applicable here. The biological endpoints were evaluated on product samples.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The data presented are from laboratory test results (physical properties, biological safety, physicochemical analysis) rather than clinical evaluations requiring expert interpretation for ground truth establishment.
4. Adjudication Method
This information is not applicable for laboratory test results.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done for this device. The nature of the device (a surgical suture) and the presented data (laboratory tests) do not align with studies typically requiring MRMC analysis.
6. Standalone Performance (Algorithm Only) Study
This information is not applicable. The device is a physical medical product (suture), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the performance data presented is derived from objective laboratory measurements and established test methodologies (e.g., USP standards for sutures, ISO 10993 standards for biocompatibility) that yield quantifiable and reproducible results. For example:
- Physical properties: Measured values (lbf, kgf, %) directly from mechanical testing.
- Biocompatibility: Categorical results (e.g., "Non-Cytotoxic," "Non-Sensitizer") based on established criteria within the ISO 10993 series.
- Physicochemical: Measured residue masses and infrared spectral analysis.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this device.
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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, (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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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 (800) 638-2041 or (301) 796-7100 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
3
(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: 512-339-8000 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 ePTFESuture | Gore-Tex Suturefor ChordaeTendineae | Osteogenics -Cytoplast Suture |
|---|---|---|---|
| Material(s) | ePTFEmonofilament | ePTFEmonofilament | ePTFEmonofilament |
| Intended Use | Chordal repair | Chordal repair | Cardiovascularsoft tissue |
| Meets USP | Yes | No - differs indiameter and knotpull strength | Yes |
| Configuration | USP 2-0 and 3-0 | CV-4CV-5(approx. 2-0 and 3-0) | USP 4-0 |
| NeedleChoices | 3/8 and ½circular taperpoint | ½ circular taperpoint | ½ circular taperpoint |
| Packaging | Double peel-pouch type | Same type | Same type |
| Knot PullTensileStrength (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 -Direct Contact | Nonhemolytic |
| ASTM Hemolysis -Extraction | Nonhemolytic | |
| C3a ComplementActivation | Not an activator | |
| SC5b-9 ComplementActivation | Not an activator |
Physicochemical Results following Exhaustive Extraction of the Chord-X Suture
| 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 |
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.
§ 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).