(57 days)
This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.
Xylos® Porous Surgical Mesh is a sterile, non-resorbable product composed of solvent-dehydrated, microbial-derived cellulose. The implantable unit is presented in sterile double-pouched packages for appropriate removal in preparation for surgery.
The provided text describes a 510(k) premarket application for the Xylos® Porous Surgical Mesh, which is a modification of a previously cleared device. The "study" referenced is an evaluation of this modification, rather than a clinical trial in the traditional sense, focusing on establishing substantial equivalence to the predicate device.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "The verification and validation tests that were performed confirmed that the Xylos® Porous Surgical Mesh met the acceptance criteria. Therefore the device should perform as intended." However, it does not explicitly list the specific acceptance criteria or the numerical performance results from these tests.
The primary "acceptance criterion" demonstrated in this 510(k) summary is that the additional perforation processing step does not adversely affect the safety or effectiveness of the device compared to the predicate. The performance in this context is deemed acceptable if this equivalence is maintained.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness are not adversely affected by the new processing step. | "The Xylos® Porous Surgical Mesh met the acceptance criteria. Therefore the device should perform as intended." |
| Continued substantial equivalence to the predicate device (Xylos Surgical Mesh, K081882). | "The additional perforation processing step... does not change the intended use nor affect the safety and effectiveness as compared to the Xylos Surgical Mesh previously cleared in K081882." |
| The device maintains the same indicated use, operating principle, basic design, physical properties, materials, and is manufactured identically except for the additional perforation. | The conclusion explicitly states these similarities as reasons for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "verification and validation tests" but does not specify the sample size used for these tests.
The data provenance is not explicitly detailed but would likely originate from laboratory and engineering testing conducted by Xylos Corporation, not from patient data (retrospective or prospective) in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. "Ground truth" established by human experts, especially for clinical endpoints, is generally associated with clinical trials or diagnostic device evaluations. This submission focuses on engineering and material characteristics to demonstrate substantial equivalence for a manufacturing process change.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Adjudication methods are relevant in clinical studies where expert consensus is needed to resolve discrepancies in diagnoses or assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this concept is not applicable as the device is a physical surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
For this specific submission, the "ground truth" would be established through engineering specifications, material science standards, and established test methodologies to evaluate the physical and mechanical properties of the mesh with the new perforation process. This likely includes:
- Mechanical Testing Results: Tensile strength, burst strength, pore size, etc.
- Biocompatibility Testing: According to ISO standards.
- Sterility Assurance: Validation of the gamma irradiation process.
It is not expert consensus, pathology, or outcomes data in a clinical sense for this particular submission, as it's not a de novo device or a major change requiring new clinical data.
8. The Sample Size for the Training Set
This concept is not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for the same reason as point 8.
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Xylos® Porous Surgical Mesh
2090880 2 Special 510(k) Premarket Application
Section 6: 510(k) Summary
MAY 27 2009
510(k) Summary
- Applicant: Xylos Corporation Joyce Elkins 838 Town Center Drive Langhorne, PA 19047 Xylos Corporation US Contact: Joyce Elkins 838 Town Center Drive Langhorne, PA 19047 Phone: 215-867-0220 ext. 642 Facsimile: 215-741-4804 joyce.elkins@xyloscorp.com Manufacturing/ Xylos Corporation Distribution Address: 838 Town Center Drive Langhorne, PA 19047
Establishment Registration Number: N/A
| Date submitted: | March 30, 2009(Section 6: 510(k) Summary was revised and re-submitted on May 18, 2009) |
|---|---|
| Proprietary Name: | Xylos® Porous Surgical Mesh |
| Common Name: | Surgical Mesh |
| Classification Status: | Class II |
| Product Codes: | FTM |
| Predicate Device: | Xylos Surgical Mesh (K081882) |
Device Description:
Xylos® Porous Surgical Mesh is a sterile, non-resorbable product composed of
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solvent-dehydrated, microbial-derived cellulose. The implantable unit is presented in sterile double-pouched packages for appropriate removal in preparation for surgery.
Processing: The microbial derived cellulose undergoes a strict quality controlled procedure that involves thorough cleaning and dehydration. The process leaves no harmful residue. Assurance of sterility is maintained with the validated dose range of gamma irradiation having no adverse effect on the biomechanical property of the device.
Indications for Use:
Xylos® Porous Surgical Mesh is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. Xylos® Porous Surgical Mesh is intended for one-time use.
Summary of Technological Characteristics:
The process modification to the Xylos Surgical Mesh since its previous clearance in K081882 is an additional processing step increasing porosity of the finished product. In addition, the name was changed to Xylos® Porous Surgical Mesh in this submission to distinguish it from Xylos Surgical Mesh. These modifications do not affect the safety or performance of the device and do not change the intended use of the Xylos Surgical Mesh.
Summary of Nonclinical Testing:
The verification and validation tests that were performed confirmed that the Xylos® Porous Surgical Mesh met the acceptance criteria. Therefore the device should perform as intended.
Substantial Equivalence Discussion:
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Xylos® Porous Surgical Mesh
As shown in the verification and validation testing, the additional perforation processing step of the Xylos® Porous Surgical Mesh does not change the intended use nor affect the safety and effectiveness as compared to the Xylos Surgical Mesh previously cleared in K081882.
Conclusion:
The modified Xylos® Porous Surgical Mesh has the following similarities to the Xylos Surgical Mesh previously cleared in K081882:
- . has the same indicated use,
- . has the same operating principle,
- incorporates the same basic device design and physical properties, .
- is manufactured identically except for an additional perforation process prior . to packaging, and
- incorporates the same materials. .
Therefore the modification to the Xylos® Porous Surgical Mesh can be found substantially equivalent to the Xylos Surgical Mesh cleared in K081882.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
MAY 27 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Xylos Corporation % Ms. Joyce Elkins Director RA/QA 838 Town Center Drive Langhorne, Pennsylvania 19047
Re: K090880
Trade/Device Name: Xylos® Porous Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 11, 2009 Received: May 13, 2009
Dear Ms. Elkins:
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.
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
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Page 2 - Ms. Joyce Elkins
(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 Dulo Vm D.Frios.
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Xylos® Porous Surgical Mesh
Special 510(k) Premarket Application
Section 5: Indications for Use Statement Indications for Use
510(k) Number (if known): KOGOSSO
Device Name:
:
Xylos® Porous Surgical Mesh
Indications for Use: This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 14 of 28
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dainl Krone by MXM
(Division Sign-Off Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number. Km09880
Page 1 of
Xylos Corporation March 30, 2009
§ 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.