(203 days)
No
The 510(k) summary describes a physical implant and delivery system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The sections specifically looking for mentions of AI, DNN, or ML are marked as "Not Found".
Yes
The Refine™ Support System is indicated for reinforcement of soft tissue, which is a therapeutic intervention aimed at treating or improving a medical condition.
No
Justification: The device's 'Intended Use' states it is "indicated for reinforcement of soft tissue in plastic or reconstructive procedures." This describes a therapeutic or supportive function, not a diagnostic one (e.g., detecting, identifying, or monitoring a disease or condition).
No
The device description explicitly states it consists of a non-absorbable implant (mesh and suture anchor) and a delivery system, 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 "reinforcement of soft tissue in plastic or reconstructive procedures." This describes a surgical implant used directly on the patient's body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as a "non-absorbable implant and a delivery system." This further confirms it's a physical device implanted in the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Refine™ Support System does not fit this description.
N/A
Intended Use / Indications for Use
The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
Product codes
FTL
Device Description
The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant consists of a mesh and suture anchor. The device and the delivery system are delivered sterile and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Bench studies and cadaver evaluations substantiate that the Refine™ Support System meets user needs and requirements for performance.
Key Metrics
Not Found
Predicate Device(s)
K080216 SupraMesh EXTRATM, K081069 INFINIT Mesh, K001122 Prolene™ Soft (polypropylene) Mesh
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
510(k) Summary
MAY 11 2009
| General Information | |
|---|---|
| Submitter/Manufacturer Name/Address: | Alure Medical, Inc. |
| 2445 Impala Drive | |
| Carlsbad, CA 92010 | |
| Alternate Manufacturing Location: | Alure Medical, Inc. |
| 3637 Westwind Blvd., Suite B |
Establishment Registration Number:
Contact Person:
Phone Number:
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
Santa Rosa, CA 95403
Not Available
Jasper Benke
(707) 526-4400
October 17, 2008
Refine™ Support System
Surgical Mesh
Mesh, Surgical, Polymeric, (21 CFR 878.3300, Product Code FTL)
Predicate Device Information
K080216 SupraMesh EXTRATM K081069 INFINIT Mesh K001122 Prolene™ Soft (polypropylene) Mesh
Product Description
The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant consists of a mesh and suture anchor. The device and the delivery system are delivered sterile and are for single use only.
Intended Use
The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
Substantial Equivalence
Indications
Indications for use of the Refine™ Support System are similar to those of the predicate devices and have been substantiated by performance evaluations and comparison studies.
1
K083102 Page 2/2
Technological Characteristics
In establishing substantial equivalence to the predicate devices, Alure Medical evaluated the materials, technology, and specifications of the subject and predicate devices. The technological characteristics are similar to many non-absorbable, implantable devices used in the reinforcement of soft tissue.
Performance
The Refine™ Support System is considered substantially equivalent in performance to the predicate devices. The device conforms to specifications and meets clinical user needs and intended uses. Bench studies and cadaver evaluations substantiate that the Refine™ Support System meets user needs and requirements for performance.
Summary of Safety and Effectiveness
Indications for use, technological characteristics, and performance evaluations of the Refine™ Support System show that the device is substantially cquivalent to the predicate devices. Any differences arc minor and do not raise any additional concerns regarding safety or effectiveness of the device.
CONFIDENTIAL - Alure Medical, Inc.
H
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple sans-serif font.
Public Health Service
11 2009 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alure Medical Inc. % Mr. Jasper Benke Director, Regulatory Affairs, Quality Assurance & Clinical Affairs 2445 Impala Drive Carlsbad, California 92010
Re: K083102
Trade/Device Name: Refine™ Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: May 7, 2009 Received: May 8, 2009
Dear Mr. Benke:
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 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 (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.
3
Page 2 - Mr. Jasper Benke
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 D. Whinn
Mark N. Melkerson Division of General, Restorativ and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
Device Name:
Refine™ Support System
Indications for Use:
The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
Daniel Keane for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K053102