MonoPlus Poly-p-dioxanone absorbable suture are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.

Device Description

The subject device is an absorbable, flexible monofilament suture thread which is supplied sterile. It is composed of a synthetic Poly (p-dioxanone), and it is indicated for soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue. It will be offered undeyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3602. It is available uncoated, and will be available with or without standard needles attached.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called MonoPlus Poly-p-dioxanone absorbable suture. It does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for AI/ML or diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's why the requested information cannot be extracted and what the document does communicate:

No Performance Data Section: The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This means there aren't formal, pre-defined acceptance criteria (like sensitivity/specificity targets) for this type of suture that the manufacturer needed to meet through a specific performance study.
Substantial Equivalence Pathway: The submission uses the "substantial equivalence" pathway, meaning the manufacturer is demonstrating that their new device is as safe and effective as a legally marketed predicate device (Ethicon's PDS II Polydioxanone Suture). This typically involves comparing design, materials, and intended use, rather than conducting new clinical performance trials against numerical acceptance criteria.

Therefore, most of the requested fields are not applicable or cannot be found in the provided text.

Here's a breakdown of the available information based on your request, with explanations for why other fields are not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document states, "No performance standards have been promulgated..." and relies on substantial equivalence. Therefore, there are no explicit acceptance criteria or reported performance metrics (e.g., accuracy, sensitivity, specificity) for this device in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No specific performance study with a "test set" is described. The submission focuses on substantial equivalence to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No performance study with a test set requiring expert ground truth is described.

4. Adjudication Method for the Test Set

Not applicable. No performance study with a test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study is mentioned. The submission is for a medical suture, not a diagnostic or AI-assisted device where such studies are common.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical surgical suture, not an algorithm or software.

7. Type of Ground Truth Used

Not applicable. No performance study requiring ground truth is described. For substantial equivalence, the "ground truth" is effectively that the predicate device is already deemed safe and effective, and the new device is demonstrated to be similar enough.

8. Sample Size for the Training Set

Not applicable. This type of information is relevant for AI/ML models, not for a physical medical device like a suture where the development process would involve materials science, engineering, and biocompatibility testing, not "training sets."

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this concept doesn't apply to the development of a surgical suture.

Summary of what the document does provide regarding device clearance:

Device: MonoPlus Poly-p-dioxanone absorbable suture.
Indicated Use: General soft tissue approximation and/or ligation, especially where extended wound support (>4 weeks) is desired, and in pediatric cardiovascular surgery (not adult cardiovascular, microsurgery, or neural tissue).
Regulatory Pathway: 510(k) Pre-market Notification, seeking clearance based on substantial equivalence.
Predicate Device: Ethicon, Inc.; PDS II Polydioxanone Suture (N18331).
Conclusion: The FDA determined the device is substantially equivalent to the predicate device, allowing it to be marketed.

This document demonstrates compliance through a regulatory pathway of substantial equivalence, which for this type of device, does not involve the detailed performance study and acceptance criteria breakdown you've outlined, which are more typical for novel diagnostic devices, AI/ML products, or devices requiring new clinical efficacy data.

Summary

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KΦ312/6

Page 1 of 1

C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

[in Accordance with SMDA of 1990]

MonoPlus Poly-p-dioxanone absorbable suture

April 18, 2003

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Georg Keller800-258-1946 x 5073 (phone)610-791-6882 (fax)
TRADE NAME:	MonoPlus Poly-p-dioxanone monofilament absorbable surgical suture
COMMON NAME:	Synthetic Absorbable Surgical Suture
DEVICE CLASS:	Class II
PRODUCT CODE:	79NEW
CLASSIFICATION:	878.4840 - Suture, surgical, absorbable , polydioxanone
REVIEW PANEL:	General & Plastic Surgery

INDICATIONS FOR USE

DEVICE DESCRIPTION

PURPOSE FOR SUBMISSION

This submission seeks marketing clearance for Aesculap's MonoPlus Poly-p-dioxanone absorbable suture.

PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

SUBSTANTIAL EQUIVALENCE

Aesculap® Inc. believes that MonoPlus Poly-p-dioxanone monofilament absorbable surgical suture is substantially equivalent to:

Ethicon, Inc.; PDS II Polydioxanone Suture (N18331) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUL 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K031216

Trade/Device Name: MonoPlus Poly-p-dioxanone absorbable suture Regulation Number: 21 CFR 878.4840 Regulation Name: Suture, surgical, absorbable, polydioxanone Regulatory Class: II Product Code: NEW Dated: April 16, 2003 Received: May 6, 2003

Dear Mr. Keller:

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 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.

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Page 2 - Mr. Georg Keller

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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B. INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number:

φ3/2/6

Device Name:

MonoPlus Poly-p-dioxanone absorbable suture

Indication for Use:

MonoPlus Poly-p-dioxanone absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in pediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ or Over-the-C

(per 21 CFR 801.109)

or Over-the-Counter Use

Miriàm C. Provost

ral. Restorative and Neurological Dev

510(k) Number K031216

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.