(204 days)
Not Found
No
The 510(k) summary describes a surgical suture with an antibacterial coating. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The performance studies focus on the antibacterial efficacy of the suture.
No.
A surgical suture, even if antibacterial, is not considered a therapeutic device as its primary function is mechanical closure and support of tissue, not the treatment of a disease or condition. Its antibacterial property is preventative/supplementary, not therapeutic.
No
The device is a surgical suture used for tissue approximation and support, not for diagnosing conditions or diseases.
No
The device description clearly indicates it is a physical suture made from polyester, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that this is a surgical suture intended for direct implantation into the body for tissue approximation.
- The performance studies are in vitro, but they are testing the antibacterial properties of the suture itself, not analyzing a human specimen to diagnose a condition. The "in vitro" aspect refers to the testing environment (outside of a living organism), not the type of diagnostic information being gathered.
- The key metrics are related to bacterial colonization on the suture, not diagnostic values from a patient sample.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
PDS™ Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDS™ Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
PDS™ Plus Antibacterial Suture is a sterile synthetic absorbable monofilament suture made from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4H6O3)n.
PDS™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2
PDS™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 ug/m.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, pediatric cardiovascular tissue, adult cardiovascular and neurological 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)
The subject device has the same technological characteristics as the predicate device. Like the currently marketed predicate device, it is a sterile, monofilament synthetic absorbable suture that complies with the requirements of the United States Pharmacopoeia (USP) for absorbable surgical sutures except for a slight oversize in diameter.
Like the currently marketed predicate device, PDS™ Plus Antibacterial Suture, the subject device will continue to be available as a suture product with Irgacare®† MP (triclosan), an antibacterial agent.
Using in vitro studies. Ireacare®† MP (triclosan) in PDS™ Plus Antibacterial Suture has been shown to inhibit colonization of the suture by Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-resistant S. aureus, Methicillin-resistant S. epidermidis, Escherichia coli, and Klebsiella pneumoniae, and Enterobacter cloacae.
The Performance/Actions section in the Instructions for Use of the subject device was revised to include in-vitro effectiveness against one an additional microorganism, Enterobacter cloacae. This was demonstrated through quantitative in-vitro attachment assay which demonstrates efficacy of the antibacterial suture surface to prevent bacterial colonization against Enterobacter cloacae. The efficacy is reported as a log difference in attached bacteria between treated and untreated suture controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
efficacy is reported as a log difference in attached bacteria between treated and untreated suture controls.
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.
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
§ 878.4840 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 22, 2022
Ethicon, Inc. Marife Sevek Sr. Regulatory Affairs Program Lead 1000 Route 202 Raritan, New Jersey 08869
Re: K212380
Trade/Device Name: PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: December 17, 2021 Received: December 20, 2021
Dear Marife Sevek:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212380
Device Name
PDSTM Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
Indications for Use (Describe)
PDS™ Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDS™ Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
ption 300 (Part 21 CFR 1301, Subpart B)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
ETHICOL N, INC.
Johnson company a
510(k) Summary
| Submitter: | Ethicon, Inc., a Johnson & Johnson Company
1000 Route 202
Raritan, New Jersey 08869
USA |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marife Sevek
Sr. Regulatory Affairs Program Lead
Phone: (908) 808-6602
Fax: (908) 927-7230
E-mail: msevek1@its.jnj.com |
| Date Prepared: | February 14, 2022 |
| Device Trade Name: | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic
Absorbable Surgical Suture |
| Device Common Name: | Suture, Surgical, Absorbable, Polydioxanone |
| Class: | II |
| Classification Name: | Absorbable Polydioxanone Surgical Suture
(21 CFR 878.4840) |
| Product Code: | NEW |
Predicate Device:
| Predicate Device | 510(k) Number |
|---|---|
| PDSTM Plus Antibacterial (Polydioxanone) | |
| Sterile Synthetic Absorbable Surgical Suture | K061037 |
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Device Description:
PDS™ Plus Antibacterial Suture is a sterile synthetic absorbable monofilament suture made from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4H6O3)n.
PDS™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2
PDS™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 ug/m.
Indications for Use:
PDS™ Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDS™ Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.
Summary of Technological Characteristics and Performance:
The subject device has the same technological characteristics as the predicate device. Like the currently marketed predicate device, it is a sterile, monofilament synthetic absorbable suture that complies with the requirements of the United States Pharmacopoeia (USP) for absorbable surgical sutures except for a slight oversize in diameter.
Like the currently marketed predicate device. PDS™ Plus Antibacterial Suture, the subject device will continue to be available as a suture product with Irgacare®† MP (triclosan), an antibacterial agent.
Using in vitro studies. Ireacare@t MP (triclosan) in PDS™ Plus Antibacterial Suture has been shown to inhibit colonization of the suture by Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-resistant S. aureus, Methicillin-resistant S. epidermidis, Escherichia coli, and Klebsiella pneumoniae, and Enterobacter cloacae.
Substantial Equivalence:
The subject device is identical to the predicate device in terms of material, construction, specification, manufacturing, and sterilization process. The subject device and currently marketed device differ only in the labeling (Instruction for Use and device box). The Performance/Actions section in the Instructions for Use of the subject device was revised to include in-vitro effectiveness against one an additional microorganism, Enterobacter cloacae. This was demonstrated through quantitative in-vitro attachment assay which demonstrates efficacy of the antibacterial suture surface to prevent bacterial colonization against Enterobacter cloacae. The efficacy is reported as a log difference in attached bacteria between treated and untreated suture controls. Additionally, the Indication statement in the Instructions for Use of the subject device were revised to remove ophthalmic surgery. Minor changes to the package label
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of the subject devices also includes a new descriptor and icon to allow customers to easily distinguish between Ethicon PDS™ Suture and Ethicon PDS™M Plus Antibacterial Suture.
Conclusion:
There are no physical or technological characteristic changes to the currently marketed predicate device. The proposed labeling changes for the subject device have been shown to be appropriate for its intended use based on the test result that was submitted. Therefore, the subject device is substantially equivalent to the predicate device.
- Trademark Irgacare® : MP (triclosan) "Registered Trademark of BASF Group"