(121 days)
P820083, K072076
Not Found
No
The device description and performance studies focus on the material properties and biological compatibility of a suture, with no mention of AI or ML.
Yes
This device is a suture indicated for the repair or replacement of chordae tendinae, which are structures within the heart. Repairing or replacing a damaged bodily structure is a therapeutic intervention.
No
This device is a suture, used for repair or replacement of chordae tendinae, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical suture made of ePTFE, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "repair or replacement of chordae tendinae." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "non-absorbable monofilament ePTFE suture." This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
Chord-X ePTFE Suture for chordae tendinae repair or replacement is indicated for the repair or replacement of chordae tendinae.
Product codes
PAW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chordae tendinae
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
Biological Test Data:
- Cytotoxicity: Grade 0, Non-Cytotoxic
- Sensitization: Non-Sensitizer
- Intracutaneous Irritation: Nonirritant
- Acute Systemic Toxicity: No signs of acute, systemic toxicity
- Material Mediated Pyrogenicity: Nonpyrogenic
- Hemocompatibility: Nonhemolytic (ASTM Hemolysis - Direct Contact and ASTM Hemolysis - Extraction), Not an activator (C3a Complement Activation, SC5b-9 Complement Activation)
Physicochemical Results following Exhaustive Extraction:
- Extraction Vehicle: PW, Sample Amount: 123.7 cm², 89.5 cm length, Number of Extractions: 2, Residue Mass: 0.2 mg, Residue Mass/cm Length: 0.002 mg
- Extraction Vehicle: Ethanol, Sample Amount: 127.2 cm², 90.0 cm length, Number of Extractions: 2, Residue Mass: 0.4 mg, Residue Mass/cm Length: 0.004 mg
- Extraction Vehicle: Hexane, Sample Amount: 127.2 cm², 89.5 cm length, Number of Extractions: 2, Residue Mass: 0.5 mg, Residue Mass/cm Length: 0.006 mg
Infrared Scans of the Residues:
- Extraction Vehicle: PW, IR Match: No major bands detected, NAMSA Lab Number: 12T_20903_15
- Extraction Vehicle: Ethanol, IR Match: No major bands detected, NAMSA Lab Number: 12T_20903_16
- Extraction Vehicle: Hexane, IR Match: No major bands detected, NAMSA Lab Number: 12T_20903_17
Shelf Life:
- Testing conducted by LSO as per ISO 11607-1.
- Accelerated aging method employed to simulate 3-years shelf life duration.
- Sterile barrier and product integrity tests confirm the package is robust enough for 3-years shipping and storage.
Sterilization:
- Ethylene oxide (EO) used and validated to ISO 11135-1.
Key Metrics
Not Found
Predicate Device(s)
P820083, K072076
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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
3
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: 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.
5
Summary of Technological Characteristics
:
:
| Characteristic | Chord-X ePTFE
Suture | Gore-Tex Suture
for Chordae
Tendineae | Osteogenics -
Cytoplast Suture |
|----------------------------------------|--------------------------------------|-------------------------------------------------------|-----------------------------------|
| Material(s) | ePTFE
monofilament | ePTFE
monofilament | ePTFE
monofilament |
| Intended Use | Chordal repair | Chordal repair | Cardiovascular
soft tissue |
| Meets USP | Yes | No - differs in
diameter and knot
pull strength | Yes |
| Configuration | USP 2-0 and 3-0 | CV-4
CV-5
(approx. 2-0 and 3-0) | USP 4-0 |
| Needle
Choices | 3/8 and ½
circular taper
point | ½ circular taper
point | ½ circular taper
point |
| Packaging | Double peel-
pouch type | Same type | Same type |
| Knot Pull
Tensile
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 |
র প্র
: 上一篇: 上一篇: .
:
:
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| Biological Endpoint | Results | |
|---|---|---|
| Material Mediated Pyrogenicity | Nonpyrogenic | |
| Hemocompatibility | ASTM Hemolysis - | |
| Direct Contact | Nonhemolytic | |
| ASTM Hemolysis - | ||
| Extraction | Nonhemolytic | |
| C3a Complement | ||
| Activation | Not an activator | |
| SC5b-9 Complement | ||
| Activation | Not an activator |
Physicochemical Results following Exhaustive Extraction of the Chord-X Suture
| Extraction
Vehicle | Sample
Amount | Number of
Extractions | Residue
Mass | Residue
Mass/cm Length |
|-----------------------|-----------------------------|--------------------------|-----------------|---------------------------|
| PW | 123.7 cm²
89.5 cm length | 2 | 0.2 mg | 0.002 mg |
| Ethanol | 127.2 cm²
90.0 cm length | 2 | 0.4 mg | 0.004 mg |
| Hexane | 127.2 cm²
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.