(100 days)
Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.
The Synthes Titanium Wire is a non-absorbable, monofilament, sterile surgical wire composed of Commercially Pure Titanium wire is available in a length of 500mm with different gauge sizes (26, 28, 30, 32) and is available with or without a permanently attached stainless steel needle.
The provided text describes a 510(k) submission for the Synthes (USA) Titanium Wire, which seeks to establish substantial equivalence to a predicate device, Ethilon™ Nylon Suture. The submission focuses on comparing the new device's characteristics and performance to the predicate and relevant standards.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (USP Standards) | Reported Device Performance (Synthes Titanium Wire) |
|---|---|
| Meet USP standards for length | Met USP standards for length |
| Meet USP standards for tensile strength | Met USP standards for tensile strength |
| Meet USP standards for needle attachment strength | Met USP standards for needle attachment strength |
| Meet USP standards for diameter | Did NOT explicitly meet USP standards for diameter (stated as "not diameter" in the text, implying this was a point of difference or non-conformance compared to the predicate, though overall "technically equivalent") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set of the comparative study. It mentions "tests according to methods presented in United States Pharmacopia (U.S.P.) were conducted for titanium wire with and without needle." The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this submission. The device is a surgical wire, and its performance is evaluated against physical and mechanical standards (USP), not by expert interpretation of images or clinical outcomes that typically require ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The evaluation methods are laboratory-based, objective measurements against USP standards, so no human adjudication process typical of clinical or imaging studies is involved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This is a submission for a surgical wire, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device (surgical wire), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's technical equivalency was based on United States Pharmacopeia (U.S.P.) standards for materials and mechanical properties of sutures/wires. These are objective, pre-defined standards.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | Synthes (USA) Titanium Wire |
| CLASSIFICATION: | Class II § 21 CFR 878.4495: Stainless Steel |
| PREDICATE DEVICE: | Ethicon Inc .: Ethilon™ Nylon Sutures |
| DEVICE DESCRIPTION: | The Synthes Titanium Wire is a nonabsorbable, monofilament,sterile surgical wire composed of Commercially Pure Titanium Thetitanium wire is available in a length of 500mm with different gauge sizesand is available with or without a permanently attached stainless steelneedle. |
| INTENDED USE: | Synthes (USA) Titanium Wire is indicated for use in soft tissueapproximation and/or ligation, for canthoplasty, canthopexy and/or canthaltendon repair. |
| SUBSTANTIALEQUIVALENCE: | Comparative information presented supports substantial equivalence.The term "substantial equivalence" as used in this 510(k) notification islimited to the definition of substantial equivalence found in the FederalFood, Drug and Cosmetic Act, as amended and as applied under 21CFR807, Subpart E under which a device can be marketed without premarketapproval or reclassification. A determination of substantial equivalencyunder this notification is not intended to have any bearing whatsoever onthe resolution of patent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalence herein shall beconstrued as an admission against interest under the US Patent Laws ortheir application by the courts. |
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4.0 Device Name
Synthes (USA) [Synthes] Titanium Wire
Establishment Registration 5.0
The devices subject to this Pre-market Notification will be distributed by Synthes (USA), 1101 Synthes Avenue, Monument, CO 80312 (FDA Registration No. 1719045) and manufactured by Unique Instruments, Inc. 6688 Dixie Highway, Bridgeport, MI 48722 (FDA Registration No. 1828288).
Classification Information 6.0
The classification of the Synthes Titanium Wire has been determined to be Class II, as per Title 21 of the Code of Federal Regulations, section : 878.5020: Suture, Nonabsorbable, Synthetic, Polyamide.
Information Relating to Performance Standards and Special Controls 7.0
The material used in the manufacture of the Synthes Titanium Wire is Commercially Pure (CP) Titanium, which adheres to American Society for Testing and Materials (ASTM) standards [F-1341]
Sterilization Information 8.0
Synthes will provide these devices STERILE. Information supporting the sterile device can be found in Attachment 1. These devices are for single use only.
Description of the Device 9.0
The Synthes Titanium Wire is a non-absorbable, monofilament, sterile surgical wire composed of Commercially Pure Titanium wire is available in a length of 500mm with different gauge sizes (26, 28, 30, 32) and is available with or without a permanently attached stainless steel needle.
Confidential engineering drawings can be found in Attachment II.
10.0 Proposed Labels/Labeling
Please sec Attachment III.
Commercially Available Device Information 11.0
The predicate device, Ethilon Nylon Suture, has been cleared for commercial distribution via the premarket notification process. Information on the predicate device can be found in Attachment IV.
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Image /page/2/Picture/1 description: The image shows the fraction 3/4. The number 3 is above the fraction bar, and the number 4 is below the fraction bar. The numbers are written in a simple, handwritten style.
12.0 Comparison to Commercially Available Device(s)
A comparison of the Synthes Titanium Wire to the predicate Ethilon™ Nylon Suture is below:
| New DeviceSynthes Titanium Wire | Predicate DeviceEthicon, Inc.Ethilon™ Nylon Suture510(k) Unknown |
|---|---|
| Indications:Synthes (USA) Titanium Wire isindicated for use in general soft tissueapproximation and /or ligation, includinguse in ophthalmic procedures,such ascanthoplasty. | Indications:ETHILON suture is indicated for use ingeneral soft tissue approximation, and / orligation, including use in cardiovascular,ophthalmic and neurological procedures. |
| Design Features:• Monofilament• Sterile• Nonabsorbable• Available with or withoutneedle | Design Features:• Monofilament• Sterile• Nonabsorbable• Available with or withoutneedle |
| Dimensions (mm):Sizes:• Diameter: 0.20, 0.25, 0.31, 0.40(26, 28, 30 & 32 gauge)• Length: 500 | Dimensions (mm):Sizes:• Diameter: 0.01 - 0.5• Length: Various |
| Material:Titanium | Material:Nylon |
Device Comparison Chart
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KD41333
Determination of Substantial Equivalence: (ref. Office of Device Evaluation (ODE) Blue 13.0 Book Memorandum #86-3, Attachment I "510(k) "Substantial Equivalence" Decision-Making Process (Detailed)" |
New Device [Synthes (USA) Titanium Wire] is Compared to Marketed Device [Ethicon: Ethilon Nylon Suturel.
Does New Device Have Same Indication Statements? Essentially yes. Both devices are indicated for soft tissue approximation and/or ligation: however the Titanium Wire has a more specific indication to include canthoplasty.
New Device Has Same Intended Use and May be "Substantially Equivalent".
Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.? Design: Yes. The design of the Titanium Wire is similar to the predicate device in that it is a nonabsorbable, monofilament wire which is available in a range of diameters/gauge sizes with or without attached needle. The subject device is 500 mm in length and provided sterile only.
Materials: No. The Synthes Titanium Wire is manufactured from CP Titanium where as, the predicate device is manufactured from Nylon.
Could the New Characteristics Affect Safety or Effectiveness? No.
To establish the technical equivalency of the Synthes Titanium Wire to the predicate device, tests according to mcthods presented in United States Pharmacopia (U.S.P.) were conducted for titanium wire with and without needle. The test results show that the Synthes titanium wire tested met USP standards for length, tensile strength, and needle attachment strength, not diameter, and are technically equivalent to the predicate device tested. Please see the attached mechanical test summary, which can be found in Attachment V.
14.0 Confidentiality Certification
We consider our intent to market this device to be confidential commercial information. Synthes has not disclosed the intent to market this product to others who are not collaborators and consultants. We have taken caution to protect the confidentiality of our intent.
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Image /page/4/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized emblem, consisting of three overlapping, curved shapes that resemble a human form or a symbol representing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K041333
Trade/Device Name: Synthes (USA) Titanium Wire Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: July 26, 2004 Received: July 27, 2004
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your be determined the device is substantially equivalent (for the indications forcrenced above and norsure) to legally marketed predicate devices marketed in interstate for ass stated in the encreased 9776, 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). and Oosmeter fore, market the device, subject to the general controls provisions of the Act. The r ou may, chere, many 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 11 your de subject to such additional controls. Existing major regulations affecting your device can may or subject to de 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 or any I odotar states and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 - Ms. Lisa M. Boyle
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 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 yours,
Miriam C. Provost
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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2.0 Indications for Use Statement
Page _ 1 of __ 1 __ 1
1999 1992 11
| 510(k) Number (if known): | K041333 |
|---|---|
| --------------------------- | --------- |
Synthes (USA) Titanium Wire Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications:
Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.
X x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Pcr 21 CFR 801.109)
ાર
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Musiam C. Provost
(Division Sign-Off) Division of General, Restoration, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.