(29 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of the suture and anchor system, with no mention of AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used for soft tissue approximation, which is a surgical procedure to repair tissue, rather than treating a disease or condition itself.
No
The device is described as a "Tissue Repair System" used for "soft tissue approximation," which indicates a therapeutic or surgical function, not a diagnostic one. There is no mention of it gathering information for diagnosis.
No
The device description clearly outlines physical components (suture, T-anchor, delivery instrument) and performance testing related to these physical components (tensile testing). There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation for procedures such as general and orthopedic surgery." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from a patient.
- Device Description: The device is a surgical system involving sutures and anchors for tissue repair. This is a physical device used in surgery, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The modified Xclose™ Tissue Repair System consists of two (2) non-absorbable braided surgical 3-0 suture (Ultra High Molecular Weight Polyethylene, UHMWPE) and T-anchor (polyethylene terephthalate, PET) assemblies, connected together with a loop of green 2-0 suture (PET). The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture/anchor assemblies together, thereby re-approximating the tissue. The suture components conform to USP requirements The construct is provided sterile and preloaded on a disposable delivery instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The modifications to the Xclose Tissue Repair System were conducted in accordance with the Anulex Design Control System. Accordingly, the risk analysis identified necessary design verification and validation activities. As a result of this analysis, tensile testing was performed to confirm compliance to USP suture requirements.
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.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
Section 5 - 510(k) Summary
Anulex Technologies, Inc. Applicant: JUN 1 2 2009 5600 Rowland Road, Suite 280 Minnetonka. MN 55343 Rachel Kennedy Contact Person: Senior Regulatory Affairs Manager Telephone: 952.224.4034 Fax: 952.224.4040 e-mail: rkennedy(@anulex.com May 13, 2009 Date Prepared: Xclose™ Tissue Repair System Trade Name: 21 CFR §878.5000 Product Classification and Code: Class: II Product Code: GAT Predicate Device: K062307 - Xclose Tissue Repair System The modified Xclose™ Tissue Repair System consists of two (2) Device Description: non-absorbable braided surgical 3-0 suture (Ultra High Molecular Weight Polyethylene, UHMWPE) and T-anchor (polyethylene terephthalate, PET) assemblies, connected together with a loop of green 2-0 suture (PET). The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture/anchor assemblies together, thereby re-approximating the tissue. The suture components conform to USP requirements The construct is provided sterile and preloaded on a disposable delivery instrument. The Xclose™ Tissue Repair System is indicated for use in soft Intended Use: tissue approximation for procedures such as general and orthopedic surgery. The modifications to the Xclose Tissue Repair System were Summary of conducted in accordance with the Anulex Design Control System. Technological Accordingly, the risk analysis identified necessary design Characteristics: verification and validation activities. As a result of this analysis, tensile testing was performed to confirm compliance to USP suture requirements. The modified Xclose™ Tissue Repair System is substantially Conclusion: equivalent to the original Xclose Tissue Repair System in regards to the indications for use, technology and the basic operating principle.
CONFIDENTIAL
Special 510{k} for the Anulex Xclose Tissue Repair System
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with three prominent wing strokes, conveying a sense of strength and national identity. The overall design is simple, yet recognizable, representing the HHS's role in public health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2009
Anulex Technologies, Incorporated % Ms. Rachel Kennedy Senior Regulatory Affairs Manager 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
Re: K091432
Trade/Device Name: Xclose™ Tissue Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(ethylene terephthalate) Surgical Suture Regulatory Class: II Product Code: GAT Dated: May 13, 2009 Received: May 14, 2009
Dear Ms. Kennedy:
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 agninst 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
2
Page 2-Ms. Rachel Kennedy
practice requirements as set forth in the quality systems (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/cdrl/industry/support/index.html.
Sincerely yours
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4 - Indications For Use Statement
510(k) Number (if known): K
Device Name: Xclose™ Tissue Repair System
Indications for Use:
The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
Prescription Use X (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 Krone
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091432