MitraPatch Mitral Valve Repair System

K252126 · Chawla Heart Technologies, LLC · PAW · Dec 4, 2025 · Cardiovascular

Device Facts

• Record ID: K252126
• Device Name: MitraPatch Mitral Valve Repair System
• Applicant: Chawla Heart Technologies, LLC
• Product Code: PAW · Cardiovascular
• Decision Date: Dec 4, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MitraPatch is indicated to be used in the repair and replacement of marginal (primary) chordae tendinae only.

Device Story

MitraPatch™ Mitral Valve Repair System is a permanent, single-use implant for mitral valve repair; addresses chordae tendinea prolapse/rupture. System includes implant, delivery handle, and locator tool. Implant fixes to papillary muscle and mitral valve leaflet, creating a tension band to prevent leaflet prolapse and restore natural chordae function. Used by surgeons in clinical settings. Implant is made of nonabsorbable expanded polytetrafluoroethylene (ePTFE) monomembrane. Surgeon uses delivery and locator tools to position the patch; leaflet attachment is adjustable to achieve desired coaptation. Device restores valve function, potentially improving patient cardiac outcomes by correcting mitral regurgitation.

Clinical Evidence

No human clinical data. Evidence includes in vitro bench testing (tensile strength, creep resistance, implant capture force, particulate, simulated use, delivery system strength) and biocompatibility testing per ISO 10993 standards. Preclinical subchronic animal study demonstrated no inflammation, migration, or deterioration, with normal histopathology.

Technological Characteristics

Material: nonabsorbable expanded polytetrafluoroethylene (ePTFE). Form factor: monomembrane with attachment planes/holes. Sterilization: Ethylene Oxide (EO) to 10^-6 SAL. Standards: ISO 11135 (sterilization), ISO 10993 (biocompatibility), ASTM 1980/1929/4169/F88 (shelf life/packaging).

Indications for Use

Indicated for patients requiring repair or replacement of marginal (primary) chordae tendinae due to prolapse or rupture.

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

• On-X Life Technologies, Inc. Chord-X Pre-Measured Loops for Mitral Chordal Replacement (K141060)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 4, 2025

Chawla Heart Technologies LLC
% Semih Oktay
Founder, President
CardioMed Device Consultants LLC
3168 Braverton Street, Suite 200
Edgewater, Maryland 21037

Re: K252126
Trade/Device Name: MitraPatch™ Mitral Valve Repair System
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
Dated: November 3, 2025
Received: November 3, 2025

Dear Semih Oktay:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

JULIE B. MACKEL -S

For
Jennifer Kevit, PhD
Acting 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

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252126 | |
| Device Name MitraPatch™ Mitral Valve Repair System | |
| Indications for Use (Describe) The MitraPatch is indicated to be used in the repair and replacement of marginal (primary) chordae tendinae only. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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# 510(k) Summary

| Date Prepared | November 28, 2025 |
| --- | --- |
| 510(k) number | K252126 |
| Applicant | Chawla Heart Technologies LLC
7 Seminole Way
Bloomfield, CT 06002 |
| Contact Person | H. Semih Oktay
CardioMed Device Consultants LLC
1783 Forest Drive, Suite 254
Annapolis, MD 21401
Phone: [phone]
Email: [e-mail] |
| Proprietary Name | MitraPatch™ Mitral Valve Repair System |
| Common Name | Nonabsorbable expanded polytetrafluoroethylene surgical suture |
| Device Classification | Class II per 21 CFR §870.3470 |
| Classification Name | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture for Chordae Tendinae Repair or Replacement |
| Product Code | PAW |
| Predicate Device | On-X Life Technologies, Inc. Chord-X Pre-Measured Loops for Mitral Chordal Replacement (K141060) |

## Indication for Use:

The MitraPatch is indicated to be used in the repair and replacement of marginal (primary) chordae tendinae only.

## Device Description:

The MitraPatch™ Mitral Valve Repair System includes a single use permanent implant designed to repair a mitral valve that is compromised due to chordae tendinea prolapse/rupture. Included in the system are a delivery handle and a locator tool. The MitraPatch™ fixes to the papillary muscle and mitral valve leaflet and providing a tension band between the two fixation points to prevent valve leaflet prolapse, replacing the natural function provided by the chordae tendinae.

One MitraPatch™ implant can repair one to two scallops of the mitral valve leaflets. MitraPatch™ is made from nonabsorbable expanded polytetrafluoroethylene (ePTFE) and is provided in a monomembrane that is a nonabsorbable flexible material.

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# Comparison with Predicate Devices:

A comparison of the MitraPatch™ Mitral Valve Repair System (subject device) with the predicate devices shows that the technological characteristics of the subject device are the same, or similar, including the indication for use, principle of operation/mechanism of action, and method of sterilization.

In addition, the subject device treats the same anatomical location.

A tabular comparison of the subject and predicate device is provided below.

| Device Name | MitraPatch™ | Chord-X Pre-Measured Loops for Mitral Chordal Replacement |
| --- | --- | --- |
| Device | Subject Device | Predicate device |
| Manufacturer | Chawla Heart Technologies LLC | On-X Life Technologies Inc |
| 510(k) Number | K252126 | K141060 |
| Class/Product Code | Class II, PAW | |
| Regulation Number | 21 CFR 878.3470 | |
| Indications for Use | The MitraPatch is indicated to be used in the repair and replacement of marginal (primary) chordae tendinae only. | Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated to be used in repair of replacement of chordae tendinae. |
| Anatomical Location | Mitral Valve | Mitral Valve |
| Implant Material | ePTFE | ePTFE |
| Mechanism of Action | Serves as a neochord to connect the distance between the papillary muscle and the leaflet to restore mitral valve function that is compromised due to a ruptured chordae | Serves as a neochord to connect the distance between the papillary muscle and the leaflet to restore mitral valve function that is compromised due to a ruptured chordae |
| Product Variants | 1 size | Multiple loop sizes from 12=24mm, USP size 2-0 and 3-0 ePTFE sutures |
| Product Geometry | Mono membrane with attachment planes and holes for passing sutures | Monofilament |
| Needles | Not required | 3/8 and 1/2 circular taper |
| Use of Plegets at tissue attachment locations | Yes, not provided with the device | Yes, provided with the device |
| Adjustable | Yes, if adjustment is desired the leaflet attachment can be released and adjusted to achieve the desired leaflet coaptation. Since the positioning of the implant is based on using a reference chord, and the length required is the same for all | The adjustment is performed at the leaflet attachment, location. The location of the suture that attaches the loop to the leaflet can be adjusted to the desired length of the loop that achieves level coaptation of leaflet surfaces. |

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| Device Name | MitraPatch™ | Chord-X Pre-Measured Loops for Mitral Chordal Replacement |
| --- | --- | --- |
| | leaflets adjustment is not expected to be required to achieve level coaptation of leaflet surfaces | |
| Delivery or Other Accessories | Delivery Assist Tool and Locator Tool to assist in delivery | Measuring Device |
| How Supplied | Sterile, single use | Sterile, single use |
| Sterilization Method | EO | EO |
| Sterility Assurance Level | 10^{-6} | 10^{-6} |

## Non-Clinical Testing/Performance Data:

Non-clinical testing was performed on the MitraPatch™ Mitral Valve Repair System to support the substantial equivalence to the predicate device.

The following tests/assessments were performed:

- Tensile Strength
- Resistance to Creep
- Implant Capture Force
- Particulate
- Simulated Use
- Delivery System Clamping Bar Strength
- Sterilization- ISO 11135
- Shelf Life – ASTM 1980, ASTM 1929, ASTM 4169, ASTM F88

The in vitro bench tests demonstrated that the MitraPatch™ Mitral Valve Repair System met all acceptance criteria, functioned as intended and has a performance profile that is similar to the predicate device.

## Biocompatibility

Biocompatibility evaluation of the MitraPatch™ Mitral Valve Repair System was performed. The following biocompatibility endpoints were assessed:

- Cytotoxicity- ISO 10993-5
- Sensitization – ISO 10993-10
- Intracutaneous Reactivity – ISO 10993-10
- Acute Systemic Toxicity – ISO 10993-11
- Hemocompatibility- ISO 10993-4

- Material Mediated Pyrogenicity – ISO 10993-11
- Genotoxicity – ISO 10993-3
- Chemical Characterization – ISO 10993-18
- Bacterial Endotoxin – USP <85>

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## Preclinical Animal Testing Summary

Subchronic animal study whereby the MitraPatch device was used to repair a ruptured (severed) chordae tendinae. There was no evidence of inflammation, migration or deterioration of the implant, There were no abnormal histopathological findings. Substantially equivalent device performance, stability, and biological safety were demonstrated.

## Conclusion

The MitraPatch™ Mitral Valve Repair System has the same intended use and the same, or similar, technological characteristics as the predicate device. None of the differences between the subject and predicate devices raises any new questions or safety or effectiveness.

The conclusions drawn from the non-clinical tests exhibit that the MitraPatch™ Mitral Valve Repair System demonstrate substantially equivalent safety and effectiveness outcomes to the predicate device.