(225 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a physical hernia repair device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a hernia repair device that provides mechanical support and reinforcement for soft tissue, which is not considered a therapeutic function. Therapeutic devices typically involve active treatment, drug delivery, or diagnostic capabilities beyond structural support.
No
Explanation: The device is a hernia repair device used for reinforcement of soft tissue, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical, partially absorbable hernia repair device made of mesh and polymer film, not software.
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 "reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects." This describes a surgical implant used in vivo (within the body) to physically repair tissue.
- Device Description: The description details a physical device (plug and patch) made of mesh and polymers, designed to be implanted. This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Performance Studies: The performance studies described involve bench testing and animal models evaluating biocompatibility, physical properties, and tissue integration. These are typical studies for surgical implants, not IVDs which would involve studies on human biological samples to assess diagnostic accuracy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the ULTRAPRO COMFORT PLUG is a surgical implant used for hernia repair, which falls under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The ULTRAPRO COMFORT PLUG™ Partially Absorbable Hernia Repair Device is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
ULTRAPRO COMFORT PLUG™ is a sterile, single-use partially absorbable hernia repair device designed for open extra-peritoneal abdominal wall repair, particularly groin hernia repair, to provide permanent support during and following wound healing. ULTRAPRO COMFORT PLUG™ consists of a three-dimensional plug, which fills the defect and a flat pre-shaped onlay patch, which lays on the defect to reinforce the weak area around the defect. The Plug is composed of an undyed ULTRAPRO™ Mesh. Dyed ribs, made from dyed (D&C Violet No. 2) polydioxanone polymer film, are laminated to the Plug mesh. The onlay patch is a pre-shaped, dyed ULTRAPRO™ Mesh. The ULTRAPRO™ Mesh is manufactured from approximately equal parts of absorbable poliglecaprone 25 monofilament fibers and non-absorbable polypropylene monofilament fibers. The device is available in different sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, groin hernia defects.
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)
ULTRAPRO COMFORT PLUG™, Partially Absorbable Hernia Repair Device underwent an extensive safety and performance testing program, including bench and animal testing, to support that the device meets the requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate devices. The tests conducted include:
- Biocompatibility testing in accordance to the tests recommended in the ISO 10993-. 1:2009 standard including cytotoxicity, sentitization, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, and local tissue response and absorption study
- Bench testing including device dimensional measurement and comparison, and shelf life . testing
- Performance testing in animal model including efficacy study evaluating mesh . compression, tissue integration, and tissue reaction and infection potentiation study.
The ULTRAPRO COMFORT PLUG™ Partially Absorbable Hernia Repair Device has the same intended use, fundamental scientific technology, and principles of operation as its predicate devices. Performance data demonstrates that the device is as safe and as effective as the predicate devices for the intended use. Thus we conclude that the proposed device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
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.
0
510(K) SUMMARY
MAY 3 0 2014
| Applicant: | Ethicon Inc.
P.O. Box 151
Route 22 West
Somerville, NJ 08876
USA
Phone: +1-908-218-3323
Fax: +1-908-218-2595 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 12, 2014 |
| Contact Person: | Rey Librojo |
| Proprietary Device Name: | ULTRAPRO COMFORT PLUGTM
Partially Absorbable Hernia Repair Device |
| Common Device Name: | Surgical Mesh |
| Classification: | Class II
Regulation Number 878.3300 - Surgical Mesh, polymeric;
Product Code: FTL |
| Predicate Devices: | ULTRAPRO PLUG™ (ETHICON, Inc.) - K070224;
BARD Mesh Perfix™ Plug (Davol, Inc.) - K922916 |
| Manufacturer: | Johnson & Johnson MEDICAL GmbH
Robert-Koch-Strasse 1
22851 Norderstedt
Germany |
1 of 3
1
Description of the Device Subject to Premarket Notification:
ULTRAPRO COMFORT PLUG™ is a sterile, single-use partially absorbable hernia repair device designed for open extra-peritoneal abdominal wall repair, particularly groin hernia repair, to provide permanent support during and following wound healing. ULTRAPRO COMFORT PLUG™ consists of a three-dimensional plug, which fills the defect and a flat pre-shaped onlay patch, which lays on the defect to reinforce the weak area around the defect. The Plug is composed of an undyed ULTRAPRO™ Mesh. Dyed ribs, made from dyed (D&C Violet No. 2) polydioxanone polymer film, are laminated to the Plug mesh. The onlay patch is a pre-shaped, dyed ULTRAPRO™ Mesh. The ULTRAPRO™ Mesh is manufactured from approximately equal parts of absorbable poliglecaprone 25 monofilament fibers and non-absorbable polypropylene monofilament fibers. The device is available in different sizes.
Indications for Use:
The ULTRAPRO COMFORT PLUG™ Partially Absorbable Hernia Repair Device is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
Summary of Technological Characteristics of New Device to Predicate Devices:
Similarity:
The principle of operation and fundamental scientific technology of the proposed device are equivalent to the predicate devices. ULTRAPRO COMFORT PLUG™ and the predicate devices function in the same manner - they are designed as plug plus onlay patch devices for open extraperitoneal abdominal wall repair, particularly groin hernia repair. The polymer materials in the proposed device is identical to that of Ultrapro Plug, which is composed with approximately equal parts of absorbable poliglecaprone 25 monofilament fibers and non-absorbable, polypropylene monofilament fibers. The mash knitting structure of both plug and onlay patch of ULTRAPRO COMFORT PLUG™ is the same as the onlay patch material of ULTRAPRO Plug the proposed device has similar 3-D physical shapes as that of Bard Mesh Perfix Plug. Difference:
The plug material for proposed device is composed of undyed ULTRAPRO™ Mesh. Dyed ribs, made from dyed (D&C Violet No. 2) polydioxanone polymer film, are laminated to the Plug mesh to provide better visibility to the plug for ease of insertion into the defect and fixation.
Performance Data:
ULTRAPRO COMFORT PLUG™, Partially Absorbable Hernia Repair Device underwent an extensive safety and performance testing program, including bench and animal testing, to support that the device meets the requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate devices. The tests conducted include:
2
- Biocompatibility testing in accordance to the tests recommended in the ISO 10993-. 1:2009 standard including cytotoxicity, sentitization, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, and local tissue response and absorption study
- Bench testing including device dimensional measurement and comparison, and shelf life . testing
- Performance testing in animal model including efficacy study evaluating mesh . compression, tissue integration, and tissue reaction and infection potentiation study.
The ULTRAPRO COMFORT PLUG™ Partially Absorbable Hernia Repair Device has the same intended use, fundamental scientific technology, and principles of operation as its predicate devices. Performance data demonstrates that the device is as safe and as effective as the predicate devices for the intended use. Thus we conclude that the proposed device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
May 30, 2014
Ethicon, Inc. Reynaldo Librojo Director, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, NJ 08876
Rc: K133198
Trade/Device Name: ULTRAPRO COMFORT PLUG Partially Absorbable Hernia Repair Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 22, 2014 Received: May 28, 2014
Dear Mr. Reynaldo Librojo,
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 enacument 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). and Cosmetic room reat 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
4
Page 2 - Mr. Librojo
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 (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/Resourcesfor You/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
Enclosure
5
Ethicon Inc. October 2013
INDICATIONS FOR USE STATEMENT 4
| 510(k) No (if known): | K133198 |
|---|---|
| Device Name: | ULTRAPRO COMFORT PLUG TM |
| Partially Absorbable Hernia Repair Device | |
| Indications for Use: | The ULTRAPRO COMFORT PLUG TM Partially Absorbable Hernia Repair Device is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects. |
V Prescription Use __ (Part 2) CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Peter L. Hudson -S
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