(105 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical suture, with no mention of AI or ML technologies.
No
A therapeutic device intends to treat or cure a condition. This device, a surgical suture, is used for "general soft tissue approximation" to close wounds, which is a supportive role in the healing process rather than a direct treatment or cure.
No
Explanation: The device is indicated for "general soft tissue approximation," meaning it is used for surgical closing and holding tissues together, not for diagnosing conditions.
No
The device description clearly indicates it is a physical medical device made of polyester with barbs and a needle, intended for surgical tissue approximation. It is 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 "general soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical suture with barbs and a needle. This is a physical tool used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical tool used for physical repair of tissue.
N/A
Intended Use / Indications for Use
STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Product codes
NEW
Device Description
STRATAFIX™ Symmetric PDS™ Plus Devices are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . STRATAFIX™ Symmetric PDS™ Plus Devices will contain IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg /m. STRATAFIX™ Symmetric PDS™ Plus Devices are dyed with D&C Violet No. 2 (21CFR§ 74.3602) at a maximum of 0.15% w/w. STRATAFIX™ Symmetric PDS™ Plus Devices consists of an absorbable monofilament thread with unidirectional barbs, with a surgical needle attached at one end and a fixation tab at the other. The barbs and fixation tab design allow for tissue approximation without the need to tie surgical knots.
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)
Performance testing to demonstrate equivalence was conducted using performance testing-bench models and performance testing-animal models. Testing results are summarized as follows.
- Performance Testing-Bench Models:
- Tissue Holding Strength The results of the tissue holding testing verify the integrity and adequacy of the STRATAFIX Symmetric PDS PLUS device performance in a simulated wound closure and support substantial equivalence to the predicate device.
- Initiation Strength- The results of the initiation strength testing verify the integrity and adequacy of the device during application at the proximal end of a simulated wound closure compared to the predicate device.
- Cyclic Compression- The results of the cyclic compression testing verify the integrity and adequacy of the device when subjected to a cyclic compressive load on a simulated wound closure compared to the predicate device.
- Usability Study- The results of this study were used to confirm the usability of the device and to refine the Instructions for Use.
- Performance Testing-Animal Models:
- Preclinical Survival Study The results of the survival study demonstrated substantial equivalence in wound approximation and healing to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized image of an eagle. The eagle is depicted with three overlapping profiles, suggesting a sense of community and collaboration. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2014
Ethicon Incorporated Mr. Peter Cecchini Fellow, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
Re: K141776
Trade/Device Name: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: July 22, 2014 Received: July 23, 2014
Dear Mr. Cecchini:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Binita S. Ashar -S 2014.10.15 21:27:47 -04'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141776
Device Name
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device
Indications for Use (Describe)
STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below:
| Device Common Name: | Suture, Surgical, Absorbable, Polydioxanone |
|---|---|
| Device Proprietary Name: | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue |
| Control Device | |
| Submitter: | Ethicon Inc. |
| P.O. Box 151 | |
| Route 22 West | |
| Somerville, NJ 08876 | |
| USA | |
| Contact: | Peter Cecchini |
| Fellow, Regulatory Affairs | |
| Phone: 908-218-2457 | |
| Fax: 908-218-2595 | |
| pcecchin@its.jnj.com | |
| Date Prepared: | September 15, 2014 |
| Classification Regulation: | Absorbable Polydioxanone Surgical Suture, Class II, 21 |
| CFR 878.4840 | |
| Panel: | General and Plastic Surgery Devices |
| Product Code: | NEW |
| Predicate Device: | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue |
| Control Device |
Indication for Use:
STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
4
Device Description:
STRATAFIX Symmetric PDS Plus Devices are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . STRATAFIX Symmetric PDS Plus Devices will contain IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg /m. STRATAFIX Symmetric PDS Plus Devices are dyed with D&C Violet No. 2 (21CFR§ 74.3602) at a maximum of 0.15% w/w. STRATAFIX Symmetric PDS Plus Devices consists of an absorbable monofilament thread with unidirectional barbs, with a surgical needle attached at one end and a fixation tab at the other. The barbs and fixation tab design allow for tissue approximation without the need to tie surgical knots.
Performance Data:
Performance testing to demonstrate equivalence was conducted using performance testingbench models and performance testing-animal models. Testing results are summarized as follows.
- . Performance Testing-Bench Models:
-
- Tissue Holding Strength The results of the tissue holding testing verify the integrity and adequacy of the STRATAFIX Symmetric PDS PLUS device performance in a simulated wound closure and support substantial equivalence to the predicate device.
-
- Initiation Strength- The results of the initiation strength testing verify the integrity and adequacy of the device during application at the proximal end of a simulated wound closure compared to the predicate device.
-
- Cyclic Compression- The results of the cyclic compression testing verify the integrity and adequacy of the device when subjected to a cyclic compressive load on a simulated wound closure compared to the predicate device.
-
- Usability Study- The results of this study were used to confirm the usability of the device and to refine the Instructions for Use.
-
- Performance Testing-Animal Models:
-
- Preclinical Survival Study The results of the survival study demonstrated substantial equivalence in wound approximation and healing to the predicate device.
-
5
Substantial Equivalence:
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices has the same intended use, design, materials and technological characteristics as the predicate device. Modification to the labeling is the only difference from the predicate device.
Conclusions:
The STRATAFIX Symmetric PDS Plus Device has the same intended use and identical indications for use as the predicate device. In comparison, the technological characteristics are the same. The differences in labeling (IFU) between the proposed device and the predicate device raise no new questions of safety or effectiveness. STRATAFIX Symmetric PDS PLUS Devices met all testing criteria to demonstrate substantial equivalence to the predicate device.
- Trademark IRGACARE®* MP (triclosan) "Registered Trademark of BASF Group"