(107 days)
ProGrip™ laparoscopic self-fixating mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.
Both the predicate and the proposed mesh are made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable film made of collagen from porcine origin and glycerol, on the other side. The grips allow positioning and fixation of the mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh incorporates a green band to facilitate orientation.
The monofilament polylactic acid grips are bioresorbable and provide the fixation of the mesh to surrounding tissue for at least 8 weeks. The polylactic acid grips degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O.
The provided text describes a 510(k) submission for Sofradim Production's ProGrip™ Laparoscopic Self-Fixating Mesh, seeking to add new sizes to an existing product family. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a medical device that produces quantitative or qualitative outputs (like an AI/ML algorithm).
Therefore, based on the provided text, it's not possible to provide a table of acceptance criteria and reported device performance in the way typically expected for an AI/ML device or a device with measurable performance output. The "performance data" mentioned in the document refers to physical characteristics and compatibility of the mesh sizes with trocars, not clinical outcomes or diagnostic accuracy.
Here's an analysis based on the information provided, recognizing the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
As this submission is for a physical medical device (surgical mesh) and primarily concerns adding new sizes, the "acceptance criteria" are related to physical properties and compatibility, not a performance metric like sensitivity, specificity, or accuracy for an AI/ML device.
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| For 16x12cm and 16x14cm mesh sizes: | |
| - Passage through 10mm and/or 12mm trocar | Tests demonstrate compatibility and successful passage. (Specific numerical results or pass/fail statements are not provided, but the conclusion states equivalence). |
| - Visual inspection after trocar passage | Tests demonstrate satisfactory visual appearance after passage. (Specific details are not provided, but the conclusion states equivalence). |
| - Gripping point measurement and comparison with specification (≤27 gripping points for 16x12cm and 16x14cm) after trocar passage | Measurements were taken and compared with the specification. (Specific numerical results are not provided, but the conclusion states equivalence, implying compliance with the ≤27 gripping points specification). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "bench performance evaluations were completed to verify that the proposed additional sizes... are compatible with 10mm and/or 12mm trocars." It doesn't specify how many meshes of each size were tested.
- Data Provenance: This is bench testing of physical devices (surgical mesh). The country of origin of the data is not specified, but the submitter is "Sofradim Production (subsidiary of Covidien LLC)" with an address in Trevoux, France. The data is prospective in the sense that it was generated for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The "ground truth" for this type of physical device testing is the direct measurement and observation of physical properties and functionality (e.g., whether the mesh passes through the trocar, visual integrity, number of gripping points). It does not involve expert interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This is objective bench testing of physical properties, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a physical surgical mesh, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is for a physical surgical mesh.
7. The Type of Ground Truth Used
The ground truth for the bench testing was based on:
- Direct observation of physical events (passage through trocar).
- Visual inspection criteria.
- Quantitative measurement against a defined specification (e.g., number of gripping points).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; therefore, there is no training set in that context. The "training" in manufacturing comes from established material compositions and manufacturing processes which are stated to be unchanged from the predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" for the predicate device's design and manufacturing processes would have been established through extensive design validation, material testing, and historical performance data, none of which are detailed here beyond the statement of "ProGrip™ Laparoscopic Self-Fixating Mesh new sizes are composed of biocompatible materials that are in compliance with ISO 10993-1 standard." and that materials and manufacturing processes have not changed.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2015
Sofradim Production % Ms. Mary Mellows Surgical devices, a global business unit of Covidien 60 Middleton Avenue North Haven, Connecticut 06473
Re: K143386
Trade/Device Name: ProGrip™ laparoscopic self-fixating mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: February 10, 2015 Received: February 11, 2015
Dear Ms. Mellows:
This letter corrects our substantially equivalent letter of March 13, 2015.
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
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Page 2 - Ms. Mary Mellows
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 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/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.
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K143386
Device Name ProGrip™ laparoscopic self-fixating mesh
Indications for Use (Describe)
ProGrip™ laparoscopic self-fixating mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
This 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92.
Submitter Information
| Name: | Sofradim Production (subsidiary of Covidien LLC) |
|---|---|
| Address: | 116, avenue du formans01600 Trevoux, France |
| Phone number | +33 (0)4 74 08 90 00 |
| Fax number: | +33 (0) 4 74 08 90 02 |
| EstablishmentRegistration: | 9615742 |
| Name of contact person: | Mary MellowsCovidienSenior Regulatory Specialist60 Middletown AvenueNorth Haven, CT 06473 |
| Phone: | 203-492-5284 |
| Date prepared: | November 25, 2014 |
| Trade or proprietary name: | ProGrip™ Laparoscopic Self-Fixating Mesh |
| Common or usual name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | FTL |
| Legally marketed devicesto which equivalence isclaimed: | Progrip™ Laparoscopic Self-Fixating Mesh (K142900) |
| Referenced devices notedin this submission: | Progrip™ Laparoscopic Self-Fixating Mesh (K120897)Progrip™ Laparoscopic Self-Fixating Mesh (K123479) |
Covidien
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.
| Reason for 510(k) Submission: | The purpose of this 510(k) is to notify the Agency of the addition of additional sizes 13x9 cm, 16x12 cm and 16x14 cm to the Progrip™ Laparoscopic Self-Fixating Mesh product family (current size is 15x10 cm). These three sizes are being added to the product family to satisfy customer requirements.These proposed sizes will result in the addition of 6 new reorder codes to the predicate product, Progrip™ Laparoscopic Self-Fixating Mesh (K142900):1. The proposed size 13x9 will be available in two configurations:Right anatomical mesh,Left anatomical mesh2. The proposed size 16x12 will be available in three configurations:Right anatomical mesh,Left anatomical mesh,Rectangular mesh3. The proposed size 16x14 will be available in one configuration:Rectangular mesh |
|---|---|
| Device description: | Both the predicate and the proposed mesh are made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable film made of collagen from porcine origin and glycerol, on the other side. The grips allow positioning and fixation of the mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh incorporates a green band to facilitate orientation.The monofilament polylactic acid grips are bioresorbable and provide the fixation of the mesh to surrounding tissue for at least 8 weeks. The polylactic acid grips degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. |
| Intended use of the device: | Both the predicate and the proposed ProGrip™ Laparoscopic Self-Fixating Mesh are intended for the reinforcement of tissue during surgical repair.No change to the intended use has been made in this submission. |
| Indications for use: | Both the predicate and the proposed ProGrip™ Laparoscopic Self-Fixating Mesh are indicated for the reinforcement of soft |
Covidien
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tissues during repair of inguinal hernia defects by laparoscopic approach.
No change to the indication for use has been made in this submission.
Summary comparing the technological characteristics of the subject and predicate devices:
Both the predicate and the proposed ProGrip™ Laparoscopic Self-Fixating Mesh are knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and an absorbable film made of collagen from porcine origin and glycerol. on the other side. The intended use and technology of the three additional sizes of ProGrip™ Laparoscopic Self-Fixating Mesh are identical to that of the predicate ProGrip™ Laparoscopic Self-Fixating Mesh.
Performance data:
The materials of the new ProGrip™ Laparoscopic Self-Fixating Mesh references are identical to the predicate ProGrip™ Laparoscopic Self-Fixating Mesh and therefore, the performance data submitted in the predicate ProGrip™ Laparoscopic Self-Fixating Mesh 510k (K142900) applies to the three additional sizes.
ProGrip™ Laparoscopic Self-Fixating Mesh new sizes are composed of biocompatible materials that are in compliance with ISO 10993-1 standard.
As materials and manufacturing processes have not changed, the stability data of the predicate ProGrip™ Laparoscopic Self-Fixating Mesh (K142900) is applicable for the additional sizes of ProGrip™ Laparoscopic Self-Fixating Mesh.
In addition to tests referenced in K142900, bench performance evaluations were completed to verify that the proposed additional sizes of ProGrip™ Laparoscopic Self-Fixating Mesh (16x12cm and 16x14cm) are compatible with 10mm and/or 12mm trocars. Mesh sizes 16x12cm and 16x14cm were chosen for testing due to their worst case configuration regarding trocar passage compared to 15x10cm size.
The tests performed were:
- Passage through 10mm and/or 12mm trocar ●
- . Visual inspection after trocar passage
- Gripping point measurement and comparison . with specification (≤27 gripping points for 16x12cm and16x14cm) after trocar passage.
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ProGrip™ Laparoscopic Self-Fixating Mesh
Conclusion:
Bench testing results demonstrate that the proposed additional sizes of Progrip™ Laparoscopic Self-Fixating Mesh are substantially equivalent to the predicate Progrip™ Laparoscopic Self-Fixating Mesh (K142900).
§ 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.