(132 days)
ferroFIBRE™ Stainless Steel Suture with Crimp is intended for use in soft tissue approximation and for use in abdominal wound closure. hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair
The ferroFibre™ with Crimp is a nonabsorbable sterile surgical suture with a crimp composed of stainless steel. The ferroFibre™ with Crimp is available in USP sizes 4-0 to size 3, attached to stainless steel needles of various types and sizes. The ferroFibre™ suture was previously cleared in the K081060. A stainless steel crimp is being added to provide an alternate to knot tying. The use of the crimp for size 3-0 and 4-0 was cleared under submission K101126.
The provided FDA 510(k) summary for the PONTIS ferroFIBRE™ Stainless Steel Suture with Crimp describes a medical device, not a software algorithm or AI model. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
However, I can extract information related to the device's non-clinical testing, which serves a similar purpose of demonstrating safety and effectiveness compared to acceptance criteria for a physical device.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Study for PONTIS ferroFIBRE™ Stainless Steel Suture with Crimp
This submission is for a medical device (stainless steel suture with a crimp), not an AI algorithm. Therefore, "acceptance criteria" and "device performance" are typically assessed through physical and mechanical testing rather than AI-specific metrics like AUC, sensitivity, or specificity. The "study" refers to non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: | Verification and Validation Testing includes: |
| - Withstand anticipated forces without failure (knot/crimp integrity) | - Knot failure force tested |
| - Maintain integrity under repetitive stress (cyclic loading) | - Crimp failure force tested |
| - Cyclic loading tested | |
| Biocompatibility: | - All biocompatibility testing performed under predicate submissions K101126 and K081060 remains applicable, indicating materials are safe for intended use. (This implies the new device meets the same biocompatibility standards as the predicates). |
| Sterility: | - Device is sterile, sterilized by ethylene oxide. (This implies it meets sterility acceptance criteria, although specific standards are not listed in the summary). |
| Functional Equivalence: | - Non-clinical tests demonstrate the proposed device is safe, effective, and performs as well as the predicate devices, thereby demonstrating substantial equivalence. (This is the overarching "performance" claim, inferring that the new device meets relevant performance standards as established by the predicates and demonstrated through the mechanical tests performed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "verification and validation testing" including "knot failure force, crimp failure force and cyclic loading." However, the number of samples used for these tests is not provided.
- Data Provenance: N/A for clinical data, as this is a non-clinical device submission. The tests are laboratory-based mechanical and biological evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- N/A. This information is for AI algorithms. For a physical device, testing is conducted according to established engineering and material science standards. The "ground truth" for device performance is typically defined by the test protocols themselves, often referencing ISO or ASTM standards, and evaluated by qualified engineers or lab personnel.
4. Adjudication Method for the Test Set
- N/A. This information is for AI algorithms, often referring to expert review of ambiguous cases. Device testing involves objective measurement and analysis against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
- N/A. This is a physical medical device, not an AI system. MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a physical medical device. "Standalone performance" in this context refers to the device's mechanical and material properties as assessed in laboratory tests, which were performed.
7. The Type of Ground Truth Used
- Defined by Test Protocols and Predicate Device Performance: The "ground truth" for this device is effectively established by accepted mechanical engineering principles, material science standards, and the performance characteristics of the predicate devices. The tests (knot failure force, crimp failure force, cyclic loading) measure objective physical properties against expected or established benchmarks derived from the predicate devices, which are already considered safe and effective. Biocompatibility "ground truth" is based on established biological safety standards.
8. The Sample Size for the Training Set
- N/A. This information is for AI algorithms. There is no "training set" for this physical device in the AI sense. Device design and development might involve iterative testing of prototypes, but this is distinct from AI training.
9. How the Ground Truth for the Training Set Was Established
- N/A. As there is no AI "training set," this question is not applicable. The design and validation of physical devices rely on engineering specifications, material properties, and performance data from similar, previously cleared devices.
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ATTACHMENT 8
K140127 pg.l of 2
PONTIS
Tat
ORTHOPAEDICS
510(k) Summary
| Owner's Name | Leonard Gordon |
|---|---|
| Submitter Address | 2299 Post Street Suite 107San Francisco, CA 94115 |
| Phone Number | (415) 567-8935 |
| Fax Number | (415) 567-8934 |
| 510(k) Owner | PONTIS Orthopaedics, LLC |
| Contact Person | Leonard Gordon |
| Date Prepared | April 22, 2014 |
| Trade Name | ferroFIBRE™ with Crimp |
| Common name | Stainless Steel Suture |
| Classification Name | Stainless Steel Suture |
| Section | §C.F.R. Section 878.4495 |
| Product Code | GAQ |
| Predicate Device(s) | ferroFibre™ (K081060)PONTIS™ Sutures and Suture Anchor with Crimps (K101126) |
| Device Description | The ferroFibre™ with Crimp is a nonabsorbable sterile surgical suturewith a crimp composed of stainless steel. The ferroFibre™ with Crimpis available in USP sizes 4-0 to size 3, attached to stainless steelneedles of various types and sizes. The ferroFibre™ suture waspreviously cleared in the K081060. A stainless steel crimp is beingadded to provide an alternate to knot tying. The use of the crimp forsize 3-0 and 4-0 was cleared under submission K101126. |
| Reason for 510(k) | Device Modification - To allow the use of a crimp for securing size 3-0 to #3 ferroFibre™ cleared under K081060 as an alternate to knottying. |
| Indications for Use | ferroFibre™ Stainless Steel Suture with Crimp is intended for use insoft tissue approximation and for use in abdominal wound closure.hernia repair, sternal closure and certain orthopaedic proceduresincluding cerclage and tendon repair |
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| TechnologicalCharacteristics | The ferroFIBRE stainless steel suture is the same suture as was cleared under K081060. This submission includes the same crimp tool for 2-0, 3-0 and 4-0 as was cleared in K101126. A larger crimp tool will be used with the ferroFibreTM stainless steel sutures from 0 to size 3. The indications for use are the same as K081060.As for the crimps, each suture size and number of suture strands, 4 or 8, will require a different crimp size.All biocompatibility testing performed, which was conducted under the predicate submissions K101126 and K081060 remain applicable for this submission as the materials are the same. This indicates that the components are safe for their intended use.The PONTIS ferroFibre with Crimps is a single use, sterile implantable device, sterilized by ethylene oxide. The predicate devices are single use, sterile implantable device, sterilized by gamma irradiation and by ethylene oxide. |
|---|---|
| SubstantialEquivalence | The PONTIS ferroFibre with Crimps are substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicates ferroFibre and Pontis Suture and Suture Anchors with Crimps. The risk analysis performed, raised no new issues of safety or effectiveness.The use of the crimp was cleared under the Pontis submission K101126, for size 3-0 to and 4-0 ferroFibreTM. This submission expands the use of a crimp with the ferroFibreTM suture for the indications cleared under K081060. |
| Nonclinical TestsPerformed | The verification and validation testing of the Pontis ferroFibre with Crimps includes knot failure force, crimp failure force and cyclic loading. |
| Conclusions Drawn | Non-clinical tests conducted demonstrates that the proposed device is safe, effective, and performs as well as the predicate devices, therefore demonstrating substantial equivalence. |
and the state of the same
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Flampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2014
PONTiS Orthopacdics. LILC Mr. Leonard Gordon President 2299 Post Street San Francisco. California 94115
Re: K140127
Trade/Device Name: ferroFIBRE Stainless Steel Suture with Crimp Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless Steel Suture Regulatory Class: Class II Product Code: GAQ Dated: April 22, 2014 Received: April 28, 2014
Dear Mr. Gordon.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Leonard Gordon
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 contact the Division of Industry and Consumer Education 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" (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/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 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 yours.
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for
Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510 (K) Number (if Known): K140127
Manufacturer: PONTiS Orthopaedics, LLC
Device Name; ferroFIBRE™ Stainless Steel Suture with Crimp
ferroFIBRE™ Stainless Steel Suture are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
Prescription Use XX (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Exemption (ODE)
Peter L. Hudson -S
§ 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.