(48 days)
The Anchor Band Suturing System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
The Anchor Band Suturing System consists of a non-absorbable braided surgical suture and T-anchor, both of which are composed of polyethylene terephthalate (PET). The suture, which conforms to U.S.P. 2-0, and T-anchor assembly are provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchor in the sub-layer of the tissue.
The provided text describes a 510(k) premarket notification for the "Anchor Band Suturing System." This submission focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a performance study with detailed acceptance criteria of the type typically seen for new AI/algorithm-driven devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not present in the provided document. The submission relies on biocompatibility and bench testing to support safety and effectiveness and concludes substantial equivalence based on intended use, technological characteristics, materials, and performance compared to predicate devices.
Here's a breakdown of what can be extracted based on the provided text, and what information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific performance metrics or thresholds. | "Biocompatibility and bench testing were completed and support the safety and effectiveness of the Anchor Band Suturing System." (This is a general statement, not specific performance data.) |
| Substantial equivalence to predicate devices in intended use, technological characteristics, materials, and performance. | "The Anchor Band Suturing System is substantially equivalent in intended use, technological characteristics, materials and performance to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Not available. The document mentions "bench testing" but does not provide details on sample sizes or data provenance for any specific performance tests. This submission is for a medical device (suturing system), not a software/AI device, and therefore the concept of a "test set" in the context of an algorithm's performance isn't applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not available. This information is relevant for studies involving human interpretation or consensus, typically for AI or diagnostic devices. The submission for the Anchor Band Suturing System does not describe such a study.
4. Adjudication method for the test set
- Not applicable/Not available. Similar to point 3, this is not relevant for the type of device and submission described.
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. An MRMC study is not mentioned as this device is not an AI/software-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used
- Not applicable/Not available. The submission focuses on physical characteristics, biocompatibility, and mechanical performance through bench testing, not on a "ground truth" for diagnostic accuracy.
8. The sample size for the training set
- Not applicable/Not available. The concept of a "training set" applies to machine learning algorithms, which are not relevant to this device.
9. How the ground truth for the training set was established
- Not applicable/Not available. The concept of a "training set" and "ground truth" in this context does not apply to the Anchor Band Suturing System.
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Ko61386 1/1
:
Section 5—510(k) Summary
| Submitter: | Anulex Technologies, Inc.5600 Rowland Road, Suite 280Minnetonka, MN 55343 | JUL - 5 2006 |
|---|---|---|
| Contact Person: | Tim MillerVice President, Regulatory and Clinical AffairsAnulex Technologies, Inc.Direct: 952.224.4003Fax: 952.224.4040E-Mail: tmiller@anulex.com | |
| Date Prepared: | May 17, 2006 | |
| Trade Name: | Anchor Band Suturing System | |
| Classification: | II | |
| Product Code: | GAT | |
| 21 CFR 878.5000 | ||
| Predicate Device(s): | The subject device is substantially equivalent to the followingpredicate devices: | |
| ArthroCare Speedstitch(K042031 cleared October 19, 2004)AutoSuture SurgiStitch(K972911 cleared April 25, 1998)Teleflex Medical Polyester Nonabsorbable Suture(K021019 cleared June 18, 2002) | ||
| Device Description: | The Anchor Band Suturing System consists of a non-absorbablebraided surgical suture and T-anchor, both of which are composedof polyethylene terephthalate (PET). The suture, which conformsto U.S.P. 2-0, and T-anchor assembly are provided sterile andpreloaded on a disposable delivery instrument. The instrument'sneedle facilitates placement of the suture by positioning the T-anchor in the sub-layer of the tissue. | |
| Indications for Use: | The Anchor Band Suturing System is indicated for use in soft tissueapproximation for procedures such as general and orthopedicsurgery. | |
| Functional andSafety Testing: | Biocompatibility and bench testing were completed and support thesafety and effectiveness of the Anchor Band Suturing System. | |
| Conclusion: | The Anchor Band Suturing System is substantially equivalent inintended use, technological characteristics, materials andperformance to the predicate devices. | |
| Anchor Band Suturing SystemAnulex Technologies, Inc.Confidential_ | Traditional 510(k) Premarket NotificationPage 18 | 5/17/2006 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2006
Anulex Technologies, Inc. % Mr. Tim Miller Vice President, Regulatory and Clinical Affairs 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
Re: K061386
Trade/Device Name: Anchor Band Suturing System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: May 17, 2006 Received:, May 18, 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. EDA way 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 not incl net or any Federal statutes and regulations administered by other Federal agencies. Youndation 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
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Page 2 - Mr. Tim Miller
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 100-1050. This letter will allow you to begin marketing your device as described in your Section 10(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, perrorts 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 von ; } pos "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon vibtain other general information on your responsibilities under the Act from the Division of Voall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/i03e20ml.
Sincerely yours.
Huker Lernerius
Radiological Health
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and
Enclosure
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Section 4 - Indications for Use Statement
Device Name: Anchor Band Suturing System
Indications for Use:
The Anchor Band Suturing 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulen Lemmer
Division of General, Restorative, and Neurological Devices
510(k) Number K061386
Anchor Band Suturing System Anulex Technologies, Inc. Confidential
Traditional 510(k) Premarket Notification
Page 17
5/17/2006
§ 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.