(26 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML technologies.
No.
The device is a surgical mesh intended for reinforcement of soft tissue, not for providing therapy or treatment. Its function is to provide structural support during the healing process, not to independently deliver a therapeutic effect.
No
The device is a surgical mesh intended for reinforcing soft tissue; it does not perform any diagnostic function.
No
The device description clearly states that the X-RepairSL is a physical, bioabsorbable surgical mesh made from PLLA fiber, 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 clearly states that X-RepairSL is for "reinforcement of soft tissue where weakness exists" and for "reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery". This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a "bioabsorbable, rectangular, single-layered, flexible, woven surgical mesh manufactured from poly-i-lactic acid (PLLA) fiber". This is a physical material designed to be implanted.
- 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) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in vitro (outside the body) for testing purposes.
Therefore, X-RepairSL is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
X-RepairSL is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
X-RepairSL is also intended for reinforcement of soft tissues that are repaired by suture anchors, during tendon repair sugery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
X-RepairSL is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
Product codes
FTL, OWW
Device Description
The X-RepairSL is a bioabsorbable, rectangular, single-layered, flexible, woven surgical mesh manufactured from poly-i-lactic acid (PLLA) fiber. It has locked top and bottom edges and welded ends. It is provided sterile, intended for single use, and labeled non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue where weakness exists; soft tissues that are repaired by suture anchors, during tendon repair sugery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
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
Bench testing was conducted to evaluate the tensile strength and suture pullout strength of the subject device. The results showed that the subject device has similar performance characteristics as the predicate device. In addition, the package integrity was tested to evaluate the maintenance of the sterile barrier and the maintenance of mechanical properties up to five years. The results of performance testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use and do support a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
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JUL 0 2 2014
Page 1 of 3
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87
| Establishment Registration Number: | 3008008164 |
|---|---|
| Address of Manufacturer: | Synthasome, Inc. |
| 3030 Bunker Hill Street, #308 | |
| San Diego, CA 92109 | |
| Contact Person: | Anthony Ratcliffe, PhD |
| President and CEO | |
| Date Prepared: | May 28, 2014 |
| Trade or Proprietary Name: | X-RepairSL |
| Common or Usual Name: | Surgical mesh |
| Classification Name: | 21 CFR 878.3300, class II, FTL: OWW |
| Mesh, Surgical, Polymeric | |
| Predicate Device Identification: | X-Repair (K083307) |
| Device Description: |
The X-RepairSL is a bioabsorbable, rectangular, single-layered, flexible, woven surgical mesh manufactured from poly-i-lactic acid (PLLA) fiber. It has locked top and bottom edges and welded ends. It is provided sterile, intended for single use, and labeled non-pyrogenic.
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K141499
Intended use and comparison to predicate devices:
X-RepairSL is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
X-RepairSL is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
X-RepairSL is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
"Indications for Use" are identical to the predicate X-Repair (K083307) except the addition of "SL" to the Trade Name.
"Directions for Use" are modified in comparison to the predicate X-Repair (K083307) by adding "SL" to the Trade Name and replacing "double" with "single" in the device description.
Product labels have been modified to reflect the single-layer device, the additional sizes and additional part numbers.
Technological characteristics and comparison to predicate devices:
The technological characteristics are identical to the predicate X-Repair (K083307), namely:
- Have the same indications for use .
- Use the same basic technology .
- . Have equivalent mechanical properties
- Incorporate the same basic woven fabric design .
- . Use the same PLLA fiber material
- Are packaged and sterilized using the same materials and processes .
Minor changes to the predicate comprise the single layer device, additional widths for the device, starting at 4mm up to 40mm (the largest width of the predicate) and additional lengths for the device, starting at 20mm up to 160mm. In addition, the shelf life has been established at five (5) years.
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Summary of performance data:
Bench testing was conducted to evaluate the tensile strength and suture pullout strength of the subject device. The results showed that the subject device has similar performance characteristics as the predicate device. In addition, the package integrity was tested to evaluate the maintenance of the sterile barrier and the maintenance of mechanical properties up to five years. The results of performance testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use and do support a determination of substantial equivalence.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
Synthasome Incorporated Mr. Anthony Ratcliffe President and Chief Executive Officer 3030 Bunker Hill Street, Suite 308 San Diego, California 92109
Re: K141499
Trade/Device Name: X-RepairSL Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, OWW Dated: June 5, 2014 Received: June 6, 2014
Dear Mr. Ratcliffe:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Anthony Ratcliffe
forth in the quality systems (OS) 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" (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/ReportalProblem/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,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K141499
Device Name
X-RepairSL
Indications for Use (Describe)
X-RepairSL is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
X-RepairSL is also intended for reinforcement of soft tissues that are repaired by suture anchors, during tendon repair sugery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
X-RepairSL is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)