(68 days)
SURGIDAC® Nonabsorbable Surgical Suture, ETHIBOND® Nonabsorbable Surgical Suture, TI-CRON® Nonabsorbable Surgical Suture, Synthofil® Nonabsorbable Surgical Suture
Not Found
No
The 510(k) summary describes a standard surgical suture and does not mention any AI or ML components or functionalities.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a supportive rather than a therapeutic function.
No
The device is a surgical suture used for approximation and/or ligation of soft tissue, not for diagnosis.
No
The device description clearly states it is a physical, multifilament thread made of PET, which is a hardware component.
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 is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "surgical suture," a physical material used to close wounds or hold tissues together during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the PremiCron® Nonabsorbable PET Surgical Suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PremiCron® Nonabsorbable PET Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue.
PremiCron® Nonabsorbable Surgical Suture is indicated for use in I reneral soft tissue approximation and/or ligation, including use in Echeral soft itsins appscular, ophthalmic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The subject device is an mutlifilament, nonabsorbable, sterile, flexible thread composed of 100% poly(ethylene terephthalate), or PET, and is indicated for soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue. It is available uncolored, or colored with D&C Green No. 6. It is available uncoated, or with a silicone coating. It is available with or without standard or detachable stainless steel needles.
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)
Non-clinical testing conducted on the subject device sterilization validation and evaluation of sterilant residues, shelf-life testing, and a series of state-of-the-art in vitro and in vivo assays to establish biocompatibility and in vivo behavior. The results of testing demonstrated the substantial equivalence of the subject device in terms of its biocompatibility and in vivo behavior.
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.
SURGIDAC® Nonabsorbable Surgical Suture, ETHIBOND® Nonabsorbable Surgical Suture, TI-CRON® Nonabsorbable Surgical Suture, Synthofil® Nonabsorbable Surgical Suture
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
AESCULAP®, Inc.
VII. 510(k) Summary
SEP 1 9 2001
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
Submitted for A.
AESCULAP®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034 Telephone: (610) 797-9300 Contact: Joyce Thomas, Director of Regulatory Affairs & Quality Assurance Date Prepared: July 9, 2001
Device Name B.
| Trade or Proprietary Name: | PremiCron® Nonabsorbable PET Surgical
Suture |
|----------------------------|---------------------------------------------------------------|
| Common or Usual Name: | NonabsorbablePolyester Surgical Suture |
| Classification Name: | Nonabsorbable Poly(Ethylene terephthalate)
Surgical Suture |
C. Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
- SURGIDAC® Nonabsorbable Surgical Suture (U. S. Surgical Corp.) ●
- ETHIBOND® Nonabsorbable Surgical Suture (Ethicon, Inc.) .
- TI-CRON® Nonabsorbable Surgical Suture (Sherwood Davis & Geck) .
- Synthofil® Nonabsorbable Surgical Suture (AESCULAP®) .
Device Description D.
The subject device is an mutlifilament, nonabsorbable, sterile, flexible thread composed of 100% poly(ethylene terephthalate), or PET, and is indicated for soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue. It is available uncolored, or colored with D&C Green No. 6. It is available uncoated, or with a silicone coating. It is available with or without standard or detachable stainless steel needles.
1
E. Intended Use
PremiCron® Nonabsorbable PET Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue.
F. Comparison to Predicate Devices
The subject device is composed of 100% poly(ethylene terephthalate) polymer, as is true of the predicate ETHIBOND®, TI-CRON®, SURGIDAC®, and Synthofil® sutures. As is also true of these predicate devices, the subject device is offered uncolored, or colored with D&C Green No. 6 at a concentration that conforms to the requirements of Title 21 CFR, §74.3206. Like TI-CRON® and other sutures, the subject device is offered with a silicone coating.
The subject device has the same design as do the ETHIBOND®, TI-CRON®, SURGIDAC®, and Synthofil® predicate devices, being a sterile, flexible braided multifilament thread.
As is true of the predicate sutures, the subject suture is offered in a variety of lengths and a range of diameters, and is offered with or without one of a selection of standard or detachable stainless steel needles. Further, as is the case with the predicate devices, the subject device conforms in all respects to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIV, including Sutures -- Diameter, Sutures -- Needle Attachment, and Tensile Strength.
The subject device is manufactured in a manner typical of the industry and equivalent to that used to produce the predicate devices, wherein the poly (ethylene terephthalate) polymer is synthesized, and polymer is then melt extruded (colorant is added if desired) and spun to form fine filaments of specified diameter. These filaments are then "drawn" to enhance tensile properties, braided to form a fiber of the desired diameter, and where appropriate, coated with a lubricant to enhance handling properties and reduce tissue drag. The fibers are then cut to length and attached to needles.
As is true of the predicate ETHIBOND® sutures, PremiCron® sutures are offered with small "pledgets" of 100% TEFLON® polytetrafluoroethylene.
2
The subject device is packaged and sterilized in the same or equivalent manner, and has the same or equivalent labeling claims as do the predicate devices, including indications, contraindications, warnings, cautions and precautions.
Summary of Non-Clinical Tests G.
Non-clinical testing conducted on the subject device sterilization validation and evaluation of sterilant residues, shelf-life testing, and a series of state-of-the-art in vitro and in vivo assays to establish biocompatibility and in vivo behavior.
H. Summary of Clinical Tests
(Not applicable)
Conclusions of Non-Clinical and Clinical Tests I.
The results of testing demonstrated the substantial equivalence of the subject device in terms of its biocompatibility and in vivo behavior.
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
SEP 1 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap, Inc. c/o Mr. Steve Reitzler, RAC Regulatory Consulting Services 13221 Maricotte Place San Diego, California 92130
Re: K012201
K012201
Trade/Device Name: PremiCron® Nonabsorbable PET Surgical Suture Regulation Number: 878.5000 Regulation Name: Nonabsorbable polyethylene terephthalate surgical suture Regulatory Class: II Product Code: GAT Dated: July 9, 2001 Received: July 13, 2001
Dear Mr. Reitzler:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Security pro(x) premainer's substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tuse stated in the encrosule) to regally manatiment date of the Medical Device Ameral Food. Days commerce prior to May 28, 1770, the encordance with the provisions of the Federal Food. Drug. devices that have been recalise in assess approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl alle Cosment Act (Act) that to not requence subject to the general controls provisions of the Act. The You may, merefore, market the do received be requirements for annual registration, listing of general controls provisions of the 110 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 classified (socrative) also Existing major regulations affecting your device can may be subject to such additional controller Life 21, Parts 800 to 898. In addition, FDA may be found in the Oods acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe advised allat 1 Dri blocation of our device complies with other requirements of the Act that I DA has made a actorinations administered by other Federal agencies. You must or any it catal statutes and regularents, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements, and manufacturing practice requirements as set CFR Part 807); adoming (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Steve Reitzler, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse FDA finding of substantial equivalence of your device to a legally promation in a classification for your device and thus, permits 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 31 31 3 594-4659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 + + the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Suse Walk, us
Image /page/4/Picture/5 description: The image contains a handwritten symbol that resembles a cursive letter 'f' with a loop at the top. The symbol is bold and slightly tilted to the right. It is the only element in the image, set against a plain white background.
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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V. Draft Labeling
Indications for Use A.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AESCULAP®, Inc, Monosyn® Synthetic Absorbable Suture
Indications for Use:
PremiCron® Nonabsorbable Surgical Suture is indicated for use in I reneral soft tissue approximation and/or ligation, including use in Echeral soft itsins appscular, ophthalmic and neurological procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
$\frac{1}{2}$
(Division Sign-Off) Division of General, Restorative and Ney
510(k) Number_Ko1220