(54 days)
Not Found
No
The summary describes a surgical suture with buttressing components and does not mention any AI/ML terms or functionalities.
Yes.
The device is a surgical suture used for soft tissue approximation and ligation, which is a therapeutic intervention.
No
The device is described as an absorbable surgical suture with buttressing components, used for soft tissue approximation and ligation. Its function is to physically join or tie tissues, not to diagnose conditions.
No
The device description clearly states it is a suture supplied with integral polymer components, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation". This describes a surgical procedure performed directly on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "synthetic absorbable suture supplied with two integral acetal polymer buttressing components". This is a physical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVDs are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures.
Product codes
GAM
Device Description
Dekna-lok™ is Deknatel® Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture supplied with two integral acetal polymer buttressing components designed to spread the pressure of the suture across tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
All materials used in the fabrication of Dekna-lok™ were evaluated through the recognized consensus standards as outlined in USP 28:2005 Absorbable Surgical Sutures and biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Verification and Validation testing was performed according to the risk analysis. The design and materials were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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
060801
Image /page/0/Picture/1 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with a stylized "T" that resembles a right angle. Below "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is in black and white.
page 1/2
v + 7 0006
Teleflex Medical 2917 Weck Drive RTP. NC 27709 USA 919-544-8000 Phone: Fax: 919-361-4061 www.teleflex.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dekna-lok™
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-361-8000 Fax: 919-361-4061
B. Contact Person
Kimberly Edgerton Regulatory Affairs Specialist
C. Date Prepared
March 23, 2006
D. Device Name
Trade Name: Dekna-lok™
Common Name: Polyglycolytic Acid Surgical Suture
Classification Name: Absorbable poly(glycolide/l-lactide) surgical suture
Product Code: GAM
Regulation Number: 21 CFR 878.4493
Class: Il
E. Device Description
Dekna-lok™ is Deknatel® Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture supplied with two integral acetal polymer buttressing components designed to spread the pressure of the suture across tissue.
A Division of Teleflex Incorporated
BERATE | HUDSON RCI | KMedic | Filling | MBR-EMC | RUSCH | WECK
1
F. Intended Use
Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures.
G. Substantial Equivalence
Dekna-lok™ is substantially equivalent to Teleflex Medical's Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture (K992088) with respect to functionality, design, and intended use and performance characteristics.
H. Summary of Testing
All materials used in the fabrication of Dekna-lok™ were evaluated through the recognized consensus standards as outlined in USP 28:2005 Absorbable Surgical Sutures and biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Verification and Validation testing was performed according to the risk analysis. The design and materials were found to be acceptable for the intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2006
Teleflex Medical % Ms. Kimberly Edgerton Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K060801
Trade/Device Name: Dekna-lok™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: March 23, 2006 Received: March 24, 2006
Dear Ms. Edgerton:
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
3
Page 2 - Ms. Kimberly Edgerton
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Hubert Werner ws
Mark N. Melkerson Director Division of General, Restorative and.Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and white, with the word "Teleflex" in a bold, sans-serif font. Below the word "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is simple and modern.
Teleflex Medical 2917 Weck Drive RTP, NC 27709 USA Phone: 919-544-8000 Fax:919-361-4061 www.teleflex.com
、中国人民共和国际
Indications for Use
510(k) Number (if known):
Device Name: Dekna-lok TM
Indications For Use:
Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures.
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 (Of
Page 1 of 1
uation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K060801
A Division of Teleflex Incorporated
| HUDSON RC/ | KMedic | Filling | PLAR-EUC | RUSCH | WECK