(129 days)
Not Found
No
The summary describes a traditional surgical suture and needle, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No
The device, a surgical suture, is used for tissue approximation and ligation rather than directly treating a disease or condition, which is the primary function of a therapeutic device.
No.
The device is a surgical suture used for approximation and ligation of tissues, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a physical surgical suture made of various materials, with or without needles, and the performance studies focus on mechanical properties, biocompatibility, and sterilization, all indicative of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a surgical suture used for "soft tissue approximation and/or ligation." This is a device used within the body during a surgical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
The device described is a surgical tool used for physical repair and closure of tissues, which falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For safe and reliable soft tissue approximation, wound closure and ligation.
General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT, GAW, GAP, GAR
Device Description
AMERICAN SUTURE™ Non-Pyrogenic devices used for safe and reliable soft tissue approximation, wound closure, and ligation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle have AMENTO IN OO to refformance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility.
The American Sutures™ Surgical sutures intended to be introduced have been tested The Amenoun Guturoo - Ourgromance with the following test methods:
FDA Recognized Standards
- ecogmized Standards
AAMI / ANSI / ISO 10993-5:1999, Biological evaluation of medical devices -- Part 5: . Tests for In Vitro Cytotoxicity. (Biocompatibility) - Fests for In Ville Ofter 3-10:2002, Biological evaluation of medical devices Part 10: ● Tests for irritation and delayed-type hypersensitivity. (Biocompatibility)
- Tests for Inteation and dolarsa type tify on and routine control of ETO Sterilization
- AAMI / ANSI / ISO 11137-1:2000 Validation and routine control of GAMMA Sterilization
Currently FDA recognized USP Edition Monographs
USP 30 :2007 Sutures Diameter USP 30 2007 Sutures Needle Attachment USP 30 :2007 Sutures Tensile Strength
Mexican Norms.
Federal Mexican Code for Medical Devices - F.E.U.M. 2006 (Mex. Pharmacopoeia) FEUM- MGA-DM-3171, pages 220-221- Intracutaneous Irritation Test FEUM-MGA-DM-3083, pages 217-220 - Systemic Injection Test FEUM-MGA-DM-3081, pages 215-216 Implantation Test
Official Mexican Norms NOM-067-SSA-1993 for Medical Sutures NOM -B-1-70 Analysis Methods for Steels and Smelting (Needles) NOM -- B-119-78 Determination of Rockwell Hardness for Metals (Needles) NOM-BB-46-76 Determination of Corrosion Resistance for Hypodermic Needles
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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
510(k) Number: K091574
page 1/3
510(k) SUMMARY (As Required by 21 CFR 807. 92)
| Submitted by: | Jorge Lay
Principal
Suplidores Unidos Internacionales S.A.
Avenida Miguel Hidalgo 31B
Colonia Lago de Guadalupe
Cuautitlan Estado de Mexico
Mexico
Tel: +52 (55) 58 77 42 41
Fax: (305) 551-9139 | OCT - 9 2009 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date of Summary: | May 1 st , 2009 | |
| Device Name: | AMERICAN SUTURE TM Non Absorbable Surgical Sutures with/without Needles (Silk, Nylon, Polypropylene, and Polyester) | |
| Common Name: | Surgical Sutures | |
| Classification Name: | Sutures | |
| Class: | 2 | |
| Product Code: | GAT, GAW, GAP, and GAR | |
| Regulation Number: | 21 CFR 878-5000, 5010, 5020, and 5030 | |
| Predicative Device: | CP Medical Non-absorbable Surgical Sutures | |
| 510 K Number | Product Description |
|---|---|
| K001184 | Silk Non-absorbable Surgical Sutures |
| K001173 | Nylon Non-absorbable Surgical Sutures |
| K001185 | Polypropylene Non-absorbable Surgical Sutures |
Modifications:
There are no modifications to the device design that affect safety and effectiveness for its intended use.
Polyester Non-absorbalbe surgical Sutures
1
K091574 page 2/3
AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle ⁄ Device Description AMERIOAN OOTORE - Non-Pyrogenic devices used for safe and reliable soft tissue approximation, wound closure, and ligation.
For safe and reliable soft tissue approximation, wound closure and ligation. Intended Use:
AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle Technological AMERICAN OO FORE - Non Abberbast of the legally marketed CP Medical Non-absorbable Surgical Sutures.
Technical Comparison to Predicative Devices
| American ™ Non Absorbable
Surgical Sutures | CP Medical Non Absorbable
Surgical Sutures |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| American Surgical Sutures are indicated for soft
tissue approximation and ligation | CP Medical non Absorbable Sutures are indicated
soft tissue approximation and ligation. |
| American Silk sutures are Intended for Use in
gastrointestinal, neurological, and cardiovascular
surgery | CP Medical sutures are Intended for Use in
gastrointestinal, neurological, and cardiovascular
surgery |
| American Sutures are made of Silk, Nylon,
Polypropylene, and Polyester materials. Sterile, Single
Use, Non Absorbable. With or without Needles
attached | CP Medical Sutures made of Silk, Nylon,
Polypropylene and Polyester materials.
Sterile, Single Use, Non Absorbable. With or
without Needles attached. |
| American Silk sutures are made from pure Silk
monofilaments, braided then coated with
Silicone | CP Medical Silk Sutures are braided from pure
Silk Monofilaments, braided then coated with
Silicone |
| American Nylon Sutures are made from
monofilaments of a polyamide material and dyed
colored Black or Blue | CP Medical sutures are made from monofilaments
polyamide material and dyed colored Black or Blue |
| American Polypropylene sutures are made from
Monofilaments of synthetic Polyolefin | CP Medical Polypropylene sutures are made from
monofilaments of synthetic Polypropylene 1 |
| American Polyester Sutures are made from
monofilaments of synthetic Polyethylene, braided
then coated with Silicone | CP Medical Polyester sutures are made form
monofilaments of synthetic Polyethylene, braided,
then coated with Silicone |
| American Surgical Sutures meet or exceed the
performance requirements for Non-Absorbable
surgical sutures as defined in the Official monograph
of the United States Pharmacopeia:
Diameter
Tensile Strength
Needle Attachment
Suture Length Requirement | CP Medical Sutures meet or exceed the
performance requirements for Non-Absorbable
surgical sutures as defined in the Official
monograph of the United States Pharmacopeia:
Diameter
Tensile Strength
Needle Attachment
Suture Length Requirement |
| American surgical Sutures are offered with or without
Needles | CP Medical sutures are offered with or without
Needles |
: ....
¹ Polyolefin and Polypropylene are both synthetic polymers widely used in the manufacturing of surgical sutures.
2
K091524
page 3/3
Testing:
AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle have AMENTO IN OO to refformance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility.
The American Sutures™ Surgical sutures intended to be introduced have been tested The Amenoun Guturoo - Ourgromance with the following test methods:
FDA Recognized Standards
- ecogmized Standards
AAMI / ANSI / ISO 10993-5:1999, Biological evaluation of medical devices -- Part 5: . Tests for In Vitro Cytotoxicity. (Biocompatibility) - Fests for In Ville Ofter 3-10:2002, Biological evaluation of medical devices Part 10: ● Tests for irritation and delayed-type hypersensitivity. (Biocompatibility)
- Tests for Inteation and dolarsa type tify on and routine control of ETO Sterilization
- AAMI / ANSI / ISO 11137-1:2000 Validation and routine control of GAMMA Sterilization
Currently FDA recognized USP Edition Monographs
USP 30 :2007 Sutures Diameter USP 30 2007 Sutures Needle Attachment USP 30 :2007 Sutures Tensile Strength
Mexican Norms.
Federal Mexican Code for Medical Devices - F.E.U.M. 2006 (Mex. Pharmacopoeia) FEUM- MGA-DM-3171, pages 220-221- Intracutaneous Irritation Test FEUM-MGA-DM-3083, pages 217-220 - Systemic Injection Test FEUM-MGA-DM-3081, pages 215-216 Implantation Test
Official Mexican Norms NOM-067-SSA-1993 for Medical Sutures NOM -B-1-70 Analysis Methods for Steels and Smelting (Needles) NOM -- B-119-78 Determination of Rockwell Hardness for Metals (Needles) NOM-BB-46-76 Determination of Corrosion Resistance for Hypodermic Needles
State States
. : routine : 3
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three flowing lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Suplidores unidos Internacionales S.A. % VHP Consulting Mr. Victor Pereira P.O. Box 97-0132 Coconut Creek, Florida 33067-0132
OCT - 9 2009
Re: K091574
Trade/Device Name: AMERICAN SUTURE™ Surgical Sutures – SILK BLACK – Braided AMERICAN SUTURE™ Surgical Sutures - NYLON BLACK and BLUE - Braided
AMERICAN SUTURE™ Surgical Sutures – POLYPROPYLENE AMERICAN SUTURE™ Surgical Sutures – POLESTER - Braided
Regulation Number: 21 CFR 878.5000
Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: August 1, 2009
Received: August 11, 2009
Dear Mr. Pereira:
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 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
4
Page 2 - Mr. Victor Pereira
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 vours
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K091574
Device Name: AMERICAN SUTURE™ Surgical Sutures- SILK BLACK - Braided
INDICATIONS FOR USE:
General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.
Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR
Over- The Counter Use: (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krave for MKM
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K091574
6
510(k) Number: K091574
Device Name: AMERICAN SUTURE™ Surgical Sutures- NYLON BLACK and BLUE - Braided
INDICATIONS FOR USE:
General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over- The Counter Use: (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
DEN Darind Krane for arxи
(ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091574
7
510(k) Number: K091574
Device Name AMERICAN SUTURE™ Surgical Sutures- POLYPROPYLENE
INDICATIONS FOR USE:
General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over- The Counter Use: (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for MXul
(Division S Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091574
8
510(k) Number: K091574
Device Name: AMERICAN SUTURE™ Surgical Sutures- POLESTER - Braided
INDICATIONS FOR USE:
General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.
X Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
Over- The Counter Use: (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for mxm
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091524