(74 days)
No
The device description and performance studies focus on the material properties and mechanical performance of the barbed suture, with no mention of AI or ML.
No
The device is a barbed suture used for soft tissue approximation, which is a structural implantation for surgical closure, not a device that provides therapy for a condition.
No
The device is a PDS Barbed Suture used for general soft tissue approximation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, absorbable suture made of polydioxanone with barbs and a needle, indicating it is a hardware 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 "general soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical suture with barbs and a needle, designed for physically joining tissues. This is a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
PDS Barbed Sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Product codes
NEW
Device Description
PDS Barbed Sutures (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . PDS Barbed Sutures will be available marketed with and without IRGACARE®+ MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 ug /m. PDS Barbed Sutures are dved with D&C Violet No. 2 (21CFR& 74.3602). PDS Barbed Sutures consists of an absorbable monofilament strand 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
general 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)
Non-clinical laboratory testing was performed demonstrating that the device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. In addition, bench, human cadaver and animal testing was provided showing that the device performed as intended and as claimed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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K113004
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510(k) Summary
DEC 2 0 2011
| Applicant: | Ethicon Inc.
P.O. Box 151
Route 22 West
Somerville, NJ 08876
USA
Phone: +1-918-218-2457
Fax: +1-918-218-2595 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 6, 2011 |
| Contact Person: | Peter Cecchini |
| Proprietary Device Name: | PDSTM Barbed Sutures |
| Common Device Name: | Suture, Surgical, Absorbable, Polydioxanone |
| Classification: | Absorbable Polydioxanone Surgical Suture, Class II, 21
CFR 878.4840, Product Code: NEW |
| Predicate Devices: | PDS IITM (polydioxanone) Suture (N18331)
PDSTM Plus Antibacterial (polydioxanone) Suture (K061037)
Quill™ Self-Retaining System (SRS) (K080985) |
| Manufacturer: | Ethicon Inc.
P.O. Box 151
Route 22 West Somerville, NJ 08876
USA |
Substantially Equivalent To:
ジ
PDS Barbed sutures are substantially equivalent to the following devices:
PDS II (polydioxanone) Suture (N18331) PDS Plus Antibacterial (polydioxanone) Suture (K061037) Quill™ Self-Retaining System (SRS) (K080985)
The V-Loc™ 180 device (K091087) is being referenced as a device with unidirectional barbs. Therefore, the technology of unidirectional barbs is not new.
1
113004
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Description of the Device Subject to Premarket Notification:
PDS Barbed Sutures (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . PDS Barbed Sutures will be available marketed with and without IRGACARE®+ MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 ug /m. PDS Barbed Sutures are dved with D&C Violet No. 2 (21CFR& 74.3602). PDS Barbed Sutures consists of an absorbable monofilament strand 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.
Indications for Use:
PDS Barbed Sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Performance Data:
Non-clinical laboratory testing was performed demonstrating that the device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. In addition, bench, human cadaver and animal testing was provided showing that the device performed as intended and as claimed.
Summary of Technological Characteristics of the New Device to Predicate Devices:
The new device has similar technological characteristics as the predicate devices. Like the currently marketed devices, PDS Barbed Suture is a sterile, monofilament synthetic absorbable suture intended for the approximation of soft tissue that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. Similar to the currently marketed PDS Plus suture. PDS Barbed Suture will also be available as a suture product with IRGACARE @+ MP. an antibacterial agent.
Conclusions:
PDS Barbed Sutures have the same intended use and similar indications for use as the predicate devices. The technological differences between PDS Barbed Sutures and the predicate devices raise no new questions of safety or effectiveness. PDS Barbed Sutures met all testing criteria to demonstrate substantial equivalence to the predicates devices.
* Trademark
IRGACARE®+ MP (triclosan) "Registered Trademark of BASF Group"
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 eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
DEC 2 0 2011
Ethicon. Inc. % Mr. Peter Cecchini P.O. Box 151 Route 22 West Somerville, New Jersey 08876
Re: K113004
Trade/Device Name: PDS™ Barbed Sutures Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture -Regulatory Class: Class II Product Code: NEW Dated: October 06, 2011 Received: October 07, 2011
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
3
Page 2 - Mr. Peter Cecchini
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) No (if known): K113004
Device Name: PDSTM Barbed Sutures
Indications for Use:
PDS Barbed Sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Prescription Use V (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)
Daniel Krone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113004