(142 days)
Not Found
No
The device description focuses on the material composition and mechanical function of a surgical plug and mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a surgical plug and mesh intended for abdominal reinforcement and the repair of hernias, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No.
The 4DDome® is described as a "semi-resorbable surgical plug and mesh for abdominal reinforcement," which is a therapeutic device used for structural support, not for diagnosis.
No
The device description clearly states it is a physical surgical plug and mesh made of polypropylene and PLLA, which are hardware components.
Based on the provided information, the 4DDome® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "abdominal reinforcement, including open surgical repair and reinforcement of iguinal and crural hernias." This describes a surgical implant used directly on the patient's body to repair a physical defect.
- Device Description: The description details a physical surgical plug and mesh made of specific materials (polypropylene and PLLA) designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The 4DDome® is a surgical implant used inside the body for structural support.
N/A
Intended Use / Indications for Use
4DDome® is a semi-resorbable surgical plug and mesh for abdominal reinforcement, including open surgical repair and reinforcement of iguinal and crural hernias.
Product codes
FTL
Device Description
The 4DDOME® device is composed of a dome and onlay patch. The dome is made of 10 % light polypropylene and 90 % resorbable Poly-L-Lactide (PLLA). The dimensional stability of the dome combined with the physiological absorption of the PLLA ensure that the hernia sac is kept in place and the transversalis fascia is strengthened due to the PLLA generating cellular fibrosis.
The 4DDOME® medical device is composed of two prosthesis:
- . one semi-resorbable dome
- one semi-resorbable onlay patch .
The dome is the architectural structure with the best resistance to pressure. It keeps the hernia sac in the preperitoneal space behind the transversalis fascia by supporting itself on the sides of the defected area, where it is fixed with non-resorbable threads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, iguinal, crural
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)
WL Gore - Bio-Absorbable® Hernia plug - K033671, Bard - Perfix® plug mesh - K922916, Atrium - Atrium® self forming plug - K930669
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
K070918/51
Premarket Notification 510(k) Section 5 - 510(k) Summary
4DDome®
5 510(k) Summary
| Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2
| 30-Mar-07 | AUG 2 2 200 | |||
|---|---|---|---|---|
| Cousin Biotech. | ||||
| 8 rue de l'Abbe Bonpain | ||||
| 59117 Wervicq-Sud | ||||
| France | Tel - 011-33 (0) 3 20 14 41 19 | |||
| Fax - 011-33 (0) 3 20 14 41 22 | ||||
| Official Contact: | Stephan Ploquin, Quality Manager, Regulatory Affairs | |||
| Proprietary or Trade Name: | 4DDome® | |||
| Common/Usual Name: | Polymeric Surgical Mesh | |||
| Classification Name: | Polymeric Surgical Mesh | |||
| Predicate Devices: | WL Gore - Bio-Absorbable® Hernia plug - K033671 | |||
| Bard - Perfix® plug mesh - K922916 | ||||
| Atrium - Atrium® self forming plug - K930669 |
Device Description:
The 4DDOME® device is composed of a dome and onlay patch. The dome is made of 10 % light polypropylene and 90 % resorbable Poly-L-Lactide (PLLA). The dimensional stability of the dome combined with the physiological absorption of the PLLA ensure that the hernia sac is kept in place and the transversalis fascia is strengthened due to the PLLA generating cellular fibrosis.
The 4DDOME® medical device is composed of two prosthesis:
- . one semi-resorbable dome
- one semi-resorbable onlay patch .
The dome is the architectural structure with the best resistance to pressure. It keeps the hernia sac in the preperitoneal space behind the transversalis fascia by supporting itself on the sides of the defected area, where it is fixed with non-resorbable threads.
| Indicated Use: | 4DDome® is a semi-resorbable surgical plug and mesh for
abdominal reinforcement, including open surgical repair and
reinforcement of iguinal and crural hernias. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contraindications: | Do not implant in the following cases:
Allergy to one of components
Septic environment
Pregnancy
Growing children |
1
070918/51 21
Premarket Notification 510(k) Section 5 – 510(k) Summary
4DDome@
| Non-Confidential Summary of Safety and Effectiveness |
|---|
| Page 2 of 2 |
| 30-Mar-07 |
| Type of product | DOME | DOME | DOME |
|---|---|---|---|
| Reference | 4DDOME24SR | 4DDOME30SR | 4DDOME38SR |
| Size | Small | ||
| (Diameter 24 mm) | Large | ||
| (Diameter 30 mm) | Extra Large | ||
| (Diameter 38 mm) | |||
| Material | 88.3 % PLLA | ||
| 11.7 % Polypropylene | 88.3 % PLLA | ||
| 11.7 % Polypropylene | 88.3 % PLLA | ||
| 11.7 % Polypropylene | |||
| Weight/m2 | |||
| (gm/m2) | 256 | 256 | 256 |
| Macropores | |||
| percentage (%) | 74 | 74 | 74 |
| Thickness (mm) | 0.8 to 1 | 0.8 to 1 | 0.8 to 1 |
| Weight | |||
| per dome (gm) | 0.2873 | 0.4573 | 0.6811 |
| Weight of the | |||
| dome after | |||
| absorption (gm) | 0.035 | 0.054 | 0.080 |
Physical properties of Dome component
| Type of product | Onlay patch |
|---|---|
| Material | 75 % PLLA monofilament |
| 25 % polypropylene monofilament | |
| Weight/m² | |
| (gm/m²) | 116 |
| Structure | Knitwear semi-resorbable |
| Dimensions | Mesh 90 x 52 mm |
| Thickness (mm) | 0.8 |
Physical properties of the semi-resorbable onlay patch:
Differences Between Other Legally Marketed Predicate Devices
The 4DDome® is viewed as substantially equivalent to the following predicate device – WL Gore - Bio-Absorbable® Hernia plug - K033671,Bard - Perfix® plug mesh - K922916, and Atrium - Atrium® self forming plug - K930669
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
2(
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cousin Biotech % ProMedic, Inc. Mr. Paul Dryden Regulatory Consultant 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134-2015
AUG 2 2 2007
Re: K070918
Trade/Device Name: 4DDome® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 2, 2007 Received: August 6, 2007
Dear Mr. Dryden:
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
3
Page 2 - Mr. Paul Dryden
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.
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, permitts your revice 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 ventitled, "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) 633-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
FOR Mark N. Melkerson
FOR
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K Ü +0"718/51
Premarket Notification 510(k) Section 4 - Indications for Use Statement
Indications for Use Statement 4
Page 1 of 1
4DDome®
| 510(k) Number: | |
|---|---|
KO70918 (To be assigned)
Device Name:
4DDome®
Indications for Use:
4DDome® is a semi-resorbable surgical plug and mesh for abdominal reinforcement, including open surgical repair and reinforcement of iguinal and crural hernias.
Prescription Use XX (Part 21 CFR 801 Subpart D)
01
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070918