(24 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of the suture system, with no mention of AI or ML.
No.
The device is a surgical system used for soft tissue approximation, which aids in healing rather than directly treating a disease or condition itself.
No
This device is described as a tissue repair system that re-approximates tissue using sutures and anchors. Its indicated use is for soft tissue approximation in surgical procedures, which is a therapeutic function, not a diagnostic one. No part of the description mentions identifying a disease, condition, or its characteristics.
No
The device description clearly outlines physical components (suture, T-anchor assemblies, delivery instrument) and materials (polyethylene terephthalate), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the Xclose™ Tissue Repair System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue approximation for procedures such as general and orthopedic surgery." This describes a surgical device used in vivo (within the body) to repair tissue.
- Device Description: The description details a surgical suture and anchor system designed to physically bring tissue together. This is a mechanical device used during surgery.
- Lack of IVD Characteristics: An IVD is a device used in vitro (outside the body) to examine specimens (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The Xclose™ system does not perform any such analysis of biological specimens.
The Xclose™ Tissue Repair System is a surgical device used for tissue repair, not a diagnostic test performed on samples outside the body.
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
GAT
Device Description
The Xclose™ Tissue Repair System consists of two (2) non-absorbable braided surgical 3-0 suture and T-anchor assemblies, connected together with a loop of green 2-0 suture. The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture assemblies together, thereby re-approximating the tissue. The device construct is composed of polyethylene terephthalate (PET) and conforms 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
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
The modifications to the Anchor Band Suturing 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 2006
Section 5 – 510(k) Summary
| Applicant: | Anulex Technologies, Inc.
5600 Rowland Road, Suite 280
Minnetonka, MN 55343 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Miller
Vice President, Regulatory and Clinical Affairs
Telephone: 952.224.4003
Fax: 952.224.4040
e-mail: tmiller@anulex.com |
| Date Prepared: | August 7, 2006 |
| Trade Name: | Xclose™ Tissue Repair System |
| Product Classification
and Code: | 21 CFR §878.5000
Class: II
Product Code: GAT |
| Predicate Device: | K061386 - Anulex Anchor Band Suturing System |
| Device Description: | The Xclose™ Tissue Repair System consists of two (2) non-
absorbable braided surgical 3-0 suture and T-anchor assemblies,
connected together with a loop of green 2-0 suture. The 2-0 suture
loop is used to facilitate tightening, drawing the 3-0 suture
assemblies together, thereby re-approximating the tissue. The
device construct is composed of polyethylene terephthalate (PET)
and conforms to USP requirements. The construct is provided
sterile and preloaded on a disposable delivery instrument. |
| Intended Use: | The Xclose™ Tissue Repair System is indicated for use in soft
tissue approximation for procedures such as general and orthopedic
surgery. |
| Summary of
Technological
Characteristics: | The modifications to the Anchor Band Suturing 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. |
| Conclusion: | The Xclose™ Tissue Repair System is substantially equivalent to
the Anchor Band Suturing System in regards to the indications for
use, the basic operating principle, materials, sterilization, packaging
and shelf-life. |
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Image /page/1/Picture/2 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized representation of a human figure with three wavy lines forming the body and head. The text "DEPARTMENT OF HEALTH AS..." is partially visible, wrapping around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2006
Anulex Technologies, Inc. % Mr. Tim Miller VP Regulatory and Clinical Affairs 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
Re: K062307
Trade/Device Name: Xclose™ Tissue Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: August 7, 2006 Received: August 8, 2006
Dear Mr. Miller:
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA
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Page 2 - Mr. Tim Miller
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4 - Indications For Use Statement
510(k) Number (if known): Ko CQ 30 7
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)
Division Sign-Off
Division of General, Restoral : and Neurological Devices
510(k) Number L062307
CONFIDENTIAL