(152 days)
Not Found
No
The summary describes a surgical mesh made of a synthetic absorbable copolymer and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The device is described as temporary wound or organ support, fitting the definition of a surgical mesh, which is a structural device rather than a therapeutic one that treats a disease or condition.
No
Explanation: The device, VICRYL™ Mesh, is described as a synthetic absorbable sterile copolymer used for temporary wound or organ support. Its intended use is to provide physical support, not to diagnose medical conditions or analyze patient data.
No
The device description clearly states it is a synthetic absorbable sterile copolymer mesh, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing "temporary wound or organ support" during surgical procedures. This is a direct interaction with the body for therapeutic or supportive purposes.
- Device Description: The description details the material and structure of a surgical mesh, designed to be implanted or used within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not involve the analysis of biological samples.
Therefore, VICRYL™ Mesh is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VICRYL Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). VICRYL Mesh may be cut to the shape or size desired for each specific application.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.
VICRYL™ Knitted Mesh, which is more porous than VICRYL™ Woven Mesh, may be used in instances in which compliant and stretchable support material is desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, liver, spleen
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): 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.
Not Found
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.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 22, 2019
Ethicon, Inc. Melina Escobar Regulatory Affairs Specialist II Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K191373
Trade/Device Name: VICRYL Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 22, 2019 Received: May 23, 2019
Dear Melina 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. 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 located 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
For Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191373
Device Name VICRYL Mesh
Indications for Use (Describe)
VICRYL Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). VICRYL Mesh may be cut to the shape or size desired for each specific application.
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/0 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, the text "a Johnson & Johnson company" is written in a smaller, cursive font. The logo is simple and clean, with a focus on the company name.
510(k) Summary
Submission Date: 10/23/2019
SUBMITTER INFORMATION:
| Company Name: | Ethicon, Inc. a Johnson & Johnson compan |
|---|---|
| Company Address: | P.O. Box 151 |
| Route 22 West | |
| Somerville, NJ 08876-0151 | |
| Contact Person: | Melina Escobar |
| Regulatory Affairs Specialist II | |
| Phone: 908-218-2583 | |
| Fax: 908-218-2595 | |
| Email: mescob14@its.jnj.com | |
| Device Trade Name: | VICRYL™ Mesh |
| Device Common Name: | VICRYL™ Mesh |
| Class: | Class II |
| Classification: | 21 CFR 878.3300 – Surgical Mesh |
| Product Code: | FTL |
Predicate Devices:
| Device | Company | Product
Code | 510(k)
Number | Predicate for |
|---------------------------------------|------------------|-----------------|------------------|------------------------------------------------------------------------------------------------------------------------|
| VICRYLTM
(Polyglactin
910) Mesh | Ethicon,
Inc. | FTL | K810428 | Fundamental Scientific Technology,
Design, Intended Use, Materials,
Construction, Performance
Characteristics |
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Image /page/4/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 the company name, the words "a Johnson & Johnson company" are written in a smaller, cursive font.
| Device | Company | Product
Code | 510(k)
Number | Predicate for |
|----------------------|---------------|-----------------|------------------|------------------------------------------------------------------------------------------------------------------------|
| VICRYLTM
Mesh Bag | Ethicon, Inc. | FTL | K051701 | Fundamental Scientific Technology,
Design, Intended Use, Materials,
Construction, Performance
Characteristics |
Device Description:
VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.
VICRYL™ Knitted Mesh, which is more porous than VICRYL™ Woven Mesh, may be used in instances in which compliant and stretchable support material is desired.
Indications for Use:
VICRYL™ Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). VICRYL™ Mesh may be cut to the shape or size desired for each specific application.
Summary of Technological Characteristics:
VICRYL™ Mesh is substantially equivalent to the VICRYL™ Mesh (K810428) and VICRYL™ Mesh Bag (K051701) predicate devices with respect to technological characteristics. Both the subject and predicate devices are synthetic absorbable sterile copolymer. The devices function in the same manner and are designed to be used wherever temporary wound or organ support is required (kidney, liver, spleen). The subject mesh is manufactured within the existing manufacturing processes for the predicate device. There are no changes to the manufacturing, packaging, sterilization processes, or shelf life of the currently marketed device.
The subject VICRYL™ Mesh, for which this 510(k) Premarket Notification is being submitted, differs from the currently marketed device, K810428, in the labeling (Instructions for Use). The Instructions for Use has been revised to clarify the indications. Additionally, several other sections of the Instructions for Use of the subject devices have been reworded/ reformatted for clarity to address and align with evolving regulatory expectations.
Substantial Equivalence:
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VICRYL™ Mesh is substantially equivalent to the VICRYL™ Mesh (K810428) and VICRYL™ Mesh Bag (K051701) predicate devices with respect to technological characteristics. Both the subject and predicate device are synthetic absorbable sterile copolymer. The devices function in the same manner and are designed to be used wherever temporary wound or organ support is required (kidney, liver, spleen). The subject mesh is manufactured within the existing manufacturing processes for the predicate device. There are no changes to the manufacturing, packaging, sterilization processes, or shelf life of the currently marketed device.
The subject VICRYL™ Mesh, for which this 510(k) Premarket Notification is being submitted, differs from the currently marketed device. K810428, in the labeling (Instructions for Use). The Instructions for Use has been revised to clarify the indications. Additionally, several other sections of the Instructions for Use of the subject devices have been reworded/ reformatted for clarity to address evolving regulatory expectations.
Conclusion:
VICRYL™ Mesh is substantially equivalent to the predicate devices, K810428 and K051701 in indications for use, fundamental scientific technology, and technological characteristics. It is as safe and effective as the predicates. Ethicon considers VICRYL™ Mesh to be substantially equivalent to the predicate devices.