(163 days)
No
The device is a physical mesh implant for hernia repair and the description focuses on its material properties and physical performance, with no mention of software, algorithms, or data processing.
Yes
The device is intended for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair, which is a therapeutic purpose.
No
Explanation: The device is a surgical mesh intended for the reinforcement of abdominal wall soft tissues during hernia repair. It is a therapeutic device, not a diagnostic one, as it does not gather or analyze data for the purpose of identifying a medical condition.
No
The device description clearly states it is a physical mesh made of polypropylene and polylactic acid, intended for surgical implantation. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a physical mesh made of polypropylene and polylactic acid, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Progrip™ Self-Gripping Polypropylene Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
Progrip™ self-gripping polypropylene mesh is a sterile non-pyrogenic device made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side.
Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.
The non-absorbable textile is designed to ensure long term reinforcement of soft tissues.
The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.
Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial envelope with the Instructions for Use (IFU) and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial envelope (single pack configuration: 1 unit per commercial envelope).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall soft tissues
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data: The following performance data is provided in support of substantial equivalence demonstration:
- . Sterilization: the sterilization process has been validated in accordance with ISO 11135 (2014) and AAMI TIR28 (2016) standards.
- Shelf-life: the 5-year shelf life has been demonstrated for the subject ● device.
- Shipping test: shipping test was performed in accordance with the . ASTM D4169 (2022) standard.
- Biocompatibility: biocompatibility evaluation was performed for the ● subject Progrip™ self-gripping polypropylene mesh in accordance with the FDA quidance "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 4, 2020, and international standard ISO 10993-1 (2018). The subject device meets the criteria for biocompatibility set forth in the FDA guidance and ISO standard.
- Performance testing In vitro (bench) tests has been performed to . compare the subject and predicate in accordance with the FDA Guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999. Results demonstrate that physical and mechanical performance of the subject are substantially equivalent to the predicate.
- Human factors evaluation was conducted. A comparison of the critical tasks of the subject device and the predicate device was performed. The critical tasks are the same and there are no critical tasks introduced and no existing critical tasks have been impacted. Therefore, human factors data are not needed to demonstrate substantial equivalence.
This premarket submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
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.
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.
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
§ 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.
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 & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2024
Sofradim Production % Nancy Sauer Regulatory Affairs Senior Director Covidien Ilc 200 Medtronic Drive Lafayette, Colorado 80026
Re: K232373
Trade/Device Name: Progrip™ Self-Gripping Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: December 18, 2023 Received: December 18, 2023
Dear Nancy Sauer:
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.
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).
1
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 OS 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 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-reportingcombination-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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Tek N.
Lamichhane -S | Digitally signed by Tek
N. Lamichhane -S
Date: 2024.01.18
15:36:39 -05'00' |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Tek Lamichhane, Ph.D. | |
| Assistant Director | |
| DHT4B: Division of Infection Control
and Plastic and Reconstructive Surgery Devices | |
| OHT4: Office of Surgical
and Infection Control Devices | |
| Office of Product Evaluation and Quality | |
| Center for Devices and Radiological Health | |
2
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232373
Device Name
ProGrip™ Self-Gripping Polypropylene Mesh
Indications for Use (Describe)
ProGrip™ Self-Gripping Polypropylene Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach.
| 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) |
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4
510(k) Summary
| Date Prepared: | Jan 17, 2024 |
|---|---|
| Submitter: | Sofradim Production (subsidiary of Covidien Ilc |
| 116, avenue du Formans | |
| 01600 Trevoux, France | |
| Telephone: +33 (0)4 74 08 90 00 | |
| Fax: +33 (0) 4 74 08 90 02 | |
| Contact: | Nancy Sauer |
| Regulatory Affairs Senior Director | |
| 200 Medtronic Dr. | |
| Lafayette, CO 80026 | |
| Phone: 720-361-5290 | |
| Email: nancy.k.sauer@medtronic.com | |
| Name of device: | |
| Trade/Proprietary name: | Progrip™ self-gripping polypropylene mesh |
| Common name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Product code: FTL | |
| Regulation number: 21 CFR 878.3300 | |
| Predicate Device: | |
| Trade/Proprietary name: | Progrip™ self-gripping polyester mesh |
| Common name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Product code: FTL | |
| Regulation number: 21 CFR 878.3300 | |
| 510(k) Number: | K220586 |
| Manufacturer: | Sofradim Production (subsidiary of Covidien Ilc) |
| 116, avenue du Formans | |
| 01600 Trevoux, France | |
| Reference Device: | |
| Trade/Proprietary name: | PROLENE® Soft Polypropylene Mesh |
| Common name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Product code: FTL | |
| Regulation number: 21 CFR 878.3300 | |
| 510(k) Number: | K172089 |
| Trade/Proprietary name: | Progrip™ self-gripping polypropylene mesh |
| Common name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Product code: FTL | |
| Regulation number: 21 CFR 878.3300 | |
| 510(k) Number: | K220540 |
| Manufacturer: | Sofradim Production (subsidiary of Covidien Ilc) |
| 116, avenue du Formans | |
| 01600 Trevoux France |
5
Manufacturer: Ethicon, Inc. a Johnson & Johnson company P.O. Box 151 Route 22 West Somerville, NJ 08876-0151
Reference Device:
Progrip™ self-gripping polypropylene mesh is designed to allow Device Description: extraperitoneal mesh placement for the repair of inquinal and ventral hernias by open approach.
Progrip™ self-gripping polypropylene mesh is a sterile non-pyrogenic device made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side.
Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.
The non-absorbable textile is designed to ensure long term reinforcement of soft tissues.
The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.
Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial envelope with the Instructions for Use (IFU) and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial envelope (single pack configuration: 1 unit per commercial envelope).
Intended Use: Reinforcement of soft tissue where weakness exists.
6
Indications for use:
Progrip™ self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissue where weakness exists, in procedures involving inguinal and ventral hernia repair by open approach.
Summary comparing the technological characteristics of the subject and predicate device:
The subject device is substantially equivalent to Progrip™ self-gripping polyester mesh (K220586), which is the primary predicate device.
| | Progrip™ self-
gripping
polypropylene mesh
K232373
(subject device) | Progrip™ self-
gripping polyester
mesh (K220586)
(predicate device) | Comparison |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Reinforcement of soft
tissue where a
weakness exists | Reinforcement of soft
tissue where
weakness exists. | Same |
| Classification | FTL, per 21 CFR
878.3300 | FTL, per 21 CFR
878.3300 | Same |
| Indications for
use | Inguinal and ventral
hernias repair | Inguinal and incisional
hernias repair | Different |
| Method of
Insertion | Open | Open and
Laparoscopic
(conventional and
robotically assisted
approach) | Equivalent |
| Location of
placement | Extraperitoneal | Extraperitoneal | Same |
| Defect Closure | Recommended | Recommended | Same |
| Materials | Surgical mesh, textile
based, knitted,
monofilament,
synthetic made of
polypropylene and
polylactic acid yarns | Surgical mesh, textile
based, knitted,
monofilament,
synthetic made of
polyester and
polylactic acid yarns
only for elliptic
(precut) codes:
polyester yarn marker
dyed with D&C blue
no. 6. | Different |
| Shape | Rectangular and
square | Rectangular and
square
Elliptic | Equivalent |
| Sizes | Rectangular and
square:
15x15cm
20x15cm
30x20 cm
30x30cm
40x30cm
The mesh may be
recut as needed | - Rectangular:
15x9 cm
15x15 cm
20x15 cm
30x15 cm
- Elliptic, slit with
overlapping flap left
side/right side: 12x8
cm
The mesh may be
recut as needed | Different |
| | | | |
| Texture | Two-dimensional
monofilament textile
with monofilament
absorbable grips on
one side of the mesh | Two-dimensional
monofilament textile
with monofilament
absorbable grips on
one side of the mesh | Same |
| Pore size | $1.6\pm0,1$ mm and
$0.6\pm0,0$ mm | $1.6\pm0,1$ mm and
$0.6\pm0,1$ mm | Same |
| Fixation
instructions | The technique used to fixate the mesh (suture
and/or tacks) is left up to the surgeon.
Compatibility with other fixation devices may
not have been established. Using means of
fixation other than those for which compatibility
is established may lead to mesh damage. If
tacks are used to fixate the mesh, the use of
CovidienTM fixation devices is recommended. It
is suggested to fixate the mesh at a distance of
approximately 1 cm from the edge of the mesh.
The textile self-gripping feature makes it
possible to position the mesh without fixation,
depending on the size of the defect, the hernia
position and the quality of the anatomical
structures. | The technique used to fixate the mesh (suture
and/or tacks) is left up to the surgeon.
Compatibility with other fixation devices may
not have been established. Using means of
fixation other than those for which compatibility
is established may lead to mesh damage. If
tacks are used to fixate the mesh, the use of
CovidienTM fixation devices is recommended. It
is suggested to fixate the mesh at a distance of
approximately 1 cm from the edge of the mesh.
The textile self-gripping feature makes it
possible to position the mesh without fixation,
depending on the size of the defect, the hernia
position and the quality of the anatomical
structures. | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Packaging | Sealed Tyvek®//
polyester/polyethylene
pouch (double sterile
barrier system) | Sealed Tyvek®//
polyester/polyethylene
pouch (double sterile
barrier system) | Same |
7
The subject device and predicate device have the same intended use and nearly identical indications for use, differing only in the addition of primary ventral hernia repair for the subject device. Differences in the technological characteristics between the subject and predicate devices do not raise new questions of safety or effectiveness. Performance testing demonstrated substantial equivalence for biocompatibility, has mechanical properties such as strength, human factors evaluation, sterilization, packaging, transport and shelf life.
This 510(k) also references the PROLENE® Soft Polypropylene Mesh (K172089) and the Progrip™ self-gripping polypropylene mesh (K220540). PROLENE® Soft Polypropylene Mesh (K172089) was selected because this legally marketed mesh includes large sizes (up to 50x50cm). Progrip™ self-gripping polypropylene mesh (K220540) was selected because this legally marketed mesh presents the same base materials as the subject device.
Performance data: The following performance data is provided in support of substantial equivalence demonstration:
- . Sterilization: the sterilization process has been validated in accordance with ISO 11135 (2014) and AAMI TIR28 (2016) standards.
8
- Shelf-life: the 5-year shelf life has been demonstrated for the subject ● device.
- Shipping test: shipping test was performed in accordance with the . ASTM D4169 (2022) standard.
- Biocompatibility: biocompatibility evaluation was performed for the ● subject Progrip™ self-gripping polypropylene mesh in accordance with the FDA quidance "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 4, 2020, and international standard ISO 10993-1 (2018). The subject device meets the criteria for biocompatibility set forth in the FDA guidance and ISO standard.
- Performance testing In vitro (bench) tests has been performed to . compare the subject and predicate in accordance with the FDA Guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999. Results demonstrate that physical and mechanical performance of the subject are substantially equivalent to the predicate.
- Human factors evaluation was conducted. A comparison of the critical tasks of the subject device and the predicate device was performed. The critical tasks are the same and there are no critical tasks introduced and no existing critical tasks have been impacted. Therefore, human factors data are not needed to demonstrate substantial equivalence.
This premarket submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusion:
Comparison of the subject and predicate devices and labeling as well as the results of performance testing demonstrate that the subject Progrip™ self-gripping polypropylene mesh is substantially equivalent to the predicate device Progrip™ self-aripping polvester mesh (K220586).