(29 days)
The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
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.
The provided text describes a 510(k) submission for the Anulex Xclose™ Tissue Repair System. This is a medical device for soft tissue approximation, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance evaluation (such as sample size for test/training sets, ground truth establishment for AI, MRMC studies, etc.) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device (K062307 - Xclose Tissue Repair System) through design control processes and specific testing, primarily tensile testing to confirm compliance with USP suture requirements.
Here's an attempt to answer the applicable questions based on the provided text, while clearly stating when information is not present or relevant to this type of device submission.
Acceptance Criteria and Device Performance for Xclose™ Tissue Repair System
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Conformance | Suture components conform to USP requirements. | "The suture components conform to USP requirements." (Implied successful conformance) |
| Mechanical Strength | Tensile strength in compliance with USP suture requirements. | "tensile testing was performed to confirm compliance to USP suture requirements." (Implied successful compliance) |
| Functionality | Facilitates tightening, drawing 3-0 suture/anchor assemblies together, re-approximating tissue. | "The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture/anchor assemblies together, thereby re-approximating the tissue." (Description of intended function, implied to be met for substantial equivalence) |
| Biocompatibility | (Not explicitly stated, but assumed to be met for predicate device and new materials, if any, as part of substantial equivalence for non-absorbable sutures/anchors). | Not explicitly detailed in this summary. |
| Sterility | Provided sterile. | "The construct is provided sterile..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The statement "tensile testing was performed" does not include details on the number of samples tested.
- Data Provenance: Not specified, but generally, such testing for regulatory submissions is conducted in-house by the manufacturer (Anulex Technologies, Inc. in Minnetonka, MN, USA) or by a contracted testing lab. This would be prospective testing as part of design verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the device is not an AI/ML diagnostic or predictive tool, but rather a physical surgical device. The "ground truth" for its performance is objective mechanical testing (tensile strength, material properties) and verification of its physical function. There are no "experts" establishing a "ground truth" in the way a clinical image might be adjudicated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This device does not involve subjective assessment or interpretation of results by multiple experts that would require an adjudication method. Performance is measured against engineering specifications and USP standards.
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 is a physical surgical device, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the performance of diagnostic devices, especially those involving human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device does not contain an algorithm; it is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to established engineering standards and material specifications, specifically "USP suture requirements." Performance is measured against these objective, pre-defined criteria. There is no biological "ground truth" (like pathology or outcomes data) being directly evaluated in this specific submission summary for the device modifications.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply. The development of the device itself would follow established engineering design and manufacturing principles, with "ground truth" for its individual components being their adherence to material and mechanical specifications.
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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
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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
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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
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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
§ 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.