(24 days)
The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
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.
The provided text is related to a 510(k) submission for the Xclose™ Tissue Repair System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document states:
"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."
This indicates that tensile testing was performed to verify compliance with USP suture requirements. While this is a verification activity, the document does not provide the specific "acceptance criteria" for tensile strength (e.g., minimum tensile strength in Newtons) or the "reported device performance" against those criteria in a tabular format. It also doesn't detail the study design for this tensile testing (e.g., sample size, methodology).
Therefore, based solely on the provided text, I cannot complete most of the requested fields. I can only infer that "USP suture requirements" were the general acceptance criteria for tensile strength, and "tensile testing was performed to confirm compliance" is the study description, but without specifics.
Here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: USP suture requirements (for tensile strength).
- Reported Device Performance: "Tensile testing was performed to confirm compliance to USP suture requirements." (No specific numerical performance is reported in this document beyond compliance).
| Acceptance Criteria (for Tensile Strength) | Reported Device Performance |
|---|---|
| Compliance with USP suture requirements | Confirmed compliance |
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: Not specified.
- Data provenance: Not specified (likely internal testing by Anulex Technologies, Inc. based in Minnetonka, MN, USA, but this is not explicitly stated as the origin of data). Not specified if retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a physical device testing (tensile strength) and not an interpretive task requiring expert ground truth in the medical imaging or diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of physical device testing.
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
- No. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for tensile testing would be the measured tensile strength compared against the specified USP requirements. It's an objective measurement, not an expert consensus or pathology.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable.
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SEP 1 2006
Section 5 – 510(k) Summary
| Applicant: | Anulex Technologies, Inc.5600 Rowland Road, Suite 280Minnetonka, MN 55343 |
|---|---|
| Contact Person: | Tim MillerVice President, Regulatory and Clinical AffairsTelephone: 952.224.4003Fax: 952.224.4040e-mail: tmiller@anulex.com |
| Date Prepared: | August 7, 2006 |
| Trade Name: | Xclose™ Tissue Repair System |
| Product Classificationand Code: | 21 CFR §878.5000Class: IIProduct 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 sutureloop is used to facilitate tightening, drawing the 3-0 sutureassemblies together, thereby re-approximating the tissue. Thedevice construct is composed of polyethylene terephthalate (PET)and conforms to USP requirements. The construct is providedsterile and preloaded on a disposable delivery instrument. |
| Intended Use: | The Xclose™ Tissue Repair System is indicated for use in softtissue approximation for procedures such as general and orthopedicsurgery. |
| Summary ofTechnologicalCharacteristics: | The modifications to the Anchor Band Suturing System wereconducted in accordance with the Anulex Design Control System.Accordingly, the risk analysis identified necessary designverification and validation activities. As a result of this analysis,tensile testing was performed to confirm compliance to USP suturerequirements. |
| Conclusion: | The Xclose™ Tissue Repair System is substantially equivalent tothe Anchor Band Suturing System in regards to the indications foruse, the basic operating principle, materials, sterilization, packagingand 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
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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
§ 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.