(87 days)
Not Found
No
The device description focuses on the material composition and physical structure of a surgical mesh, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is a surgical mesh used for the repair of hernias and abdominal wall deficiencies, which is a structural implant and not a device that provides therapy.
No
This device is a surgical mesh indicated for the repair of abdominal wall hernias and deficiencies, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a mesh manufactured from fibers, indicating a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of abdominal wall hernias and deficiencies by providing a reinforcing material. This is a surgical intervention on the body.
- Device Description: The device is a surgical mesh made of synthetic fibers (polypropylene and poliglecaprone-25). It is implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or diagnostic purposes.
The device is clearly intended for surgical implantation to physically repair a defect, which falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
ULTRAPRO ADVANCED™M Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
Product codes
FTL
Device Description
ULTRAPRO™ Mesh is manufactured from approximately equal parts* of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber. The polymer of the undyed and dyed polypropylene fiber (phthalocyanine blue, Color Index No .: 74160) is identical to the material used for dyed/undyed PROLENE™ suture material. Poliglecaprone-25 fiber consists of a copolymer containing glycolide and &-caprolactone; this copolymer is identical to the material used for MONOCRYL™ suture. After absorption of the poliglecaprone-25 component, only the polypropylene mesh remains. The structure and size of this remaining mesh are optimally designed for the physiological stresses of the abdominal wall.
ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh is a sterile, partially absorbable mesh*, designed for the repair of abdominal wall hernias and other abdominal wall deficiencies. The device is manufactured out of dyed (phtalocyanine blue) and undyed nonabsorbable polypropylene monofilaments (3.5 mil PROLENE™) as well as a twist, composed of dyed (phtalocyanine blue) and undyed non-absorbable polypropylene monofilaments (3.5 mil PROLENE™) and undyed absorbable poliglecaprone 25 monofilaments (5 mil MONOCRYL™). Blue stripes provide orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two main elements: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue.
Ethicon Inc % Ms. Melina Escobar Regulatory Affairs Specialist P.O. Box 151 U.S. Route 22 West Somerville, New Jersey 08876
July 2, 2018
Re: K180910
Trade/Device Name: ULTRAPRO™ Mesh and ULTRAPRO ADVANCED™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: April 5, 2018 Received: April 6, 2018
Dear Ms. Escobar:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K180910
Device Name ULTRAPRO™ Mesh ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh
Indications for Use (Describe)
ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
ULTRAPRO ADVANCED™M Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
| 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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Image /page/3/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is in large, red, sans-serif font. Below it, in a smaller, cursive font, is the text "a Johnson & Johnson company."
510(k) Summary
| Submitter: | Ethicon, Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Melina Escobar
Regulatory Affairs Specialist
Phone: 908-218-2583
Fax: 908-218-2595
Email: mescob14@its.jnj.com |
| Date Prepared: | April 5, 2018 |
| Device Trade Name: | ULTRAPRO™ Mesh
ULTRAPRO ADVANCED™ Macroporous Partially Absorbable
Mesh |
| Device Common Name: | ULTRAPRO™ Mesh
ULTRAPRO ADVANCED™ |
| Class: | Class II |
| Classification: | 21 CFR 878.3300 – Surgical Mesh |
| Product Code: | FTL |
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K180910 Page 2 of 4
Image /page/4/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters. Below the company name, in a smaller, cursive font, is the text "a Johnson & Johnson company". The logo is simple and clean, with a focus on the company name.
Predicate Device:
| Device | Company | Product Code | 510(k) Number | Predicate for |
|---|---|---|---|---|
| ULTRAPRO™ | ||||
| Mesh | Ethicon, Inc. | FTL | K033337 | Fundamental Scientific |
| Technology, Design, | ||||
| Intended Use, Materials, | ||||
| Construction, Performance | ||||
| Characteristics | ||||
| ULTRAPRO | ||||
| ADVANCED | Ethicon, Inc. | FTL | K150906 | Fundamental Scientific |
| Technology, Design, | ||||
| Intended Use, Materials, | ||||
| Construction, Performance | ||||
| Characteristics |
Device Description:
ULTRAPRO™ Mesh is manufactured from approximately equal parts* of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber. The polymer of the undyed and dyed polypropylene fiber (phthalocyanine blue, Color Index No .: 74160) is identical to the material used for dyed/undyed PROLENE™ suture material. Poliglecaprone-25 fiber consists of a copolymer containing glycolide and &-caprolactone; this copolymer is identical to the material used for MONOCRYL™ suture. After absorption of the poliglecaprone-25 component, only the polypropylene mesh remains. The structure and size of this remaining mesh are optimally designed for the physiological stresses of the abdominal wall.
ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh is a sterile, partially absorbable mesh*, designed for the repair of abdominal wall hernias and other abdominal wall deficiencies. The device is manufactured out of dyed (phtalocyanine blue) and undyed nonabsorbable polypropylene monofilaments (3.5 mil PROLENE™) as well as a twist, composed of dyed (phtalocyanine blue) and undyed non-absorbable polypropylene monofilaments (3.5 mil PROLENE™) and undyed absorbable poliglecaprone 25 monofilaments (5 mil MONOCRYL™). Blue stripes provide orientation.
5
Image /page/5/Picture/0 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, serif font. Below it, in a smaller, cursive font, is the phrase "a Johnson & Johnson company."
Indications for Use:
ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
ULTRAPRO ADVANCED™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
Summary of Technological Characteristics:
ULTRAPRO Mesh is identical to the ULTRAPRO Mesh (K033337) marketed mesh with respect to technological characteristics. There are no material, construction, manufacturing or sterilization process changes to the currently marketed device differs only in the labeling which certain sections of the Instructions for Use of the subject device have been reworded/ reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date.
ULTRAPRO ADVANCED is identical to the ULTRAPRO ADVANCED (K150906) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed device. The device differs only in the labeling which has been revised to reworded/ reformatted most of the Instructions for Use sections for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date.
Substantial Equivalence:
ULTRAPRO™ Mesh and ULTRAPRO ADVANCED are identical to the ULTRAPRO™ Mesh (K033337) and ULTRAPRO ADVANCED (K150906) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the labeling (Instructions for Use). Where several sections of the Instructions for Use of the subject devices have been reworded reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date and aligned within the Mesh Harmonization project noted in the Cover Letter. The Indication statement of the subject meshes have been modified to add clarity. The Indication of the subject devices do not introduce any new indications or expand the patient population of the predicate meshes.
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Image /page/6/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif font. Below it, the phrase "a Johnson+Johnson company" is written in a smaller, cursive font.
Conclusion:
The subject mesh, ULTRAPRO™ Mesh and ULTRAPRO ADVANCED are identical to the predicate marketed meshes, ULTRAPRO™ Mesh (K033337) and ULTRAPRO ADVANCED (K150906) with respect to intended use, technological characteristics, material, construction, specification, manufacturing and sterilization. In conclusion, the subject ULTRAPRO™ Mesh and ULTRAPRO ADVANCED are substantially equivalent to the predicate meshes.