(43 days)
Not Found
No
The device description focuses on the physical characteristics of a pre-measured suture and pledgets, and the performance studies are related to biological and physicochemical properties, not algorithmic performance. There is no mention of AI, ML, image processing, or data sets for training or testing.
Yes
The device is indicated for the repair or replacement of chordae tendineae, which is a therapeutic intervention for a medical condition.
No
The device is described as a non-absorbable monofilament ePTFE suture used for the repair or replacement of chordae tendinae, indicating it is a surgical implant for treatment, not for diagnosis.
No
The device description clearly outlines a physical medical device consisting of ePTFE sutures, needles, and pledgets. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury.
- Device Description and Intended Use: The description clearly states that the Chord-X Pre-Measured Loops are a surgical device (suture and pledgets) intended for the repair or replacement of chordae tendinae within the mitral valve. This is a direct surgical intervention on the body, not an examination of a specimen taken from the body.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
The device is a surgical implant designed to physically repair a damaged part of the heart.
N/A
Intended Use / Indications for Use
Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated for the repair or replacement of chordae tendinae.
Product codes (comma separated list FDA assigned to the subject device)
PAW
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
Loop Length Adjustable: CXL-20-2238-0, CXL-20-2212-0, CXL-20-1838-0, CXL-20-1812-0
Loop Length 12mm: CXL-20-2238-12, CXL-20-2212-12, CXL-20-1838-12, CXL-20-1812-12
Loop Length 16mm: CXL-20-2238-16, CXL-20-2212-16, CXL-20-1838-16, CXL-20-1812-16
Loop Length 20mm: CXL-20-2238-20, CXL-20-2212-20, CXL-20-1838-20, CXL-20-1812-20
Loop Length 24mm: CXL-20-2238-24, CXL-20-2212-24, CXL-20-1838-24, CXL-20-1812-24
3-0 Suture
Loop Length Adjustable: CXL-30-2238-0, CXL-30-2212-0, CXL-30-1838-0, CXL-30-1812-0
Loop Length 12mm: CXL-30-2238-12, CXL-30-2212-12, CXL-30-1838-12, CXL-30-1812-12
Loop Length 16mm: CXL-30-2238-16, CXL-30-2212-16, CXL-30-1838-16, CXL-30-1812-16
Loop Length 20mm: CXL-30-2238-20, CXL-30-2212-20, CXL-30-1838-20, CXL-30-1812-20
Loop Length 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chordae tendinae (Mitral Chordal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Operating Room
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biological Test Data of Chord-X Pre-Measured Loops:
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:
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 Loops:
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, IR Match: No major bands detected, NAMSA Lab Number: 12T_20903_15
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, IR Match: No major bands detected, NAMSA Lab Number: 12T_20903_16
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, IR Match: No major bands detected, NAMSA Lab Number: 12T_20903_17
Shelf Life: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K121173 (Chord-X ePTFE Suture), K953289 (Tetraflouroethylene (TFE) Polymer Pledget)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
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
4
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 |
5
| 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
Suture | Covidien Pledget |
|----------------------------------------|--------------------------------------|-----------------------------------|-----------------------------------|
| Material(s) | ePTFE
monofilament | ePTFE
monofilament | PTFE felt |
| Intended Use | Chordal repair | Chordal repair | Cardiovascular
suture buttress |
| Meets USP | Yes | Yes | NA |
| Configuration | USP 2-0 and 3-0
with pledgets | USP 2-0 and 3-0 | 3 X 7 X 1.5 mm
with 2 holes |
| Needle
Choices | 3/8 and ½
circular taper
point | 3/8 and ½ circular
taper point | NA |
| Packaging | Case within a
peel-pouch | Double peel-pouch
type | -- |
| Knot Pull
Tensile
Strength (2-0) | 4.85 lbf | 4.85 lbf | -- |
| Stiffness | 62779 kgf | 62779 kgf | -- |
| % Elongation | 2.23% | 2.23% | -- |
6
| AND AND AND
| Jsage | 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 ﺍﻟﻤ | |||
| 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
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 |
3
・
.
. . . .
:
7
| 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