(231 days)
Not Found
No
The 510(k) summary describes a standard surgical suture and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device, a surgical suture, is used for tissue approximation and ligation rather than treating a disease or condition.
No
This device is a surgical suture, which is used for soft tissue approximation and/or ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a surgical suture, which is a physical medical device made of a copolymer. There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "absorbable sutures in general soft tissue approximation and/or ligation." This describes a device used within the body for surgical purposes.
- Device Description: The description details a "synthetic absorbable sterile monofilament surgical suture." This is a physical material used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are used to diagnose, monitor, or screen for conditions.
This device is a surgical suture, which is a medical device used for closing wounds or holding tissues together during surgery. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surqical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
Atramat® Poly(glycolide-co-epsilon-caprolactone) PGC25 Surgical Suture are synthetic absorbable sterile monofilament surgical sutures composed from a copolymer of glycolide and epsilon-caprolactone. This product is offered as undyed or dyed with an FDA listed color additive, D&C Violet No. 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft 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)
Invivo/in vitro testing was provied showing that the device performed as intended and as claimed. No clinical trials were conducted.
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.
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
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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
K07 2863
pg 1022
510(k) SUMMARY
MAY 2 3 2008
This Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requeriments of SMDA 1990 and 21 CFR§807.92
The assigned 510(k) number is:
Submitter's identification:
Internacional Farmacéutica, S.A. de C.V. Carreteraco 44 Col. Párque San Andrés Coyoacán C.P. 04040 México, D.F. Contact: Mr. Alejandro von Mohr, General Director Phone: (52 55) 55 44 87 60 to 62 ext. 227, 219 Fax: (52 55) 55 49 42 34
US Contact: Mr. Alan P. Schwartz 55 Northern Boulevard Great Neck, New York 11021 Phone: 516-482-9001 Fax: 516-482-0186
Date Summary prepared: May 31, 2007
Trade Name of the Device:
Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures
Common or Usual Name:
Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures
Classification of Device:
Class II in 21 CFR § 878.4493, Absorbable poly(glycolide/Ilactide) Surgical Suture
Classification Panel:
General & Plastic Surgery Devices Panel
Product Code:
GAM
Predicate Devices:
Monocryl* (poliglecaprone 25) Suture (K960653 and K964072)
Device Description
Atramat® Poly(glycolide-co-epsilon-caprolactone) PGC25 Surgical Suture are synthetic absorbable sterile monofilament surgical sutures composed from a copolymer of glycolide and epsilon-caprolactone. This product is offered as undyed or dyed with an FDA listed color additive, D&C Violet No. 2.
1
K072863
pg 292
Intented Use:
Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surqical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Summary of Thechnological Characteristics, comparison to predicate device
PGC25 Atramat® Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures have similar technological characteristics as the predicate device. Like the predicate device, Atramat® Poly(glycolide-co-epsilon-caprolactone) Surgical PGC25 Sutures are sterile, monofilament synthetic absorbable surgical sutures that conform to the requeriments of United States Pharmacopoeia (USP), except for diameter, and Mexicans United States Farmacopoeia, Medical Devices Supplement (FEUM) for absorbable surgical sutures. The poly(glycolideco-epsilon-caprolactone) material used for both "new" and "predicate" medical devices is commonly used in surgical applications and has been proven to be biocompatible. Invivo/in vitro testing was provied showing that the device performed as intended and as claimed.
Discussion of Clinical Test Performed:
No clinical trials were conducted.
Conclusions
Based on the technological characteristics and physical properties of the Poly(glycolide-co-epsilon-caprolactone) sutures, the description, the intented use of the device and conformance with the following performance standars like:
USP 30 ISO 9001 and ISO 13485
FDA Guidance for Surgical Suture 510(k)
Internacional Farmaceutica believes that the subject devices demonstrate a substantial equivalence to the predicate devices and are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2008
Internacional Farmaceutica S.A. de C.V. % mdi Consultants, Inc. Mr. Alan P. Schwartz 55 Northern Boulevard Great Neck, New York 11021
Re: K072863
Trade/Device Name: Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) surgical sutures Regulation Number: 21 CFR 878.4493
Regulation Name: Absorbable poly(glycolide/L- lactide)surgical suture Regulatory Class: II Product Code: GAM Dated: May 01, 2008 Received: May 22, 2008
Dear Mr. Schwartz:
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
3
Page 2 - Mr. Alan P. Schwartz
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO72863
ATTACHMENT # 3
Page 1 of 1
510(k) Number (if known):
Device Name: Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures
Indications for Use:
Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Prescription use X (Per 21 CFR 801.109)
Over-The Counter Use OR (Optional Format 1-2-96)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden for mka
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number