The Atramat ® Synthetic Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Atramat ® Synthetic Absorbable Polydioxanone Surgical Sutures are not indicated for use in adult cardiovascular, microsurgical, and neurological surgery uses.

Device Description

Atramat ® Monofilament Polydioxanone are synthetic absorbable sterile surgical sutures composed of poly (p-dioxanone) synthetic polymer. These products are offered as monofilament or and it is offered uncoated or coated, it could also be undyed or dyed with D&C Violet No. 2.

AI/ML Overview

The Atramat® Synthetic Absorbable Polydioxanone Surgical Suture is substantially equivalent to the Ethicon PDS II® Polydioxanone Synthetic Absorbable Polydioxanone Surgical Sutures. The substantial equivalence was proven by non-clinical testing.

1. Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (USP 26 Standards)	Reported Device Performance
Material Composition	Conformance to poly (p-dioxanone) polymer composition.	Meets or exceeds USP 26 requirements. Identical to predicate device.
Physical Properties	Conformance to USP 26 standards for absorbable surgical sutures.	Meets or exceeds USP 26 requirements. Identical to predicate device.
Functionality	Conformance to USP 26 standards for absorbable surgical sutures.	Meets or exceeds USP 26 requirements. Identical to predicate device.
Packaging	Comparable to predicate device.	Identical to predicate device.
Sterilization Method	Comparable to predicate device.	Identical to predicate device.
Sizes	Comparable to predicate device.	Identical to predicate device.
Monofilament/Dyed/Undyed	Comparable options to predicate device.	Identical to predicate device.

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

Sample Size: Not explicitly stated as a number of sutures. The testing involved comparing the Atramat® PDO sutures directly against the requirements of USP 26 for absorbable surgical sutures.
Data Provenance: Not applicable in a traditional sense of patient data. The tests were non-clinical, likely laboratory-based, and performed on the subject devices themselves. Country of origin for the data is not specified, but the submitter is based in Mexico.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for this non-clinical study was established by the universally recognized standards set forth in USP 26 (United States Pharmacopoeia). These are objective, published standards, not subjective expert consensus on individual cases.

4. Adjudication method for the test set:

Not applicable. The determination of conformance to USP 26 standards is objective, based on laboratory measurements and comparison to defined physical and chemical criteria. No adjudication method involving human experts interpreting results was required.

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:

No. This was a non-clinical study for a surgical suture, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are not relevant.

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

No. This device is a surgical suture, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used:

Standard-based Ground Truth: The ground truth for the non-clinical tests was established by the performance requirements and specifications detailed in the United States Pharmacopoeia (USP) 26 for absorbable surgical sutures.

8. The sample size for the training set:

Not applicable. This was a non-clinical evaluation of a physical medical device against established standards, not a machine learning model requiring a training set.

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

Not applicable, as there was no training set for a machine learning model.

Summary

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JUN = 4 2004

Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads "K041048". Below that, it says "page 1/2". At the bottom, it says "Attachment 1".

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

The assigned 510(k) number is:

Submitter's identification: 1.

Ing. Aleiandro von Mohr Internacional Farmaceutica S. A. de C.V. Carreteraco 44 Col. Parque San Andrés Coyoacan 04040 México D.F. Phone: (00 52) 55 55 44 87 60 to 62 Fax: (00 52) 55 55 49 42 34 E-mail: avonmohr@ifsa.com.mx

Date Summary prepared: April 21, 2004

2. Name of the Device:

Proprietary: Polydioxanone Synthetic Absorbable Surgical Suture a: Trade Mark: Atramat ® Synthetic Absorbable Suture, Sterile
b: Common Name: Monofilament Polydioxanone Surgical Suture
c: Classification Name: Polydioxanone Synthetic Absorbable Surgical Suture
તં. Device Class: Class II, 21 CFR 878.4840
e. Classification Panel: General & Plastic Surgery Devices Panel
f. Product Code: NEW

3. Predicate Device Information:

Atramat ® PDO Polydioxanone Absorbable sutures are substantially equivalent to the following absorbable suture marketed by Ethicon Inc. PDS II @ Polydioxanone Synthetic Absorbable Polydioxanone Surgical Sutures (PMA N18331).

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4. Device Description:

ક. Intended Use:

6. Comparison to Predicate Devices:

With respect to substantial equivalence, the predicate device represents a virtually identical device. Materials, packaging, sterilization method, sizes, monofilament, dyed and undyed as well as functional characteristics. Equivalence also demonstrated in material composition, performance, and intended use. Atramat ®, PDO and Ethicon PDS II ® both meet or exceed the performance requirements of USP 26.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Non-clinical testing was conducted on the subject devices to prove conformance to the requirements of USP standards to demonstrate substantial equivalence to the predicate device. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses.

Results of the non-clinical testing demonstrate conformance with the USP standards and requirements for Absorbable surgical suture.

8. Discussion of Clinical Tests Performed:

Clinical testing was not performed.

9. Conclusions:

The Atramat® Polydioxanone Absorbable Surgical Suture is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized image of an eagle with three curved lines representing its wings. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Internacional Farmaceutica S.A. de C.V. c/o Ms. Carolann Kotula

55 Northern Boulevard, Suite 200 Great Neck, New York 11021

MDI Consultants, Inc.

Re: K041048

KU41046
Trade/Device Name: The Atramat® Synthetic Absorbable Polydioxanone Surgical Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: April 21, 2004 Received: April 22, 2004

JUN - 4 2004

Dear Ms. Kotula:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to the enactment date of the Medical Device Amendments, or 10 commerce processified in accordance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval approval application (PMA). alla Cosmetic Act (Tee) that do nevice, subject to the general controls provisions of the Act. The r ou may, mercrore, manel of the Act include requirements for annual registration, listing of gencrai controls provisions of ractice, 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 If your device is onashing (600 as 1970). Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a Provi may oc subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Icast oc advised that I Dr o lesantes a your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I cacal statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 6077, lucemig (21 CFR Part 820); and if applicable, the electronic forth in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Carolann Kotula

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and wyour of substantial equivalence of your device of your device to a legally premance noticated 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 If you t the Office of Compliance at (301) 594-4659. 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 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 vours,

Sincerely yours,

Mark A. Melkersen

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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Attachment 3 Revised 4/29/04

Indications for Use Statement

Page _ 1 of __ of __ 1

510(k) Number (if known): K041048

Device Name: Atramat ® Synthetic Absorbable Polydioxanone Surgical Suture.

Indications For Use: The Atramat ® Synthetic Absorbable Polydioxanone matedons i er Coor including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Atramat ® Synthetic Absorbable Polydioxanone Surgical Sutures are not indicated for use in adult cardiovascular, microsurgical, and neuro surgery uses.

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of DRA, Office of Device Evaluation (ODE)
Mark N. Melkerson

Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K041048

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.