(48 days)
Not Found
No
The description focuses on a mechanical suturing system and does not mention any computational or data-driven components indicative of AI/ML.
No
This device is a surgical suturing system used for soft tissue approximation, not a device intended for therapy or treatment of conditions.
No
The Anchor Band Suturing System is a surgical device used for soft tissue approximation (suturing), not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components: a non-absorbable braided surgical suture, a T-anchor, and a disposable delivery instrument with a needle. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Anchor Band Suturing System is a surgical device used to physically approximate soft tissue within the body during surgery. It's a tool for performing a surgical procedure, not for analyzing biological samples.
- Intended Use: The intended use is for "soft tissue approximation for procedures such as general and orthopedic surgery," which is a surgical application, not a diagnostic test.
The device description clearly indicates it's a physical tool for surgical repair, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Anchor Band Suturing 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 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility and bench testing were completed and support the safety and effectiveness of the Anchor Band Suturing System.
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.
ArthroCare Speedstitch (K042031), AutoSuture SurgiStitch (K972911), Teleflex Medical Polyester Nonabsorbable Suture (K021019)
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
Ko61386 1/1
:
Section 5—510(k) Summary
| Submitter: | Anulex Technologies, Inc.
5600 Rowland Road, Suite 280
Minnetonka, MN 55343 | JUL - 5 2006 |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Tim Miller
Vice President, Regulatory and Clinical Affairs
Anulex Technologies, Inc.
Direct: 952.224.4003
Fax: 952.224.4040
E-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 following
predicate 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-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. | |
| Indications for Use: | The Anchor Band Suturing System is indicated for use in soft tissue
approximation for procedures such as general and orthopedic
surgery. | |
| Functional and
Safety Testing: | Biocompatibility and bench testing were completed and support the
safety and effectiveness of the Anchor Band Suturing System. | |
| Conclusion: | The Anchor Band Suturing System is substantially equivalent in
intended use, technological characteristics, materials and
performance to the predicate devices. | |
| Anchor Band Suturing System
Anulex Technologies, Inc.
Confidential_ | Traditional 510(k) Premarket Notification
Page 18 | 5/17/2006 |
1
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
2
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
3
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