(43 days)
PMA N18331
Not Found
No
The document describes a surgical suture and does not mention any AI or ML capabilities.
No.
The device is a surgical suture used for approximation of soft tissues, which is a medical device but not classified as a therapeutic device in the context of devices that deliver therapy or treatment in a broader sense (e.g., drug delivery, radiation therapy, electrical stimulation). Its function is to hold tissues together temporarily for healing.
No.
The device is a surgical suture used for tissue approximation, not for diagnosing conditions. Its function is to hold tissues together, not to identify or monitor diseases.
No
The device description clearly states it is a surgical suture composed of a synthetic polymer, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Atramat ® Synthetic Absorbable Polydioxanone Surgical Suture is a surgical suture used for "soft tissue approximation." This is a physical device used during surgery to hold tissues together, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Atramat ® Synthetic Absorbable Polydioxanone Surgical Suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NEW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, pediatric cardiovascular tissue, ophthalmic
Indicated Patient Age Range
pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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 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. Clinical testing was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
PMA N18331
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.
0
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).
1
4. 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.
ક. Intended Use:
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.
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
4
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