(232 days)
Stainless Steel Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
Stainless Steel Suture is a sterile monofilament or multifilament, non-absorbable sterile surgical suture composed of 316L stainless steel. The suture is also available coated with polyethylene. Stainless Steel Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes. Stainless Steel Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for Sterile Non-Absorbable Strands and the United States Pharmacopoeia (USP) for Non Absorbable Surgical Sutures. The European Pharmacopoeia recognizes units of measure Metric and Ph. Eur. sizes as equivalent which is reflected on the labeling.
Stainless Steel Suture elicits a minimal acute inflammatory reaction in tissue and is not absorbed. Implantation studies in animals show that no significant change in the retention of tensile strength of the suture occurs during the lifetime of the implantation.
The provided text describes a 510(k) premarket notification for a medical device called "Stainless Steel Suture" by Ethicon Incorporated. This is not a study proving device performance against acceptance criteria in the manner typically seen for new, innovative devices with novel performance characteristics or AI components. Instead, it's a submission to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, and ground truth types related to performance metrics) are not applicable in this context because the FDA cleared this device based on its substantial equivalence to an existing device, rather than novel performance data from a clinical or algorithm-based study.
The primary "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the predicate device, with a focus on updated labeling for MRI safety. The "study" isn't a complex clinical trial or AI algorithm validation, but rather a series of bench and design verification tests and a comparison to the predicate.
Here's the information extracted and adapted to the prompt, with explanations for why certain fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Target) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device is as safe and effective as the predicate device. Technology and intended use are equivalent. | The proposed device is identical to the legally marketed predicate device (Surgical Stainless Steel Suture, K946173) in material, construction, design, and specifications, except for labeling and trade name modifications. The modification does not change the intended use or the fundamental scientific technology. |
| MRI Safety - Translational Attraction | Deflection Angle test for Translational Attraction at 3-Tesla (worst case) compliant with ASTM F2052. | Non-clinical testing demonstrated that Stainless Steel Suture is MR Conditional. |
| MRI Safety - Torque | Qualitative Assessment of Torque at 3-Tesla (worst case) compliant with ASTM F2213. | Performed and results included in MRI Conditional labeling. |
| MRI Safety - Heating | Maximum temperature rise of less than 4.5°C after 15 minutes of continuous scanning, using RF coils running in quadrature mode, at 1.5-Tesla and 3.0 Tesla, compliant with ASTM F2182. | Expected to produce a maximum temperature rise of less than 4.5°C after 15 minutes of continuous scanning. |
| MRI Safety - Image Artifacts | Image artifact caused by the device extends approximately 20 mm when imaged with a gradient echo pulse sequence and a 2.0 T MRI system, at 3-Tesla (worst case), compliant with ASTM F2119. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | The image artifact caused by the Stainless Steel Suture extends approximately 20 mm from the device when imaged with a gradient echo pulse sequence and a 2.0 T MRI system. |
| Suture Integrity - Needle Attachment | Compliant with U.S.P. <871> (e.g., adequate needle pull-out strength). | Bench/Design Verification activities were performed and demonstrated continued conformance. Specific performance values are not detailed in the summary but were considered compliant with the standard. |
| Suture Integrity - Tensile Strength | Compliant with U.S.P. <881> (e.g., sufficient tensile strength for intended use). | Bench/Design Verification activities were performed and demonstrated continued conformance. Specific performance values are not detailed in the summary but were considered compliant with the standard. |
| Suture Integrity - Diameter | Compliant with U.S.P. <861> (e.g., within specified gauge limits). | Bench/Design Verification activities were performed and demonstrated continued conformance. Specific performance values are not detailed in the summary but were considered compliant with the standard. |
| Sterilization & Biocompatibility | EO residual testing per AAMI/ANSI/ISO 10993-7. Pyrogenicity testing / Bacterial Endotoxin Test (BET) per ANSI/AAMI ST72:2011 and USP <161> / <85>. | Performed and demonstrated compliance. Specific performance values are not detailed in the summary but were considered compliant with the standards. |
| Additional Compliance | European Pharmacopoeia (Ph. Eur.) for Sterile Non-Absorbable Strands compliance. | Stainless Steel Suture complies with all the requirements of the European Pharmacopoeia (Ph. Eur.) for Sterile Non-Absorbable Strands. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as this was a substantial equivalence submission based on bench testing of the product, not a clinical study with patient data. The tests would have used appropriate numbers of suture samples per the relevant ASTM and USP standards.
- Data Provenance: The data provenance is from bench/design verification activities performed by Ethicon Inc., in compliance with design control requirements. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission on the device to verify compliance with standards and MRI safety guidelines. Country of origin not specified, but likely where Ethicon's primary R&D/manufacturing takes place (e.g., USA given the submitter's address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. For a device like a stainless steel suture cleared via substantial equivalence, ground truth as typically defined for AI or diagnostic studies (i.e., expert consensus on clinical findings, pathology confirmation) is not relevant. The "ground truth" for the bench tests would be the established scientific/engineering principles and the specifications within the referenced ASTM and USP standards. The "experts" involved are the testing personnel and engineers who conducted and validated the bench tests according to recognized industry standards.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies or AI algorithm validation to resolve discrepancies among human readers or between AI and human reads. This submission is based on objective bench testing against pre-defined engineering and safety standards, not subjective interpretations requiring adjudication.
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
- Not Applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study involving human readers or AI assistance was conducted or is relevant for its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical surgical implant, not an algorithm or software. No standalone algorithm performance testing was performed.
7. The Type of Ground Truth Used
- Engineering Standards and Specifications: The "ground truth" for this device's performance is compliance with established and recognized engineering and medical device standards, specifically:
- United States Pharmacopoeia (USP) monographs for sutures (<871> Needle Attachment, <881> Tensile Strength, <861> Diameter).
- ASTM Standards for MRI Safety (F2503, F2052, F2119, F2182, F2213).
- AAMI/ANSI/ISO 10993-7 for EO residual testing.
- ANSI/AAMI ST72:2011 and USP <161>, <85> for Bacterial Endotoxin Testing (BET).
- European Pharmacopoeia (Ph. Eur.) for Sterile Non-Absorbable Strands.
- The "ground truth" also stems from the long history of safe and effective use of the predicate device (Surgical Stainless Steel Suture, K946173) which the proposed device is substantially equivalent to.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2017
Ethicon Incorporated Mr. Hrishikesh Khatav, RAC Senior Regulatory Affairs Specialist U.S. Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K170767
Trade/Device Name: Stainless Steel Suture Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless Steel Suture Regulatory Class: Class II Product Code: GAQ Dated: March 13, 2017 Received: March 14, 2017
Dear Mr. Khatav:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) к170767
Device Name Stainless Steel Suture
Indications for Use (Describe)
mainless Steel Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Sponsor: | ETHICON, Inc.P.O. Box 151Route 22 WestSomerville, New Jersey 08876 |
|---|---|
| Contact: | Hrishikesh Khatav, RACETHICON, Inc.P.O. Box 151Route 22 WestSomerville, New Jersey 08876Phone: 908-218-2348Fax: 908-218-2595Email: hkhatav@its.jnj.com |
| Date of Submission: | March 13, 2017 |
| Trade/ ProprietaryName: | Stainless Steel Suture |
| Common Name: | Surgical Stainless Steel SutureSuture, Non-absorbable, Steel, Monofilament and Multifilament,Sterile |
| Regulation Number: | 21 CFR 878.4495 |
| Regulatory Class: | II |
| Product Code: | GAQ |
| Predicate Devices: | Surgical Stainless Steel Suture; K946173, cleared January 9, 1995; Labeling Changes for Generic Suture Types, by Ethicon, Inc., Surgical Stainless Steel Suture; Pre-amendment Device by Ethicon, Inc.; marketed prior to May 28, 1976 |
| Device Description: | Stainless Steel Suture is a sterile monofilament or multifilament, non-absorbable sterile surgical suture composed of 316L stainless steel.The suture is also available coated with polyethylene. Stainless SteelSuture is available in a range of gauge sizes and lengths, non-needledor attached to needles of various types and sizes. Stainless Steel Suturecomplies with the requirements of the European Pharmacopoeia (Ph.Eur.) for Sterile Non-Absorbable Strands and the United StatesPharmacopoeia (USP) for Non Absorbable Surgical Sutures. TheEuropean Pharmacopoeia recognizes units of measure Metric and Ph.Eur. sizes as equivalent which is reflected on the labeling. |
| Stainless Steel Suture elicits a minimal acute inflammatory reaction intissue and is not absorbed. Implantation studies in animals show that nosignificant change in the retention of tensile strength of the sutureoccurs during the lifetime of the implantation. | |
| Indications for Use: | Stainless Steel Suture is indicated for use in abdominal wound closure,hernia repair, sternal closure and orthopaedic procedures includingcerclage and tendon repair. |
| Contraindications: | The use of this suture is contraindicated in patients with knownsensitivities or allergies to 316L stainless steel, or constituent metalssuch as chromium and nickel |
| Summary ofTechnologicalCharacteristics ofProposed Device toPredicate- Labelingchanges only: | The principle of operation and fundamental scientific technology of theproposed device are equivalent to the predicate device. Theperformance modification was accomplished via testing in MRIenvironment and update labeling per FDA guidance "EstablishingSafety and compatibility of Passive implants in the MagneticResonance (MR) environment" dated December 11, 2014. |
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A comparison between the proposed and the predicate device is given below
| Predicate Device | Proposed Device | |
|---|---|---|
| 510(k)Number | K946173 | K170767 |
| ProductCode | GAQ | Same |
| Regulation | 21 CFR 878.4495 | Same |
| Absorbable | No | Same |
| TradeName | Surgical Stainless SteelSuture | Stainless Steel Suture |
| IntendedUse | Surgical Stainless SteelSuture is indicated for usein abdominal woundclosure, hernia repair,sternal closure andorthopaedic proceduresincluding cerclage andtendon repair. | Same |
| Contraindication | The use of this suture iscontraindicated inpatients with knownsensitivities or allergies to316L stainless steel, orconstituent metals such aschromium and nickel | Same |
| MRI SafetyInformationinWarningsSection | N/A | Image: MR Conditional symbolMR ConditionalNon-clinical testing hasdemonstrated thatStainless Steel Suture isMR Conditional. A patientwith this device can besafely scanned in an MRsystem meeting thefollowing conditions:• Static magnetic field of1.5 T or 3.0 T• Maximum spatial fieldgradient of 2000 gauss/cm(20 T/m)• Maximum MR systemreported, whole bodyaveraged specificabsorption rate (SAR) of 1W/kg• Under the scanconditions defined, theStainless Steel Suture isexpected to produce amaximum temperaturerise of less than 4.5°Cafter 15 minutes ofcontinuous scanning,using RF coils running inquadrature mode.In non-clinical testing, theimage artifact caused bythe Stainless Steel Sutureextends approximately 20mm from the device whenimaged with a gradientecho pulse sequence and a2.0 T MRI system. |
| HowSupplied | Surgical Stainless steelsutures are available insizes 10-0 through 7(metric sizes 0.2 -9.0) in avariety of lengths withand without permanentlyattached needles in one,two and three dozenboxes. | Stainless steel sutures areavailable in sizes 5-0through 7 (metric sizes 1.0- 9.0) in a variety oflengths with and withoutpermanently attachedneedles in one, two andthree dozen boxes. |
| Color | Undyed | Same |
| Material | 316L Stainless Steel | Same |
| Sterilization | Sterilized by GammaIrradiation OR EthyleneOxide | Same |
| Packaging | Surgical Stainless SteelSuture is packaged inpaper folders. The foldersare packaged inpoly/paper and/orpoly/Tyvek overwraps.The overwraps are thenpacked into cartons withIFU's. The cartons arethen wrapped with a filmor closed with a securitylabel. | Same |
| U.S.P.continuedComplianceAdditionalCompliancetoEuropeanPharmacopeia | Surgical Stainless steelsuture complies with allthe requirements of theUnited StatesPharmacopoeia U.S.P.Monograph 861, 871 and881 for Non AbsorbableSurgical Sutures | Stainless Steel Suturecomplies with all therequirements of theEuropean Pharmacopoeia(Ph. Eur.) for Sterile Non-Absorbable Strands andthe United StatesPharmacopoeia (U.S.P.)Monograph 861, 871 and881 for non-absorbablesurgical sutures. |
Table 1: Device Comparison Table
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Performance Data: The proposed device is identical with the predicate device in respect to technological characteristics. No changes to material, construction, design or specifications. Only device labeling is updated to reflect MRI safety information, updated "How Supplied" section and additional compliance to European Pharmacopeia requirement for non
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absorbable sutures per "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Surgical Sutures".
The following Bench/Design Verification activities were performed on Stainless Steel Suture in compliance with design control requirements per 820.30 to demonstrate the continued conformance to respective FDA recognized standards for the proposed device:
Sutures - Needle Attachment per U.S.P. < 871> Tensile Strength per U.S.P. <881> Sutures - Diameter per U.S.P. <861>
Sterilization and Biocompatibility testing
EO residual testing per AAMI/ANSI/ISO 10993-7 Biological Evaluation of Medical devices. Pyrogenicity testing - Bacterial Endotoxin Test (BET) per ANSI/AAMI ST72:2011- Bacterial Endotoxins - Test Methods, routine monitoring and alternatives to batch testing USP <161> Transfusion and Infusion Assemblies and Medical Devices Bacterial Endotoxin Testing (BET) as defined in USP <85>
MRI specific Testing:
Magnetic field interactions at 3-Tesla considering worst case for magnetic field interactions: Deflection Angle test for Translational Attraction and Qualitative Assessment of Torque MRI-related Heating, 1.5-Tesla and 3.0 Tesla MR Image Artifacts at 3-Tesla considering worst case for artifacts
Above MRI tests are in compliance with below ASTM Standards: F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Conclusions: For the purposes of determining substantial equivalence per FD&C Act Section 510(k), the proposed device is compared with the same device and design that is currently being marketed. The proposed Stainless
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Steel Suture is identical to the legally marketed predicate device. Surgical Stainless Steel Suture except for labeling and trade name modifications. The modification does not change the intended use or the fundamental scientific technology. The proposed device uses the same operating principle, incorporates the same basic design and is packaged, manufactured and sterilized using the same materials and processes.
In summary, the Stainless Steel Suture described in this submission is, in our opinion, substantially equivalent to the predicate device which is legally marketed, by Ethicon, Inc. class II device with FDA product code (GAQ), regulatory definition (21 CFR 878.4495) and intended use.
§ 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.