(83 days)
Not Found
No
The summary describes a physical surgical mesh device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, a surgical plug and patch for hernia repair, is used to treat a medical condition (groin hernia defects), aligning with the definition of a therapeutic device designed to alleviate or cure a disease or medical condition.
No
This device, ULTRAPRO Plug, is used for the open repair of groin hernia defects. It is a physical implant (a plug and an onlay patch) used in a surgical procedure, not a tool for identifying or characterizing a disease or condition. The document describes materials, functional performance testing, and predicate devices, all of which relate to a therapeutic surgical device, not a diagnostic one.
No
The device description explicitly states it is composed of two sterile components: a thermoformed, three-dimensional plug and a flat, preshaped onlay patch, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for open repair of groin hernia defects." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "thermoformed, three-dimensional plug and a flat, preshaped onlay patch." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on in vitro analysis.
Therefore, the ULTRAPRO Plug is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ULTRAPRO Plug is a partially absorbable device used to fill and reinforce inguinal hernia defects. ULTRAPRO Plug is indicated for open repair of groin hernia defects.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The ULTRAPRO Plug device is composed of two sterile components: a thermoformed, three-dimensional plug and a flat, preshaped onlay patch. The ULTRAPRO Plug device is indicated for the open repair of groin hernia defects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal hernia defects, 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)
Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements.
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.
ULTRAPRO* Mesh (ETHICON, Inc.) - K033337, BARD Mesh PerFix Plug (Davol, Inc.) - K922916
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
Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
Submitted by:
Bryan A. Lisa Sr. Regulatory Affairs Associate ETHICON, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876
APR 1 7 2007
Name/Classification of Device:
Class II in 21 CFR § 878.3300, Surgical Mesh (FTL)
Trade Name:
ULTRAPRO* Plug
Predicate Devices:
ULTRAPRO* Mesh (ETHICON, Inc.) - K033337 BARD Mesh PerFix Plug (Davol, Inc.) - K922916
Statement of Intended Use:
ULTRAPRO Plug is a partially absorbable device used to fill and reinforce inguinal hernia defects. ULTRAPRO Plug is indicated for open repair of groin hernia defects.
Device Description:
The ULTRAPRO Plug device is composed of two sterile components: a thermoformed, three-dimensional plug and a flat, preshaped onlay patch. The ULTRAPRO Plug device is indicated for the open repair of groin hernia defects.
Summary of Technological Characteristics of New Device to Predicate Devices:
The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, it is a sterile, mesh implant intended for the repair of hernia defects. The proposed device is made of nonabsorbable and absorbable polymers, which are identical to those found in ULTRAPRO Mesh, currently marketed by ETHICON, Inc.
Performance Data:
Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements.
1
BAL-2007-001
22
Conclusions:
Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
.
:
- Trademark of ETHICON, Inc.
510(K) SUMMARY
.. .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ethicon, Inc. % Mr. Bryan A. Lisa Sr. Regulatory Affairs Associate Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
APR 1 7 2007
Re: K070224
Trade/Device Name: ULTRAPRO* Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 6, 2007 Received: April 9, 2007
Dear Mr. Lisa:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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,
3
Page 2 - Mr. Bryan A. Lisa
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For Pete O Rum
Mark N. Melkerson
Director
m
D&P Dir
4/1/09
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K870224
Device Name: ULTRAPRO* Plug
Indications for Use:
ULTRAPRO Plug is indicated for open repair of groin hernia defect
hernia defects.
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
*Trademark.
510(k) Number
(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)