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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture. The document focuses on establishing substantial equivalence to a predicate device (K061037) rather than presenting a performance study with detailed acceptance criteria for a new AI/CAD device.

Therefore, the requested information regarding acceptance criteria, study details, and AI/CAD specific metrics cannot be found or inferred from the provided text.

The document states: "The subject device is identical to the predicate device in terms of material, construction, specification, manufacturing, and sterilization process." and "There are no physical or technological characteristic changes to the currently marketed predicate device." The primary change described is a revision to the Indications for Use, removing ophthalmic surgery and adding in-vitro effectiveness against Enterobacter cloacae.

To address the prompt, I can only provide the information that is present in the document.

Based on the provided text, the following information is not available:

A table of acceptance criteria and reported device performance (as would be typical for a new performance claim or an AI/CAD device).
Sample size used for a test set.
Data provenance for a test set.
Number of experts used to establish ground truth for a test set.
Qualifications of experts.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Effect size of human readers improving with AI vs. without AI assistance.
Standalone (algorithm only) performance study.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
Sample size for a training set.
How ground truth for a training set was established.

However, the document does mention an in-vitro study related to antibacterial efficacy. Here's what can be extracted about that:

1. Acceptance Criteria and Reported Device Performance (Related to antibacterial efficacy for the new claim):

Acceptance Criteria (Implied)	Reported Device Performance
Demonstrated efficacy of the antibacterial suture surface to prevent bacterial colonization against Enterobacter cloacae.	"Using in vitro studies, Irgacare®† 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 efficacy is reported as a log difference in attached bacteria between treated and untreated suture controls."

Acceptance Criteria (Implied)

Reported Device Performance

Demonstrated efficacy of the antibacterial suture surface to prevent bacterial colonization against Enterobacter cloacae.

"Using in vitro studies, Irgacare®† 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 efficacy is reported as a log difference in attached bacteria between treated and untreated suture controls."

2. Sample size used for the test set and the data provenance:

The document refers to "in-vitro studies" but does not specify sample sizes for these studies or data provenance beyond being "in-vitro."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not mentioned. The efficacy claim is for an antibacterial agent, likely assessed through microbiological methods, not human expert interpretation of images or other clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/CAD or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/CAD or diagnostic imaging device.

7. The type of ground truth used:

For the antibacterial claim, the ground truth is established through quantitative in-vitro attachment assays measuring bacterial colonization. This is primarily a laboratory measurement rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

Not applicable/Not mentioned. This is not a machine learning or AI device that would typically have a "training set."

9. How the ground truth for the training set was established:

Not applicable/Not mentioned.

In summary, the provided document is a 510(k) for a surgical suture and does not contain the detailed performance study information typically requested for an AI/CAD device. The "study" mentioned is an in-vitro assay for antibacterial efficacy, and even for that, specific sample sizes and detailed methodology are not provided in this regulatory summary.

Summary

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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

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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)

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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ETHICOL N, INC.

Johnson company a

510(k) Summary

Submitter:	Ethicon, Inc., a Johnson & Johnson Company1000 Route 202Raritan, New Jersey 08869USA
Contact Person:	Marife SevekSr. Regulatory Affairs Program LeadPhone: (908) 808-6602Fax: (908) 927-7230E-mail: msevek1@its.jnj.com
Date Prepared:	February 14, 2022
Device Trade Name:	PDS™ Plus Antibacterial (Polydioxanone) Sterile SyntheticAbsorbable 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:

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"

Regulation Number and Section

§ 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.