(72 days)
Not Found
No
The device description and performance studies focus on the physical properties and conformance to USP standards for surgical sutures, with no mention of AI or ML capabilities.
No
The device is a surgical suture used for approximation and ligation of tissues, which is a supportive role in a medical procedure, not a primary therapeutic action.
No
Explanation: The device, POLYESTER, is a surgical suture used for "general soft tissue approximation and/or ligation." Its function is to approximate and ligate tissues, which is a therapeutic intervention, not a diagnostic one. There is no mention of it being used to identify or analyze a medical condition.
No
The device description clearly states it is a surgical suture composed of Poly (ethylene terephthalate), which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which are surgical procedures performed directly on a patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical suture, a physical material used to close wounds or tie off vessels during surgery. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the POLYESTER surgical suture described is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
POLYESTER is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, longchain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYESTER meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form. POLYESTER could be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). POLYESTER will be offered with or without standard needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular, ophthalmic, neurological
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)
Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and 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 U.S.P. standards and requirements for Absorbable surgical suture.
Clinical Testing: Not available at the present time.
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.
Tri-Cron® Non-Absorbable Polyester Surgical Suture (Davis & Geck (K930591)), Ethibond@ Nonabsorbable Polyester Surgical Suture (Ethicon, Inc.)
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
SECTION III
510(K) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and Title 21 CFR 8807.92
- A. Applicant & Submitted By:
Trading Consultants And Distributors International Inc. (T.CAD International) 157 WindDance Dr. Chicago, IL 60046-6681 Telephone: (847) 265-7676 Fax. : (847) 265-7686 Contact Person: Main M. Ghazal, President September 28th 1999. Date Prepared:
B. Device Name:
- Trade Name: POLYESTER a.
- b. Common or Usual Name: Polyester Surgical Suture
- Classification Name: Nonabsorbable Poly (ethyleme terephthalate) C.
- Surgical Suture (Per 21CFR878.5000)
C. Predicate Device:
Tri-Cron® Non-Absorbable Polyester Surgical Suture (Davis & Geck (K930591)) Ethibond@ Nonabsorbable Polyester Surgical Suture (Ethicon, Inc.)
D. Device Description:
POLYESTER is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, longchain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYESTER meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form. POLYESTER could be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). POLYESTER will be offered with or without standard needles attached.
- E. Intended Use:
POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
1
| POLYESTER | Predicate Device | |
|---|---|---|
| Intended Use | General soft tissue approximation | |
| and/or ligation, including use in | ||
| cardiovascular, ophthalmic and | ||
| neurological procedures. | General soft tissue approximation | |
| and /or ligation, including use in | ||
| cardiovascular, ophthalmic and | ||
| neurological procedures. | ||
| Suture Material | Flexible fibers of high-molecular | |
| weight, long-chain, linear poly- | ||
| (ethylene terephthalate) having | ||
| recurrent aromatic rings as an | ||
| integral component | Flexible fibers of high-molecular | |
| weight, long-chain, linear poly- | ||
| (ethylene terephthalate) having | ||
| recurrent aromatic rings as an | ||
| integral component | ||
| Suture | ||
| Characteristics | Not absorbed and no significant | |
| change in tensile strength retention | ||
| known to occur in vivo. | Not absorbed and no significant | |
| change in tensile strength retention | ||
| known to occur in vivo. | ||
| Sterilization Method | Gamma Irradiation | Same or equivalent process. |
| How Supplied | Multifilament thread, it will be | |
| offered coated or uncoated, | ||
| undyed or dyed with an FDA | ||
| listed color additive, D&C Green | ||
| No. 6. (21CFR74.3206). Sterile | ||
| and offered for Single Use Only. | ||
| Available with or without surgical | ||
| needles. | Same or equivalent manner. | |
| Offered in a multifilament form, | ||
| coated or uncoated, undyed and | ||
| dyed with the same FDA listed | ||
| colorant. Sterile and for single use | ||
| only. Available with or without | ||
| surgical needles. | ||
| Suture Diameter, | ||
| Suture Length, | ||
| Knot Pull Tensile | ||
| Strength and Needle | ||
| Attachment | ||
| Strength | Meet U.S.P. Requirements | Meet U.S.P. Requirements |
| Packaging | Dry packaged in Aluminum Foil | |
| and Polyester tear open packaging. | Same or equivalent manner. | |
| Labeling | In conformance with CDRH | |
| instructions of the "Medical | ||
| Device Quality Manual" dated | ||
| December 1996. Package Inserts | ||
| in accordance with the FDA | ||
| Guidance documents "Alternate | ||
| Suture Labeling" Resulting from | ||
| the January 11th 1993 meeting with | ||
| HIMA, reformatted on December | ||
| 17th 1997. | Same |
Comparison to Predicate Device: F.
2
G. Clinical & Non-Clinical Testing:
Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and 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 U.S.P. standards and requirements for Absorbable surgical suture.
Clinical Testing: Not available at the present time.
H. Conclusion:
Based on the technological characteristics and physical properties of the device, the device description, the intended use of the device, and conformance with voluntary performance standards like:
- a. United States Pharmacopeia Standards
- b. ISO 9002, EN 46002 & EN 552 Standards
- c. FDA Guidance documents " Alternate Suture Labeling" Resulting from the January 11th 1993 meeting with HIMA.
T.CAD International believes that the subject device demonstrates a substantial equivalence to the predicate device.
3
Image /page/3/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. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Main M. Ghazal Trading Consultants and Distributors International, Inc. 157 WindDance Drive Chicago, Illinois 60046-6681
Rc: K994000 Trade Name: Polyester Regulatory Class: II Product Code: GAT Dated: November 22, 1999 Received: November 24, 1999
Dear Mr. Ghazal:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Ilrug, and Cosmetic Act (Act) and the following limitations:
- 1 . The Polyester Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procecurrys.
-
- This device may not be manufactured from any material other than high molecular weight fibers composed of long chain linear polyester having recurrent aromatic rings as an integral component. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Polyester surgical suture. Any devization of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance pror to commercial distribution of the modified device.
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
4
Page 2 - Mr. Main M. Ghazal
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil K.P. Eglen
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
大9999800
SECTION II
Statement of indication for use
Device Name: POLYESTER
510(k) Number:
Indication for use: POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
(PLEASE DO NOT WRITE BELOW THE LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21CFR 801.109) OR
Over-the-Counter Use
8
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