(203 days)
The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
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.
The Alure Medical Refine™ Support System is a non-absorbable implant and delivery system intended for reinforcement of soft tissue in plastic or reconstructive procedures.
The provided text does not contain the detailed information required to describe the acceptance criteria and a specific study proving the device meets those criteria, as it might for an AI/ML medical device.
This 510(k) summary is for a surgical mesh, a physical medical device, not a software device or an AI/ML algorithm. Therefore, the questions related to AI/ML specific aspects (like test set size, data provenance, ground truth establishment, MRMC studies, standalone performance, training set size, etc.) are not applicable to this document.
However, based on the information provided, here's what can be extracted and inferred about the performance and criteria for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Material Equivalence: Materials are similar to predicate non-absorbable implantable devices. | "The technological characteristics are similar to many non-absorbable, implantable devices used in the reinforcement of soft tissue." |
| Technological Equivalence: Technology is similar to predicate non-absorbable implantable devices. | "The technological characteristics are similar to many non-absorbable, implantable devices used in the reinforcement of soft tissue." |
| Specification Conformance: Device meets its predefined specifications. | "The device conforms to specifications..." |
| Clinical User Needs: Device meets the needs of clinical users. | "...and meets clinical user needs and intended uses." |
| Intended Use Equivalence: Indications for use are similar to predicate devices. | "Indications for use of the Refine™ Support System are similar to those of the predicate devices..." |
| Performance Equivalence: Performance is substantially equivalent to predicate devices for soft tissue reinforcement. | "The Refine™ Support System is considered substantially equivalent in performance to the predicate devices." |
| Safety and Effectiveness Equivalence: No new safety or effectiveness concerns compared to predicates. | "Any differences are minor and do not raise any additional concerns regarding safety or effectiveness of the device." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a physical surgical mesh device, not an AI/ML device requiring a test set of data for performance evaluation in the same manner. The performance evaluation involved "Bench studies and cadaver evaluations." The specific sample sizes for these studies are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical surgical mesh device. The concept of "ground truth" established by experts for a test set, as applied to AI/ML, does not apply here. Device performance likely relies on material testing standards and biomechanical properties rather than expert annotation of data.
4. Adjudication method for the test set
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This summary is for a surgical mesh, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This summary is for a physical surgical mesh, not an algorithm.
7. The type of ground truth used
- Not Applicable / Inferred physical properties. For a surgical mesh, "ground truth" would relate to its physical and mechanical properties (e.g., tensile strength, pore size, biocompatibility) as measured through standardized bench tests and potentially cadaveric studies, rather than expert consensus on data interpretation. The "ground truth" essentially comes from scientific measurement against established standards for surgical meshes.
8. The sample size for the training set
- Not Applicable. This is a physical surgical mesh, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical surgical mesh, not an AI/ML device.
Study That Proves the Device Meets Acceptance Criteria
The document references two types of studies used to substantiate the performance and substantial equivalence:
- Bench Studies: These studies would typically involve laboratory testing of the material properties (e.g., tensile strength, burst strength, suture retention strength, porosity, biocompatibility) of the mesh itself and potentially the delivery system. The results of these tests would be compared against the specifications of the predicate devices or established engineering standards.
- Cadaver Evaluations: These studies would involve testing the device in human anatomical cadavers to assess aspects like ease of deployment, fixation strength, tissue interaction, and overall performance in a simulated surgical environment. This would help confirm that the device meets "clinical user needs and intended uses" in a more realistic setting than purely bench models.
The summary states: "Bench studies and cadaver evaluations substantiate that the Refine™ Support System meets user needs and requirements for performance." And further, "Indications for use, technological characteristics, and performance evaluations of the Refine™ Support System show that the device is substantially equivalent to the predicate devices. Any differences are minor and do not raise any additional concerns regarding safety or effectiveness of the device."
Conclusion:
For this type of physical device, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence to existing, legally marketed predicate devices in terms of indications for use, technological characteristics, and performance. The "study" consisted of bench studies and cadaver evaluations which served to confirm that the Refine™ Support System's materials, specifications, and function are comparable to its predicates and meet the stated intended use without raising new safety or effectiveness concerns. The specific numerical data, methodologies, and detailed results of these studies are not disclosed in this 510(k) summary, which is typical for this type of FDA submission.
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510(k) Summary
MAY 11 2009
| General Information | |
|---|---|
| Submitter/Manufacturer Name/Address: | Alure Medical, Inc.2445 Impala DriveCarlsbad, 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.
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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
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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.
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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
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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
§ 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.