(9 days)
Not Found
No
The 510(k) summary describes a surgical mesh, a physical implantable device, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a surgical mesh intended for soft tissue reinforcement and reconstruction, which is a structural or supportive function rather than a therapeutic one (i.e., treating or curing a disease or medical condition).
No
Explanation: The device description states it is a surgical mesh intended for tissue reinforcement and repair, not for diagnosing conditions.
No
The device description clearly describes a physical surgical mesh intended for implantation, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for implantation to reinforce soft tissue. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a surgical mesh that functions as a non-absorbable biomaterial for tissue reinforcement and fixation. This is consistent with a surgically implanted device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used to repair or reinforce tissue directly within the body.
N/A
Intended Use / 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."
Product codes
FTM
Device Description
"The XYLOS Surgical Mesh will function as a non-absorbable surgical biomaterial that enables rapid fixation by tissue incorporation. The device incorporates a microporous structure that ensures early fixation to host tissue with minimal foreign body response. The double-pouched, sterile, single use unit is designed to allow maintenance of the sterile field prior to implantation. The material is conducive to size with sterile surgical instruments to avoid excessive tension on the suture line."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic wall, pelvic floor
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)
"Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10."
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.
XYLOS Surgical Mesh (K023237)
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
Section 6: 510(k) Summary
JUL 1 1 2008
510(k) Summary
| Applicant: | Xylos Corporation
Gerry Ann Oster
838 Town Center Drive
Langhorne, PA 19047 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| US Contact: | Xylos Corporation
Gerry Ann Oster
838 Town Center Drive
Langhorne, PA 19047
Phone: 215-867-0220 ext. 611
Facsimile: 215-741-4804
gerry.oster@xyloscorp.com |
| Manufacturing/
Distribution Address: | Xylos Corporation
838 Town Center Drive
Langhorne, PA 19047 |
| Establishment Registration Number: | N/A |
| Date submitted: | 02JULY2008 |
| Proprietary Name: | XYLOS Surgical Mesh |
| Common Name: | Surgical Mesh |
| Classification Status: | Class II |
| Product Codes: | FTM |
| Predicate Device: | XYLOS Surgical Mesh (K023237) |
Device Description:
The XYLOS Surgical Mesh will function as a non-absorbable surgical biomaterial that enables rapid fixation by tissue incorporation. The device incorporates a microporous structure that ensures early fixation to host tissue with minimal foreign body response. The
1
XYLOS Surgical Mesh ---------------------------------------------------------------------------------------
double-pouched, sterile, single use unit is designed to allow maintenance of the sterile field prior to implantation. The material is conducive to size with sterile surgical instruments to avoid excessive tension on the suture line.
Indication 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.
Summary of Technological Characteristics:
The modifications to the XYLOS Surgical Mesh since its previous clearance in K023237 include a change to the processing conditions that has led to slight changes in certain physical properties of the mesh as well as a change to rehydrate the mesh before packaging with a wetting solution. These minor differences 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:
Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10.
Substantial Equivalence Discussion:
The changes to the chemical processing and the slight change in physical properties of the XYLOS Surgical Mesh do not change the intended use nor do they affect the safety and effectiveness as compared to the XYLOS Surgical Mesh previously cleared in K023237.
Conclusion:
The modified XYLOS Surgical Mesh has the following similarities to the XYLOS Surgical Mesh previously cleared in K023237:
- . has the same indicated use.
- � uses the same operating principle,
- � incorporates the same basic device design and physical properties,
- . incorporates the same materials.
2
XYLOS Surgical Mesh
Therefore the modification to the XYLOS Surgical Mesh can be found substantially equivalent to the XYLOS Surgical Mesh cleared in K023237.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Xylos Corporation % Ms. Gerry Ann Oster 838 Town Center Drive Langhorne, Pennsylvania 19047
JUL 11 2008
Re: K081882
Trade/Device Name: XYLOS Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: July 2, 2008 Received: July 3, 2008
Dear Ms. Oster:
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.
4
Page 2 – Ms. Gerry Ann Oster
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 5: Indications for Use Statement
Indications for Use
510(k) Number (if known): K081882
XYLOS Surgical Mesh Device Name:
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 _____________________________________________________________________________________________________________________________________________________________ (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)
(Division_Sign-Off) Division of General, Restorative, and Neurosogical Devices
510(k) Number L081882
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
XYLOS Corporation July, 2008
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